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Randomized, Multicenter, Phase III Trial of Heptaplatin 1-hour Infusion and 5-Fluorouracil Combination Chemotherapy Comparing with Cisplatin and 5-Fluorouracil Combination Chemotherapy in Patients with Advanced Gastric Cancer
Kyung Hee Lee, Myung Soo Hyun, Hoon-Kyo Kim, Hyung Min Jin, Jinmo Yang, Hong Suk Song, Young Rok Do, Hun Mo Ryoo, Joo Seop Chung, Dae Young Zang, Ho-Yeong Lim, Jong Youl Jin, Chang Yeol Yim, Hee Sook Park, Jun Suk Kim, Chang Hak Sohn, Soon Nam Lee
Cancer Res Treat. 2009;41(1):12-18.   Published online March 31, 2009
DOI: https://doi.org/10.4143/crt.2009.41.1.12
AbstractAbstract PDFPubReaderePub
Purpose

Heptaplatin (Sunpla) is a cisplatin derivative. A phase IIb trial using heptaplatin resulted in a 34% response rate with mild nephrotoxicity. We conducted a randomized phase III trial of heptaplatin plus 5-FU compared with cisplatin plus 5-FU in patients with advanced gastric cancer.

Materials and Methods

One hundred seventy-four patients (heptaplatin, n=88; cisplatin, n=86) from 13 centers were enrolled. The eligibility criteria were as follows: patients with pathologically-proven adenocarcinoma, chemonaive patients, or patients who had received only single adjuvant chemotherapy, and who had a measurable or evaluable lesion. On day 1, heptaplatin (400 mg/m2) or cisplatin (60 mg/m2) was given over 1 hour with 5-FU (1 gm/m2) on days 1~5 every 4 weeks.

Results

At the time of survival analysis, the median overall survival was 7.3 months in the 5-FU + heptaplatin (FH) arm and 7.9 months in the 5-FU + cisplatin (FP) arm (p=0.24). Of the FH patients, 34.2% (complete response [CR], 1.3%; partial response [PR], 32.9%) experienced a confirmed objective response compared with 35.9% (CR 0%, PR 35.9%) of FP patients (p=0.78). The median-time-to-progression was 2.5 months in the FH arm and 2.3 months in the FP arm. The incidence of neutropenia was higher with FP (28%) than with FH (16%; p=0.06); grade 3~4 nausea and vomiting were more frequent in the FP than in the FH arm (p=0.01 and p=0.05, respectively). The incidence of increased proteinuria and creatininemia was higher with FH than with FP; however, there was no statistical difference. There were no treatment-related deaths.

Conclusion

Heptaplatin showed similar effects to cisplatin when combined with 5-FU in advanced gastric cancer patients with tolerable toxicities.

Citations

Citations to this article as recorded by  
  • The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
    Bum Jun Kim, Chi Hoon Maeng, Bhumsuk Keam, Young-Hyuck Im, Jungsil Ro, Kyung Hae Jung, Seock-Ah Im, Tae Won Kim, Jae Lyun Lee, Dae Seog Heo, Sang-We Kim, Keunchil Park, Myung-Ju Ahn, Byoung Chul Cho, Hoon-Kyo Kim, Yoon-Koo Kang, Jae Yong Cho, Hwan Jung Yu
    Cancer Research and Treatment.2025; 57(1): 39.     CrossRef
  • Quantum mechanical approaches and molecular docking analysis of platinum metal-based anticancer drugs Lobaplatin and Heptaplatin targeting cancer DNA - a comparative analysis
    Madhavi Sahadevan, Mullainathan Sundaram, Karunagaran Subramanian
    Chemical Physics Letters.2024; 842: 141191.     CrossRef
  • Cisplatin Resistance in Cancer Therapy: Causes and Overcoming Strategies
    S. Shruthi, K. Bhasker Shenoy
    ChemistrySelect.2024;[Epub]     CrossRef
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    Giulia Ferrari, Ines Lopez-Martinez, Thomas Wanek, Claudia Kuntner, Diego Montagner
    Molecules.2024; 29(15): 3453.     CrossRef
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    Vinay K. Sharma, Yehuda G. Assaraf, Zeev Gross
    Drug Resistance Updates.2023; : 100931.     CrossRef
  • Application of Approved Cisplatin Derivatives in Combination Therapy against Different Cancer Diseases
    Dobrina Tsvetkova, Stefka Ivanova
    Molecules.2022; 27(8): 2466.     CrossRef
  • Second and third-row transition metal compounds containing benzimidazole ligands: An overview of their anticancer and antitumour activity
    Galdina V. Suárez-Moreno, Delia Hernández-Romero, Óscar García-Barradas, Óscar Vázquez-Vera, Sharon Rosete-Luna, Carlos A. Cruz-Cruz, Aracely López-Monteon, Jesús Carrillo-Ahumada, David Morales-Morales, Raúl Colorado-Peralta
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  • Metalofármacos en la terapia contra el cáncer
    Elizabeth Márquez López, Esmeralda Sánchez Pavón, Rodolfo Peña Rodríguez, Delia Hernández Romero, José M. Rivera Villanueva, Raúl Colorado Peralta, David Morales Morales
    TECNOCIENCIA Chihuahua.2022; 16(3): e1010.     CrossRef
  • Platinum(IV) anticancer agents; are we en route to the holy grail or to a dead end?
    Dan Gibson
    Journal of Inorganic Biochemistry.2021; 217: 111353.     CrossRef
  • Monofunctional Platinum(II) Anticancer Agents
    Suxing Jin, Yan Guo, Zijian Guo, Xiaoyong Wang
    Pharmaceuticals.2021; 14(2): 133.     CrossRef
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    Daniil Spector, Olga Krasnovskaya, Kirill Pavlov, Alexander Erofeev, Peter Gorelkin, Elena Beloglazkina, Alexander Majouga
    International Journal of Molecular Sciences.2021; 22(8): 3817.     CrossRef
  • Multi-action Pt(IV) anticancer agents; do we understand how they work?
    Dan Gibson
    Journal of Inorganic Biochemistry.2019; 191: 77.     CrossRef
  • TOXview: a novel graphical presentation of cancer treatment toxicity profiles
    Lok Lam Ngai, Emil ter Veer, Héctor G. van den Boorn, E. Hugo van Herk, Jessy Joy van Kleef, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
    Acta Oncologica.2019; 58(8): 1138.     CrossRef
  • Photoactivated platinum-based anticancer drugs
    Muhammad Imran, Wagma Ayub, Ian S. Butler, Zia-ur-Rehman
    Coordination Chemistry Reviews.2018; 376: 405.     CrossRef
  • Survival impact of post-progression chemotherapy in advanced gastric cancer: systematic review and meta-analysis
    Sakura Iizumi, Atsuo Takashima, Kentaro Sakamaki, Satoshi Morita, Narikazu Boku
    Cancer Chemotherapy and Pharmacology.2018; 81(6): 981.     CrossRef
  • An Analytics Approach to Designing Combination Chemotherapy Regimens for Cancer
    Dimitris Bertsimas, Allison O’Hair, Stephen Relyea, John Silberholz
    Management Science.2016; 62(5): 1511.     CrossRef
  • Platinum(iv) anticancer prodrugs – hypotheses and facts
    Dan Gibson
    Dalton Transactions.2016; 45(33): 12983.     CrossRef
  • Platinum(II) carboxylato complexes containing 7-azaindoles as N-donor carrier ligands showed cytotoxicity against cancer cell lines
    Pavel Štarha, Zdeněk Trávníček, Lucia Pazderová, Zdeněk Dvořák
    Journal of Inorganic Biochemistry.2016; 162: 109.     CrossRef
  • VEGF- and VEGFR2-Targeted Liposomes for Cisplatin Delivery to Glioma Cells
    Sergey A. Shein, Ilya I. Kuznetsov, Tatiana O. Abakumova, Pavel S. Chelushkin, Pavel A. Melnikov, Anna A. Korchagina, Dmitry A. Bychkov, Irina F. Seregina, Mikhail A. Bolshov, Alexander V. Kabanov, Vladimir P. Chekhonin, Natalia V. Nukolova
    Molecular Pharmaceutics.2016; 13(11): 3712.     CrossRef
  • Condensations of single DNA molecules induced by heptaplatin and its chiral isomer
    Hong-Yan Zhang, Yu-Ru Liu, Wei Li, Hui Li, Shuo-Xing Dou, Ping Xie, Wei-Chi Wang, Peng-Ye Wang
    AIP Advances.2014;[Epub]     CrossRef
  • Nanocarriers for delivery of platinum anticancer drugs
    Hardeep S. Oberoi, Natalia V. Nukolova, Alexander V. Kabanov, Tatiana K. Bronich
    Advanced Drug Delivery Reviews.2013; 65(13-14): 1667.     CrossRef
  • Progression-free survival and time to progression as surrogate markers of overall survival in patients with advanced gastric cancer: analysis of 36 randomized trials
    Kohei Shitara, Junko Ikeda, Tomoya Yokota, Daisuke Takahari, Takashi Ura, Kei Muro, Keitaro Matsuo
    Investigational New Drugs.2012; 30(3): 1224.     CrossRef
  • Cellular interactions of platinum drugs
    Ezequiel Wexselblatt, Eylon Yavin, Dan Gibson
    Inorganica Chimica Acta.2012; 393: 75.     CrossRef
  • What do we know about the reduction of Pt(IV) pro-drugs?
    Ezequiel Wexselblatt, Dan Gibson
    Journal of Inorganic Biochemistry.2012; 117: 220.     CrossRef
  • Prospective, randomized trial comparing 5-FU/LV with or without oxaliplatin as adjuvant treatment following curative resection of gastric adenocarcinoma
    X.-L. Zhang, H.-J. Shi, S.-Z. Cui, Y.-Q. Tang, M.-C. Ba
    European Journal of Surgical Oncology (EJSO).2011; 37(6): 466.     CrossRef
  • The status of platinum anticancer drugs in the clinic and in clinical trials
    Nial J. Wheate, Shonagh Walker, Gemma E. Craig, Rabbab Oun
    Dalton Transactions.2010; 39(35): 8113.     CrossRef
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The Efficacy of an Induction Chemotherapy Combination with Docetaxel, Cisplatin, and 5-FU Followed by Concurrent Chemoradiotherapy in Advanced Head and Neck Cancer
Jae-Sook Ahn, Sang-Hee Cho, Ok-Ki Kim, Joon-Kyoo Lee, Deok-Hwan Yang, Yeo-Kyeoung Kim, Je-Jung Lee, Sang-Chul Lim, Hyeoung-Joon Kim, Woong-Ki Chung, Ik-Joo Chung
Cancer Res Treat. 2007;39(3):93-98.   Published online September 30, 2007
DOI: https://doi.org/10.4143/crt.2007.39.3.93
AbstractAbstract PDFPubReaderePub
Purpose

