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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
  • Recent Advances on Pt-Based Compounds for Theranostic Applications
    Giulia Ferrari, Ines Lopez-Martinez, Thomas Wanek, Claudia Kuntner, Diego Montagner
    Molecules.2024; 29(15): 3453.     CrossRef
  • Hallmarks of anticancer and antimicrobial activities of corroles
    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
    Coordination Chemistry Reviews.2022; 472: 214790.     CrossRef
  • 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
  • Pt(IV) Prodrugs with NSAIDs as Axial Ligands
    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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A Phase II Trial of Haptaplatin/5-FU and Leucovorin for Advanced Stomach Cancer
Won Sup Lee, Gyeong-Won Lee, Hwal Woong Kim, Ok-Jae Lee, Young-Joon Lee, Gyung Hyuck Ko, Jong-Seok Lee, Joung Soon Jang, Woo Song Ha
Cancer Res Treat. 2005;37(4):208-211.   Published online August 31, 2005
DOI: https://doi.org/10.4143/crt.2005.37.4.208
AbstractAbstract PDFPubReaderePub
Purpose

Heptaplatin (SKI-2053 R) is a new platinum analogue, with a better toxicity profile than cisplatin, and has antitumor activity even in cisplatin resistant cell lines. 5-fluoruracil (5-FU) has shown synergy with platinum compounds. This phase II trial was designed to determine the efficacy and toxicities of heptaplatin/ 5-FU (5-fluorouracil) for treating stomach cancer.

Materials and Methods

Thirty-two patients with advanced, measurable gastric adenocarcinomas were enrolled in this trial. The treatment consisted of heptaplatin, 400 mg/m2/day (1 hour IV infusion), on day 1 and 5-FU, 800 mg/m2/day (12 hours IV infusion), on days 1 to 5. The cycles were repeated every 3 weeks.

Results

Of the 26 evaluable patients, 9 had partial responses and 1a complete response (overall response rate, 38%; 95% confidence interval, 19~57%). The median response duration was 23 weeks (range: 4~60 weeks). The median time to progression was 26 weeks (range: 3~68 weeks). The grades III-IV toxicities were mostly hematological toxicities: leucopenia was observed in 11 patients (35%) and thrombocytopenia 4 (13%). No definite neuropathy was observed. Grade I-II nephropathy was also noted: grade I high BUN/creatinine levels occurred in 5 patients (16%), grade II proteinuria 2 (6%), grade I proteinuria 5 (16%). Neutropenic fever developed in 5 patients (16%) and 1 died of pneumonia in a neutropenic state.

Conclusion

This study suggests that the regimen of Heptaplatin/5-FU should be effective and have a favorable toxicity profile for the patients suffering with advanced stomach cancer.

Citations

Citations to this article as recorded by  
  • Cisplatin Resistance in Cancer Therapy: Causes and Overcoming Strategies
    S. Shruthi, K. Bhasker Shenoy
    ChemistrySelect.2024;[Epub]     CrossRef
  • 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
  • The extract of Paris polyphylla exerts apoptotic induction and synergic antiproliferative effect with anticancer drugs in SMMC-7721 human liver cancer cells
    Jing Sun, Bao-rui Liu, Jia Wei, Xiao-ping Qian, Li-xia Yu, Ren-hua Guo, Hua Shen, Tong-shan Wang, Yong-qian Shu
    Biomedicine & Preventive Nutrition.2011; 1(3): 186.     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
  • Prognostic value of expression of ERCC1, thymidylate synthase, and glutathione S-transferase P1 for 5-fluorouracil/oxaliplatin chemotherapy in advanced gastric cancer
    H.-C. Kwon, M.S. Roh, S.Y. Oh, S.-H. Kim, M.C. Kim, J.-S. Kim, H.-J. Kim
    Annals of Oncology.2007; 18(3): 504.     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
  • 7,920 View
  • 51 Download
  • 2 Crossref
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Pilot Study of Heptaplatin, UFT-E and Leucovorin in Advanced Gastric Carcinoma
Sang Cheul Oh, So Young Yoon, Jae Hong Seo, Chul Won Choi, Byung Soo Kim, Sang Won Shin, Yeul Hong Kim, Si Young Kim, Hwi Joong Yoon, Kyung Sam Cho, Jun Suk Kim
Cancer Res Treat. 2003;35(2):117-122.   Published online April 30, 2003
DOI: https://doi.org/10.4143/crt.2003.35.2.117
AbstractAbstract PDF
PURPOSE
Heptaplatin (SKI-2053R, Sunpla ), a new platinum analogue which has a better toxicity profile than cisplatin, has been used with 5-fluorouracil (5-FU) continuous infusion for the treatment of advanced gastric carcinoma. However, continuous 5-FU infusion had a inconvenience to administration. The aim of this study was to evaluate the efficacy and toxicity of heptaplatin, UFT-E and leucovorin combination chemotherapy in advanced gastric cancer.
MATERIALS AND METHODS
A total of 22 patients was enrolled in this study at Kyung Hee University and Korea University from September 1999 to May 2001. Heptaplatin 400 mg/m2 was given as intravenous infusion for 1 hour at day 1. Oral UFT-E 360 mg/m2 and leucovorin 45 mg/day were administered for 21 consecutive days followed by a 7-day drug free interval. This schedule was repeated every 4 weeks. RESULTS: The 22 enrolled patients received 81 courses of chemotherapy and the median number of course per patient was three with a range of one to six. Five of 21 patients achieved partial responses (23.8%; 95% confidence interval, 5.6% to 42%) without complete response. Out of the 5 responding patients, three had unresectable perigastric lymph-nodes, one patient had a ovarian metastasis, and one patient had a peritoneal metastasis respectively. Main toxicities were neutropenia and nausea/vomiting. Grade 3 and 4 neutropenia were observed in 4 patients (18%) and grade 3 nausea/vomiting were observed in 5 patients (22.7%). The median time to progression was 4 months (range, 0.5 to 13 months), and median survival duration was 7.5 months (range, 2.0 to 14 months). Median response duration was 5.0 months (range, 1.5 to 10 months). CONCLUSION: A combination chemotherapy of heptaplatin, UFT-E and leucovorin has a comparable efficacy with those of previously reported heptaplatin and intravenous regimen of 5-FU and controllable toxicity in advanced gastric carcinoma. Further study with large patient population is warranted to determine the usefulness of this regimen.

