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A Multicenter Phase II Study of Modified FOLFIRINOX for First-line Treatment for Advanced Urachal Cancer (ULTMA; KCSG GU20-03)
Inkeun Park, Jae Lyun Lee, Shinkyo Yoon, Sang Joon Shin, Seong-Hoon Shin, Jung Hoon Kim, Kwonoh Park, Hyo Jin Lee
Received December 21, 2024  Accepted February 12, 2025  Published online February 13, 2025  
DOI: https://doi.org/10.4143/crt.2024.1231    [Accepted]
AbstractAbstract PDF
Purpose
To assess the efficacy and safety of the first-line modified FOLFIRINOX in patients with advanced urachal cancer.
Materials and Methods
The ULTIMA trial (NCT04611724) is a single-arm, open-label, multicenter phase II study evaluating modified FOLFIRINOX (Oxaliplatin 85 mg/m2 over 2 hours, Irinotecan 150 mg/m2 over 1.5 hours, Leucovorin 400 mg/m2 over 2 hours, and 5-FU 2400 mg/m2 over 46 hours) plus prophylactic pegteograstim in patients with recurrent or metastatic urachal cancer every 2 weeks for up to 12 cycles, or until disease progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and the incidence of febrile neutropenia.
Results
Between April 2021 and November 2023, 21 patients with advanced urachal cancer were enrolled across five cancer centers. The median age was 50 (28–68), with 15 male patients. The most common metastatic site was the lung (47.6%), followed by lymph nodes (38.1%) and peritoneal seeding (33.3%). Two patients and 11 patients achieved a complete and partial response, respectively, yielding an ORR of 61.9%. The study met its primary endpoint in the first stage. With a median follow-up of 23.3 months, the median PFS was 9.3 months (95% CI, 6.7–11.9), and the median OS was 19.7 months (95% CI, 14.3–25.1). The treatment regimen was well tolerated, with no unexpected adverse events, and no instances of febrile neutropenia or grade 4 adverse events.
Conclusion
In this preliminary analysis of ULTIMA trial, Modified FOLFIRINOX demonstrated a promising ORR and PFS in patients with advanced urachal cancer. Completing the full study is essential to confirm the potential role of this regimen in the management of advanced urachal cancer.
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CXCL-13 Regulates Resistance to 5-Fluorouracil in Colorectal Cancer
Guolin Zhang, Xin Luo, Wei Zhang, Engeng Chen, Jianbin Xu, Fei Wang, Gaoyang Cao, Zhenyu Ju, Dongai Jin, Xuefeng Huang, Wei Zhou, Zhangfa Song
Cancer Res Treat. 2020;52(2):622-633.   Published online December 31, 2019
DOI: https://doi.org/10.4143/crt.2019.593
AbstractAbstract PDFPubReaderePub
Purpose
5-Fluorouracil (5-Fu) is used as a conventional chemotherapy drug in chemotherapy for patients with advanced colorectal cancer, but many patients still suffer from treatment failure due to 5-Fu resistance. Emerging observations revealed the important role of chemokine (C-X-C motif) ligand 13 (CXCL-13) in tumor microenvironment and its relationship with prognosis in patients with colorectal cancer. This study is designed to reveal the important role of CXCL-13 in causing colorectal cancer resistance to 5-Fu.
Materials and Methods
CXCL-13 levels of patient's serum or cell culture supernatants were measured separately by enzyme-linked immunosorbent assay. In cell assays, cell viability is detected by Cell Counting Kit-8. Therefore, the recombinant human CXCL-13 was used to simulate its high expression in cells while its antibody and siRNA were used to reduce CXCL-13 expression in cells.
Results
In this study, we demonstrated that CXCL-13 is associated with 5-Fu resistance by culture medium exchange experiments and cytokine arrays of colorectal cancer resistant and nonresistant cells. Clinical studies showed that CXCL-13 is highly expressed in the serum of 5-Fu–resistant patients. High levels of serum CXCL-13 also predict a worse clinical outcome. The addition of recombinant CXCL-13 cytokine resulted in 5-Fu resistance, while its antibody overcame 5-Fu resistance, and knockdown of CXCL-13 expression by siRNA also reduced 5-Fu resistance, which can be saved by added recombination CXCL-13.
Conclusion
These results not only identify a CXCL-13 mediated 5-Fu resistance mechanism but also provide a novel target for 5-Fu–resistant colorectal cancer in prevention and treatment strategies.

Citations

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    Naunyn-Schmiedeberg's Archives of Pharmacology.2024; 397(11): 8445.     CrossRef
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    Journal of Cancer Research and Clinical Oncology.2023; 149(10): 7235.     CrossRef
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    Journal of Gastrointestinal Cancer.2022; 53(3): 649.     CrossRef
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    Cancers.2022; 14(2): 294.     CrossRef
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    Scientific Reports.2022;[Epub]     CrossRef
  • Kaempferol Can Reverse the 5-Fu Resistance of Colorectal Cancer Cells by Inhibiting PKM2-Mediated Glycolysis
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    International Journal of Molecular Sciences.2022; 23(7): 3544.     CrossRef
  • Chemokines and chemokine receptors in colorectal cancer; multifarious roles and clinical impact
    Maria Braoudaki, Mohammed Saqif Ahmad, Denis Mustafov, Sara Seriah, Mohammad Naseem Siddiqui, Shoib Sarwar Siddiqui
    Seminars in Cancer Biology.2022; 86: 436.     CrossRef
  • Bioinformatics Analysis of Prognostic Significance and Immune Characteristics of CXC Chemokine Family in Patients with Lung Adenocarcinoma
    Dachen Bian, Yanhua Chen, Ahmed Faeq Hussein
    Computational and Mathematical Methods in Medicine.2022; 2022: 1.     CrossRef
  • Chemokines in progression, chemoresistance, diagnosis, and prognosis of colorectal cancer
    Qian Zou, Xue Lei, Aijing Xu, Ziqi Li, Qinglian He, Xiujuan Huang, Guangxian Xu, Faqing Tian, Yuanlin Ding, Wei Zhu
    Frontiers in Immunology.2022;[Epub]     CrossRef
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    Biochimica et Biophysica Acta (BBA) - Reviews on Cancer.2022; 1877(5): 188799.     CrossRef
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    Frontiers in Immunology.2022;[Epub]     CrossRef
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    Frontiers in Immunology.2022;[Epub]     CrossRef
  • Recent Updates on Mechanisms of Resistance to 5-Fluorouracil and Reversal Strategies in Colon Cancer Treatment
    Shamin Azwar, Heng Fong Seow, Maha Abdullah, Mohd Faisal Jabar, Norhafizah Mohtarrudin
    Biology.2021; 10(9): 854.     CrossRef
  • CXCL2-mediated ATR/CHK1 signaling pathway and platinum resistance in epithelial ovarian cancer
    Sipei Nie, Yicong Wan, Hui Wang, Jinhui Liu, Jing Yang, Rui Sun, Huangyang Meng, Xiaolin Ma, Yi Jiang, Wenjun Cheng
    Journal of Ovarian Research.2021;[Epub]     CrossRef
  • The CXCL Family Contributes to Immunosuppressive Microenvironment in Gliomas and Assists in Gliomas Chemotherapy
    Zeyu Wang, Yuze Liu, Yuyao Mo, Hao Zhang, Ziyu Dai, Xun Zhang, Weijie Ye, Hui Cao, Zhixiong Liu, Quan Cheng
    Frontiers in Immunology.2021;[Epub]     CrossRef
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    Louis Boafo Kwantwi, Shujing Wang, Youjing Sheng, Qiang Wu
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  • CXCL13 in Cancer and Other Diseases: Biological Functions, Clinical Significance, and Therapeutic Opportunities
    San-Hui Gao, Sheng-Zhi Liu, Gui-Zhen Wang, Guang-Biao Zhou
    Life.2021; 11(12): 1282.     CrossRef
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    Margarita Neganova, Junqi Liu, Yulia Aleksandrova, Sergey Klochkov, Ruitai Fan
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A Phase II Trial of Paclitaxel, 5-fluorouracil (5-FU) and Cisplatin in Patients with Metastatic or Recurrent Gastric Cancer
Gun Hi Kang, Gwang Sil Kim, Hyo Rak Lee, Young Jin Yuh, Sung Rok Kim
Cancer Res Treat. 2008;40(3):106-110.   Published online September 30, 2008
DOI: https://doi.org/10.4143/crt.2008.40.3.106
AbstractAbstract PDFPubReaderePub
Purpose

We wanted to assess the effectiveness and safety of combination chemotherapy with paclitaxel, 5-fluorouracil (5-FU) and cisplatin for treating advanced gastric cancer.

