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

被引:109
作者
von Minckwitz, G. [1 ,2 ]
Loibl, S. [1 ]
Untch, M. [3 ]
Eidtmann, H. [4 ]
Rezai, M. [5 ]
Fasching, P. A. [6 ]
Tesch, H. [7 ]
Eggemann, H. [8 ]
Schrader, I. [9 ]
Kittel, K. [10 ]
Hanusch, C. [11 ]
Huober, J. [12 ]
Solbach, C. [2 ]
Jackisch, C. [13 ]
Kunz, G. [14 ]
Blohmer, J. U. [15 ]
Hauschild, M. [16 ]
Fehm, T. [17 ]
Nekljudova, V. [1 ]
Gerber, B. [18 ]
机构
[1] German Breast Grp, Neu Isenburg, Germany
[2] Univ Hosp, Dept Obstet & Gynaecol, Frankfurt, Germany
[3] Klinikum Berlin, Dept Obstet & Gynaecol, Berlin, Germany
[4] Univ Hosp, Dept Obstet & Gynaecol, Kiel, Germany
[5] Luisenkrankenhaus, Breast Ctr, Dusseldorf, Germany
[6] Univ Hosp, Dept Gynecol & Obstet, Erlangen, Germany
[7] Chop GmbH, Dept Canc Med, Frankfurt, Germany
[8] Univ Hosp, Dept Obstet & Gynaecol, Magdeburg, Germany
[9] Henriettenstiftung, Dept Obstet & Gynaecol, Hannover, Germany
[10] Praxisklinik, Dept Obstet & Gynaecol, Berlin, Germany
[11] Rot Kreuz Klinikum, Dept Obstet & Gynaecol, Munich, Germany
[12] Univ Hosp, Dept Obstet & Gynaecol, Ulm, Germany
[13] Sana Klinikum, Dept Obstet & Gynaecol, Offenbach, Germany
[14] St Johannes Hosp, Dept Obstet & Gynaecol, Dortmund, Germany
[15] St Gertrauden Hosp, Dept Obstet & Gynaecol, Berlin, Germany
[16] Hosp Rheinfelden, Dept Obstet & Gynaecol, Rheinfelden, Germany
[17] Univ Tubingen Hosp, Dept Obstet & Gynaecol, Tubingen, Germany
[18] Univ Hosp, Dept Obstet & Gynaecol, Rostock, Germany
关键词
bevacizumab; everolimus; neoadjuvant chemotherapy; disease-free survival; overall survival; TAXANE-BASED CHEMOTHERAPY; III RANDOMIZED GEPARTRIO; PHASE-3; TRIAL; GEPARQUINTO; TRASTUZUMAB; THERAPY;
D O I
10.1093/annonc/mdu455
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 (alpha = 0.05, beta = 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.
引用
收藏
页码:2363 / 2372
页数:10
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