German Breast Group, GBG ForschungsGmbH, Martin-Behaim Str. 12, 63263 Neu-Isenburg, Germany.
Eur J Cancer. 2011 Oct;47(15):2273-81. doi: 10.1016/j.ejca.2011.06.021. Epub 2011 Jul 7.
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 with HER2-positive, advanced breast cancer who progressed during treatment with trastuzumab with or without 1st-line metastatic chemotherapy were prospectively randomised to X (2500mg/m(2) on days 1-14, q3w) or XH (6 (8)mg/kg, q3w). Overall survival was a pre-specified secondary end-point.
Median follow-up at June 2010 was 20.7months. Fifty nine of 74 and 60 of 77 patients died in the X and XH arm, respectively. Median overall survival was 20.6 and 24.9months 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 13.3months for those who did not receive 3rd line treatment with anti-HER2 agents (N=88) (HR 0.63; p=0.02).
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.
曲妥珠单抗联合卡培他滨（XH）组的总缓解率和无进展生存期明显优于曲妥珠单抗单药组（X），后者是在曲妥珠单抗治疗过程中进展的 HER2 阳性乳腺癌患者。在此，我们报告了总生存的最终分析。
HER2 阳性、晚期乳腺癌患者，在曲妥珠单抗治疗期间或无 1 线转移性化疗的情况下进展，前瞻性随机分为 X（第 1-14 天，2500mg/m2，每 3 周 1 次）或 XH（6（8）mg/kg，每 3 周 1 次）。总生存是预先指定的次要终点。
截至 2010 年 6 月的中位随访时间为 20.7 个月。X 组和 XH 组分别有 59/74 和 60/77 例患者死亡。X 组和 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）。表现状态和转移部位是总生存的独立预后因素。对于分别达到临床反应或临床获益的患者，治疗组之间没有差异。对于第二次进展后（N=52）继续/重新开始抗 HER2 治疗（曲妥珠单抗或拉帕替尼）的患者，无进展生存期为 18.8 个月，而未接受第三线抗 HER2 药物治疗的患者（N=88）为 13.3 个月（HR 0.63；p=0.02）。
GBG-26 研究的最终总生存分析并未显示曲妥珠单抗进展后治疗有显著的生存获益。然而，在事后分析中，接受第三线抗 HER2 治疗的患者的无进展后生存期优于未接受该靶向治疗的患者。
