Efficacy and safety of oral 5‐ FU ‐based adjuvant chemotherapy for geriatric patients with colorectal cancer: Integrated analysis of seven clinical trials conducted at the Japanese Foundation for Multidisciplinary Treatment of Cancer

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BACKGROUND: Adjuvant chemotherapy after radical resection is recommended for patients with high-risk Stages II and III colorectal cancer (CRC). However, the efficacy and safety of adjuvant chemotherapy in geriatric patients require elucidation. METHODS: We analysed data from seven clinical trials conducted by the Japanese Foundation for the Multidisciplinary Treatment of Cancer. Survival curves were estimated using the Kaplan-Meier method and compared using the log-rank test. Survival analysis was performed using a Cox proportional hazards model. RESULTS: This study included 7756 non-geriatric (<70 years) and 1706 geriatric patients (≥70 years). Adjuvant chemotherapy significantly improved the 5-year overall survival in non-geriatric patients (81.6% vs. 73.6%, p < 0.001) but did not significantly improve the survival rate in geriatric patients (78.9% vs. 76.1%, p = 0.129). However, adjuvant chemotherapy was effective for N+ geriatric patients (hazard ratio, 0.48; 95% confidence interval, 0.35-0.66; p < 0.001). Adverse events associated with adjuvant chemotherapy were significantly more frequent in geriatric than in non-geriatric patients. CONCLUSION: Adjuvant chemotherapy in geriatric patients with node-positive CRC was as effective as in non-geriatric patients, although no benefit was shown in geriatric patients with node-negative CRC. More adverse events were observed in geriatric patients than in non-geriatric patients.