Materials and Methods

Patients with metastatic or recurrent gastric cancer were entered into this study. Paclitaxel at a dose of 135 mg/m2 on day 1, 5-FU 1 g/m2/day in a 24 hour continuous infusion from day 1 to day 4 and cisplatin 60 mg/m2 on day 1 were administered. This regimen was repeated every 3 weeks.

Results

A total of 34 patients were enrolled in this study. Among them, 33 patients were finally evaluable for their response. 17 (51.5%) patients had a partial response (95% CI: 26.0~77.0%). The median duration of overall survival was 13.2 months. Grade 3 or 4 neutropenia and thrombocytopenia were observed in 15.2% and 1.1% of all the cycles, respectively. Grade 3 stomatitis and neurotoxicity were observed in 20.6% and 1.1% of all patients, respectively. Grade 4 non-hematologic toxicity was not observed.

Conclusions

The regimen of paclitaxel, 5-FU and cisplatin demonstrated activity and accepatable toxicity for treating metastatic gastric cancer.

Citations

Citations to this article as recorded by  
  • Intraperitoneal administration of biocompatible hyaluronic acid hydrogel containing multi-chemotherapeutic agents for treatment of colorectal peritoneal carcinomatosis
    Jia Luo, ZhouXue Wu, Yun Lu, Kang Xiong, Qian Wen, Ling Zhao, BiQiong Wang, Yan Gui, ShaoZhi Fu
    International Journal of Biological Macromolecules.2020; 152: 718.     CrossRef
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Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Relapsed or Metastatic Colorectal Cancer as Second Line Therapy
Duk-Joo Lee, Ho-Suk Oh, Jung-Hye Choi, Young-Yeul Lee, In-Soon Kim, Myung-Ju Ahn
Cancer Res Treat. 2006;38(4):201-205.   Published online December 31, 2006
DOI: https://doi.org/10.4143/crt.2006.38.4.201
AbstractAbstract PDFPubReaderePub
Purpose

The purpose of the study was to assess the efficacy and safety of biweekly oxaliplatin in combination with leucovorin (LV)-modulated bolus plus infusion of 5-fluorouracil (5-FU) in patients with relapsed or metastatic colorectal cancer (CRC) as a second line therapy.

Materials and Methods

Between November 2002 and October 2005, 26 patients with histologically confirmed relapsed or metastatic CRC were enrolled. All patients were previously treated with irinotecan-based combination chemotherapy. The chemotherapy regimen consisted of oxaliplatin 85 mg/m2 on day 1; LV 200 mg/m2 on days 1 and 2; and 5-FU 400 mg/m2 bolus IV with 600 mg/m2 with a 22-hour infusion on days 1 and 2 every 2 weeks.

Results

The median age of the 26 patients was 50.5 years (range, 31~72). Their metastatic sites included: the liver (42.3%), peritoneum (26.9%), lung (23.1%) and ovary (7.7%). Twenty five patients were evaluated for their response. Four patients achieved partial responses and 15 patients had stable disease. The overall response rate was 16% (95% confidence interval; 1.7~30.3%). The median follow-up duration for the surviving patients was 7.4 months (range, 2.08~21.2). Median overall survival (OS) and 1-year OS rates were 16.7 months and 63.9%, respectively. The most common hematological toxicities were: NCI grade I/II leucopenia (49.3%), grade I/II neutropenia (41%) and grade I/II anemia (65.2%). The main non-hematological toxicities were: grade I/II peripheral neuropathy (16.1% and 21.5%, respectively) and nausea/vomiting (23.6%/18.5%). There was no life-threatening toxicity.

Conclusion

The oxaliplatin, 5-FU and LV combination chemotherapy, scheduled as a biweekly protocol, was effective and well tolerated in the treatment of relapsed or metastatic colorectal cancer patients as second line chemotherapy.

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Review Article
Lapatinib - Overview and Current Role in Metastatic Breast Cancer
Arlene Chan
Cancer Res Treat. 2006;38(4):198-200.   Published online December 31, 2006
DOI: https://doi.org/10.4143/crt.2006.38.4.198
PDFPubReaderePub

Citations

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  • The landscape of exosomal non-coding RNAs in breast cancer drug resistance, focusing on underlying molecular mechanisms
    Malihe Rezaee, Fatemeh Mohammadi, Atoosa Keshavarzmotamed, Sheida Yahyazadeh, Omid Vakili, Yaser Eshaghi Milasi, Vida Veisi, Rohollah Mousavi Dehmordi, Sepideh Asadi, Seyedeh Sara Ghorbanhosseini, Mehdi Rostami, Mina Alimohammadi, Abbas Azadi, Nushin Mous
    Frontiers in Pharmacology.2023;[Epub]     CrossRef
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    Xiaoli Wu, Yi Ren, Rong Yao, Leilei Zhou, Ruihua Fan
    Frontiers in Oncology.2021;[Epub]     CrossRef
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    Zhe Li, Sheng‐Sheng Yang, Pei‐Hao Yin, Tao Chang, Lin‐Xiang Shi, Lin Fang, Guo‐En Fang
    Thoracic Cancer.2015; 6(6): 695.     CrossRef
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    Jae-Cheol Jo, Myoung Joo Kang, Jeong Eun Kim, Jin-Hee Ahn, Kyung Hae Jung, Gyungyub Gong, Hak Hee Kim, Seung Do Ahn, Su Ssan Kim, Byung Ho Son, Sei Hyun Ahn, Sung-Bae Kim
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    Béla Pikó
    Magyar Onkológia.2009; 53(4): 369.     CrossRef
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Original Articles
A Pilot Study of Cisplatin, Irinotecan, Leucovorin and 5-fluorouracil (PILF) Combination Chemotherapy for Advanced Gastric Cancer
Se Hoon Park, Soo Yeon Jeon, Kwang Il Ko, Eunmi Nam, Soo-Mee Bang, Eun Kyung Cho, Dong Bok Shin, Jae Hoon Lee, Woon Ki Lee, Min Chung
Cancer Res Treat. 2006;38(3):121-125.   Published online June 30, 2006
DOI: https://doi.org/10.4143/crt.2006.38.3.121
AbstractAbstract PDFPubReaderePub
Purpose

Irinotecan, in combination with leucovorin/5-fluorouracil (FU) or with cisplatin, is known to be active for treating advanced gastric cancer (AGC). This pilot study evaluated a novel three-drug combination of irinotecan, leucovorin/FU and cisplatin as a first-line treatment of AGC. The primary endpoint was to assess the feasibility in anticipation of conducting a larger phase II study.

Materials and Methods

Chemotherapy-naive AGC patients received irinotecan 150 mg/m2 on day 1, and leucovorin 200 mg/m2 and a 22-h infusion of FU 1000 mg/m2 on days 1 and 2. Cisplatin 30 mg/m2 was administered on day 2. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity.

Results

Of the 17 eligible patients, two patients had an ECOG performance status of 2 and their median age was 48 years (range: 31 to 69). A total of 117 chemotherapy cycles were delivered (median: 6, range: 1 to 12). The causes of treatment discontinuation were disease progression in 9 patients (53%), refusal (35%) and toxicity (12%). Although grade 3 or 4 neutropenia (41% of patients) was the major toxicity that required dose adjustments, only one episode of febrile neutropenia occurred. Grade 3 or 4 nausea and vomiting, diarrhea and fatigue were observed in 35%, 35% and 29% of patients, respectively. None of the patients died of toxicity during treatment. Of the 16 patients who were evaluable for response, 7 (44%) experienced a partial response.

Conclusion

This novel multi-drug combination was tolerated well in patients with AGC. Based on the encouraging efficacy and tolerability, a randomized phase II study is ongoing in this disease setting.

