A Phase II Trial of Haptaplatin/5-FU and Leucovorin for Advanced Stomach Cancer.
- Author:
Won Sup LEE
1
;
Gyeong Won LEE
;
Hwal Woong KIM
;
Ok Jae LEE
;
Young Joon LEE
;
Gyung Hyuck KO
;
Jong Seok LEE
;
Joung Soon JANG
;
Woo Song HA
Author Information
1. Department of Internal Medicine, College of Medicine, Gyeong-Sang National University, Jinju, Korea. lwshmo@hanmail.net.
- Publication Type:Original Article
- Keywords:
Stomach neoplasms;
Heptaplatin (SKI-2053 R);
5-FU;
Chemotherapy
- MeSH:
Adenocarcinoma;
Cell Line;
Cisplatin;
Drug Therapy;
Fever;
Fluorouracil;
Humans;
Leucovorin*;
Platinum;
Platinum Compounds;
Pneumonia;
Proteinuria;
Stomach Neoplasms*;
Stomach*;
Thrombocytopenia
- From:Cancer Research and Treatment
2005;37(4):208-211
- CountryRepublic of Korea
- Language:English
-
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.
