Cancer Res Treat.  2009 Mar;41(1):12-18.

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

• Lee KH
• Hyun MS
• Kim HK
• Jin HM
• Yang J
• Song HS
• Do YR
• Ryoo HM
• Chung JS
• Zang DY
• Lim HY
• Jin JY
• Yim CY
• Park HS
• Kim JS
• Sohn CH
• Lee SN

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.

Keyword

Combination chemotherapy; Advanced gastric cancer; Heptaplatin

MeSH Terms

Adenocarcinoma
Arm
Chemotherapy, Adjuvant
Cisplatin
Drug Therapy, Combination
Fluorouracil
Humans
Incidence
Malonates
Nausea
Neutropenia
Organoplatinum Compounds
Proteinuria
Stomach Neoplasms
Vomiting
Cisplatin
Fluorouracil
Malonates
Organoplatinum Compounds

Figure

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  Fig. 1 Overall survival.

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  Fig. 2 Time to progression.

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