Citations

Citations to this article as recorded by  
  • Randomized phase II study of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) combination chemotherapy for advanced gastric cancer
    S.H. Park, E. Nam, J. Park, E.K. Cho, D.B. Shin, J.H. Lee, W.K. Lee, M. Chung, S.I. Lee
    Annals of Oncology.2008; 19(4): 729.     CrossRef
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A Phase II Study of Irinotecan, 5-Fluorouracil and Leucovorin for Treatment in Patients with Previously Untreated Advanced Colorectal Cancer
Sang-Byung Bae, Nam-Su Lee, Han-Jo Kim, Kyoung-Ha Kim, Hyun-Jung Kim, Chan-Kyu Kim, Kyu-Taeg Lee, Sung-Kyu Park, Jong-Ho Won, Dae-Sik Hong, Hee-Sook Park
Cancer Res Treat. 2006;38(2):72-77.   Published online April 30, 2006
DOI: https://doi.org/10.4143/crt.2006.38.2.72
AbstractAbstract PDFPubReaderePub
Purpose

We prospectively conducted a non-randomized phase II trial to evaluate the efficacy and safety of combination irinotecan, leucovorin (LV) and 5-fluorouracil (FU) as a first-line regimen for treating patients with previously untreated advanced colorectal cancer (CRC).

Materials and Methods

Twenty-six previously untreated patients with advanced, recurrent or metastatic CRC were enrolled in this study. The patients received either irinotecan 180 mg/m2 on day 1 with LV bolus of 200 mg/m2 and FU bolus of 400 mg/m2, and this was followed by FU continuous infusion of 600 mg/m2 on day 1 and day 2 (the FOLFIRI regimen), or they were treated with LV bolus of 400 mg/m2 and FU bolus of 400 mg/m2 followed by FU continuous infusion of 2,400 mg/m2 for 46 hours (the simplified FOLFIRI regimen), and these treatments were repeated every 2 weeks until disease progression.

Results

The objective response rate was 23.1% (6/26) respectively, for both treatments. The median time to progression was 5.3 months (range: 0.4~19.9), and the overall survival was 11.2 months (range: 0.5~52.3). The prognostic factor for longer survival was the Eastern Cooperative Oncology Group (ECOG) performance status (PS). The non-hematological toxicities were similar for both treatment groups, with more frequent grade ≥3 neutropenia being noted for the simplified FOLFIRI regimen.

Conclusion

The biweekly irinotecan based regimen was demonstrated to have a moderate antitumor activity with acceptable toxicity profiles, and the ECOG PS was the independent prognostic factor.

Citations

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  • Oncological Treatment-Related Fatigue in Oncogeriatrics: A Scoping Review
    Louise André, Gabriel Antherieu, Amélie Boinet, Judith Bret, Thomas Gilbert, Rabia Boulahssass, Claire Falandry
    Cancers.2022; 14(10): 2470.     CrossRef
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    B. Budai, T. Nagy, I. Láng, E. Hitre
    Angiogenesis.2013; 16(1): 113.     CrossRef
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    Dong Min Kim, Hyun Lee Kim, Choon Hae Chung, Chi Young Park
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Combination Chemotherapy of Oxaliplatin, 5-Fluorouracil and Low Dose Leucovorin in Patients with Advanced Colorectal Cancer
Yoon Mi Shin, Hae Suk Han, Seong Woo Lim, Byung Chul Kim, Kyung Suck Cheoi, Young Ook Eum, Seung Taek Kim, Ki Hyeong Lee
Cancer Res Treat. 2005;37(5):284-289.   Published online October 31, 2005
DOI: https://doi.org/10.4143/crt.2005.37.5.284
AbstractAbstract PDFPubReaderePub
Purpose

The aim of this study was to evaluate the efficacy and tolerability of the oxaliplatin, 5-fluorouracil (5-FU) and low dose leucovorin (LV) combination in patients with advanced colorectal cancer.

Materials and Methods

Patients with unresectable or recurrent colorectal carcinomas were prospectively accrued. Up to one prior chemotherapy regimen was allowed. Patients received oxaliplatin, 85 mg/m2, administered as a 2-hour infusion on day 1, followed by LV, 20 mg/m2, as a bolus and 5-FU, 1,500 mg/m2, via continuous infusion for 24 hours on days 1 and 2. Treatment was repeated every 2 weeks until disease progression or adverse effects prohibited further therapy.

Results

Between August 1999 and May 2004, 31 patients were enrolled in this study. Of the patients enrolled, 24 and 31 were evaluable for tumor response and survival analysis, respectively. The patients' characteristics included a median age of 59, with 6 (19%) having had prior chemotherapy. No patient achieved a complete response, but nine (38%) attained a partial response. Seven (29%) patients maintained a stable disease and 8 (33%) experienced increasing disease. The median duration of the response was 6 months. After a median follow-up of 9.6 months, the median time to progression was 3.8 months, with a median survival of 10.7 months. The hematological toxicities were mild to moderate, with no treatment-related mortality or infection. The major non-hematological toxicity was gastrointestinal toxicity.

Conclusion

The combination chemotherapy of oxaliplatin, low dose LV and continuous infusion of 5-FU is safe and has a cost-benefit, but is a moderately effective regimen in advanced colorectal cancer. A randomized trial comparing low and high dosages of leucovorin in the FOLFOX regimen is warranted.

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    JaeJin An, Eun-Mi Ha
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    Joon Ho Moon, Jong Gwang Kim, Sang Kyun Sohn, Jin Ho Baek, Yoon Young Cho, Yee Soo Chae, Byung Min Ahn, Shi Nae Kim, Soo Jung Lee, In Taek Lee, Gyu Seog Choi, Soo Han Jun
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Oxaliplatin with Biweekly Low Dose Leucovorin and Bolus and Continuous Infusion of 5-fluorouracil (Modified FOLFOX 4) as a Salvage Therapy for Patients with Advanced Gastric Cancer
Sung-Hwan Suh, Hyuk-Chan Kwon, Ji-Hoon Jo, Young-Rak Cho, Bong-Gun Seo, Dong-Mee Lee, Sung-Hyun Kim, Jae-Seok Kim, Hyo-Jin Kim
Cancer Res Treat. 2005;37(5):279-283.   Published online October 31, 2005
DOI: https://doi.org/10.4143/crt.2005.37.5.279
AbstractAbstract PDFPubReaderePub
Purpose

To determine the activity and the toxicity associated with a low dose regimen of leucovorin (LV) plus 5-fluorouracil (5-FU) combined with oxaliplatin every two weeks (modified FOLFOX 4) as a salvage therapy for advanced gastric cancer patients.

Materials and Methods

Between December 2003 and December 2004, 33 patients were enrolled in this study. The patients were treated with oxaliplatin 85 mg/m2 as a 2-hour infusion on the first day plus LV 20 mg/m2 over 10 minutes. Subsequently, the patients were given a 5-FU bolus 400 mg/m2 followed by a 22-hour continuous infusion of 600 mg/m2 on days 1~2. The treatment was repeated at 2 week intervals.

Results

The median age of the patients was 50 years (range: 31~74), 82% (27/33) had the Eastern Cooperative Oncology Group performance status was 0 and 1. Of the 30 patients who could be evaluated for their tumor response, 8 achieved a partial response, with an overall response rate of 26.7% (95% confidence interval (CI): 20.5~32.7%). Fifteen patients (50%) showed stable disease and 7 patients (23.3%) progressed during the course of treatment. The median time from the start of chemotherapy to progression was 3.5 months (95% CI: 2.6~4.4 months) and the median overall survival time was 7.9 months (95% CI: 5.9~9.9 months). The major grade 3/4 hematological toxicity encountered included neutropenia (45.4%) and thrombocytopenia (3.0%). Neutropenic fever occurred during only 2 of the 178 cycles. The most common non-hematological toxicity encountered was grade 1/2 nausea/vomiting, which occurred in 18.2% of patients, diarrhea in 12.1% and neuropathy in 15.2%. There were no treatment related deaths.

Conclusion

The modified FOLFOX 4 regimen appears to be a safe and effective salvage therapy for advanced gastric cancer patients.

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cDNA Microarray Analysis of Differential Gene Expression in Gastric Cancer Cells Sensitive and Resistant to 5-Fluorouracil and Cisplatin
Myung-Ju Ahn, Young-Do Yoo, Ki-Hwan Lee, Joon-Ik Ahn, Dong-Hyun Yu, Hye-Sook Lee, Ho-Suck Oh, Jung-Hye Choi, Yong-Sung Lee
Cancer Res Treat. 2005;37(1):54-62.   Published online February 28, 2005
DOI: https://doi.org/10.4143/crt.2005.37.1.54
AbstractAbstract PDFPubReaderePub
Purpose

Gastric cancer is one of the most prevalent cancers worldwide. 5-fluorouracil (5-FU) and cisplatin are the most commonly used drugs for the treatment of gastric cancer. However, a significant number of tumors often fail to respond to chemotherapy.

