Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer

Timothy J. Iveson, Alberto F. Sobrero, Takayuki Yoshino, Ioannis Souglakos, Fang Shu Ou, Jeffrey P. Meyers, Qian Shi, Axel Grothey, Mark P. Saunders, Roberto Labianca, Takeharu Yamanaka, Ioannis Boukovinas, Niels H. Hollander, Fabio Galli, Kentaro Yamazaki, Vassilis Georgoulias, Rachel Kerr, Eiji Oki, Sara Lonardi, Andrea HarkinGerardo Rosati, James Paul

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

PURPOSE: As oxaliplatin results in cumulative neurotoxicity, reducing treatment duration without loss of efficacy would benefit patients and healthcare providers. PATIENTS AND METHODS: Four of the six studies in the International Duration of Adjuvant Chemotherapy (IDEA) collaboration included patients with high-risk stage II colon and rectal cancers. Patients were treated (clinician and/or patient choice) with either fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX) and randomly assigned to receive 3- or 6-month treatment. The primary end point is disease-free survival (DFS), and noninferiority of 3-month treatment was defined as a hazard ratio (HR) of < 1.2- v 6-month arm. To detect this with 80% power at a one-sided type one error rate of 0.10, a total of 542 DFS events were required. RESULTS: 3,273 eligible patients were randomly assigned to either 3- or 6-month treatment with 62% receiving CAPOX and 38% FOLFOX. There were 553 DFS events. Five-year DFS was 80.7% and 83.9% for 3-month and 6-month treatment, respectively (HR, 1.17; 80% CI, 1.05 to 1.31; P [for noninferiority] .39). This crossed the noninferiority limit of 1.2. As in the IDEA stage III analysis, the duration effect appeared dependent on the chemotherapy regimen although a test of interaction was negative. HR for CAPOX was 1.02 (80% CI, 0.88 to 1.17), and HR for FOLFOX was 1.41 (80% CI, 1.18 to 1.68). CONCLUSION: Although noninferiority has not been demonstrated in the overall population, the convenience, reduced toxicity, and cost of 3-month adjuvant CAPOX suggest it as a potential option for high-risk stage II colon cancer if oxaliplatin-based chemotherapy is suitable. The relative contribution of the factors used to define high-risk stage II disease needs better understanding.

Original languageEnglish (US)
Pages (from-to)631-641
Number of pages11
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume39
Issue number6
DOIs
StatePublished - Feb 20 2021

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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