This study was performed to determine the feasibility and safety of the use of induction chemotherapy combined with docetaxel, cisplatin, and 5-fluorouracil (TPF) followed by concurrent chemoradiation therapy for locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Materials and Methods

The patients, that were initially not treated for locally advanced SCCHN, underwent three cycles of induction chemotherapy every 3 weeks at a dose of 70 mg/m2 docetaxel D1, 75 mg/m2 cisplatin D1, 1000 mg/m2 5-FU D1-4, and subsequently received concurrent chemoradiation therapy.

Results

Forty-nine patients were enrolled in this study and forty-three of the patients completed the treatment. The median duration of follow-up was 18 months (range, 6~39 months). All of the patients had stage III (26.5%) or IV (73.5%) squamous cell carcinoma. After sequential therapy, a complete response and partial response was seen in 28 (65.2%) and 13 (30.2%) patients, respectively. The overall response rate was 95.4%. Overall survival and progression-free survival (PFS) at 2 years were 88.7% and 69.7%, respectively. Grade 3~4 neutropenia occurred in 42.2% of the patients and grade 4 thrombocytopenia in 1 cycle (0.7%). Two patients (4.1%) died during the induction chemotherapy due to pneumonia and a subdural hemorrhage, respectively. The group of patients over 65 years of age showed a significant lower dose intensity than that of patients under 65 years of age, but PFS was not significantly different between two groups (p=0.105).

Conclusion

TPF induction chemotherapy followed by concurrent chemoradiotherapy showed a high level of CR and moderate treatment-induced toxicity. Adequate dose modification in elderly patients should be considered to maintain efficacy and avoid treatment-related toxicity.

Citations

Citations to this article as recorded by  
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    Yungan TAO, Xu-Shan Sun, Yoann Pointreau, Christophe Le Tourneau, Christian Sire, Marie-Christine Kaminsky, Alexandre Coutte, Marc Alfonsi, Benôit Calderon, Pierre Boisselier, Laurent Martin, Jessica Miroir, Jean-Francois Ramee, Jean-Pierre Delord, Floria
    European Journal of Cancer.2023; 183: 24.     CrossRef
  • Serum Levels of Stromal Cell-Derived Factor-1α and Vascular Endothelial Growth Factor Predict Clinical Outcomes in Head and Neck Squamous Cell Carcinoma Patients Receiving TPF Induction Chemotherapy
    Yen-Hao Chen, Chih-Yen Chien, Yu-Ming Wang, Shau-Hsuan Li
    Biomedicines.2022; 10(4): 803.     CrossRef
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    Ching-Yun Hsieh, Ming-Yuh Lein, Shih-Neng Yang, Yao-Ching Wang, Yin-Jun Lin, Chen-Yuan Lin, Chun-Hung Hua, Ming-Hsul Tsai, Ching-Chan Lin
    BMC Cancer.2020;[Epub]     CrossRef
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Combination Chemotherapy of Heptaplatin, Paclitaxel and 5-Fluorouracil in Patients with Advanced Gastric Cancer: a Pilot Study
Myung-Ju Ahn, Ho-Suck Oh, Jung-Hye Choi, Young-Yeul Lee, In-Soon Kim, Il-Young Choi, Oh Young Lee, Ho-Soon Choi, Sung-Joon Kwon
Cancer Res Treat. 2004;36(3):182-186.   Published online June 30, 2004
DOI: https://doi.org/10.4143/crt.2004.36.3.182
AbstractAbstract PDFPubReaderePub
Purpose

To evaluate the efficacy and toxicity of heptaplatin, paclitaxel, and 5-fluorouracil combination chemotherapy in patients with advanced gastric cancer.

Materials and Methods

Between July 2002 and September 2003, nineteen patients were enrolled in this study. Paclitaxel 135 mg/m2 iv on day 1, heptaplatin 400 mg/m2 iv on day 2 and 5-fluorouracil 800 mg/m2 on day 2~4 were administered and the regimen was repeated every 3 weeks.

Results

The median age of the patients was 60 years (range: 32~74) and the most common sites of metastasis were liver and lymph nodes. In the 16 evaluated patients, the overall response rate was 43.8%, but this was without any complete response. The median time to disease progression was 3.93 months (range: 0.26~8.1) and the median response duration for the 7 responding patients was 3.83 months (range: 1.48~6.07). The median overall survival for 19 patients was 7.01 months (range: 0.26~17.44). A median of 3 cycles (range: 1~7) and a total of 65 cycles were administered and evaluated for toxicity. The most common hematologic toxicities were NCI grade I/II anemia (47.7%), neutropenia (9.2%) and thrombocytopenia (6.2%). The most common non-hematologic toxicities more than grade II were nausea/vomiting (30.8%/9.2%). One elderly patient with ECOG 2 had a life-threatening complication of pneumonia.

Conclusion

The combination of heptaplatin, paclitaxel, and 5-fluorouracil showed significant activity and favorable toxicity profiles in patients with advanced gastric cancer. However, one elderly patient who had poor performance experienced a life-threatening toxicity/complication. Our results suggest that the efficacy of this combination chemotherapy can be maximized when administered to the patients with good performance status. Further studies with large numbers of patients and long-term follow-up study will be needed.

Citations

Citations to this article as recorded by  
  • Application of Approved Cisplatin Derivatives in Combination Therapy against Different Cancer Diseases
    Dobrina Tsvetkova, Stefka Ivanova
    Molecules.2022; 27(8): 2466.     CrossRef
  • Synthesis of novel heptaplatin derivatives and evaluation of their ability to inhibit proliferation of cancer cell lines
    W. Xu, D. C. Wang
    Russian Journal of General Chemistry.2016; 86(4): 939.     CrossRef
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  • 2 Crossref
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Effect of Combination Chemotherapy with Docetaxel Plus Cisplatin in Patients with Advanced Non-Small Cell Lung Cancer
Hee Jung Kang, Min Kyoung Kim, Young Gil Kim, Jae Lyun Lee, Kyung Hee Lee, Myung Soo Hyun, Sung Hwa Bae, Hun Mo Ryoo
Cancer Res Treat. 2003;35(4):299-303.   Published online August 31, 2003
DOI: https://doi.org/10.4143/crt.2003.35.4.299
AbstractAbstract PDF
PURPOSE
This study was conducted to evaluate the efficacy and safety of combination chemotherapy, with docetaxel and cisplatin, as a first line treatment for advanced non-small cell lung cancer.
MATERIALS AND METHODS
Between March 1998 and December 2001, 35 patients with advanced non-small cell lung cancer were enrolled in this study. The patients were treated at 3-week intervals, with one course of a regimen consisting of docetaxel (75 mg/m2 IV for 1 hours) on day 1 and cisplatin (60 mg/m2 IV) on day 2.
RESULTS
The median age of the patients was 60.3 years. Of the 35 patients, 20 and 15 had stage IIIb and stage IV diseases, respectively. A complete response was observed in 1 patient and partial response in 15, with an overall response rate of 46%. The overall median survival duration was 40.3+/-25.2 weeks. The median time to progression and response duration were 21.6+/-5.5 and 15.1+/-5.9 weeks, respectively. The survival duration was statistically significantly longer in the response group (50.6 weeks) than in the non-response group (31.6 weeks) (p<0.05). Of the hematological side effects, grades III and IV leukopenia were observed in 4.8% of patients. Grades III and IV nausea and vomiting were observed in 48.5%, and grades I and II neuropathy in 11.4% of the treated patients. These toxicities were well tolerable and reversible. There were no hypersensitivity reactions.
CONCLUSION
Docetaxel and cisplatin combination chemotherapy is relatively effective and safe in advanced non-small cell lung cancer patients.
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Infusional 5-Fluorouracil, Leucovorin and Docetaxel in Advanced Gastric Cancer
Yong Tai Kim, Joo Hyuk Sohn, So Hun Kim, Sun Young Rha, Chul Kim, Jae Kyung Roh, Byung Soo Kim, Woo Ick Jang, Hyun Cheol Chung
Cancer Res Treat. 2003;35(2):123-129.   Published online April 30, 2003
DOI: https://doi.org/10.4143/crt.2003.35.2.123
AbstractAbstract PDF
PURPOSE
This study was performed to estimate the response rate and toxicity of a combination chemotherapy, which included infusional 5-Fluorouracil, Leucovorin and Docetaxel in the treatment of patients with an advanced gastric carcinoma. MATERIALS AND METHODS: Twenty two advanced gastric cancer patients, with a bidimensionally measurable or an evaluable disease, were enrolled in this study. The patients received a 5-fluorouracil 1, 000 mg/m2 intravenous (IV) 24 hour infusion (Day 1~3), leucovorin 20 mg/m2 (Day 1~3) and docetaxel 75 mg/m2 intravenously (Day 2) every 3 weeks. RESULTS: The overall response rate was 45.0%. The median duration of response was 10.0 weeks (range: 4~24), the median time to response was 8 weeks (range: 8~20) the median time to progression was 30.0 weeks (95% CI: 16.3~43.2) and the median overall survival duration was 36.0 weeks (95% CI: 1.7~70.2). The median cumulative dose of 5-fluorouracil were 316.2 mg/m2/week and docetaxel was 23.9 mg/m2/week. WHO grade III, IV neutropenia, thromocytopenia and anemia occurred in 50.0%, 4.5% and 4.5% of patients, respectively. There were no occurrence of WHO grade III and IV nausea, vomiting, mucositis, conspitation, diarrhea, or neurotoxicity. CONCLUSION: This chemotherapy regimen, including infusional 5-fluorouracil, leucovorin and docetaxel was an active agent against advanced gastric cancer patients, especially for previous chemotherapy naive patients.