Materials and Methods

To better understand the molecular mechanisms underlying drug resistance in gastric cancer the gene expression in gastric cancer cells, which were either sensitive or resistant to 5-FU and cisplatin, were examined using cDNA microarray analysis. To confirm the differential gene expression, as determined using the microarray, semiquantitative RT-PCR was performed on a subset of differentially expressed cDNAs.

Results

69 and 45 genes, which were either up-regulated (9 and 22 genes) or down-regulated (60 and 25 genes), were identified in 5-FU- and cisplatin-resistant cells, respectively. Several genes, such as adaptor-related protein complex 1 and baculoviral IAP repeat-containing 3, were up-regulated in both drug-resistant cell types. Several genes, such as the ras homolog gene family, tropomyosin, tumor rejection antigen, protein disulfide isomerase-related protein, melanocortin 1 receptor, defensin, cyclophilin B, dual specificity phosphatase 8 and hepatocyte nuclear factor 3, were down-regulated in both drugresistant cell types.

Conclusion

These findings show that cDNA microarray analysis can be used to obtain gene expression profiles that reflect the effect of anticancer drugs on gastric cancer cells. Such data may lead to the assigning of signature expression profiles of drug-resistant tumors, which may help predict responses to drugs and assist in the design of tailored therapeutic regimens to overcome drug resistance.

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    Xiandong Lin, Yongzhong Zhao, Won-min Song, Bin Zhang
    Computational and Structural Biotechnology Journal.2015; 13: 448.     CrossRef
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    Shizhu Zang, Ruifang Guo, Rui Xing, Liang Zhang, Wenmei Li, Min Zhao, Jingyuan Fang, Fulian Hu, Bin Kang, Yonghong Ren, Yonglong Zhuang, Siqi Liu, Rong Wang, Xianghong Li, Yingyan Yu, Jing Cheng, Youyong Lu
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    Francisco R.M. Laurindo, Luciana A. Pescatore, Denise de Castro Fernandes
    Free Radical Biology and Medicine.2012; 52(9): 1954.     CrossRef
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Phase II Study of Irinotecan, 5-Fluorouracil, and Leucovorin in Relapsed or Metastatic Colorectal Cancer as First-line Therapy
Young-Woong Won, Young-Hyo Lim, Ho-Yong Park, Ho-Suk Oh, Jung-Hye Choi, Young-Yeul Lee, In-Soon Kim, Il-Young Choi, Myung-Ju Ahn
Cancer Res Treat. 2004;36(4):235-239.   Published online August 31, 2004
DOI: https://doi.org/10.4143/crt.2004.36.4.235
AbstractAbstract PDFPubReaderePub
Background

The purpose of this study was to assess the efficacy and toxicity of biweekly irinotecan plus 5-fluorouracil (FU) and leucovorin (LV) in patients with relapsed or metastatic colorectal cancer.

Materials and Methods

Between March 2002 and May 2004, 24 patients with histologically confirmed relapsed or metastatic colorectal cancer were enrolled in this study. One chemotherapy cycle consisted of irinotecan 180 mg/m2 on days 1 and 15; 5-FU 400 mg/m2 bolus IV with 600 mg/m2 by a 22 hour intravenous infusion on days 1, 2, 15 and 16; and leucovorin 20 mg/m2 on days 1, 2, 15 and 16, every 4 weeks.

Results

The median age of the 24 was 57.5 years (range, 38~69). Their metastatic sites included: the liver (62.5%), lung (20.8%), peritoneum (16.7%), lymph node (12.5%), ovary (8.3%) and pelvis/vagina (8.3%). Twenty-two patients were evaluable for a response. Six and 7 patients achieved partial responses and stable diseases, respectively. The overall response rate was 27.3% (95% Confidence interval; 10.3~44.5%). The median follow-up duration for surviving patients was 14.7 months (range, 1.7~26.5). Median overall survival (OS) and 1-year OS rates were 19 months and 86.3%, respectively. Median response duration and median progression free survival were 7.47 and 5.57 months, respectively. A total of 83 cycles (median 4 cycles) were administered. The main non-hematologic toxicities were nausea/vomiting (44.5%/18.1%) and diarrhea (8.4%). The most common hematologic toxicity was NCI grade I/II anemia (31.3%) and grade I/II neutropenia was 10.8%. There was no life-threatening toxicity.

Conclusion

The results suggested that irinotecan, 5-FU and leucovorin combination chemotherapy in a biweekly schedule is a practical and tolerable treatment option in patients with advanced colorectal cancer.

Citations

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  • A Phase I Study of UGT1A1 *28/*6 Genotype-Directed Dosing of Irinotecan (CPT-11) in Korean Patients with Metastatic Colorectal Cancer Receiving FOLFIRI
    Kyu-Pyo Kim, Yong Sang Hong, Jae-Lyun Lee, Kyun Seop Bae, Ho-Sook Kim, Jae-Gook Shin, Jung Shin Lee, Tae Won Kim
    Oncology.2015; 88(3): 164.     CrossRef
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    Seung Hyun Lee, Byung Kwon Ahn, Sung Uhn Baek
    Journal of the Korean Society of Coloproctology.2007; 23(5): 333.     CrossRef
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    Sang-Byung Bae, Nam-Su Lee, Han-Jo Kim, Kyoung-Ha Kim, Hyun-Jung Kim, Chan-Kyu Kim, Kyu-Taeg Lee, Sung-Kyu Park, Jong-Ho Won, Dae-Sik Hong, Hee-Sook Park
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    Myung-Ah Lee, Jae-Ho Byun, Byoung-Young Shim, In-Sook Woo, Jin-Hyung Kang, Young Seon Hong, Kyung Shik Lee, Myung Gyu Choi, Suk Kyun Chang, Seong Taek Oh, Sung Il Choi, Doo Suk Lee
    The Korean Journal of Internal Medicine.2005; 20(3): 205.     CrossRef
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    In Ja Park, Hee Cheol Kim, Chang Sik Yu, Heung Moon Chang, Jea Hwan Lee, Jong Hoon Kim, Tae Won Kim, Jung Sun Kim, Jin Cheon Kim
    Cancer Research and Treatment.2004; 36(6): 360.     CrossRef
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Efficacy of Postoperative Concurrent Chemoradiation for Resectable Rectal Cancer: A Single Institute Experience
Joong Bae Ahn, Hee Chul Chung, Nae Choon Yoo, Jae Kyung Roh, Nam Kyu Kim, Chang Ok Suh, Gwi Eon Kim, Jin Sil Seong, Woong Ho Shim, Hyun Cheol Chung
Cancer Res Treat. 2004;36(4):228-234.   Published online August 31, 2004
DOI: https://doi.org/10.4143/crt.2004.36.4.228
AbstractAbstract PDFPubReaderePub
Purpose

For patients with Dukes' stage B and C rectal cancer, surgery followed by adjuvant chemoradiotherapy is considered to be the standard treatment. However, the drugs used in combination with 5-fluorouracil (5-FU), the method of administration, duration of adjuvant therapy and the frequencies of administration presently remain controversial topics. We investigated (1) the efficacy and safety of adjuvant radiotherapy and 5-FU/leucovorin (LV) chemotherapy for patients who had undergone curative resection and (2) the effect of dose related factors of 5-FU on survival.

Materials and Methods

130 rectal cancer patients with Dukes' B or C stage disease who were treated with curative resection were evaluated. The adjuvant therapy consisted of two cycles of 5-FU/LV chemotherapy followed by pelvic radiotherapy with chemotherapy, and then 4~10 more cycles of the same chemotherapy regimen were delivered based on the disease stage. The cumulative dose of 5-FU per body square meter (BSA), actual dose intensity and relative dose intensity were obtained. The patients were divided into two groups according to the median value of each factor, and the patients' survival rates were compared.

Results

With a median follow-up duration of 52 months, the 5-year disease-free survival and overall survival rates of 130 patients were 57% and 73%, respectively. Locoregional failure occurred in 17 (13%) of the 130 patients, and the distant failure rate was 27% (35/130). The chemotherapy related morbidity was minimal, and there was no mortality for these patients. The cumulative dose of 5-FU/BSA had a significant effect on the 5-year overall survival for Dukes' C rectal cancer patients (p=0.03). Multivariate analysis demonstrated that only the performance status affected the 5-year overall survival (p=0.003).

Conclusion

An adjuvant therapy of radiotherapy and 5-FU/LV chemotherapy is effective and tolerable for Dukes' B and C rectal cancer patients. A prospective, multicenter, randomized study to evaluate the effects of the cumulative dose of 5-FU/BSA on survival is required.

