• Matthew J Ellis, Antonio Llombart-Cussac, David Feltl, John A Dewar, Marek Jasiówka, Nicola Hewson, Yuri Rukazenkov, and John F R Robertson.
• Matthew J. Ellis, Baylor College of Medicine, Houston, TX; Antonio Llombart-Cussac, Hospital Arnau de Vilanova, Lérida, Spain; David Feltl, FNsP Ostrava, Ostrava-Poruba, Czech Republic; John A. Dewar, Ninewells Hospital and Medical School, Dundee; Nicola Hewson and Yuri Rukazenkov, AstraZeneca Pharmaceuticals, Macclesfield; John F.R. Robertson, University of Nottingham, Derby, United Kingdom; and Marek Jasiówka, Instytut im Marii Skłodowskiej-Curie, Kraków, Poland. Matthew.Ellis@bcm.edu.
• J. Clin. Oncol. 2015 Nov 10; 33 (32): 3781-7.

PurposeTo compare overall survival (OS) for fulvestrant 500 mg versus anastrozole as first-line endocrine therapy for advanced breast cancer.Patients And MethodsThe Fulvestrant First-Line Study Comparing Endocrine Treatments (FIRST) was a phase II, randomized, open-label, multicenter trial. Postmenopausal women with estrogen receptor-positive, locally advanced/metastatic breast cancer who had no previous therapy for advanced disease received either fulvestrant 500 mg (days 0, 14, 28, and every 28 days thereafter) or anastrozole 1 mg (daily). The primary end point (clinical benefit rate [72.5% and 67.0%]) and a follow-up analysis (median time to progression [23.4 months and 13.1 months]) have been reported previously for fulvestrant 500 mg and anastrozole, respectively. Subsequently, the protocol was amended to assess OS by unadjusted log-rank test after approximately 65% of patients had died. Treatment effect on OS across several subgroups was examined. Tolerability was evaluated by adverse event monitoring.ResultsIn total, 205 patients were randomly assigned (fulvestrant 500 mg, n = 102; anastrozole, n = 103). At data cutoff, 61.8% (fulvestrant 500 mg, n = 63) and 71.8% (anastrozole, n = 74) had died. The hazard ratio (95% CI) for OS with fulvestrant 500 mg versus anastrozole was 0.70 (0.50 to 0.98; P = .04; median OS, 54.1 months v 48.4 months). Treatment effects seemed generally consistent across the subgroups analyzed. No new safety issues were observed.ConclusionThere are several limitations of this OS analysis, including that it was not planned in the original protocol but instead was added after time-to-progression results were analyzed, and that not all patients participated in additional OS follow-up. However, the present results suggest fulvestrant 500 mg extends OS versus anastrozole. This finding now awaits prospective confirmation in the larger phase III FALCON (Fulvestrant and Anastrozole Compared in Hormonal Therapy Naïve Advanced Breast Cancer) trial (ClinicalTrials.gov identifier: NCT01602380).© 2015 by American Society of Clinical Oncology.

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