Citations

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  • The Efficacy of Docetaxel and Cisplatin Combination Chemotherapy for the Treatment of Advanced Gastric Cancer after Failing to 5-Fluorouracil Based Chemotherapy
    Sang-Joon Shin, Min-Kyoung Kim, Kyung-Hee Lee, Myung-Soo Hyun, Sang Woon Kim, Sun Kyo Song, Sung-Hwa Bae, Hun-Mo Ryoo
    Cancer Research and Treatment.2004; 36(6): 367.     CrossRef
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Effect of Vinorelbine, Ifosfamide and Cisplatin Combination Chemotherapy in Stage III-IV Non-Small-Cell Lung Cancer
Young Chul Kim, So Young Lee, Hong Joo Cho, Jung A Kim, So Hyang Song, Chi Hong Kim, Hoon Kyo Kim, Meyung Im Ahn, Jin Young You, Sung Whan Kim, Deng Gon Cho, Kyu Do Cho, Jin Hyung Kang
Cancer Res Treat. 2002;34(5):352-356.   Published online October 31, 2002
DOI: https://doi.org/10.4143/crt.2002.34.5.352
AbstractAbstract PDF
PURPOSE
To evaluate the response rates, toxicitiesy, and survival rates, to vinorelbine (Navelbine(R)), cisplatin and ifosfamide combination chemotherapy, of the patients with inoperable NSCLC (stage III and IV), who received vinorelbine (Navelbine(R)), cisplatin, ifosfamide combinationthe mentioned chemotherapy every 4 weeks.
MATERIALS AND METHODS
This study included 26 patients with inoperable NSCLC (stage III and IV), who attended St. Vincent's Hospital Bbetween April 1999 and December 2001, 26 patients were included at St.Vincent's Hospital. The chemotherapy regimen consisted of vinorelbine (25 mg/m2 on days 1 and 8), ifosfamide (1,500 mg/m2 on days 1- and 2 with mesna), and cisplatin (30 mg/m2 on days 1- to 3). The cycles were administered every 4 weeks. A 25% reduction in the doses reduction was applied into subsequent courses if there werewas grade 3~4 neutropenia.
RESULTS
The median age was 63 (range, 44~73) years and the male : to female ratio was 19 : 7. One patient had stage IIIa, 6 had stage IIIb and 19 had stage IV. Twenty two patients had an ECOG performance status of 0 or 1, andwith 4 hadhave one of 2. Eighteen of the patients had adenocarcinoma, 7 had squamous cell carcinomas, and 1 had an undifferentiated NSCLC. Two patients were innot able to be evaluatedble due to follow-up loss. Among Of the 24 patients able to be evaluatedble patients, 1 patient had a complete response and 9 patients hada partial responses, and thewith an overall response rate wasof 41.7%. During a total of 104 cycles, grade 3 neutropenia occurred in 29%, grade 4 neutropenia in 12%, grade 3~4 thrombocytopenia in 4%, grade 3 anemia in 11%, and grade 3~4 mucositis in 2%. The mean time to progression was 6.4 months (range 1~13) and the median overall survival was 10 months (range 1.5~32).
CONCLUSION
The combination of vinorelbine, ifosfamide and cisplatin, in the dose and schedule employed in this study, shows an response rate of 41.7%, but, because grade 3- or 4 neutropenia occurred in 41%, a careful investigation is needed.
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Phase II Study of Topotecan and Etoposide as Second-line Treatment in Chemotherapy-refractory Small-cell Lung Cancer
Chul Kim, Joo Hyuk Sohn, Joo Hang Kim, Se Kyu Kim, Young Sam Kim, Joon Chang, Jae Yong Cho
Cancer Res Treat. 2002;34(5):334-338.   Published online October 31, 2002
DOI: https://doi.org/10.4143/crt.2002.34.5.334
AbstractAbstract PDF
PURPOSE
Refractory small-cell lung cancer (SCLC) has a poor prognosis, and current salvage chemotherapy for refractory SCLC, such as CAV (cyclophosphamide, adriamycin, vincristine) or topotecan, has an unsatisfactory outcome, with a response rate and overall survival of less than 10% and 6 months, respectively. This phase II study evaluated the role of topotecan combined with etoposide in SCLC patients that have progressed, or relapsed, within 3 months following completion of the initial chemotherapy.
MATERIALS AND METHODS
Twenty-seven patients were entered into this study. Eligible patients had an ECOG performance status of less than, or equal to, 2, at least one bidimensionally measurable lesion and adequate end organ function. IV topotecan, 1.0 mg/m2/d for 5 consecutive days, and etoposide, 100 mg/m2/d through days 1 to 3, were administered every 3 weeks until disease progression or undue toxicity.
RESULTS
The major toxicity was myelosuppression. Grade 3/4 anemia, granulocytopenia, and thrombocy-topenia occurred in 14.2, 34.8, and 27.3% of cycles, respectively. There was no treatment-related death, and other non-hematologic toxicities were generally mild. Four patients achieved partial responses, with a response rate RR of 14.8%. The progression-free survival PFS ranged from 1 to 7 months, with a median of 2.0 months (95% confidence interval 1.22~2.78 months). Twenty-five patients died, with a median overall survival of 5.5 months (ranging from 1 to 21 months, 95% CI 4.32~6.68 months), and the 6-month survival rate was 32.1% (95% confidence interval 14.4~49.8%).
CONCLUSION
The combination of topotecan and etoposide chemotherapy showed a modest response rate, but failed to prolong survival of refractory SCLC patients compared to topotecan monotherapy.

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  • Real-World Outcomes with Lurbinectedin in Second Line and Beyond for Extensive Stage Small Cell Lung Cancer in Korea
    Joo Sung Shim, Youhyun Kim, Taeho Yuh, Jii Bum Lee, Hye Ryun Kim, Min Hee Hong, Byoung Chul Cho, Sun Min Lim
    Lung Cancer: Targets and Therapy.2024; Volume 15: 149.     CrossRef
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A Phase II Study of Oxaliplatin Combined with 5-Fluorouracil and Leucovorin (Mayo Clinic Regimen) in 5-Fluorouracil Refractory Colorectal Cancer
Yee Zee Bae, Jae Hyuk Jung, Chang Hoon Moon, Seong Hyun Kim, Hyuk Chan Kwon, Jae Seok Kim, Hyo Jin Kim
Cancer Res Treat. 2002;34(3):218-222.   Published online June 30, 2002
DOI: https://doi.org/10.4143/crt.2002.34.3.218
AbstractAbstract PDF
PURPOSE
There are few therapeutic options in patients with colorectal cancer that have progressed or recurred following 5-fluorouracil (5-FU) based therapy. We evaluated the efficacy and toxicity of oxaliplatin, 5-FU, leucovorin (Mayo clinic regimen) in 5-FU pretreated advanced colorectal cancer patients. MATERIALS AND METGODS: Twenty-eight patients were enrolled in this study between January 1999 and May 2001. Patients were treated with oxaliplatin 150 mg/m2 on day 1 as a 2-hr infusion and 5-FU 425 mg/m2, leucovorin 20 mg/m2, bolus for 5 days. Treatment courses were repeated in 4-week intervals.
RESULTS
The objective response rate was 25% for 28 assessable patients, all cases registered a partial response. Eleven patients (39%) demonstrated stable disease, and ten (36%) progressed. The median response duration was 5.5 months, and the median time to progression was 6.3 months. The median overall survival time was 13.5 months from the start of the chemotherapy. From the 120 cycles analyzed, grade 3,4 hematologic toxicities included neutropenia: 1.6%, and thrombocytopenia: 1.6%. The frequent grade 3.4 non-hematologic adverse reactions were nausea/vomiting (25.0%), diarrhea (14.3%), stomititis (3.6%), and neuropathy (3.6%). There were no treatment-related deaths.
CONCLUSION
This phase II study had relatively higher toxicity than previous studies, and did not show an increased significant response rate. These high levels of toxicity suggest that the study treatment combination of oxaliplatin with a full dose Mayo clinic regimen arm is no feasible. Therefore, this regimen will be discontinued and a safer regimen will be adopted.