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    Kangsan Roh, Seung-Gu Yeo, Byong Chul Yoo, Kyung-Hee Kim, Sun Young Kim, Min-Jeong Kim
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    Nurul Ainin Abdul Aziz, Norfilza M. Mokhtar, Roslan Harun, Md Manir Hossain Mollah, Isa Mohamed Rose, Ismail Sagap, Azmi Mohd Tamil, Wan Zurinah Wan Ngah, Rahman Jamal
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    Seung Ho Shin, Sun-Il Lee, Dong-Jin Choi, Si-Uk Woo, Jin Kim, Byung-Wook Min, Hong-Young Moon, Seon Hahn Kim
    Journal of the Korean Society of Coloproctology.2009; 25(6): 429.     CrossRef
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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 Res Treat. 2004;36(3):199-204.   Published online June 30, 2004
DOI: https://doi.org/10.4143/crt.2004.36.3.199
AbstractAbstract PDFPubReaderePub
Purpose

To determine the efficacy and tolerability of a modified chronomodulated infusion of oxaliplatin, 5-fluorouracil (5-FU) and leucovorin in the treatment of advanced colorectal cancer.

Materials and Methods

Sixteen patients with relapsed or metastatic colorectal cancer were treated with an intravenous infusion of oxaliplatin 25 mg/m2, 5-FU 700 mg/m2 and leucovorin 20 mg/m2 on days 1 to 5. The infusion of oxaliplatin was chronomodulated with a peak delivery rate at 16:00 p.m., with 5-FU infused constantly overnight. Each course was repeated every 21 days.

Results

The response rate was 38.5% (95% confidence interval [CI], 13.9% to 68.4%) in the 13 measurable patients, including 1 complete response (7.7%) and 4 partial responses (30.8%). Five patients (38.5%) had a stable disease and 3 (23.0%) a progressive disease. Three patients without a measurable lesion had improved status. The median time to progression and overall survival were 29 weeks and 85 weeks, respectively. Grade 3 thrombocytopenia occurred in 2.5% (2 cycles) and grade 3 vomiting in 12.5% (2 patients). Anorexia, stomatitis, diarrhea, pruritus, alopecia and peripheral neuropathy were mild and tolerable.

Conclusion

The modified chronomodulated infusion of oxaliplatin, 5-FU and leucovorin is effective and tolerable, but the number of patients was too small. Further study will be needed to confirm the efficacy of this regimen with a larger population of patients.

Citations

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  • Combination Chemotherapy of Oxaliplatin, 5-Fluorouracil and Low Dose Leucovorin in Patients with Advanced Colorectal Cancer
    Yoon Mi Shin, Hae Suk Han, Seong Woo Lim, Byung Chul Kim, Kyung Suck Cheoi, Young Ook Eum, Seung Taek Kim, Ki Hyeong Lee
    Cancer Research and Treatment.2005; 37(5): 284.     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

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    Dobrina Tsvetkova, Stefka Ivanova
    Molecules.2022; 27(8): 2466.     CrossRef
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    W. Xu, D. C. Wang
    Russian Journal of General Chemistry.2016; 86(4): 939.     CrossRef
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Randomized Phase III Trial of Cisplatin, Epirubicin, Leucovorin, 5-Fluorouracil (PELF) Combination versus 5-fluorouracil Alone as Adjuvant Chemotherapy in Curative Resected Stage III Gastric Cancer
Jae Jin Lee, Si-Young Kim, Im sik Shin, Kyung Sam Cho, Hoong-Zae Joo, Choong Yoon, Yoon Wha Kim, Hwi Joong Yoon
Cancer Res Treat. 2004;36(2):140-145.   Published online April 30, 2004
DOI: https://doi.org/10.4143/crt.2004.36.2.140
AbstractAbstract PDFPubReaderePub
Purpose

The combination of cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) administration, as adjuvant chemotherapy after curative resection for gastirc cancer, was compared with 5-fluorouracil (5-FU) administration alone. This paper reports the results of a prospective randomized comparison of the two regimens, PELF and 5-FU.

Methods

From August 1996 to July 1999, 54 patients were selected subsequent to being diagnosed with stage III cancer after a curative resection for gastric cancer. The patients were stratified according to stage IIIA/IIIB and subtotal/total gastrectomy, and then they were randomized into each treatment group, i.e. the PELF or 5-FU alone groups.

Results

54 assessable patients were enrolled in this study: 28 received PELF and 26 received 5-FU alone. 12 patients relapsed in each group and the median follow-up duration was 42 months (range: 10~77 months). The overall survival rate and disease-free survival rate (DFS) were not significantly different between two groups, (5-year survival of PELF vs. 5-FU: 57% vs. 64%, 5-year DFS: 54% vs. 51%). The PELF combination was more toxic in terms of anemia, anorexia, nausea and diarrhea than the 5-FU.

Conclusions

This study showed that the PELF combination, as an adjuvant therapy for gastric cancer after a curative resection, was a less effective treatment, and it had more toxic effects than the 5-FU.

