Predicting severe toxicities and mortality in older patients with colorectal cancer: An analysis of 3 clinical trials and 3 prospective cohorts.

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INTRODUCTION: Patients over 75 years old account for 40% of incident colorectal cancer (CRC) cases. Predicting chemotherapy (CT)-related toxicities is crucial for guiding treatment decisions. This study aimed to identify predictors of severe toxicities (ST) after 3 months of CT in older CRC patients; the secondary endpoint was 36-month mortality. MATERIALS AND METHODS: We analyzed three prospective cohorts and three trials involving patients aged ≥ 75 years. ST was defined as grade ≥ 3 toxicity. Multivariable logistic regression was used to assess factors associated with ST. For mortality, a multivariable Cox proportional hazards model was used. RESULTS: 777 patients were included, with a median age of 80·3 years. 20·6% had ECOG-PS > 2, 20·8% had impaired independence for essential activities of daily living (ADL<6), and 46% had impaired IADL (<8). 48·4% had metastatic disease and 45·0% received doublet CT. ST occurred in 25·0% and 43·7% of patients in cohorts and trials, respectively. The independent risk factors for ST were: female sex, cognitive impairment in men, doublet CT, low albumin level in patients receiving single-agent CT, and low glomerular filtration rate. A model combining these parameters had an AUC of 0·700. The independent factors associated with 12-month mortality among metastatic patients were: impaired IADL, higher neutrophil count, and lower albumin. A model combining these variables with targeted therapy use and a history of primary tumor surgery achieved an AUC of 0.691. DISCUSSION: By pooling six trials and cohorts dedicated to older CRC patients, we identified clinical and biological factors associated with ST and mortality. If confirmed through external validation, these findings may inform personalized treatment decisions.

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