Trastuzumab beyond progression: Overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer
Trastuzumab beyond progression: Overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer
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DOI：
10.1016/j.ejca.2011.06.021
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发表时间：
2011-10-01
影响因子：
8.4
通讯作者：
Loibl, Sibylle
中科院分区：
文献类型：
--
作者：
von Minckwitz, Gunter;Schweller, Kathrin;Loibl, Sibylle
背景：在曲妥珠单抗治疗期间进展为her2阳性乳腺癌的妇女中，继续使用曲妥珠单抗加卡培他滨（XH）与单独使用卡培他滨(X)相比，总体缓解率和进展时间显着提高。在这里，我们报告总体生存的最终分析。患者和方法：在曲妥珠单抗治疗期间进展的her2阳性晚期乳腺癌患者伴或不伴一线转移性化疗，前瞻性随机分为X组（2500 mg/m(2)，第1-14天，q3w）或XH组（6 (8)mg/kg, q3w）。总生存期是预先指定的次要终点。结果：2010年6月的中位随访时间为20.7个月。在X组和XH组，74名患者中有59名死亡，77名患者中有60名死亡。X和XH组的中位总生存期分别为20.6和24.9个月（HR = 0.94 [0.65-1.35]; p = 0.73）。功能状态和转移部位是总体生存的独立预后因素。对于分别获得临床反应或临床获益的患者，治疗组之间没有观察到差异。在第二次进展（N = 52）后继续/重新开始抗her2治疗（曲妥珠单抗或拉帕替尼）的患者的进展后生存期为18.8个月，而未接受抗her2药物三线治疗的患者（N = 88）的进展后生存期为13.3个月（HR 0.63; p = 0.02）。结论：GBG-26研究的最终总生存分析未显示曲妥珠单抗治疗进展后的显着生存获益。然而，在事后分析中，接受抗her2治疗作为三线治疗的患者比未接受这种靶向治疗的患者表现出更好的进展后生存率。(C) 2011 Elsevier Ltd.版权所有。
Background: Continuation of trastuzumab plus capecitabine (XH) showed a significantly improved overall response rate and time to progression compared with capecitabine (X) alone in women with HER2-positive breast cancer progressing during trastuzumab treatment. Here, we report the final analysis on overall survival.Patients and methods: Patients with HER2-positive, advanced breast cancer who progressed during treatment with trastuzumab with or without 1st-line metastatic chemotherapy were prospectively randomised to X (2500 mg/m(2) on days 1-14, q3w) or XH (6 (8) mg/kg, q3w). Overall survival was a pre-specified secondary end-point.Results: Median follow-up at June 2010 was 20.7 months. Fifty nine of 74 and 60 of 77 patients died in the X and XH arm, respectively. Median overall survival was 20.6 and 24.9 months with X and XH, respectively (HR = 0.94 [0.65-1.35]; p = 0.73). Performance status and metastatic site were independent prognosticators for overall survival. No difference between treatment arms was observed for patients who achieved clinical response or clinical benefit, respectively. Patients who continued/restarted anti-HER2 treatment (trastuzumab or lapatinib) after 2nd progression (N = 52) had a post-progression survival of 18.8 compared with 13.3 months for those who did not receive 3rd line treatment with anti-HER2 agents (N = 88) (HR 0.63; p = 0.02).Conclusions: Final overall survival analysis of the GBG-26 study did not demonstrate a significant survival benefit for treatment beyond progression with trastuzumab. However, in a post-hoc analysis, patients receiving anti-HER2 treatment as 3rd line therapy showed a better post-progression survival than those not receiving this targeted treatment. (C) 2011 Elsevier Ltd. All rights reserved.