Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3

Eric Van Cutsem, Roberto Labianca, György Bodoky, Carlo Barone, Enrique Aranda, Bernard Nordlinger, Claire Topham, Josep Tabernero, Thierry André, Alberto F. Sobrero, Enrico Mini, Richard Greil, Francesco Di Costanzo, Laurence Collette, Laura Cisar, Xiaoxi Zhang, David Khayat, Carsten Bokemeyer, Arnaud D. Roth, David Cunningham

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: The primary objective of this randomized, multicenter, phase III trial was to investigate whether the addition of irinotecan to the de Gramont infusional fluorouracil (FU)/leucovorin (LV) adjuvant regimen (LV5FU2) would improve disease-free survival (DFS) in patients with stage III colon cancer. Patients and Methods: After curatively intentioned surgery, patients with stage II and III colon cancer were randomly allocated surgery to receive LV5FU2 (LV 200 mg/m2 as a 2-hour infusion, followed by FU; as a 400 mg/m 2 bolus and then a 600 mg/m2 continuous infusion over 22 hours, days 1 and 2, every 2 weeks for 12 cycles: de Gramont regimen) with or without irinotecan (180 mg/m2 as a 30- to 90-minute infusion, day 1, every 2 weeks). In total, 260 (7.9%) of 3,278 patients received an alternative high-dose infusional FU/LV regimen (Arbeitsgemeinschaft Internische Onkologie regimen) with or without irinotecan. Results: The principal efficacy analysis was based on 2,094 treated patients with stage III disease, randomly allocated in the LV5FU2 strata. After a median follow-up of 66.3 months, the 5-year DFS rate was 56.7% with irinotecan/LV5FU2 and 54.3% with LV5FU2 alone (primary end point: log-rank P = .106). Combining irinotecan with LV5FU2 did not significantly improve overall survival in this patient group compared with LV5FU2 alone (5-year rate 73.6% v 71.3%, respectively; log-rank P = .094). The addition of irinotecan to LV5FU2 was associated with an increased incidence of grade 3 to 4 GI events and neutropenia. Conclusion: Irinotecan added to LV5FU2 as adjuvant therapy did not confer a statistically significant improvement in DFS or overall survival in patients with stage III colon cancer compared with LV5FU2 alone.

Original languageEnglish
Pages (from-to)3117-3125
Number of pages9
JournalJournal of Clinical Oncology
Volume27
Issue number19
DOIs
Publication statusPublished - Jul 1 2009

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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