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  • Effect of Betulinic Acid on Anticancer Drug‐Resistant Colon Cancer Cells
    Gwon‐Ryul Jung, Kyung‐Jong Kim, Cheol‐Hee Choi, Tae‐Beum Lee, Song Iy Han, Hyo‐Kyung Han, Sung‐Chul Lim
    Basic & Clinical Pharmacology & Toxicology.2007; 101(4): 277.     CrossRef
  • Oxaliplatin/5-FU without Leucovorin Chemotherapy in Metastatic Colorectal Cancer
    Byoung Yong Shim, Kang Moon Lee, Hyeon-Min Cho, Hyun Jin Kim, Hong Joo Cho, Jinmo Yang, Jun-Gi Kim, Hoon-Kyo Kim
    Cancer Research and Treatment.2005; 37(4): 212.     CrossRef
  • The Efficacy of a Modified Chronomodulated Infusion of Oxaliplatin, 5-Fluorouracil and Leucovorin in Advanced Colorectal Cancer (Preliminary Data)
    Ji Young Park, Si-Young Kim, Jae Jin Lee, Hwi Joong Yoon, Kyung Sam Cho
    Cancer Research and Treatment.2004; 36(3): 199.     CrossRef
  • Oxaliplatin with Biweekly, Low Dose Leucovorin and Bolus and Continuous Infusion 5-fluorouracil (Modified FOLFOX 4) as First-line Therapy for Patients with Metastatic Colorectal Cancer
    Hyuk-Chan Kwon, Kyoung Tae Kim, Shin Ae Lee, Jong-Sung Park, Sung-Hyun Kim, Jae-Seok Kim, Hyo Jin Kim
    Cancer Research and Treatment.2004; 36(2): 115.     CrossRef
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MINE (mesna, ifosfamide, mitoxantrone, etoposide) Chemotherapy as a Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Seong Hoon Chang, Yang Soo Kim, Wan Kyu Eo
Cancer Res Treat. 2002;34(2):145-152.   Published online April 30, 2002
DOI: https://doi.org/10.4143/crt.2002.34.2.145
AbstractAbstract PDF
PURPOSE
The prognosis of non-Hodgkin's lymphoma (NHL) is disappointing for patients who experience primary treatment failure or relapse after an initial response. Patients in relapse may respond again to chemotherapy, however the time to disease progression becomes shorter and eventually the disease becomes resistant. The aim of this study was to evaluate the efficacy and safety of the MINE regimen in the treatment of patients with relapsed or refractory NHL. Material and Methods: Forty-three pretreated patients with a median age of 56 years were enrolled into the study between October 1995 and June 2000. Most patients (60.5%) had a performance status of 0 to 1, and a diffuse large cell subtype (55.8%). Seventy-four percent of patients had stage III or IV disease at the start of MINE treatment. Eighteen (41.9%) patients had complete response, 5 (11.6%) had partial response, and 20 (46.5%) had failed to respond to prior therapy. Ifosfamide 4 g/m2 was divided over 3 days and administered IV over a 1 hour period. Mitoxantrone 8 mg/m2 was administered as a short IV infusion on day 1. Etoposide (65 mg/m2/day) was infused over 1 hour on days 1 to 3. A total of 144 cycles was administered, with a mean of 3.34 cycles per patient (range, 1-8). The mean relative dose intensity was 87.4%.
RESULTS
1) Nine patients achieved a complete response and nine patients achieved a partial response, resulting in an overall response rate of 43.8% of the 41 assessable patients. 2) The median survival time was 6 months (95% CI, 4 to 8 months), and the median time to failure was 5 months (95% CI, 3 to 7 months). 3) A statistically significant association with complete response rates was found for complete response to prior therapy (p=0.049). The significant factors for overall survival were a complete response after MINE chemotherapy and serum 2-microglobulin (p=0.003, p=0.012, respectively). The significant factors for time to treatment failure were a complete response after MINE chemotherapy and serum 2-microglobulin (p=0.003, p=0.044, respectively). 4) The main result of toxicity of MINE was bone marrow suppression.
CONCLUSION
The response to MINE chemotherapy and serum 2-microglobulin were both independent prognostic factors for overall survival and time to treatment failure. As the median time to treatment failure for complete responses was 14 months, the best use of this regimen could be in a strategy that includes prompt consolidation of a complete response with intense chemotherapy, with or without hematopoietic stem cell rescue.

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  • Clinical feasibility of oral low-dose etoposide and sobuzoxane for conventional chemotherapy–intolerant lymphoma patients
    Akihiro Ohmoto, Shigeo Fuji
    Expert Review of Anticancer Therapy.2021; 21(7): 715.     CrossRef
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Phase II Trial of Gemcitabine, UFT-E, Leucovorin Combination Chemotherapy in Advanced Pancreatic Adenocarcinoma
So Young Yoon, Kyong Hwa Park, Sang Chul Oh, Jae Hong Seo, Chul Won Choi, Byung Soo Kim, Jae Seon Kim, Chang Duck Kim, Sang Won Shin, Yeul Hong Kim, Jun Suk Kim
Cancer Res Treat. 2002;34(2):111-116.   Published online April 30, 2002
DOI: https://doi.org/10.4143/crt.2002.34.2.111
AbstractAbstract PDF
PURPOSE
To evaluate the efficacy and toxicity of a Gemcitabine, UFT-E, Leucovorin combination chemotherapy in the treatment of advanced pancreatic adenocarcinoma. PATIENTS AND METHODS: Patients <=70 years, with no prior chemotherapy and with bidimensionally measurable advanced pancreatic adenocarcinoma, ECOG performance status <=2, and adequate bone marrow, kidney, and liver function were eligible for this trial. Eligibility criteria for clinical benefit assessment were pain with at least a daily analgesic consumption of two nonsteroidal anti-inflammatory drugs or a Karnofsky performance status between 50 and 70. Treatment consisted of 1,000 mg/m2 of Gemcitabine on days 1, 8 and 15, repeated every 4 weeks, with UFT-E administered orally 500 mg-700 mg by body surface area (BSA). Leucovorin was administered 45 mg/day orally. Dosages of UFT-E and Leucovorin were divided and administered three times per day from day 1 to day 21. After 7 days of rest, UFT-E and Leucovorin were administered repeatedly.
RESULTS
Twenty-three patients were enrolled between April 1999 to April 2000. Eighty two cycles (median, four cycles) were delivered to all patients. The objective response rate was 15.8% in 19 assessable patients and 13.0% in the intent-to-treat population. Twelve patients (57.9%) displayed stable disease. Grade 3 or 4 neutropenia occurred in 30.4% of patients, nausea/vomiting in 8.3%, diarrhea in 4.3%, and mucositis in 4.3%. The median time to progression was 8 months. The median survival was 8 months in the assessable population and 6 months in the intent-to-treat population Clinical benefit was achieved in 11 (57.9%) of 19 assessable patients.
CONCLUSION
Gemcitabine, UFT-E, Leucovorin combination chemotherapy is a well-tolerated and safe regimen in cases of advanced pancreatic adenocarcinoma. Although the response rate is low, it shows a survival benefit and clinical benefit and deserves further evaluation in a phase III trial.

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  • Gemcitabine and oxaliplatin combination as first-line treatment for advanced pancreatic cancer: a multicenter phase II study
    Kyung Hee Lee, Min Kyoung Kim, Yeol Hong Kim, Baek Yeol Ryoo, Ho Yeong Lim, Hong Suk Song, Hoon Kyo Kim, Myung Ah Lee, Seock Ah Im, Heung Moon Chang, Jae Yong Cho, Dae Young Zang, Bong Seog Kim, Jun Suk Kim
    Cancer Chemotherapy and Pharmacology.2009; 64(2): 317.     CrossRef
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Efficacy of Combination Chemotherapy with Paclitaxel and Cisplatin in Patients with Advanced Non-Small Cell Lung Cancer
Eun Jung Rhee, Hyun Sik Jeong, Seung Sei Lee
Cancer Res Treat. 2002;34(1):28-33.   Published online February 28, 2002
DOI: https://doi.org/10.4143/crt.2002.34.1.28
AbstractAbstract PDF
PURPOSE
To evaluate the efficacy and toxicity of the combination therapy of paclitaxel and cisplatin in advanced, non-small cell, lung cancer patients MATERIALS AND METHODS: Between December 1997 and September 2001, 37 patients with advanced, non-small cell, lung cancer were enrolled in this study. Patients were treated with paclitaxel (135 mg/m2, 24 hr infusion) and cisplatin (75 mg/m2). The treatments were repeated every 4 weeks.
RESULTS
Among the 37 patients enrolled, 21 were treated with paclitaxel and cisplatin as a first-line and 16 patients as a second-line. The median age of the patients was 59. In the first-line group, 10 had stage IIIB and 11 had stage IV, non small cell lung cancer. Of 21 patients in first-line treatment group that could be evaluated, objective responses were observed in 6 patients (response rate: 28.6%, CR: 4.8%, PR: 23.8%). The mediansurvival duration for patients was 48 weeks. With the second-line group, 3 patients showed a partial response (response rate: 18.7%) to treatment, with median survival duration of 44 weeks. Grade 3-4 leukopenia was observed in 27.1% of the first-line, and 23.6% in second- line, treatment groups.
CONCLUSION
Combination chemotherapy, with paclitaxel and cisplatin, in non-small cell lung cancer has acceptable toxicities in both first and second-line treatment groups. In terms of efficacy, no superior response was shown for either group. More randomized studies, with a larger group of patients, are required to prove the true efficacy.