Citations

Citations to this article as recorded by  
  • Platinum drugs: from Pt(II) compounds, Pt(IV) prodrugs, to Pt nanocrystals/nanoclusters
    Xi Hu, Fangyuan Li, Nabila Noor, Daishun Ling
    Science Bulletin.2017; 62(8): 589.     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
  • A Phase II Trial of Haptaplatin/5-FU and Leucovorin for Advanced Stomach Cancer
    Won Sup Lee, Gyeong-Won Lee, Hwal Woong Kim, Ok-Jae Lee, Young-Joon Lee, Gyung Hyuck Ko, Jong-Seok Lee, Joung Soon Jang, Woo Song Ha
    Cancer Research and Treatment.2005; 37(4): 208.     CrossRef
  • 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 Research and Treatment.2004; 36(3): 182.     CrossRef
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  • 4 Crossref
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Phase I and Pharmacokinetic Study of Intraoperative Intraperitoneal Heptaplatin in Patients with Surgically Resected Advanced Gastric Cancer
Wansik Yu, Ho Young Chung, So Hyang Park, Yong Baik Cho, Yang Soo Lim
Cancer Res Treat. 2003;35(1):25-29.   Published online February 28, 2003
DOI: https://doi.org/10.4143/crt.2003.35.1.25
AbstractAbstract PDF
PURPOSE
Heptaplatin, a new platinum analog, has favorable toxicity profiles and antitumor activity, comparable to those of cisplatin, in the treatment of gastric cancer. This study was designed to define the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and pharmacokinetics of heptaplatin administered by an intraperitoneal route in patients with resected advanced gastric cancer. MATERIALS AND METHODS: Seventeen patients with resected advanced gastric cancer were entered onto the study. After completion of a curative resection and an astomosis, heptaplatin was administered intraperiton eally in one liter of 5% dextrose solution. The starting heptaplatin dose was 400 mg/m2 of the body surface area, and was escalated in 200 mg/m2 increments, to cohorts of three patients. A pharmacokinetic analysis was carried out to determine the total and ultrafiltratable platinum concentrations in the plasma, peritoneal fluid, and urine. RESULTS: Patients were unable to tolerate a 1, 000 mg/m2 dose level, and at 800 mg/m2, reVersible Grade III toxic ities, including elevated creatinine, proteinuria, hypon- atremia, abdominal pain, and intraabdominal bleeding were noted. No significant toxicity was noted up to a 600 mg/m2 dose level. The ratio of the peak peritoneal to peak plasma drug concentrations were 19.4, 16.6 and 22.8 at doses of 400 mg/m2, 600 mg/m2 and 800 mg/m2, respectively. The pharmacological advantage, expressed as the peritoneal to plasma AUC ratio ranged from 4.3 to 7.0. CONCLUSION: Heptaplatin can be delivered by an intra peritoneal route, with both an acceptable toxicity profile and a major pharmacokinetic advantage for cavity exposure. The MTD of intraperitoneal heptaplatin was 800 mg/m2. The major DLTs were nephrotoxicity and intraabdominal bleeding. The recommended starting dose for a subsequent study would be 600 mg/m2.
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