TY - JOUR
T1 - Final Analysis of 3 Versus 6 Months of Adjuvant Oxaliplatin and Fluoropyrimidine-Based Therapy in Patients with Stage III Colon Cancer
T2 - The Randomized Phase III ACHIEVE Trial
AU - Yoshino, Takayuki
AU - Oki, Eiji
AU - Misumi, Toshihiro
AU - Kotaka, Masahito
AU - Manaka, Dai
AU - Eto, Tetsuya
AU - Hasegawa, Junichi
AU - Takagane, Akinori
AU - Nakamura, Masato
AU - Kato, Takeshi
AU - Munemoto, Yoshinori
AU - Nakamura, Fumitaka
AU - Bando, Hiroyuki
AU - Taniguchi, Hiroki
AU - Sakamoto, Yasuhiro
AU - Shiozawa, Manabu
AU - Nishi, Masayasu
AU - Horiuchi, Tetsuya
AU - Yamagishi, Hisakazu
AU - Sakamoto, Junichi
AU - Mizushima, Tsunekazu
AU - Ohtsu, Atsushi
AU - Mori, Masaki
N1 - Funding Information:
Medical writing support was provided by Dr Anne R. Kinsella and Dr Jim Heighway of Cancer Communications and Consultancy (Knutsford, UK), and was funded by JFMC under a contract with Yakult Honsha Co, Ltd.
Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2022/5/1
Y1 - 2022/5/1
N2 - PURPOSEThe phase III ACHIEVE trial conducted in Japan was one of six prospective studies included in the International Duration Evaluation of Adjuvant Therapy collaboration, which explored whether 3 months of adjuvant fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX) therapy would be noninferior to 6 months of treatment in patients with curatively resected stage III colon cancer. We report the final analyses of survival and long-term safety.PATIENTS AND METHODSEligible patients were randomly assigned (1:1) to either 3 or 6 months of adjuvant chemotherapy (modified [m]FOLFOX6 or CAPOX, as selected by the treating physician). Random assignment was stratified according to number of involved lymph nodes, center, regimen, primary site, and age. The primary end point was disease-free survival, assessed in the modified intention-to-treat population. Overall survival (OS) was a secondary end point.RESULTSThe modified intention-to-treat population comprised 1,291 patients: 641 in the 6-month treatment group and 650 in the 3-month treatment group. Median follow-up for this analysis was 74.7 months. Five-year OS rates were comparable: 87.0% in the 3-month treatment group and 86.4% in the 6-month treatment group (hazard ratio, 0.91; 95% CI, 0.69 to 1.20; P =.51). Subgroup analysis of OS did not reveal a significant interaction between baseline characteristics and treatment duration. Peripheral sensory neuropathy lasting longer than 5 years was more common in the 6- compared with 3-month treatment group (16% v 8%, respectively), and in those receiving mFOLFOX6 compared with CAPOX (14% v 11%, respectively).CONCLUSIONIn Asian patients, shortening adjuvant therapy duration from 6 to 3 months did not compromise efficacy and reduced the rate of long-lasting peripheral sensory neuropathy. In this setting, 3 months of CAPOX therapy is an appropriate adjuvant treatment option.
AB - PURPOSEThe phase III ACHIEVE trial conducted in Japan was one of six prospective studies included in the International Duration Evaluation of Adjuvant Therapy collaboration, which explored whether 3 months of adjuvant fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX) therapy would be noninferior to 6 months of treatment in patients with curatively resected stage III colon cancer. We report the final analyses of survival and long-term safety.PATIENTS AND METHODSEligible patients were randomly assigned (1:1) to either 3 or 6 months of adjuvant chemotherapy (modified [m]FOLFOX6 or CAPOX, as selected by the treating physician). Random assignment was stratified according to number of involved lymph nodes, center, regimen, primary site, and age. The primary end point was disease-free survival, assessed in the modified intention-to-treat population. Overall survival (OS) was a secondary end point.RESULTSThe modified intention-to-treat population comprised 1,291 patients: 641 in the 6-month treatment group and 650 in the 3-month treatment group. Median follow-up for this analysis was 74.7 months. Five-year OS rates were comparable: 87.0% in the 3-month treatment group and 86.4% in the 6-month treatment group (hazard ratio, 0.91; 95% CI, 0.69 to 1.20; P =.51). Subgroup analysis of OS did not reveal a significant interaction between baseline characteristics and treatment duration. Peripheral sensory neuropathy lasting longer than 5 years was more common in the 6- compared with 3-month treatment group (16% v 8%, respectively), and in those receiving mFOLFOX6 compared with CAPOX (14% v 11%, respectively).CONCLUSIONIn Asian patients, shortening adjuvant therapy duration from 6 to 3 months did not compromise efficacy and reduced the rate of long-lasting peripheral sensory neuropathy. In this setting, 3 months of CAPOX therapy is an appropriate adjuvant treatment option.
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U2 - 10.1200/JCO.21.02628
DO - 10.1200/JCO.21.02628
M3 - Article
C2 - 35512259
AN - SCOPUS:85131320757
SN - 0732-183X
VL - 350
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
M1 - e2102628
ER -
