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KMID : 0939920090410010012
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대한암학회지
2009 Volume.41 No. 1 p.12 ~ p.18
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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
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Lee Kyoung-Hee
Jin Jong-Youl
Hyun Myung-Soo
Yim Chang-Yeol
Lee Soon-Nam
Lim Ho-Yeong
Park Hee-Sook
Ryoo Hun-Mo
Kim Jun-Suk
Sohn Chang-Hak
Kim Hoon-Kyo
Yang Jin-Mo
Chung Joo-Seop
Do Young-Rok
Song Hong-Suk
Jin Hyung-Min
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Abstract
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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.
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KEYWORD
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Combination chemotherapy, Advanced gastric cancer, Heptaplatin
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