A Phase II Trial of Haptaplatin/5-FU and Leucovorin for Advanced Stomach Cancer
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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.
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 medianresponse 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 Iproteinuria 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 advancedstomach cancer.
참고문헌 (16)
- "Cancer of the stomach principles and practice of oncology", pp.1092~126 (2001), Lippincott-Raven
- "Annual report of the central cancer registry in Korea - 1999:Based on registered data from 128 hospitals", 33, pp.367~72 (2001)
- "Results of immunochemo-surgery forgastric carcinoma", 48, pp.1227~30 (2001)
- "A phase II study of combined 5-fluorouracil andcisplatin in the treatment of advanced upper gastrointestinaladenocarcinomas", pp.1053~7 (1986)
- "Combination chemotherapy with cisplatin and5-fluorouracil 5-day infusion in the therapy of advanced gastriccancer:a phase II trial", 2, pp.751~4 (1991)
- "A phase III randomized study of 5-fluorouracil and cisplatinversus 5-fluorouracil,doxorubicin,and mitomycin C versus5-fluorouracil alone in the treatment of advanced gastriccancer", 71, pp.3813~8 (1993)
- platinum(II) a new platinumanalogue, as an anticancer agent, , 1995, 441~5
- "In vitro cytotoxicity, pharmacokinetics and ex vivo pharmacodynamicsof a new platinum compound, cis-malonato [(4R,5R-4,5-bis(aminomethyl)-1,3-dioxolane-2-spiro-1'-cyclopentane)platinum (II).", 16, pp.251~6 (1996)
- "Phase II clinical trial of SKI-2053R,a new platinum analog,in the treatment of patients with advanced gastric adenocarcinoma", 86, pp.1109~15 (1999)
- "A phase II study of combined 5-fluorouracil andcisplatin in the treatment of advanced upper gastrointestinaladenocarcinomas", pp.1053~7 (1986)
- "Optimal two-stage designs for phase II clinical trials", pp.1~10 (1989)
- "Weekly high-dose 5-fluorouracil (5-FU) leucovorin(LV) and bimonthly cisplatin in patients with advanced gastriccancer", 31, pp.605~9 (2001)
- "Phase II study of oxaliplatin, 5-fluorouracil and leucovorinin previously platinum-treated patients with advanced gastriccancer.", 14, pp.383~7 (2003)
- "Phase II trial of biweeklyinfusional fluorouracil,folinic acid,and oxaliplatin in patientswith advanced gastric cancer", 15, pp.658~63 (2004)
- "Nephrotoxicity of heptaplatin:a randomizedcomparison with cisplatin in advanced gastric cancer", 50, pp.104~10 (2002)
- "Pilot study of heptaplatin UFT-E and leucovorin in advancedgastric carcinoma", 35, pp.117~22 (2003)