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  • Co-delivery of paclitaxel and cisplatin in poly(2-oxazoline) polymeric micelles: Implications for drug loading, release, pharmacokinetics and outcome of ovarian and breast cancer treatments
    Xiaomeng Wan, James J. Beaudoin, Natasha Vinod, Yuanzeng Min, Naoki Makita, Herdis Bludau, Rainer Jordan, Andrew Wang, Marina Sokolsky, Alexander V. Kabanov
    Biomaterials.2019; 192: 1.     CrossRef
  • Proximal Gastrectomy Reconstructed by Jejunal Pouch Interposition for Upper Third Gastric Cancer: Prospective Randomized Study
    Chang Hak Yoo, Byung Ho Sohn, Won Kon Han, Won Kil Pae
    World Journal of Surgery.2005; 29(12): 1592.     CrossRef
  • Long-term Results of Proximal and Total Gastrectomy for Adenocarcinoma of the Upper Third of the Stomach
    Chang Hak Yoo, Byung Ho Sohn, Won Kon Han, Won Kil Pae
    Cancer Research and Treatment.2004; 36(1): 50.     CrossRef
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A Phase II Study with Gemcitabine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer
Jae Wan Park, Hwan Yang Park, Yong Bae Park, Jung Won Kang, Sung Hung Kim, Gwi Lae Lee, Bong Seog Kim, Yong Ho Roh
Cancer Res Treat. 2002;34(1):23-27.   Published online February 28, 2002
DOI: https://doi.org/10.4143/crt.2002.34.1.23
AbstractAbstract PDF
PURPOSE
To evaluate the efficacy and safety of gemcitabine and carboplatin (GC) in the treatment of advanced non-small-cell lung cancer (NSCLC).
MATERIALS AND METHODS
Between November 1999 and April 2001, 34 patients were enrolled in this study. The median age was 66 (range: 52-74) years old and all were male. Sixteen patients demonstrated stage IIIB, 15 stage IV, and 3 recurrence of disease after surgery. Twenty-two patients showed a ECOG performance status of 0 or 1 and 12 had 2. Twenty patients presented with squamous cell carcinoma, 11 adenocarcinoma and 3 unclassified NSCLC. The treatment regimen consisted of intravenous carboplatin AUC of 6 on day 1 and gemcitabine 1,250 mg/m2 on day 1 and 8. The treatment was repeated every 28 days. Toxicities were evaluated according to WHO toxicity criteria.
RESULTS
All thirty-four patients were evaluable. Partia responses were observed in 15 patients. The overall response rate was 44% (95% confidence interval: 27-61%) and the median response duration was 26 (range 8-60 ) weeks. The median survival of all patients was 50 (range 8-70 ) weeks. During a total of 144 cycles, granulocytopenia greater than WHO grade 2 occurred in 2%, thrombocytopenia in 2%, and anemia in 3%, respectively. Non- hematologic toxicities were minor and easily controlled.
CONCLUSION
A combination chemotherapy of intravenous gemcitabine and carboplatin has a relatively high activity with acceptable toxicities in patients with advanced NSCLC.

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  • A Phase II Study of Single-Agent Gemcitabine as a Second-Line Treatment in Advanced Non-Small Cell Lung Cancer
    Keun-Hyok Cho, Young-Bong Song, Ik-Sung Choi, Eun-Hee Cho, Jae-Won Choi, Young Mi Ahn, Yong Ho Roh, Seung-Hyun Nam, Bong-Seog Kim
    Japanese Journal of Clinical Oncology.2006; 36(1): 50.     CrossRef
  • A 21-day Schedule of Gemcitabine and Cisplatin Administration in the Treatment of Advanced Non-Small Cell Lung Carcinoma: a Phase II Study
    Jong-Sung Park, Chang-Min Lee, Shin-Ae Lee, Chang-kil Jung, Sung-Hyun Kim, Hyuk-Chan Kwon, Jae-Seok Kim, Hyo-Jin Kim
    Cancer Research and Treatment.2004; 36(1): 62.     CrossRef
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Combination Chemotherapy of Oxaliplatin, 5-Fluorouracil, and Leucovorin in 5-Fluorouracil-Pretreated Patients with Metastatic Colorectal Cancer
Soo Mee Bang, Eun Kyung Cho, Jae Hwan Oh, Heung Moon Chang, Jin Seok Ahn, Jung Ae Lee, Young Iee Park, Myung Jue Ahn, Young Suk Park, Dong Bok Shin, Jae Hoon Lee
Cancer Res Treat. 2001;33(5):414-419.   Published online October 31, 2001
DOI: https://doi.org/10.4143/crt.2001.33.5.414
AbstractAbstract PDF
PURPOSE
To evaluate the efficacy and toxicity of oxaliplatin in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic colorectal cancer who previously treated with 5-FU-based chemotherapy.
MATERIALS AND METHODS
Between April 1999 and January 2001, thirty-two patients were enrolled in this study. Oxaliplatin 130 mg/m2 was given intravenously (IV) on day 1 as was 5-FU 500 mg/m2 IV followed by continuous infusion of 5-FU 3,000 mg/m2 and LV 100 mg/m2 for 48 hours administered every 3 weeks. Six patients had received 5-FU as an adjuvant setting and 26 patients as a palliative regimen.
RESULTS
The median age of the patients was 50 years (range; 19-69) and the dominant sites of metastasis were the liver, lung or both in 9, 5 and 2 patients respectively. In 30 evaluable patients, the overall response rate was 27% including 1 complete response and 7 partial responses. The median response duration was 28 weeks (95% confidence interval; 22~34 weeks) and the median progression free survival of all patients was 24 weeks (95% confidence interval; 15~33 weeks). A median 5 cycles (range; 2~9) and total 155 cycles were performed in 32 patients. 150 cycles were evaluable for toxicity. The most common hematologic toxicity was grade 1~2 anemia in 78 cycles (52%). Leukopenia (39%) and thrombocytopenia (23%) were fully reversible. The most common non-hematologic toxicity was nausea/vomiting (43/30%) followed by diarrhea (23%), hepatotoxicity (21%) and neurotoxicity (21%). One patient ceased therapy due to grade 4 diarrhea. No other severe toxicity interrupted this treatment.
CONCLUSION
Oxaliplatin, 5-FU and LV in combination showed significant activity in previously treated metastatic colorectal cancer with favorable toxicity.

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  • Oxaliplatin/5-FU without Leucovorin Chemotherapy in Metastatic Colorectal Cancer
    Byoung Yong Shim, Kang Moon Lee, Hyeon-Min Cho, Hyun Jin Kim, Hong Joo Cho, Jinmo Yang, Jun-Gi Kim, Hoon-Kyo Kim
    Cancer Research and Treatment.2005; 37(4): 212.     CrossRef
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Combination Chemotherapy with Mitomycin C, Vinorelbine, and Cisplatin (MVrP) in Patients with Advanced Non-Small Cell Lung Cancer
Hun Gu Kim, Gyeong Won Lee, Dae Hwan Lee, In Gyu Hwang, Ki Shik Shim, Won Sup Lee, Jong Deog Lee, Joung Soon Jang, Young Sil Hwang, Jong Seok Lee
Cancer Res Treat. 2001;33(5):377-384.   Published online October 31, 2001
DOI: https://doi.org/10.4143/crt.2001.33.5.377
AbstractAbstract PDF
PURPOSE
A phase II study was conducted in patients with advanced non-small cell lung cancer (NSCLC) in order to evaluate the efficacy and toxicity of the combination chemotherapy regimen of mitomycin C, vinorelbine, and cisplatin (MVrP).
MATERIALS AND METHODS
Between June 1996 and December 2000, fifty-nine patients with unresectable stage IIIB to IV, pathologically documented NSCLC were enrolled in this study. One cycle consisted of mitomycin C 10 mg/m2 i.v. day 1, vinorelbine 30 mg/m2 i.v. days 1 & 15, and cisplatin 80 mg/m2 i.v day 1 and the next cycle consisted of vinorelbine 30 mg/m2 i.v. days 29 & 43, and cisplatin 80 mg/m2 i.v day 29. Each cycle was alternated and treatments were repeated every 8 weeks.
RESULTS
We were able to evaluate fifty-three of 59 patients. Objective responses were seen in 22 (41.5%) patients (CR 0%, PR 41.5%). The median duration of response was 13.7 weeks and the median time to progression was 17.7 weeks. The median overall survival was 45.6 weeks. There was a significantly longer survival seen in responders (p=0.041). The toxicities of this regimen were acceptable without treatment related toxic death.
CONCLUSION
This study suggests that a combination regimen of mitomycin C, vinorelbine, and cisplatin is relatively effective and well tolerated for the treatment of advanced NSCLC.
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Phase II Trial of Vinorelbine and Cisplatin Chemotherapy in Advanced Non-Small Cell Lung Cancer
Yo Han Joh, Tae You Kim, Im Il Na, Do Youn Oh, Byung Su Kim, Jee Hyun Kim, Do Yeun Kim, Se Hoon Lee, Chul Gyu Yoo, Choon Taek Lee, Young Whan Kim, Dae Seog Heo, Yung Jue Bang, Sung Koo Han, Young Soo Shim, Noe Kyeong Kim
Cancer Res Treat. 2001;33(5):373-376.   Published online October 31, 2001
DOI: https://doi.org/10.4143/crt.2001.33.5.373
AbstractAbstract PDF
PURPOSE
Platinum-based chemotherapy has conferred a modest but significant survival benefit and the introduction of newer drugs has led to achieve higher response rate in patients with advanced non-small cell lung cancer (NSCLC). We performed a phase II trial in order to evaluate the efficacy and toxicity of combination chemotherapy with vinorelbine (Navelbine) and cisplatin in advanced NSCLC.
MATERIALS AND METHODS
Patients with previously untreated, unresectable stage IIIB or IV NSCLC with measurable lesion (s) were eligible for entry into the study. NP chemotherapy consisted of intravenous vinorelbine 25 mg/m2, on day 1 and 8, and intravenous cisplatin 80 mg/m2 on day 1; this cycle was repeated every three weeks.
RESULTS
A total of 33 patients were enrolled in the study between July 1999 and Feb 2000. Of the 30 patients deemed eligible for analysis, thirteen patients achieved a partial response and thirteen showed a stable disease. The overall response rate was 43.3%. The median duration of response was 5.7 months (95% CI: 2.8~8.5 months). The median time to progression was 7.6 months (95% CI: 5.5~9.7 months) and the overall median survival time was 15.1 months (95% CI: 9.8~20.4 months) in the intent-to-treat analysis. Chemotherapy-related grade 3 or 4 toxicities were anemia in 1.5%, leukopenia in 4.5%, nausea/vomiting in 2.3%, alopecia in 13.3%, and neurotoxicity in 3.3%.
CONCLUSION
The combination of vinorelbine and cisplatin chemotherapy seems to be active and fairly tolerable in patients with advanced NSCLC.

