Controversies in the Early Reporting of a Clinical Trial in Early Breast Cancer

Abstract

The role of adjuvant chemotherapy in the treatment of breast cancer has been the subject of intense research activity in recent years. It is now generally accepted that some types of adjuvant therapy have a positive effect on disease-free and overall survival, but the effect size appears to be modest and the optimal type of adjuvant therapy for different groups of patients remains unclear. One major study of adjuvant therapy in breast cancer patients that generated considerable interest and controversy was an intergroup trial of the value of increasing the dose of doxorubicin or adding paclitaxel (Taxol®) to standard chemotherapy. The design was a 3 x 2 factorial design (three different doses of doxorubicin with and without paclitaxel). Based on the results of the first planned interim analysis suggesting improved disease-free and overall survival in patients receiving paclitaxel, the DSMB released the results to the study team. The events and considerations leading to the decision to release the results and some of the subsequent controversies that arose in the medical community because of this decision are discussed in this paper.