title: 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.
abstract: OBJECTIVE
  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.
  
  
  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/m(2)) or cisplatin (60 mg/m(2)) was given over 1 hour with 5-FU (1 gm/m(2)) 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.
  
  
  CONCLUSIONS
  Heptaplatin showed similar effects to cisplatin when combined with 5-FU in advanced gastric cancer patients with tolerable toxicities.
authors.affiliation: Korea Cancer Study Group, College of Medicine, Yeungnam University, Daegu, Korea.
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Myung Soo
authors.initials: MS
authors.lastname: Hyun
authors.forename: Hoon-Kyo
authors.initials: HK
authors.lastname: Kim
authors.forename: Hyung Min
authors.initials: HM
authors.lastname: Jin
authors.forename: Jinmo
authors.initials: J
authors.lastname: Yang
authors.forename: Hong Suk
authors.initials: HS
authors.lastname: Song
authors.forename: Young Rok
authors.initials: YR
authors.lastname: Do
authors.forename: Hun Mo
authors.initials: HM
authors.lastname: Ryoo
authors.forename: Joo Seop
authors.initials: JS
authors.lastname: Chung
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
authors.forename: Ho-Yeong
authors.initials: HY
authors.lastname: Lim
authors.forename: Jong Youl
authors.initials: JY
authors.lastname: Jin
authors.forename: Chang Yeol
authors.initials: CY
authors.lastname: Yim
authors.forename: Hee Sook
authors.initials: HS
authors.lastname: Park
authors.forename: Jun Suk
authors.initials: JS
authors.lastname: Kim
authors.forename: Chang Hak
authors.initials: CH
authors.lastname: Sohn
authors.forename: Soon Nam
authors.initials: SN
authors.lastname: Lee
references.citation: J Med Chem. 1994 May 13;37(10):1471-85
references.pmid: 8182706
references.citation: Br J Cancer. 1989 Nov;60(5):767-9
references.pmid: 2803953
references.citation: Cancer Treat Rev. 1985 Sep;12 Suppl A:1-19
references.pmid: 3910215
references.citation: Ann Intern Med. 1984 May;100(5):704-13
references.pmid: 6370067
references.citation: J Clin Oncol. 2003 Jan 1;21(1):54-9
references.pmid: 12506170
references.citation: CA Cancer J Clin. 2002 Jan-Feb;52(1):23-47
references.pmid: 11814064
references.citation: Cancer Treat Rev. 1985 Sep;12 Suppl A:21-33
references.pmid: 3910219
references.citation: Cancer. 1993 Jun 15;71(12):3813-8
references.pmid: 8508349
references.citation: Br J Cancer. 1991 Oct;64(4):788-92
references.pmid: 1911229
references.citation: Clin Pharmacol Ther. 1979 Mar;25(3):351-7
references.pmid: 761445
references.citation: Cancer. 1981 Jan 1;47(1):207-14
references.pmid: 7459811
references.citation: J Korean Med Sci. 2004 Jun;19(3):369-73
references.pmid: 15201502
references.citation: CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36
references.pmid: 11577478
references.citation: Anticancer Res. 1995 Jan-Feb;15(1):51-4
references.pmid: 7733640
references.citation: Curr Opin Oncol. 1992 Dec;4(6):1073-9
references.pmid: 1457521
references.citation: Cancer Chemother Pharmacol. 1998;41(2):109-16
references.pmid: 9443623
references.citation: Cancer. 1999 Oct 1;86(7):1109-15
references.pmid: 10506693
references.citation: J Clin Oncol. 1986 Jul;4(7):1053-7
references.pmid: 3014083
references.citation: Cancer Res Treat. 2005 Apr;37(2):79-86
references.pmid: 19956484
references.citation: Eur J Cancer. 1994;30A(14):2091-3
references.pmid: 7857709
references.citation: Am J Med. 1978 Aug;65(2):307-14
references.pmid: 99034
references.citation: Cancer Chemother Pharmacol. 1995;37(1-2):1-6
references.pmid: 7497577
references.citation: Cancer Chemother Pharmacol. 2002 Aug;50(2):104-10
references.pmid: 12172973
references.citation: Cancer Chemother Pharmacol. 1995;35(5):441-5
references.pmid: 7850928