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  • Clinical research on the efficacy of self-made sichongsan in combination with gefitinib on NSCLC patients with EGFR mutation
    Yibo Zhao, Yu Dong, Shu Xing, Xueqi Fu
    European Journal of Inflammation.2018;[Epub]     CrossRef
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BACOD/EISHAP Alternating Combination Chemotherapy for Intermediate and High Grade Non-Hodgkin's Lymphoma
Jung Hun Kang, Young Ho Park, Soo Jin Kim, Ji Chul Yun, Gyeong Won Lee, Hun Gu Kim, In Gyu Hwang, Won Sup Lee, Joung Soon Jang, Jong Seok Lee
J Korean Cancer Assoc. 2000;32(4):793-800.
AbstractAbstract PDF
PURPOSE
We conducted a phase II study to determine the antitumor activity of BACOD/EISHAP alternating 9-drug chemotherapy in previously untreated patients with intermediate or high grade non-Hodgkin's lymphoma (NHL).
MATERIALS AND METHODS
Intermediate or high grade non-Hodgkin's lymphoma patients were treated with BACOD/EISHAP (bleomycin, doxorubicin, cyclophosphamide, vincristine, dexame thasone/etoposide, ifosfamide, high dose cytarabine, cisplatin, dexamethasone) alternating com bination chemotherapy. Stage I and IIA lymphoma patients were excluded. BACOD/EISHAP alternating chemotherapy was given to the eligible patients every 3 weeks/4 weeks respectively.
RESULTS
Between April, 1995 and December, 1997, among 25 eligible patients, 19 patients were evaluable for response. Six patients could not be evaluated for response because of follow-up loss within 2 cycles of chemotherapy. Complete response (CR) was achieved in 12 patients (63%) after BACOD/EISHAP alternating combination chemotherapy. With a follow-up period of 41 months (25~57 months), the disease free survival did not reach median (4~47 months) and 3-year disease free survival rate was 75%. Major toxicity was marrow suppression and the incidence of severe leukopenia (WBC<2,000/mm3) and thromobocytopenia (<25,000/mm3) were 15%, 5%, respectively. No treatment-related death was observed. For non-hematologic toxicities, nausea and vomiting were observed in 65% of patients, stomatitis in 25%, peripheral neuropathy in 20%.
CONCLUSION
BACOD/EISHAP alternating chemotherapy was feasible with acceptable toxicities. The 63% complete response rate was comparable to other regimens but 75% 3year disease-free survival rate was encouraging. Further evaluation of this regimen is warranted.
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Results of Treatment with ProMACE - CytaBOM Regimen for Aggressive Non - Hodgkins Lymphoma
Wan Kyu Eo
J Korean Cancer Assoc. 2000;32(1):168-177.
AbstractAbstract PDF
PURPOSE
Despite intensive search for the optimal combination chemotherapy for aggres- sive non-Hodgkins lymphoma (NHL), the CHOP regimen is still the standard therapy. We investigated the clinical efficacy of ProMACE-CytaBOM, a third generation regimen, in patients with advanced aggressive NHL.
MATERIALS AND METHODS
We prospectively analyzed the therapeutic approach and the outcome in 33 patients with previously untreated aggressive NHL enrolled into the protocol from June 1994 to June 1997.
RESULTS
Objective response was achieved in 93.9% of the patients. Complete response (CR) and partial response were 54.5% and 39.4%, respectively. The mean time to CR was 75.4 days. CR rate was significantly lower in patients aged 50 years or more (31.3% vs 76.5%, p=0.009). Five year overall (OS) and failure-free survival (FFS) rate were 56.1% and 47.2%, respectively. The age, attainment of CR, and mean relative dose intensity influenced OS significantly (p=0.002, p=0.005 and p=0.039, respectively). The age and attainment of CR influenced FFS significantly (p=0.001 and p=0.003, respec- tively). In patients aged 50 or more, mean relative dose intensity of less than 72% was more frequent than younger age group (73.3% vs 33.3%, p=0.003). There was one toxic death (3.0%).
CONCLUSION
The survival rate of present study was similar to that of previously report concerning ProMACE-CytaBOM. The outcome of elderly NHL patients was poor, and dose intensity may be correlated with the outcome.
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Combination Chemotherapy with VP - 16 , Ifosfamide , and Cisplatin ( VIP ) in the Advanced Non - Small Cell Lung Cancer
Yong Seon Cho, Si Young Kim, Jeong Hee Kim, Hwi Joong Yoon, Kyung Sam Cho
J Korean Cancer Assoc. 2000;32(1):86-92.
AbstractAbstract PDF
PURPOSE
We conducted a phase II study in previously untreated patients with unresectable stage IIIB or IV non-small cell lung cancer to evaluate the response rate and toxicity of the combination chemotherapy regimen of etoposide, ifosfamide and cisplatin. MATERIALS AND METHODS: From September 1993 to December 1996, twenty patients with advanced non-small cell lung cancer (stage IIIB 5 and IV 15) (squamous cell 8, adeno- carcinoma 12), were enrolled in this study. There were 13 (65%) males and 7 (35%) females, and median age of patients were 56 years (range: 34~66). Eighteen patients had performance status (ECOG) 0~1, two patients had performance status 2. Treatment was consisted of cisplatin (20 mg/m2 i.v., day 1~4), VP-16 (etoposide) (75 mg/m2 i.v., day 1~4), ifosfamide (1000 mg/m2 i.v., day 1~4) with mesna. This treatment was repeated every four weeks.
RESULTS
The overall response rate was 25%. Complete response rate was 5% (1/20) and partial response rate was 20% (4/20). The median cycle of response was 4 (2~6) cycles. The median overall survival time was 28 weeks (9~98 weeks). The median time to progression was 10 weeks (3~50 weeks). Toxicities were evaluated by WHO criteria. Toxicity > GradeIII included: leukopenia 1.6%, thrombocytopenia 3.2%, nausea and vomiting 15%, alopecia 30%, stomatitis 10%. These toxicities were tolerable and reversible.
CONCLUSION
VIP regimen was not superior to previous regimens for advanced non-small all lung cancer, and the toxicities were tolerable.
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The Effect of Combination Chemotherapy with Vinorelbine, Carboplatin, and Ifosfamide in Patients with Advanced Non-Small Cell Lung Cancer
Young Woo Lee, Baek Yeol Ryoo, Tae You Kim, Bong Seog Kim, Yeon Hee Park, Hyun Ju Hong, Jin Young Kwag, Sang Won Lee, Yoon Koo Kang
J Korean Cancer Assoc. 1999;31(6):1227-1235.
AbstractAbstract PDF
PURPOSE
Despite recent advances in chemotherapy, the treatment outcome of advanced non-small cell lung cancer (NSCLC) remains poor and NSCLC is still the predominant source of cancer-related mortality in worldwide. Thus, we evaluated the efficacy and safety of a combination chemotherapy with vinorelbine, carboplatin, and ifosfamide (NCI) in advanced NSCLC patients.
MATERIALS AND METHODS
A total of 26 patients was enrolled in this study between December 1997 and June 1998. All entered patients were treated with NCI combination chemotherapy (vinorelbine 25 mg/m2/day i.v. days 1 and 8; carboplatin 300 mg/m2/day i.v. day 1; ifosfamide 3 g/m2/day i.v. day I; and mesna 2.4 g/m2/day i.v. day 1 after completion of ifosfamide infusion, treatment repeated every 4 weeks).
RESULTS
Among 26 patients, 23 patients were evaluable. Nine out of 23 evaluable patients had a partial response (response rate 39%; 95% confidence interval 19~59%). The median survival of the total 23 evaluable patients was 7.4 (range; 3~9.3+) months. The median progression-free survival was 2.8 (range; 0~7.7+) months. Among total 70 cycles of chemotherapy, leukopenia of grade II or more was observed in 6%, and tbrombo- cytopenia of grade II or more in 1%. There was no treatment-related death. Main non-hematologic toxicities were nausea/vomiting, stomatitis and peripheral phlebitis, almost of which were tolerable.
CONCLUSION
NCI chemotherapy seemed to be moderately active and well tolerated in patients with advanced NSCLC.
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5-Fluorouracil, Leucovorin ( FL ) Combination Chemotherapy in Advanced or Recurrent Colo - rectal Cancer
Jeong Hwan Cho, Hyuk Chan Kwon, Hyo Jin Kim
J Korean Cancer Assoc. 1999;31(5):1003-1010.
AbstractAbstract PDF
PURPOSE
We studied the effectiveness and toxicities of 5-fluorouracil+leucovorin, combination chemotherapy in advanced or recurred colo-rectal cancer patients, who didn't have previous chemotherapy and enrolled from August 1993 to July 1998.
MATERIALS AND METHODS
All patients were treated with leucovorin followed by 5-fluorouracil for 5 consecutive days every 4 weeks. Among 43 patients who were enrolled, 40 patients received treatment at least 2 courses, and they were evaluable. Male to female ratio was 21 to 19. In serum CEA level, 27 patients were greater than 5 ng/ml and 13 were less than 5 ng/ml. And primary site was colon in 21 patients and rectum in 19 patients.
RESULTS
The complete response rate was 7,5% and the partial response rate was 25%. The median survival duration was 14.7 months, the median response duration was 16.0 months, and median time to progression was 7.3 months. In the analysis of response, survival duration, time to progression according to various characteristics of patients, serum CEA level and liver involvement were revealed significant difference in survival duration, time to progression (p=0.0122, 00350 & 0.0202, 0.0123) on univariate analysis, but no significant difference on multivariates. Hematologic and non-hematologic toxicities were mild and tolerable.
