Incidence and predictors of 1-year mortality among 9236 breast cancer patients referred for adjuvant chemotherapy

Aim: To evaluate the incidence and predictors of mortality in the first year following randomization among breast cancer patients recruited in five adjuvant chemotherapy clinical trials. Methods: This is a pooled analysis of 9236 patients from five clinical trials. Univariate and multivariate logistic regression analyses were conducted to evaluate the impact of relevant clinicopathological factors on early mortality. Results: Early death rates were 0.1% (11 patients) at 6 months and 0.8% (70 patients) at 1 year. Patients with a documented relapse within 1 year have a higher risk of death within the first year (HR: 74.20, 95% CI: 42.28-130.22) in a multivariate Cox regression model. The following factors were predictive of 1-year mortality in multivariate logistic regression analysis: higher T-stage (p =0.001), higher N-stage (p=0.004) and negative hormone receptor status (p<0.0001). Conclusion: Six-month and 1-year mortality rates are low among breast cancer patients referred for adjuvant chemotherapy within a clinical trial.