Phase III Study Comparing Exemestane With Tamoxifen As First-Line Hormonal Treatment of Metastatic Breast Cancer in Postmenopausal Women: The European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group
Phase III Study Comparing Exemestane With Tamoxifen As First-Line Hormonal Treatment of Metastatic Breast Cancer in Postmenopausal Women: The European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group
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DOI：
10.1200/jco.2007.14.4659
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发表时间：
2008-10-20
影响因子：
45.3
通讯作者：
Therasse, Patrick
中科院分区：
文献类型：
--
作者：
Paridaens, Robert J.;Dirix, Luc Y.;Therasse, Patrick
目的这项 III 期随机开放临床试验旨在评估类固醇芳香酶灭活剂依西美坦与抗雌激素他莫昔芬作为绝经后妇女转移性乳腺癌 (MBC) 一线治疗的疗效和安全性。 患者和方法该研究在 81 个中心进行，纳入患有可测量的激素敏感性转移性或局部晚期乳腺癌的绝经后患者。允许事先进行辅助化疗和/或他莫昔芬。允许既往接受过一种化疗方案且未接受过针对晚期疾病的激素治疗。患者被随机分配接受依西美坦 25 mg 或他莫昔芬 20 mg 口服，每日一次，直至疾病进展或出现不可接受的毒性。 结果 79 个中心的总共 371 名患者（182 名依西美坦，189 名他莫昔芬）纳入分析。两种治疗方法通常耐受性良好，没有重大毒性。依西美坦治疗的总体缓解率高于他莫昔芬治疗（46% vs 31%；比值比 = 1.85；95% CI，1.21 至 2.82；P = .005）。依西美坦组的中位无进展生存期 (PFS)（9.9 个月；95% CI，8.7 至 11.8 个月）比他莫昔芬组（5.8 个月；95% CI，5.3 至 8.1 个月）更长。然而，这些早期差异 (Wilcoxon P = .028) 并未转化为主要研究终点 PFS (对数秩 P = .121) 的长期获益。两个研究组之间的生存率也没有差异。 结论 对于患有 MBC 的绝经后女性来说，依西美坦是一种有效且耐受性良好的一线激素治疗方法，与他莫昔芬相比，可显着缩短肿瘤进展时间。
PurposeThis phase III randomized open-label clinical trial was designed to evaluate the efficacy and safety of the steroidal aromatase inactivator exemestane versus the antiestrogen tamoxifen as first-line treatment for metastatic breast cancer (MBC) in postmenopausal women.Patients and MethodsThe study was conducted at 81 centers and enrolled postmenopausal patients with measurable hormone-sensitive metastatic or locally advanced breast cancer. Prior adjuvant chemotherapy and/or tamoxifen were allowed. One previous chemotherapy regimen and no prior hormone therapy for advanced disease were permitted. Patients were randomly assigned to receive exemestane 25 mg or tamoxifen 20 mg orally once daily until disease progression or unacceptable toxicity occurred.ResultsA total of 371 patients enrolled at 79 sites (182 exemestane, 189 tamoxifen) were included in the analysis. Both treatments were generally well tolerated without major toxicity. Overall response rate was greater for exemestane than for tamoxifen treatment (46% v 31%; odds ratio = 1.85; 95% CI, 1.21 to 2.82; P = .005). Median progression-free survival (PFS) was longer with exemestane (9.9 months; 95% CI, 8.7 to 11.8 months) than with tamoxifen (5.8 months; 95% CI, 5.3 to 8.1 months). However, these early differences (Wilcoxon P = .028) did not translate to a longer-term benefit in PFS, the primary study end point (log-rank P = .121). There was also no difference in survival between both study arms.ConclusionExemestane is an effective and well-tolerated first-line hormonal treatment for postmenopausal women with MBC and offers significant early improvement in time to tumor progression when compared with tamoxifen.