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    Duration of adjuvant doublet chemotherapy (3 or 6 months) in patients with high-risk stage II colorectal cancer

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    Authors
    Iveson, T. J.
    Sobrero, A. F.
    Yoshino, T.
    Souglakos, I.
    Ou, F. S.
    Meyers, J. P.
    Shi, Q.
    Grothey, A.
    Saunders, Mark 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.
    Paul, J.
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    Affiliation
    University of Southampton, Southampton, United Kingdom.
    Issue Date
    2021
    
    Metadata
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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.
    Citation
    Iveson TJ, Sobrero AF, Yoshino T, Souglakos I, Ou FS, Meyers JP, et al. Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer. J Clin Oncol. 2021;39(6):631-41.
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/623784
    DOI
    10.1200/jco.20.01330
    PubMed ID
    33439695
    Additional Links
    https://dx.doi.org/10.1200/jco.20.01330
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1200/jco.20.01330
    Scopus Count
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