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Randomized Controlled Trial
. 2014 Dec;25(12):2363-2372.
doi: 10.1093/annonc/mdu455. Epub 2014 Sep 15.

Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44-GeparQuinto)†

G von Minckwitz  1 , S Loibl  2 , M Untch  3 , H Eidtmann  4 , M Rezai  5 , P A Fasching  6 , H Tesch  7 , H Eggemann  8 , I Schrader  9 , K Kittel  10 , C Hanusch  11 , J Huober  12 , C Solbach  13 , C Jackisch  14 , G Kunz  15 , J U Blohmer  16 , M Hauschild  17 , T Fehm  18 , V Nekljudova  2 , B Gerber  19 ; GBG/AGO-B study groups; K Gnauert, B Heinrich, T Prätz, U Groh, H Tanzer, C Villena, A Tulusan, B Liedtke, J-U Blohmer, K Kittel, C Mau, J Potenberg, J Schilling, M Just, E Weiss, U Bückner, M Wolfgarten, R Lorenz, G Doering, S Feidicker, P Krabisch, U Deichert, D Augustin, G Kunz, K Kast, G von Minckwitz, C Nestle-Krämling, M Rezai, C Höß, J Terhaag, P Fasching, P Staib, B Aktas, T Kühn, F Khandan, V Möbus, C Solbach, H Tesch, E Stickeler, G Heinrich, H Wagner, A Abdallah, T Dewitz, G Emons, A Belau, V Rethwisch, T Lantzsch, C Thomssen, U Mattner, A Nugent, V Müller, T Noesselt, F Holms, T Müller, J-U Deuker, I Schrader, D Strumberg, C Uleer, E Solomayer, I Runnebaum, H Link, O Tomé, H-U Ulmer, B Conrad, G Feisel-Schwickardi, H Eidtmann, C Schumacher, T Steinmetz, I Bauerfeind, S Kremers, D Langanke, U Kullmer, A Ober, D Fischer, A Kohls, W Weikel, J Bischoff, K Freese, M Schmidt, W Wiest, M Sütterlin, M Dietrich, M Grießhammer, D-M Burgmann, C Hanusch, B Rack, C Salat, D Sattler, J Tio, E von Abel, B Christensen, U Burkamp, C-H Köhne, W Meinerz, S-T Graßhoff, T Decker, F Overkamp, I Thalmann, A Sallmann, T Beck, T Reimer, G Bartzke, M Deryal, M Weigel, J Huober, P Weder, C-C Steffens, S Lemster, A Stefek, F Ruhland, M Hofmann, J Schuster, W Simon, U Kronawitter, M Clemens, T Fehm, W Janni, K Latos, W Bauer, A Roßmann, L Bauer, D Lampe, V Heyl, G Hoffmann, F Lorenz-Salehi, J Hackmann, R Schlag
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Free article
Randomized Controlled Trial

Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44-GeparQuinto)†

G von Minckwitz et al. Ann Oncol. 2014 Dec.
Free article

Abstract

Background: The GeparQuinto study showed that adding bevacizumab to 24 weeks of anthracycline-taxane-based neoadjuvant chemotherapy increases pathological complete response (pCR) rates overall and specifically in patients with triple-negative breast cancer (TNBC). No difference in pCR rate was observed for adding everolimus to paclitaxel in nonearly responding patients. Here, we present disease-free (DFS) and overall survival (OS) analyses.

Patients and methods: Patients (n = 1948) with HER2-negative tumors of a median tumor size of 4 cm were randomly assigned to neoadjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel (EC-T) with or without eight infusions of bevacizumab every 3 weeks before surgery. Patients without clinical response to EC ± Bevacizumab were randomized to 12 weekly cycles paclitaxel with or without everolimus 5 mg/day. To detect a hazard ratio (HR) of 0.75 (α = 0.05, β = 0.8) 379 events had to be observed in the bevacizumab arms.

Results: With a median follow-up of 3.8 years, 3-year DFS was 80.8% and 3-year OS was 89.7%. Outcome was not different for patients receiving bevacizumab (HR 1.03; P = 0.784 for DFS and HR 0.974; P = 0.842 for OS) compared with patients receiving chemotherapy alone. Patients with TNBC similarly showed no improvement in DFS (HR = 0.99; P = 0.941) and OS (HR = 1.02; P = 0.891) when treated with bevacizumab. No other predefined subgroup (HR+/HER2-; locally advanced (cT4 or cN3) or not; cT1-3 or cT4; pCR or not) showed a significant benefit. No difference in DFS (HR 0.997; P = 0.987) and OS (HR 1.11; P = 0.658) was observed for nonearly responding patients receiving paclitaxel with or without everolimus overall as well as in subgroups.

Conclusions: Long-term results, in opposite to the results of pCR, do not support the neoadjuvant use of bevacizumab in addition to an anthracycline-taxane-based chemotherapy or everolimus in addition to paclitaxel for nonearly responding patients.

Clinical trial number: NCT 00567554, www.clinicaltrials.gov.

Trial registration: ClinicalTrials.gov NCT00567554.

Keywords: bevacizumab; disease-free survival; everolimus; neoadjuvant chemotherapy; overall survival.

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