CONCLUSION
This study indicates that the combination of 5-fluorouracil (370 mg/m) and leucovorin (20 mg/m) is effective and tolerable regimen in advanced or recurred colo-rectal cancer patients without previous chemotherapy.
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Phase 2 Trial of FLP ( 5-FU , Leucovorin , Cisplatin ) Combination Chemotherapy for Advanced Gastric Cancer
Young Iee Park, Moon Hee Lee, Sung Woo Han, Woo Jung Park, Dong Gyu Kim, Jin Lee, Jin Seok Ahn, Jung Ae Rhee, In Sook Woo, Young Suk Park
J Korean Cancer Assoc. 1998;30(1):55-62.
AbstractAbstract PDF
PURPOSE
Advanced gastric cancer, the most common malignancy in Korea is a kind of systemic disease. At dignosis, 50~80% of patients have systemic cancer. Therefore, the most patients require systemic chemotherapy. Cisplatin and 5-FU have been suggested to be active in the treatment of gastric cancer, a high response rate was observered with a combination of 5-FU infusion and cisplatin, and the biochemical modulation of 5-FU by leucovorin has been demonstrated to enhance the activity of 5-FU in gastrointestinal tract cancer.
MATERIALS AND METHODS
The patients with advanced gastric cancer whose disease had relapsed or unresectable were treated with 5-FU(800 mg/m2 12 hr IV infusion, D 1~5), leucovorin(20 mg/m2 IV, D 1~5, max. 30 mg), cisplatin(100 mg/m2 15min IV dripping, D1). The cycles of treatment were repeated at 3-weeks intervals.
RESULTS
Between Sep. 1994 and Aug. 1996, previously untreated 44 patients(39 eligible patients) were admitted to this study, the median age was 55 years(range 17~73) and male to female ratio was 20:19. The rate of complete remission was 5%(2/39), the rate of partial remission was 21%(8/39). The median-response duration was 26 weeks(5+~38+ ). The median-time to progression was 25 weeks(4+~62+). The range of overall survival time was from 4 to 62+ weeks. 24 weeks survival rate was 71.5% but the median survival time was not reached. The leukopenia and anemia were the main hematologic toxicities. Non-hematologic side effects were nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy. These toxicities were observed commnonly, but tolerable. Two treatment-related deaths were associated with sepsis.
CONCLUSION
Based on these results, FLP combination chemotherapy seems to be a moderate efficacy for advanced gastric cancer with tolerable toxicities. To confirm the efficacy further, the long-term follow up and a large scale of clinical studies are needed.
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COPBLAM Combination Chemotherapy in Advanced , Intermediate and High - grade Non - Hodgkin's Lymphomas
Byung Hyun Yoon, Ki Young Kwon, Hong Suck Song
J Korean Cancer Assoc. 1990;22(1):151-162.
AbstractAbstract PDF
Between June 1985 and November 1988, 30 patients with advanced stage, intermediate and high- grade non-Hodgkin's lymphoma were treated with a COPBLAM regimen including cyclophos- phamide, oncovin, prednisolone, bleomycin, adriamycin, procarbazine. Median age was 50.1 years and 10 patients were 60 years or old. 15 patients (50%) achieved a complete response (CR) and 10 patients (30%) had a partial response. Of the 15 CRs, 6 patients (40%) suffered a relapse. 3-year survival was 48.2% and disease-free survival for CRs was 54.5% with a median follow-up of 16.5 months. Constitutional symptoms were negatively associated with response rate and survival but not in disease free survival. Prognostic significance of age, histologic type, stage, and serum LDH were not demonstrated. Overall toxicity was acceptible without any treatment-related deaths. The incidenca of nonfatal infection was 16.7.
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Treatment results of Definitive Radiation Therapy in Esophagaeal Cancer
Kyung Ran Park, Jun Kyu Loh, Chung Sik Rhee
J Korean Cancer Assoc. 1990;22(1):162-171.
AbstractAbstract PDF
A total of 88 patients with epidermoid carcinoma of esophagus treated with definitive radiotherapy at Department of Radiation Oncology. Yonsei University College of Medicine between Jan. 1971 and Dec. 1986 were retrospectivelv analysed. 1) Age distribution of patients was between thirty two and eighty with median age of sixty four and male to female ratio was 12:l. 2) Distributions of esophageal carcinoma were 8% at cervical esophagus, 68. 2% at thoracic upper two third. 22.7% Bt thoracic lower one third and 1.1% at multiple site. 3) Response rates were complete response 26.5%, partial response 67.6% and no response 5.9% 4) Median survival was 12 months, Two year and 5 year actuarial survival rate were 23% and 7% respec ti vely. 5) Median survival and 4 year actuarial survival rate by treatment modality were as follows; radiation therapy alc!ne was 12 months and 12.6% and combined chemo-radiotherapy was 11 months and 7.8%. There was no difference in survival rate between two groups. 6) Patterns of treatment failure were locoregional failure 43.2%, distant failure 21.6% and both locoregional and distant failure 35.2%. 7) Statistically significant prognastic factors were tumar response to radiotherapy (P=0.000) and tumor location (P=0.043), while all others such as age, sex, tumor size, chernotherapy and radiation dose were not important.
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Effects of α-difluormethylornithine ( DFMO ) on Growth Inhibition of Human Gastric and Colorectal Carcinoma Cell Lines
Ho Kyung Chun, Jae Gahb Park, Ee Sook Hwang, Sung Kuk Hong
J Korean Cancer Assoc. 1990;22(1):171-183.
AbstractAbstract PDF
DFMO, an irreversible inhibitor of ornithine decarboxylase, blocks polyamine biosynthesis, is reported to have antitumor effects in vitro at the peak achievable plasma concentration (about 0.5 mM). We determined the effects of DFMO on the growth of gastric and colorectal carcinoma cell lines using the semiautomated tetrazollum MTT assay. At a concentration of 0.5 mM and a 4 day incubation periad, DFMO inhibited the growth of 4 gastric cell lines by a median value of 5% and the growth of 7 colorectal cell lines by a median value of 22%. These effects were reversible by the addition of 0.1 mM of putrescine. Conciusians: 1) at the peak achievable plasma concentration, DFMO has very modest inhibitory effects on the growth of gastrointestinal carcinoma cell lines: and 2) DFMO may have a greater growth inhibitory effect on colorectal than on gastric carcinoma cell lines.
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A Randomized Comparison of EP Sequential Chemotherapy Versus EP / CAV Alternating Chemotherapy for Extencive - stage Small - cell Lung Cancer
Dae Seog Heo, Yung Jue Bang, Noe Kyeong Kim, Young Suk Park, Chang In Suh, Ki Suck Chang
J Korean Cancer Assoc. 1994;26(5):786-793.
AbstractAbstract PDF
The present randomized, prospective study was designed to assess whether alternating etoposide, cisplatin (EP) and cyclophosphamide, adriamycin, vincristine (CAV) is better than etoposide, cisplatin (EP) chemotherapy in improving response, survival and remission duration in 62 evaluable patients having extensive-stage small-cell lung cancer.(SCLC) There were no significant differences in treatment outcome for EP alone, EP/CAV in terms of response rate (65/ versus 75%), complete response rate (9% versus 7%), remission duration (5 months versus 5 months) or median survival (10 months versus 1 l months). Severe myelosuppressian was more common in EPiCAV alternating treatment. The EP/CAV alternating regimen and EP alone regimen can be considered equivalently effective induction therapies in extensive SCLC and these two regimens are, to some degree, cross resistant. Alternating therapy provides no therapeutic advantage with more myelosuppression compared to the EP alone chemotherapy and should not be considered as standard treatment in this clinical setting.
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Leucovorin , 5-Fluorouracil and Cisplatin ( LV - FP ) Chemotherapy for Advanced Colorectal Cancer
Young Jin Yuh, Young Hyuck Im, Yoon Koo Kang, Bong Seog Kim, Hyung Gun Kim, Tae Yong Son, Sang Goo Lee, Eun Mee Cheon, You Cheoul Kim, Chang Min Kim, Weon Seon Hong, Jhin Oh Lee, Tae Woong Kang
J Korean Cancer Assoc. 1995;27(1):44-52.
AbstractAbstract PDF
The biochemical modulation of 5-fluorouracil(5-FU) by leucovorin has been demonstrated to enhance the activity of 5-FU in patients with advanced colorectal cancer and the synergism between 5-FU and cisplatin is well known in advanced gastrointestinal tract cancers. We conducted a phase II trial to evaluate the effect of a combination of leucovorin, 5-FU, and cisplatin(LV-FP) in patients with advanced colorectal cancer. LV-FP regimen consisted of leu- covorin 20 mg/m/day IV in day 1-5, 5-FU 1,000 mg/m/day continuous IV. infusion in day 1-5, and cisplatin 20 mg/m/day IV in day 1-5. The regimen was repeated every 3 weeks. Among 46 patients with histologically confirmed advanced colorectal adenocarcinoma, 31 patients had measurable lesion(s) with median age of 55 years(22-70 years). 27 patients had previous histo- ry of chemotherapy and l9 were previously untreated. There was no complete respanse. 11 patients responded partially to the regimen to make the response rate 35%(l1/31). The median time to progression was 16 weeks (2-44 weeks), and the median survival time was 42 weeks(l+~80 weeks). There was no difference in response rates between the previously treated and the previously untreated. Hematologic toxicities were mild and non-hematologic toxicities were also tolerable. There was no treatment-related mortality. These results indicate that the LV-FP regimen is safe and effective in advanced colorectal adenocarcinoma.
