Iveson, T. J. et al. (2021) Duration of adjuvant doublet chemotherapy (3 or 6 months) in patients with high-risk stage II colorectal cancer. Journal of Clinical Oncology, 39(6), pp. 631-641. (doi: 10.1200/JCO.20.01330) (PMID:33439695)
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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.
| Item Type: | Articles |
|---|---|
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Paul, Mr James and Harkin, Mrs Andrea |
| Authors: | Iveson, T. J., Sobrero, A. F., Yoshino, T., Souglakos, I., Ou, F.-S., Meyers, J. P., Shi, Q., Grothey, A., Saunders, M. P., Labianca, R., Yamanaka, T., Boukovinas, I., Hollander, N. H., Galli, F., Yamazaki, K., Georgoulias, V., Kerr, R., Oki, E., Lonardi, S., Harkin, A., Rosati, G., and Paul, J. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Cancer Sciences |
| Journal Name: | Journal of Clinical Oncology |
| Publisher: | American Society of Clinical Oncology |
| ISSN: | 0732-183X |
| ISSN (Online): | 1527-7755 |
| Published Online: | 13 January 2021 |
| Copyright Holders: | Copyright © 2021 by American Society of Clinical Oncology |
| First Published: | First published in Journal of Clinical Oncology 39(6): 631-641 |
| Publisher Policy: | Reproduced under a Creative Commons licence |
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