| Title: |
Duration of adjuvant doublet chemotherapy (3 or 6 months) in patients with high-risk stage II colorectal cancer |
| Authors: |
Iveson, Timothy J.; Sobrero, Alberto F.; Yoshino, Takayuki; Souglakos, Ioannis; Ou, Fang-Shu; Meyers, Jeffrey P.; Shi, Qian; Grothey, Axel; Saunders, Mark P.; Labianca, Roberto; Yamanaka, Takeharu; Boukovinas, Ioannis; Hollander, Niels H.; Galli, Fabio; Yamazaki, Kentaro; Georgoulias, Vassilis; Kerr, Rachel; Oki, Eiji; Lonardi, Sara; Harkin, Andrea; Rosati, Gerardo; Paul, James |
| Publisher Information: |
American Society of Clinical Oncology |
| Publication Year: |
2021 |
| Collection: |
University of Glasgow: Enlighten - Publications |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://eprints.gla.ac.uk/224253/2/224253.pdf; 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) |
| DOI: |
10.1200/JCO.20.01330 |
| Availability: |
https://eprints.gla.ac.uk/224253/; https://eprints.gla.ac.uk/224253/2/224253.pdf; https://doi.org/10.1200/JCO.20.01330 |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.90AC8F77 |
| Database: |
BASE |