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Randomized, Multicenter, Phase III Trial of Heptaplatin 1-hour Infusion and 5-Fluorouracil CombinationChemotherapy Comparing with Cisplatin and 5-Fluorouracil Combination Chemotherapy in Patients withAdvanced Gastric Cancer

Cancer Research and Treatment 2009년 41권 1호 p.12 ~ p.18

이경희(Lee Kyoung-Hee) - 영남대학교 의과대학 내과학교실
진종율(Jin Jong-Youl) - 가톨릭대학교 의과대학 성가병원 혈액내과
현명수(Hyun Myung-Soo) - 영남대학교 의과대학 내과학교실
임창열(Yim Chang-Yeol) - 전북대학교 의과대학 내과학교실
이순남(Lee Soon-Nam) - 이화여자대학교 의과대학 내과학교실
임호영(Lim Ho-Yeong) - 성균관대학교 의과대학 삼성서울병원 혈액종양내과
박희숙(Park Hee-Sook) - 순천향대학교 의과대학 내과학교실
류헌모(Ryoo Hun-Mo) - 대구가톨릭대학교 의과대학 내과학교실
김준석(Kim Jun-Suk) - 고려대학교 구로병원 내과
손창학(Sohn Chang-Hak) - 인제대학교 의과대학 부산백병원 혈액종양내과
김훈교(Kim Hoon-Kyo) - 가톨릭대학교 의과대학 성빈센트병원 내과학교실
양진모(Yang Jin-Mo) - 가톨릭대학교 의과대학 내과학교실
정주섭(Chung Joo-Seop) - 부산대학교 의과대학 내과학교실
도영록(Do Young-Rok) - 계명대학교 의과대학 동산의료원 내과
송홍숙(Song Hong-Suk) - 계명대학교 의과대학 동산의료원 내과
진형민(Jin Hyung-Min) - 가톨릭대학교 성빈센트병원 내과학교실

Abstract

Purpose:Heptaplatin (Sunpla) is a cisplatin derivative. A phase IIb trial using heptaplatin resulted in a34% response rate with mild nephrotoxicity. We conducted a randomized phase III trial ofheptaplatin plus 5-FU compared with cisplatin plus 5-FU in patients with advanced gastriccancer.

Materials and Methods:One hundred seventy-four patients (heptaplatin, n=88; cisplatin, n=86) from 13 centers wereenrolled. The eligibility criteria were as follows: patients with pathologically-provenadenocarcinoma, chemonaive patients, or patients who had received only single adjuvantchemotherapy, and who had a measurable or evaluable lesion. On day 1, heptaplatin (400mg/m2) or cisplatin (60 mg/m2) was given over 1 hour with 5-FU (1 gm/m2) on days 1∼5 every 4weeks.

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 FHpatients, 34.2% (complete response [CR], 1.3%; partial response [PR], 32.9%) experienced aconfirmed 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 theFP 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 andp=0.05, respectively). The incidence of increased proteinuria and creatininemia was higherwith 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 gastriccancer patients with tolerable toxicities.