Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma: Results of a randomized phase II study

C. Pozzo, Carlo Barone, J. Szanto, E. Padi, C. Peschel, J. Bükki, V. Gorbunova, V. Valvere, J. Zaluski, M. Biakhov, E. Zuber, C. Jacques, R. Bugat

Research output: Contribution to journalArticlepeer-review

155 Scopus citations

Abstract

Background: To identify the most effective of two combinations, irinotecan/5-fluorouracil (5-FU)/folinic acid (FA) and irinotecan/cisplatin, in the treatment of advanced gastric cancer, for investigation in a phase III trial. Patients and methods: Patients were randomized to receive irinotecan [80 mg/m2 intravenously (i.v.)], FA (500 mg/m2 i.v.) and a 22-h infusion of 5-FU (2000 mg/m2 i.v.), weekly for 6 weeks with a 1-week rest, or irinotecan (200 mg/m2 i.v. and cisplatin (60 mg/m2 i.v.), on day 1 for 3 weeks. Results: A total of 115 patients were eligible for analysis in the per-protocol population. The overall response rate in the irinotecan/5-FU/FA arm (n = 59) was 42.4%, with a complete response rate of 5.1%. Corresponding figures for the irinotecan/cisplatin arm (n = 56) were 32.1% and 1.8%, respectively. The median time to progression was 6.5 months (irinotecan/5-FU/FA) and 4.2 months (irinotecan/cisplatin) (P<0.0001), with median survival times of 10.7 and 6.9 months, respectively (P=0.0018). The major toxicity was grade 3/4 neutropenia, which was more pronounced with irinotecan/cisplatin than with irinotecan/5-FU/FA (65.7% versus 27%). Diarrhea was the main grade 3/4 non-hematological toxicity with both irinotecan/5-FU/FA (27.0%) and irinotecan/cisplatin (18.1%). Conclusions: Both combinations were active, with acceptable safety profiles. Irinotecan/5-FU/FA was selected as the most effective combination for investigation in a phase III trial in advanced gastric cancer.

Original languageEnglish
Pages (from-to)1773-1781
Number of pages9
JournalAnnals of Oncology
Volume15
Issue number12
DOIs
StatePublished - Dec 2004
Externally publishedYes

Keywords

  • 5-FU/FA
  • Advanced gastric cancer
  • Cisplatin
  • Irinotecan
  • Phase II

Fingerprint

Dive into the research topics of 'Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma: Results of a randomized phase II study'. Together they form a unique fingerprint.

Cite this