계명대학교 의학도서관 Repository

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

Metadata Downloads
Author(s)
Kyung Hee LeeMyung Soo HyunHoon-Kyo KimHyung Min JinJinmo YangHong Suk SongYoung Rok DoHun Mo RyooJoo Seop ChungDae Young ZangHo-Yeong LimJong Youl JinChang Yeol YimHee Sook ParkJun Suk KimChang Hak SohnSoon Nam Lee
Keimyung Author(s)
Song, Hong SukDo, Young Rok
Department
Dept. of Internal Medicine (내과학)
Journal Title
Cancer Research and Treatment
Issued Date
2009
Volume
41
Issue
1
Abstract
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.

Key words: Combination chemotherapy, Advanced gastric cancer, Heptaplatin
Keimyung Author(s)(Kor)
송홍석
도영록
Publisher
School of Medicine
Citation
Kyung Hee Lee et al. (2009). 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. Cancer Research and Treatment, 41(1), 12–18. doi: 10.4143/crt.2009.41.1.12
Type
Article
ISSN
1598-2998
DOI
10.4143/crt.2009.41.1.12
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/35351
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
공개 및 라이선스
  • 공개 구분공개
파일 목록

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.