논문검색
Author 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
Place of duty Departments of 1Internal Medicine, 2Surgery, 3Pathology and 4Institute of Health Science, College of Medicine, Gyeong-Sang National University, Jinju, Korea.
Title A Phase II Trial of Haptaplatin/5-FU and Leucovorin for Advanced Stomach Cancer
Publicationinfo Cancer Res Treat. 2005 Aug; 037(04): 208-211.
Key_word Stomach neoplasms,Heptaplatin (SKI-2053 R),5-FU,Chemotherapy
Full-Text
Abstract 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. (Cancer Res Treat. 2005;37:208-211)