• Eur. J. Cancer · Oct 2011

    Randomized Controlled Trial Multicenter Study

    Trastuzumab beyond progression: overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer.

    • Gunter von Minckwitz, Kathrin Schwedler, Marcus Schmidt, Jana Barinoff, Christoph Mundhenke, Tanja Cufer, Eduard Maartense, Felix E de Jongh, Klaus H Baumann, Joachim Bischoff, Nadia Harbeck, Hans-Joachim Lück, Nicolai Maass, Christoph Zielinski, Michael Andersson, Robert C Stein, Valentina Nekljudova, Sibylle Loibl, and GBG 26/BIG 03-05 study group and participating investigators.
    • German Breast Group, GBG ForschungsGmbH, Martin-Behaim Str. 12, 63263 Neu-Isenburg, Germany. Gunter.vonMinckwitz@germanbreastgroup.de
    • Eur. J. Cancer. 2011 Oct 1; 47 (15): 2273-81.

    BackgroundContinuation 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 MethodsPatients 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.ResultsMedian 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).ConclusionsFinal 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.Copyright © 2011 Elsevier Ltd. All rights reserved.

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