Long-term survival benefits of docetaxel plus cyclophosphamide compared to doxorubicin plus cyclophosphamide in the adjuvant treatment of operable breast cancer
563 Background: The U.S. Oncology Adjuvant Trial 9735 recently demonstrated disease-free survival and overall survival (OS) benefits over 7 years for docetaxel plus cyclophosphamide (TC) compared with doxorubicin plus cyclophosphamide (AC) as adjuvant treatment for women with operable stage I-III invasive breast cancer (BC). The life-time benefits of TC vs. AC, however, are unknown. This analysis aimed to project potential life-time survival benefits of TC vs. AC as adjuvant therapy for operable BC. Methods: The 7-year follow-up results of the 9735 study combined with US average life expectancy were used to project the life-time survival benefits of TC vs. AC. In the base case (scenario 1), it was assumed the survival advantage of TC did not persist beyond the 7-year clinical trial period. Rather, all patients alive and disease-free at 7 years (from the starting age of 51 to the age of 58), regardless of treatment, were assumed to be cured and received the average remaining life expectancy of a 58-year old woman in the US general population. As survival benefits from chemotherapy may persist beyond the clinical trial period, two sensitivity analyses were conducted: 1) greater life expectancy in the TC arm of 1.8 months equivalent to the mean difference in OS between TC and AC within the clinical trial period (scenario 2) and 2) greater life expectancy in the TC arm of 22 months equivalent to the difference in survival at the end of 7 years (scenario 3). The total life years gained (LYs) and quality-adjusted life years gained (QALYs) were then calculated. Results: Per patient LYs gained in scenarios 1, 2, and 3 were 0.850, 0.930, and 1.755, respectively; while QALYs gained were slightly lower at 0.674, 0.736 and 1.383, respectively. Applying this benefit to a cohort of 167,133 women in the US with newly diagnosed stage I-III invasive BC in 2008, the gains were 142,063 LYs and 112,648 QALYS in scenario 1. Conclusions: In addition to survival benefit observed within the clinical trial period, the use of TC is associated with long-term survival benefits compared to AC in patients with stage I-III invasive BC. The results provide additional support of the value of TC in the management of early stage BC. [Table: see text]