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    Tom van den Ende, Frank A. Abe Nijenhuis, Héctor G. van den Boorn, Emil ter Veer, Maarten C. C. M. Hulshof, Suzanne S. Gisbertz, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
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    Bora Lim, Gabriel N. Hortobagyi
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    Matthew P. Fox, Victor van Berkel
    Surgical Clinics of North America.2012; 92(5): 1199.     CrossRef
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Gemcitabine and Infusional 5-Fluorouracil in Advanced Pancreatic Cancer: A Clinical Benefit Response-Oriented Phase II Study
Jung Hye Choi, Myung Ju Ahn, Seock Ah Im, Bong Seog Kim, Ho Suk Oh, Heung Woo Lee, Yeung Chul Mun, Chu Myung Seong, Soon Nam Lee, Young Yeul Lee, Il Young Choi, In Soon Kim
Cancer Res Treat. 2003;35(3):213-217.   Published online June 30, 2003
DOI: https://doi.org/10.4143/crt.2003.35.3.213
AbstractAbstract PDF
PURPOSE
Gemcitabine and 5-fluorouracil (5-FU) are two compounds with reproducible activity against advanced pancreatic carcinomas. To evaluate the activity and feasibility of this combination chemotherapy, a multi-institutional phase II study was performed. MATERIALS AND METHODS: Twenty patients (male: female 15: 5, median age: 60.5 years), with histologically verified locally advanced or metastatic pancreatic carcinomas, were enrolled between April 2000 and March 2002. Gemcitabine was administered by intravenous injection at the doses of 1, 000 mg/m2 on days 1, 8 and 15, and 5-FU 800 mg/m2/day, was given by continuous intravenous infusion on days 1~5. The treatment was repeated every 4 weeks. The clinical benefit response (CBR) was a composite of the pain, Karnofsky performance status and body weight change measurement.
RESULTS
Nineteen of the twenty patients were assessable for response. The median follow-up duration was 4.6 months (0.4~15.2 months). Five patients achieved a partial response and eight a stable disease. The overall response rate was 25.0%. The CBR was assessable in 12 patients. The overall CBR was 41.7% (5/12). The median survival of all the patients was 8.0 months. Grade 3~4 toxicities included neutropenia (9.3%) and thrombocytopenia (5.3%). CONCLUSION: This study suggested that gemcitabine, combined with infusional 5-FU, was well tolerated, and produced modest antitumor activity and symptomatic relief in advanced pancreatic cancer patients.
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Retinoic Acid Enhances Drug-Induced Cell Death in Anticancer Drug-Resistant Cell Lines
Young Mi Whang, Yeul Hong Kim, Sang Won Shin, Byung Soo Kim, Jun Suk Kim, Young Do Yoo, Sun Hee Park
Cancer Res Treat. 2002;34(3):212-217.   Published online June 30, 2002
DOI: https://doi.org/10.4143/crt.2002.34.3.212
AbstractAbstract PDF
PURPOSE
Retinoids (RA), a group of vitamin A derivatives, is known to be important for regulation of normal cellular growth and differentiation. RA treatment of various cancers resulted in cell growth inhibition and apoptosis. Therefore, the chemotherapeutic and chemopreventative activities of various types of tumor have been examined. Biological actions of RA are mediated through nuclear receptors, including the retinoic acid receptors (RARs) and retinoid X receptors (RXRs). In this study, we examined the effect of all-trans-retinoic acid (atRA) as an anticancer drug-sensitiser in cancer cell lines and in its drug- resistant cancer cell lines MATERIALS AND METGODS: Cells were maintained by RPMI 1640 medium containing 10% fetal bovine serum. Cells were treated with 1 micro M atRA for 48 h, then with the desired concentration of anticancer drug for 24 h. Cell viability was measured spectrophotometrically at 540 nm using the MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide] assay. Western blot analyses were performed with the desired antibodies.
RESULTS
We investigated if pre-treatment with atRA enhanced the drug-sensitivity of various cancer cell lines to either 5-fluorouracil, adriamycin, or cisplatin. 5-FU (SNU638-F2) and CDDP-resistant cell (SNU638-Cis) lines, from a Korean gastric cancer cell line (SNU638) and the ADR-resistant cells (AD600) was established from a colon cancer cell line (SW620). Treatment of each cell line, with 1 micro M atRA, prior to drug exposure resulted in enhanced cell death in these cell lines. Furthermore, the effect of atRA on growth inhibition, in each drug-resistant cell line, was more obvious than in their parent cell lines. Increased activity of Transglutaminase II (TgaseII) and cleavage of Poly (ADP-ribose) polymerase (PARP) were also observed (western blot analysis CONCLUSION: Based on our data, we suggest that atRA enhances anticancer drug-induced cell death and reverses the drug-sensitivity of the drug-resistant cancer cell lines.
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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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The Inhibitory Effect of Amiloride on the Growth of Human Gastric Carcinoma Cells in Vitro
Seung Su Kang, Duck Kyung Kong, Chee Whan No, Byung Joo Choi, Moo In Park, Seun Ja Park, Keun Young Park, Ja Young Koo
J Korean Cancer Assoc. 2001;33(2):113-120.
AbstractAbstract PDF
PURPOSE
In the present study the effects of amiloride on the growth of human gastric adenocarcinoma cell line, AGS cells were examined with or without the addition of 5-fluorouracil (5-FU) in vitro.
MATERIALS AND METHODS
The growth of AGS cells was examined by counting number of cells on two and four days post-treatment with 50 micrometer, 100 micrometer, 200 micrometer, 400 micrometer, 800 micrometer, amiloride, and 0.1 microgram/ml, 0.3 microgram/ml 5-FU, after plating AGS cells into 6 well plates at a density of 10 x 10(4) cells/well. The reversibility of the effects of amiloride was examined on two to eight days post-treatment with 400 micrometer amiloride after seeding 2 x 10(4) cells/dish. Cell cycle analysis was performed after four day-treatment with 400 micrometer amiloride.
RESULTS
Amiloride (50~800 micrometer) significantly inhibited the growth of AGS in a dose-dependent fashion (p<0.05). The inhibitory effect of amiloride on growth of AGS was reversible since removal of amiloride after 24 hours treatment led to resumption of rapid growth up to control levels. Amiloride combined with 5-FU markedly inhibited the growth of AGS in a dose-dependent fashion compared to that of amiloride or 5-FU alone (p<0.05). The fraction of S phase, G0-G1 phase and G2-M phase was 19.3%, 55.7%, 18.8%, in the amioride group (400 micrometer) and 43.9%, 37.4%, 25.1% in the control group, respectively, showing significantly higher G1 fraction in amiloride group compared to control.
CONCLUSION
This is the first paper which reported that amiloride inhibited in vitro growth of human gastric adenocarcinoma cells and that its effect of growth inhibition may be synergistic with 5-FU. Amiloride given with or without 5-FU may be useful agent in the treatment of gastric carcinomas. The inhibitory effects of amiloride on the growth of AGS may be mediated in part by blocking G1-S transition of cell cycle.
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The Effect of Neoadjuvant Chemotherapy with 5-Fluorouracil (5-FU), Vinblastine and Cisplatin (FVP) for Stage III Non-Small Cell Lung Cancer (NSCLC)
Jung Il Won, Jong Ho Chun, Hyeong Jun Kim, Moon Suk Jo, Dong Kyu Kim, Young Tae Kwak, Jung Suk Kim, Soo Jeon Choi, Sung Rok Kim
J Korean Cancer Assoc. 1997;29(5):807-815.
AbstractAbstract PDF
PURPOSE
As the prognosis of stage III NSCLC is still poor with or without operation, we conducted a phase II trial of neoadjuvant chemotherapy (CHT) with 5-FU, vinblastine, cisplatin prior to surgery to determine the effect on resectability and survival.
MATERIALS AND METHOD
Patients (pt) received 5-FU 500mg/m2/12 hours continuous infusion for 36 hours, vinblastine 3mg/m2/day iv bolus day 1 and day 2, and cisplatin 75mg/m2 iv day 1 every 3 weeks. This regimen was given for 2 cycles. When the tumor was responsive (stable disease or better), 1 or 2 more cycles of the CHT were given, followed by operation when totally resectable on chest CT/MRI, then 3 more cycles of the CHT to finish the treatment; when the tumor was neither responsive nor resectable after 3rd or 4th CHT, radiotherapy was started.
RESULT
Twenty nine pt were enrolled and 26 pt have been evaluable so far. Age ranged from 32 to 79 (median 59 years); 23 were male, 3 female. Total of 108 cycles were given (mean 4.2). There were 4 partial remissions out of 6 IIIAs (67%) and 10 out of 20 IIIBs (50%), with overall response rate of 53.8%; down staging was noted in 9 patients (34.6%). 9 pt (34.6%) underwent curative resection successfully; 4 out of 6 IIIAs (67%) and 5 out of 20 IIIBs (25.0%); 1 patient refused operation. Median survival was 31.3 months for 9 pt with operation, and that of all patients was 14.2 months. Radiation was given to 9 pt, resulting in 3 partial remissions (PR), 3 stable diseases (SD), 3 progressive diseases (PD). Serious (WHO grade> or =3) toxicities were nausea/emesis in 2.8%, granulocytopenia in 26.9% and thrombocytopenia in 2.8%.
CONCLUSION
This treatment modality seemed to be effective, encouraging further phase III study for better determination of its role.
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Post-operative Adjuvant Chemotherapy with 5-Fluorouracil, Leucovorin, and Mitomycin C (MLF) for Gastric Cancer
Jong Ho Chun, Dong Kyu Kim, Moon Suk Jo, Hyeong Jun Kim, Jung Il Won, Sung Rok Kim, Hong Yong Kim
