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.
- Author:
Kyung Hee LEE
1
;
Myung Soo HYUN
;
Hoon Kyo KIM
;
Hyung Min JIN
;
Jinmo YANG
;
Hong Suk SONG
;
Young Rok DO
;
Hun Mo RYOO
;
Joo Seop CHUNG
;
Dae Young ZANG
;
Ho Yeong LIM
;
Jong Youl JIN
;
Chang Yeol YIM
;
Hee Sook PARK
;
Jun Suk KIM
;
Chang Hak SOHN
;
Soon Nam LEE
Author Information
1. Korea Cancer Study Group, Korea.
- Publication Type:Multicenter Study ; Original Article ; Randomized Controlled Trial
- Keywords:
Combination chemotherapy;
Advanced gastric cancer;
Heptaplatin
- MeSH:
Adenocarcinoma;
Arm;
Chemotherapy, Adjuvant;
Cisplatin;
Drug Therapy, Combination;
Fluorouracil;
Humans;
Incidence;
Malonates;
Nausea;
Neutropenia;
Organoplatinum Compounds;
Proteinuria;
Stomach Neoplasms;
Vomiting
- From:Cancer Research and Treatment
2009;41(1):12-18
- CountryRepublic of Korea
- Language:English
-
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.
