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

被引：107

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

来源：

ANNALS OF ONCOLOGY | 2014年 / 25卷 / 12期

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

页码：2363 / 2372

页数：10

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