J Korean Cancer Assoc. 1997;29(5):791-799.
AbstractAbstract PDF
PURPOSE
The surgical resection has been still the only curative treatment modality for the gastric cancer, but the overall prognosis has not been so satisfactory because of high relapse rate. So the necessity of adjuvant chemotherapy has been increased. We evaluated the effect of MLF (5-fluorouracil, leucovorin and mitomycin C) regimen on the prevention of relapse and survival benefit after postopertive adjuvant chemotherapy.
MATERIALS AND METHOD
The MLF regimen consisted of 5-FU 375 mg/m2 IV on days 1 through 5; LV 20 mg/m2 IV just before 5-FU infusion on days 1 through 5; and MMC 9 mg/m2 IV on day 1 (7 mg/m2 from the 2nd cycle).
RESULTS
One hundred patients were entered into the trial; 56 were male & 44 female, and the range of age was 20 to 82. The total number of chemotherapy cycles was 514. According to AJCC staging, 4 cases were in stage IA, 14 IB, 23 II, 42 IIIA, 15 IIIB, respectively and 2 cases were in stage IV. The estimated median survival was 32 months in stage IIIA, and 28 months in IIIB. The 5 year survival was 90% in stage IB, 76% in II, 29.6% in IIIA and 21.8% in IIIB. Severe neutropenia (WHO grade > or = 3) was observed in 11.8%, and throbocytopenia 0.4%. Severe nausea and vomiting was observed in 1.8%, diarrhea in 1.7%, and mucositis in 1.5%, but there was no toxic death.
CONCLUSION
The MLF adjuvant chemotherapy may be effective for resectable gastric cancer with minimal toxicities, but phase III study is needed to confirm its efficacy.
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Effect of Paclitaxol, Cisplatin, and 5-Flurouracil Chemotherapy in Advanced Stomach Cancer
Yeul Hong Kim, Sang Won Shin, Byung Soo Kim, Jin Ho Kim, Jong Kuk Kim, Young Jae Mok, Jong Suk Kim, Chi Wook Song, Ho Sang Ryu, Jun Suk Kim, Jin Hai Hyun
J Korean Cancer Assoc. 1997;29(4):648-655.
AbstractAbstract PDF
PURPOSE
Paclitaxel has not been used widely in gastrointestinal cancers. However, a recent phase II report of paclitaxel in patients with esophageal adenocarcinoma has suggested a possible role of paclitaxel for the treatment of advanced gastric carcinoma. A phase II trial was initiated to determine the clinical utility of a 3 drug combination (paclitaxel, cisplatin, and 5-fluorouracil) in patients with advanced gastric carcinoma.
MATERIALS AND METHODS
Eligibility included biopsy-proven inoperable or relapsed adenocarcinoma of the stomach with adequate bone marrow, hepatic, and renal function. Patients received paclitaxel at 175 mg/m2 (3 hour infusion) on day 1 followed by cisplatin at 20 mg/m2/day infusion and 5-fluorouracil at 750 mg/m2/day continuous infusion for 5 days. Treatment has been repeated in every 4 weeks. Total 31 patients were enrolled; 7 had relapsed disease after resection and 5-fluorouracil based adjuvant chemotherapy, 5 had previous chemotherapy. Twenty-one patients had measurable disease and 9 were evaluable. Demographics included; median age, 47 years (range, 27~64 years); male: female, 21: 10; median performance status 2 (range, 0~4).
RESULTS
Major responses occurred in 16/30 (53%; 95% confidence interval, 35~71%) patients (2 complete responses, 14 partial responses); 13 of 21 (61.9%) patients with measurable disease and 3 of 9 (33%) evaluable patients. Median response duration was 17 weeks (range, 8~44+ weeks) and median time to progression was 20 weeks (range, 8~51+ weeks). Median survival was 27 weeks (range, 8~72+ weeks). WHO grade 3~4 toxicities included: neutropenia (61.9%), nausea/vomiting (23.8%), mucositis (19%), and diarrhea (9.5%). Grade 2~3 neurotoxicity, fluid retention syndrome, hypersensitive reaction had occurred in 6, 2, and 1 patients, respectively. There was 1 instance of treatment-related death due to sepsis.
CONCLUSION
This regimen was highly active in advanced gastric carcinoma and had moderate toxicity. However, the response duration was short like other regimens. Considering poor performance status of our patients, this regimen may have strong potential in the neoadjuvant setting.
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5-Fluorouracil, Leucovorin, Ifosfamide and Cisplatin (FLIP) Combination Chemotherapy for Adevanced Non-Small Cell Lung Cancer
Hyun Sik Jeong, Keunchil Park, Jung Ae Lee, Young Iee Park, In Sook Woo, Ki Suk Jung, Young Suk Park, Duk Jhe Shun, Won Seog Kim, Jeong A Kim, Sung Soo Yoon, Won Ki Kang, Hong Ghi Lee, Chan Hyung Park
J Korean Cancer Assoc. 1997;29(1):46-52.
AbstractAbstract PDF
PURPOSE
To evaluate the response rate and toxicity of combination chemotherapy including 5-fluorouracil (F), leucovorin (L), ifosfamide (I) and cisplatin (P) for the previously untreated patients with unresectable stage IIIB or IV non-small cell lung cancer.
MATERIALS AND METHOD
The doses of FLIP were 5-fluorouracil 800 mg/m2 CI days 1-5, leucovorin 20 mg/m2 IV days 1-5, ifosfamide 1000 mg/m2 CI days 1-3, cisplatin 100 mg/m2 IV day 1 respectively. Cycles were repeated every 3 weeks until disease progression. Seventy-three previously untreated patients were enrolled. Age ranged from 30 to 73 (median 56 years); 43 were male, 30 female. Fifty-three patients had performance status (ECOG) 0-1 and 19 performance status 2. Twenty-two patients had stage IIIB and 51 stage IV. Follow-up ranged from 7+ to 160weeks (median 57 weeks).
RESULTS
The overall response rate was 46.7% for 62 evaluable patients. (CR 1 patient, PR 28 patients) Median response duration was 24 weeks (range 1+ to 36+ weeks). Toxicity > Grade II (WHO) included: granulocytopenia 19.8%, anemia 13.5%, nausea and vomiting 31.5% stomatitis 46.5%, neuropathy 24.6%.
CONCLUSION
FLIP chemotherapy was comparable to other combination chemotherapy for advanced non-small cell lung cancer with moderate toxicities.
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The Combined Effects of 5 - Fluorouracil and Recombinant Interferon - gamma on Human gastric Cancinoma Cell Lines
Heung Tae Kim, Jae Gahb Park, Jin Pok Kim, Seong Hoe Park, Noe Kyeong Kim
J Korean Cancer Assoc. 1990;22(3):458-476.
AbstractAbstract PDF
Stomach cancer is a leading malignant disease in many countries. Conventional combination chernotherapy approaches to advanced gastric cancer only produce paitial response and there has been no impact on patient survival from these approaches as well. Of several promising new approaches the combination of interferon (IFN) and chemotherapeutic agents are now being made to improve the effectiveness for the treatment of cancer. Preclinical studies suggested that IFN may biochemically modulate the cellular uptake or metabolism of 5-fluorouracil (5-FU) resulting in s synergistic antitumor effect. Based on these data, Wadler reparted a promising result with combina- tion of 5-FU and IFN-alpha in patients with advanced colorectal carcinoma. This study was conducted to investigate the combined effects af 5-FU and recombinant IFN- gamma at cellular level against four gastric carcinoma cell lines (SNU-1, SNU-5, SNU-16, and NCI-NB7). We used a semiautomated tetrazolium-based colorimetric (MTT) assay for cytotoxicity and an isobologram analysis to evaluate the effect of the combination. The experiment was perfor- med three times on each of the three cell lines. Only two experirnents for SNU-16 and NCI-N87 showed supraadditivity (p< 0.02). On isobologram plotted by the mean value of three experiments for each cell line, supraadditivity was suggested for only SNU-16 (p = 0.055). In conclusion, our result did not document in vitro synergy between 5-FU and IFN-gamma for gastric carcinoma cell lines but additivity within clinically achievable dose range. Because in vivo immunomodulatory effect of IFN-gamma on host is more important rather than antiproliferative effect, the combination of 5-FU and IFN gamma is expected to improve the treatment of advanced gastric cancer.
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Significance of Serum Total Lactate Dehydrogenase ( LDH ) Level and Isoenzyma Patterns in Non - Hodgkin's Lymphoma as a Prognostic Factor
Jee Sook Hahn, Hyun Cheol Chung, Joo Hang Kim, Sun Ju Lee, Eun Hee Koh, Jae Kyung Roh, Hyon Suk Kim, Yun Woong Ko, Byung Soo Kim
J Korean Cancer Assoc. 1990;22(3):476-490.
AbstractAbstract PDF
Serum total lactate dehydrogenase (LDH) and LDH isoenzyme activities were studied in 33 cases w i th non-H odgk in's lymphom a to compare the cl inical significance of serological staging with these two serological markers to anatomical staging. Serum total LDH activity correlated with tumor burden as determined by clinical stage at presentation. Initially, LDH-3 was the major fraction of increment for the reflection of increased serum total LDH activity. With the increment of tumor burden (total LDH >200 IU/L), LDH-3 with additional LDH-4 fraction increased, which resulted in LDH-1/LDH-3 flipped pattern. These changes were normalized if complete remission state was induced with treatment. A high pretreatment LDH level (total LDH> 200 IU/L) correlated significantly to a decreased survival rate IP.0.01l> Furthermore, the flip pattern of LDH-I/LDH-3 isoenzyme at diagnosis showed a decreased survival rate (p<0.05), in which 4-year survival rate of patients with non-flipped pattern was 73.8%, comparable to 25.4%; of patients with flippd pattern. The 4-year survival rate of the low risk group Itotal LDH 200 IU/L with unftipped pattern: serological stage A) was 73g while 2-year survival rate of the high risk group (total LDH>200 IU/L withflipped pattern: serological stage D) was 0%, which showed a significant difference (p<0.05). Stepwise Cox regression analysis to identify the important prognostic factors among the serum total LDH, LDH1/LDH-3 flip, serological stage, anatomical stage, B symptoms, cell type, hepatos- plemomegaly, mediastinal mass reveated that the serological stage was the only prognostic factor. In conclusion, based on results of the multivariate analysis, we propose a new prognostic classification of patients with serological staging system in non-Hodgkins lymphoma. Furthermore, the reproducibility and therapeutic stratigies will be warranted.