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Alternating Combination Chemotherapy of CAV with EP in Small Cell Lung Gancer and Effect of Concurrent Thoracic Radiotherapy in Limited Stage
Kyung Hee Lee, Jin Jong Jeon, Byung Hoon Kim, Eun Jeong Lee, Jun Young Do, Jin Hong Chung, Kwan Ho Lee, Myung Soo Hyun, Bong Sub Shim, Hyun Woo Lee, Hyun Cheol chung
J Korean Cancer Assoc. 1996;28(1):104-113.
AbstractAbstract PDF
In order to assess the efficacy of alternating schedule chemotherapy on the outcome of patients with small cell lung cancer and effect of concurrent thoracic radiotherapy in limited disease, fifty five eligible patients with SCLC were treated with chemotherapy consisting of cyclophosphamide, adriamycin and vincristine(CAV) alternating with etoposide and cisplatin(EP). Thoracic radiotherapy was administered to the patients with limited stage disease Overall response rate was 64% with 20% of complete response. The response rate was 78%(CR 39%,PR 39%)in the patients with limited stage disease, and 53%(CR 6%, PR 47%)in those with extensive stage disease. With median follow-up period of 14 months (341+), the median survivals in patients of limited stage and extended disease were 15 months and 10 month, respectively (p<0.02) and median survivals in patients with CR, PR, and SD+PD were 20, 11.3, 8.5months, respectively(p<0.01) In patients with limited stage patients with or without concurrent use of thoracic radiotherapy, the response rates were 82%(CR 42%, PR 41%) and 67%(CR 33%, PR 34%) and median survivals were 15.8 months and 11.8 months, respectively.There were no life threatening side effects. This results suggest that alternating chemotherapy with CAV and EP may be useful as a treatement strategy in small cell lung cancer and concurrent use of thoracic radiotherapy in limited stage patients improve survival, but it was not significant statistically.
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5-Fluorouracil , Leucovorin and Mitomycin C ( MLF ) Chemotherapy for Advanced Gastric Cancer : Results of A Phase 2 Trial
Sung Hyun Yang, Sung Rok Kim, Eun Soo Yang, Jong Cheol Ryu, Joon Hee Kim, Chul Soo Kim, Re Hwe Kim
J Korean Cancer Assoc. 1996;28(2):191-198.
AbstractAbstract PDF
The results of systemic chemotherapy for advanced stomach cancer are still disappointing despite of numerous studies which has been performed to develop better treatment regimens. Mitomycin C (MMC) is one of the most active agents against stomach cancer and leucovorin (LV) enhance cytotoxicity of 5-fluorouracil (5-FU). This clinical phase II trial was designed to evaluate the efficacy of combination chemotherapy with MMC and LV-modulated 5-FU (MLF). Thirty nine patients were entered into the trial. All patients had measurable lesion. The MLF reaimen consisted of 5-FU 375 mg/§³ IV days 1 through 5: LV 20 mg/§³ IV just before 5-FU infusion days 1 through 5; and MMC 9 mg/§³ IV day l (7mg/§³ from the 2nd cycle). Cycles were repeated every 4 weeks. There were 19 responses (48%) including 6 clinical complete responses. The median survival of all 39 patients was 40.4 weeks. There was minimal myelosuppression; grade 3-4 leucopenia or thrombocytopenia in 26% of cycles. Non-hematologic toxicities were also tolerable; grade 3 nausea or vomiting in 8% of patients. This phase II study showed that the MLF therepy is comparable in effect for advanced stomach cancer with minimal toxicities, deserving phase III study with other regimens.
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A Prospective Randomized Study Comparing the Efficacy of Tropisetron Versus Metoclopramide / Dexamethasone / Diazepam (
Ki Bok Park, Dong Hoon Jeong, Jong Hoon Kim, Byoung Kee Kim, Sang Yoong Park, Eui Don Lee, Kyung Hee Lee
J Korean Cancer Assoc. 1996;28(3):562-573.
AbstractAbstract PDF
Background
Chemotherapy-induced emesis is one of the most disturbing side effects in the cancer chemotherapy. Despite a number of significant advances over the past decade, prevention and treatment of chemotherapy induced emesis remain formidable problems, particularly with cisplatin based regimens. In the prior reports, tropisetron(Navoban, Sandoz Pharma. Ltd., Basel, Switzerland), a 5-HT3-receptor antagonist, was effective in the control of cisplatin induced emesis. In this study, we compared effectiveness of tropisetron (TRP) with metoclopramide/dexamethasone /diazepam(MDD) in the prevention of emetic episodes in patients receiving cisplatin-based combination chemotherapy. Methods: Sixty-three patients with cervical carcinoma receiving 60 mg/§³ of cisplatin (day 1) and 1000mg/§³ of 5-FU(day 1~5) were randomized to two arms(arm I: tropisetron; n=32, arm II: MDD; n=31). In TRP group, tropisetron(5 mg) was given intravenously(i.v.) l5 min before cisplatin on day 1, and per orally(p.o.). 30 min before breakfast from day 2 to 6. In MDD group, metoclopramide(l mg/kg/time, 2 times/day), dexamethasone(20mg) and diazepam(5 mg) were given intravenously before cisplatin infusion on day 1, and from day 2 to 6, metoclopramide(l0 mg) was given p.o, every 6 hours, and dexamethasone was given p.o . every 12 hours at a dose of 8mg on day 2~3 and at a dose of 4mg on day 4~6. Sixty patients were evaluable and 3 patients(arm I, 2 patients; arm II, 1 patient) were excluded from the analysis due to their refusal during study due to emesis. Results: In TRP group, during first 24 hours(acute emesis), 83.3%(25/30) of patients had fewer than three emetic episodes and 63.3%(19/30) had no emetic episodes. These results were similar to those of MDD group; 90.0%(27/30) and 63.3%(l9/30), respectively. But from that time to day 6, in TRP group, anly 53.3%(16/30) of patients had less than three emetic episodes and 20.0%(6/30) had no emetic episode. These were significantly less than those of MDD group; 86.7%(26/30) and 50.0%(15/30)(p<0.001). The mean nausea ratings per visual analogue scale between two groups on day 1 were similar; 49.0¡¾7.5(mean¡¾S.E.M) for TRP group and 43.3¡¾7.1 for MDD group. But from day 2 to day 5, the mean nausea ratings for MDD group were significantly less than those for TRP group(p<0.05). We could observe various side effects such as gastrointestinal symptoms and sedation in MDD group but no side effects except mild headache(10.0%) were observed in TRP group. Extrapyramidal symptom was not observed in both groups. Conclusion: These results suggest that TRP was as effective as MDD in controlling the acute emesis but less effective in controlling the delayed emesis induced by cisplatin-based chemotherapy. Although antiemetic effect of tropisetron was not more excellent than that of MDD regimens, it seems to be a clinically efficacious drug due to simplicity of administration and less side effects.
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A Randomized comparison of Granisetron Plus Dexamethasone and Ondansetron Plus Dexamethasone in the Prevention of High - dose Cisplatin - indu
Jung Ae Rhee, Young Suk Park, In Sook Woo, Young Iee Park, Duk Jhe Shun, Jeong A Kim, Sung Soo Yoon, Won Ki Kang, Keunchil Park, Chan Hyung Park
J Korean Cancer Assoc. 1996;28(4):739-748.
AbstractAbstract PDF
We report the prospective, randomized clinical study comparing granisetron and ondansetron as antiemetics in cancer chemotherapy. This study compares the efficacy and safety of a single dose of granisetron plus dexamethasone(GD) with three doses of ondansetron plus dexamethasone(OD) in the prevention of acute emesis induced by chemotherapy. One hundred one chemotherapy-native patients who received high dose ciaplatin(¡Al00mg /§³)-based combination chemotherapy were stratified by chemotherapeutic regimen. Patients were randomized to receive either 3 mg of granisetron intravenously(i.v.) or 8 mg of ondansetron for three doses i.v. in combination with dexamethasone to prevent emesis in the first 24 hours. In the GD group, a complete response(CR)(i.e., no emetic episode) was achived in 57% cases and a major response(MR)(i.e. ¡A2 emetic episodes) in 24%. In the OD group, a CR was seen in 71% of patients and an MR in 25%. Failure was recored in 7% and 2% of cases in the GD and OD, respectively. No statistically significant difference in any response category was seen between the two groups. Both GD and OD were well tolerated with no severe or unexpected side effects. In summary, these data suggest that single daily dose of granisetron(3mg/day) appeared similarly effective and well tolerated to three daily doses of ondansetron(8mg three times daily) in prevention of acute emesis induced by high dose cisplatin-based combination chemotherapy.
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