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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.