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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
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Abstract
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ePub 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.
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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
- The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
- 12,120 View
- 114 Download
- 26 Crossref
- Oxaliplatin/5-FU without Leucovorin Chemotherapy in Metastatic Colorectal Cancer
- Byoung Yong Shim, Kang Moon Lee, Hyeon-Min Cho, Hyun Jin Kim, Hong Joo Cho, Jinmo Yang, Jun-Gi Kim, Hoon-Kyo Kim
- Cancer Res Treat. 2005;37(4):212-215. Published online August 31, 2005
- DOI: https://doi.org/10.4143/crt.2005.37.4.212
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Abstract
PDFPubReaderePub
Purpose Fluorouracil (5-FU) and leucovorin combination therapy have shown synergistic or additive effect against advanced colorectal cancer, but the frequency of mucositis and diarrhea is increased. Most previous studies have used high dose leucovorin (300~500 mg/m2). However, some studies of oxaliplatin and 5-FU with low-dose or high-dose leucovorin in Korea have shown similar response rates. Therefore, we studied the necessity of leucovorin and evaluated the objective tumor response rates and toxicities of a regimen of oxaliplatin and 5-FU without leucovorin every 2 weeks in metastatic colorectal cancer patients.
Materials and Methods Twenty-four patients with metastatic colorectal cancer were enrolled between January 2002 and March 2003. Patients received 85 mg/m2 of oxaliplatin on day 1, a bolus 5-FU 400 mg/m2 on day 1 and a continuous 5-FU infusion at 600 mg/m2/ 22 hours days 1 and 2, every 2 weeks.
Results Of the 24 patients treated, 17 patients received previous 5FU with leucovorin and/or other chemotherapy. Three patients could not be evaluated. Five partial responses were observed with overall response rate of 21% (n=24). Of the previous chemotherapy group (n=17), 4 partial responses were observed with response rate of 24%. Median overall survival was 18 months (range 4~32 months) and median progression free survival was 4 months (range 2~6 months). This regimen was well tolerated and only 1 grade 3 anemia was observed.
Conclusion Oxaliplatin/5-FU combination therapy without leucovorin achieved a relatively high response rate even in patients resistant to the previous 5-FU chemotherapy, and toxicity was minimal.
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Citations
Citations to this article as recorded by- Clinicopathological Features and Oncological Outcomes of Early and Late Recurrence in Stage III Colorectal Cancer Patients after Adjuvant Oxaliplatin-Based Therapy
Yu-Tang Chang, Hsiang-Lin Tsai, Yen-Cheng Chen, Ching-Chun Li, Ching-Wen Huang, Po-Jung Chen, Wei-Chih Su, Tsung-Kun Chang, Yung-Sung Yeh, Tzu-Chieh Yin, Jaw-Yuan Wang, Weiren Luo
Journal of Oncology.2023; 2023: 1. CrossRef - Targeting the SPHK1/HIF1 Pathway to Inhibit Colorectal Cancer Stem Cells Niche
Saeideh Gholamzadeh Khoei, Hamid Sadeghi, Fateme Karimi Dermani
Journal of Gastrointestinal Cancer.2020; 51(2): 716. CrossRef - Efficacy of 5-FU or Oxaliplatin Monotherapy over Combination Therapy in Colorectal Cancer
Maria Toloudi, Panagiotis Apostolou, Ioannis Papasotiriou
Journal of Cancer Therapy.2015; 06(04): 345. CrossRef - Gene Expression Changes in Colorectal Cancer during Metronomic Chemotherapy and High-Concentration Drug Administration
Panagiotis Apostolou, Maria Toloudi, Irene Kalliara, Vasiliki Kipourou, Ioanna Tourna, Ioannis Papasotiriou
Journal of Cancer Therapy.2015; 06(08): 679. CrossRef
- Clinicopathological Features and Oncological Outcomes of Early and Late Recurrence in Stage III Colorectal Cancer Patients after Adjuvant Oxaliplatin-Based Therapy
- 10,048 View
- 45 Download
- 4 Crossref
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