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Prior reports of the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer (CONFIRM) trial, comparing two different fulvestrant doses (1,2), did not provide details regarding the efficacy of fulvestrant in patients pretreated with chemotherapy for either early or advanced disease. As previously reported, fulvestrant 500 mg was superior to fulvestrant 250 mg in terms of progression-free survival (PFS) and overall survival (OS; hazard ratio [HR] 1⁄4 0.80, 95% confidence interval [CI] 1⁄4 0.68 to 0.94, and HR1⁄4 0.81, 95% CI 1⁄4 0.69 to 0.96, respectively) in the overall population (1,2). Three hundred and eighty-five patients included in the trial had received prior adjuvant chemotherapy, and 150 patients had had chemotherapy for advanced disease. Table 1 depicts the analysis of results of the trial according to prior exposure to chemotherapy. Patients with chemotherapy for advanced disease had hazard ratios for PFS and OS of 0.75 (95% CI 1⁄4 0.53 to 1.07) and 0.78 (95% CI 1⁄4 0.54 to 1.12), respectively. Patients with adjuvant chemotherapy had hazard ratios for PFS and OS of 0.68 (95% CI 1⁄4 0.55 to 0.85) and 0.67 (95% CI 1⁄4 0.53 to 0.84), respectively. Therefore, the advantage of fulvestrant 500 mg over fulvestrant 250 mg seems to be independent of the prior patient exposure to either adjuvant chemotherapy or chemotherapy for advanced disease. We think this information could be useful for clinicians to have a better understanding of patient characteristics from the CONFIRM trial and it could help them to make a better selection of advanced breast cancer patients for fulvestrant therapy.

RE: Final Overall Survival: Fulvestrant 500 mg vs 250 mg in the Randomized CONFIRM Trial