Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study.
Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study.
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DOI：
10.1200/jco.2015.61.5831
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发表时间：
2015-11-10
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影响因子：
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通讯作者：
Robertson JF
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作者：
Ellis MJ;Llombart-Cussac A;Feltl D;Dewar JA;Jasiówka M;Hewson N;Rukazenkov Y;Robertson JF
比较FUVESTRANT 500 mg与阿那曲唑作为晚期乳腺癌一线内分泌治疗的总存活率(OS)。Fulvestrant一线研究比较内分泌治疗(First)是一项II期随机、开放标签、多中心试验。雌激素受体阳性、局部晚期/转移性乳腺癌的绝经后妇女，如果以前没有接受过晚期疾病的治疗，可以服用500毫克(第0、14、28天，此后每隔28天)或服用阿那曲唑1毫克(每天)。福维斯特500毫克和阿那曲唑的主要终点(临床受益率[72.5%和67.0%])和随访分析(中位进展时间[23.4个月和13.1个月])分别在以前报道过。随后，对方案进行了修改，在大约65%的患者死亡后，通过未经调整的对数等级检验来评估OS。观察几个亚组对OS的治疗效果。耐受性通过不良事件监测进行评估。总共有205名患者被随机分配(富维斯特朗500 mg，n=102；阿那曲唑，n=103)。截止数据时，61.8%(富维司他500 mg，n=63)和71.8%(阿那曲唑，n=74)已死亡。福尔维斯特500 mg与阿那曲唑治疗OS的风险比(95%CI)为0.70(0.50~0.98；P=0.04；中位OS分别为54.1个月和48.4个月)。在分析的各亚组中，治疗效果似乎总体上是一致的。没有观察到新的安全问题。这种OS分析有几个局限性，包括它不是在原始方案中计划的，而是在分析进展时间结果后添加的，以及并不是所有患者都参与了额外的OS随访。然而，目前的结果表明，与阿那曲唑相比，福维斯特500毫克延长了OS。这一发现目前正在等待更大规模的猎鹰(Fulvestrant和阿那曲唑在荷尔蒙疗法中与单纯晚期乳腺癌比较)试验(ClinicalTrials.gov，识别号：NCT01602380)中的预期确认。
To compare overall survival (OS) for fulvestrant 500 mg versus anastrozole as first-line endocrine therapy for advanced breast cancer. The 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. In 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. There 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).