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A Phase 2 Study on Combined 5 - Fluorouracil , Etoposide , Doxorubicin and Cisplatin ( F - EAP ) in Patients with Advanced Gastric Cancer
J Korean Cancer Assoc. 1994;26(1):9-16.
AbstractAbstract PDF
5-Fluorouracil(5-FU), as a single agent, has a modest but reproducible activity against gastric cancer and continuous infusion of 5-FU is associated with less myelosuppresion. It has been reported that combination of etoposide, doxorubicin, and cisplatin(EAP) was very active in advanced gastric carcinoma with an overall response rate of 64% including 21% complete response from the German investigators. A phase II study of the combination of 5-FU infusion, etoposide, doxorubicin and cisplatin(F-EAP), which regimen has been demonstrated to have the different mechanisms of action and synergism between each of drugs in vitro and in vivo, was performed in attempts to evaluate the antitumor activity in patients with advanced gastric cancer. Fifty-five previously untreated patients with surgically unreasectable or metastatic advanced gastric adenocarcinoma were treated with 5-FU(800 mg/m, days 2, 3, and 4), etoposide(70 mg/m, days 2, 3, and 4), doxorubicin(30 mg/m, day 1), and cisplatin(60 mg/m(2), day 1) repeated every 26 days. Objective responses were observed in 14 of 47(30%) evaluable patients, and the median duration of response was 21 weeks(l3~60+ ). The median survival time of 47 evaluable patients was 40 weeks(16~62). F-EAP therapy was associated with mild myelosuppression. The common non-hematologic toxieities were nausea/vomiting(94%), mucositis(32%), peripheral neuropathy (15%), and infection(11%), but the majority of these toxicities were mild to moderate and well tolerated. These results suggest that F-EAP regimen has a modest antitumor activity in terms of response rate and duration of response, and is relatively well tolerated in advanced gastric cancer.
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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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5-Fluorouracil , Ifosfamide and Cisplatin ( FIP ) Combination Chemotherapy for Advanced Non - Small Cell Lung Cancer
Young II Seo, Yougn Suk Park, Jae Myung Lee, Jo Young Choi, Hyun Soo Kim, Byung Dong Cho, Yu Mi Seo, Yun Chang Han, Ho joong Kim, In Gyu Hyun, Ki Suk Shun, Keun Chil Park, Duk Jhe Shun
J Korean Cancer Assoc. 1995;27(2):284-292.
AbstractAbstract PDF
We conducted a phase II trial of combining 5-fluorouracil(5-FU), ifosfamide(IFM), and cisplating(DDP) in previously untreated patients with advanced, unresectable, non-small cell lung cancer(NSCLC). Each cycle consisted of 5-FU 100 mg/m i. v. days 1-5, IFM 1000 mg/m i. v. days 1-3 with mesna, and DDP 100 mg/m i. v. day 1. Cycles were repeated at 3 week intervals. Twenty eight patients were enralled. Age ranged from 36 to 73(median 57 yearsk 24 were male, 4 female. Eleven patients had stage IIIb disease and 17 stage IV. Two patients were not evaluable because of lost to follow up. None had a complete response, 13 patients(50%) had par- tial responses, 8(31%) had stable diseases, and 5(19%) had progressive disesses. The median response duration was 11.2 weeks; the median time to progression was l2 weeks. The overall median survival was 19 weeks(27.5 weeks for responders, 12.8 weeks for non-responders). Majar side effects were alopecia, nausea/vomiting and stomatitis, all of which were we11 tolerated and reversible. By univariate analysis, stage and performance status correlated with time to progression and overall survival time. In conclusion, FIP combination chemotherapy for patients with advanced, unresectable non- small cell lung cancer seems to be an effective and well-tolerated regimen.
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Adjuvant Chemotherapy with ' 5-Fluorouracil Plus Low - dose Leucovorin Following Surgical Resection of Stage 2 , 3 Colon Cancer
Je Hwan Lee, Tae Won Kim, Jong Soo Choi, Dai Young Zang, Ho Young Pyun, Sung Bae Kim, Sang We Kim, Cheol Won Suh, Kyoo Hyung Lee, Jung Shin Lee, Woo Kun Kim, Sang Hee Kim, Jin Cheon Kim, Suk Koo Kim
J Korean Cancer Assoc. 1995;27(5):846-857.
AbstractAbstract PDF
Obtivea: About seventy-five percent of the individuals with colon cancer will have a primary surgical resection with the hope of complete tumor eradication. Despite the high resectability rate and a general improvement in therapy, nearly half of all patients with colon cancer still die of metastatic tumor. Over the past three decades, many clinical studies have failed to demonstrate benefits from adjuvant therapy. Recently, new data from several studies have demonstrated delays in tumor recurrence and increases in survival for specific groups of patients. The objective of this study was to evaluate the effective- ness of 5-fluorouracil(5-FU) and low-dose leucovorin in reducing the recurrence rate and improving the survival of the patients with surgically resected colon cancer in stage II and III. Methods: One hundred and fifty six with surgically resected colon cancer in stage II and 1II from Nov 1989 to Dec 1993 were included in this study and were divided into two groups. First group(LF arm) included eighty five Patients who received combination chemotherapy of '5-FU and low-dose 1eucovorin' following resection of colon cancer, and second group(control arm) included seventy one patients who received only oral UFT or no adjuvant treatment. '5-FU and low-dose leucovorin' chemotherapy consisted of leucovorin 20 mg/m(2), intravenously, plus 5-FU 400 mg/m(2), intravenously, on days 1-5 every 4 weeks for 6 cycles. Results: I) There were significantly more recurrences and distant failure in control arm than LF arm. 2) The estimated 4-year disease-free survival was 82.5% in LF arm and 59.8% in control arm(p = 0.007). 3) The estimated 4-year overall survival was 94.3% in LF arm and 63.9% in control arm (p = 0.001). 4) The survival differences between LF arm and control arm were significant in stage II and III respectively. 5) Number of metastatic lymph nodes, histologic differentiation, and whether or not pa- tients received 5-FU/leucovorin chemotherapy, were each found to have prognostic significance. Concluslon: This study strongly suggests that 5-FU and low-dose leucovorin adjuvant chemotherapy is effective in patients with surgically resected stage II and III colon cancer.
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Neoadjuvant Chemotherapy with 5-Fluorouracil and Cisplatin for Locally Advanced Head and Neck Cancer
Ji Hoon Park, Hwan Suk Choi, Jeong Hee Kim, Si Young Kim, Hwi Joong Yoon, Kyung Sam Cho, Seong Eon Hong, Dong Mok Ryu, Hoe Young Ahn
J Korean Cancer Assoc. 1995;27(6):990-1002.
AbstractAbstract PDF
Background
The prognosis for patients with locally advanced head and neck cancer remains poor. In recent years, attempts at improving the poor survival rates have frquently focused on the initial use of chemotherapy followed by subsequent standard local therapy with surgery and radiation. Methods: Twenty-seven patients with previously untreated, locally advanced (stage III or IV) head and neck cancer were treated with 2 or 3 cycles of combination chemotherapy consisting of 5-fluorouracil infusion and cisplatin followed by operation or radiotherapy between January,1988 and March,1994. Results: 1) After the neoadjuvant FP chemotherapy, sixteen of 27 patients(59.2%) demonstrated an objective response, with one(3.7%) achieving a complete clinical response(CR) and fifteen(55.5%) a partial response(PR). After the definitive local therapy(DLT:operation or radiation therapy), 12(44.4%) patients had a CR and 12(44.4%) achieved PR, respectively with 88.8% overall response rates. 2) Twelve patients received operation and 15 patients received radiotherapy after the neoadjuvant chemotherapy. Among 12 patients who received operation, seven(58%) patients achieved curative resection with surgery and five(33%) patients a complete remission, seven patients(46.7%) a partial remission with radiotherapy. 3) The overall median survival of total 27 patients was 31 months. The median survival of the responders (median:54 months) to FP chemotherapy was not significantly prolonged compared with nonresponders(median:23 months). 4) Time to disease progression of the responders to definite local therapy was 19 months. 5) Leukopenia and thrombocytopenia were observed in 48%(grade I-III) and l0%(grade I- II) respectively. Nausea and vomiting were observed in all patients, but easily controlled. Alopecia, diarrhea, stomatitis and nephrotoxicity were observed infrequently. There were no treatment related fatalities. Conclusion: Neoadjuvant FP chemotherapy in patients with locally advanced head and neck cancer was tolerable, but did not improve the response rate and overall survival compared with previous other reports. The phase III randomized controlled prospective studies are warranted for the verification of this study
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Cancer Res Treat : Cancer Research and Treatment
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