Safety of bevacizumab in metastatic breast cancer patients undergoing surgery

被引:18
作者
Cortes, Javier [1 ]
Caralt, Mireia [2 ]
Delaloge, Suzette [3 ]
Cortes-Funes, Hernan [4 ]
Pierga, Jean-Yves [5 ]
Pritchard, Kathleen I. [6 ,7 ]
Bollag, David T. [8 ]
Miles, David W. [9 ]
机构
[1] Univ Autonoma Barcelona, Dept Oncol, Vall dHebron Univ Hosp, E-08193 Barcelona, Spain
[2] Univ Autonoma Barcelona, Dept Hepatobiliopancreat Surg & Transplants, Vall dHebron Univ Hosp, E-08193 Barcelona, Spain
[3] Inst Gustave Roussy, Breast Oncol Dept, Villejuif, France
[4] 12 Octubre Univ Hosp, Div Med Oncol, Madrid, Spain
[5] Univ Paris 05, Dept Med Oncol, Inst Curie, Paris, France
[6] Sunnybrook Odette Canc Ctr, Toronto, ON, Canada
[7] Univ Toronto, Toronto, ON, Canada
[8] F Hoffmann La Roche Ltd, Dept Clin Res, Div Hematol & Oncol, Basel, Switzerland
[9] Mt Vernon Canc Ctr, Breast Unit, Northwood, Middx, England
关键词
Bevacizumab; Breast neoplasms; Surgery; Safety; Haemorrhage; Wound-healing complications; ENDOTHELIAL GROWTH-FACTOR; PHASE-III; 1ST-LINE BEVACIZUMAB; COLORECTAL-CANCER; LOCALLY RECURRENT; PLUS DOCETAXEL; DOUBLE-BLIND; SURVIVAL; PACLITAXEL; EFFICACY;
D O I
10.1016/j.ejca.2011.11.021
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
Background: Evaluate the safety of surgery in relation to bevacizumab in the first-line treatment of metastatic breast cancer (mBC) in two international trials. Patients and methods: The incidence, type and timing of post-surgical bleeding events and wound-healing complications were assessed in surgical patients in the AVastin And DOcetaxel (AVADO) (NCT00333775) and Avastin THErapy for advaNced breAst cancer (ATHENA) (NCT00448591) trials. Both study protocols followed recommendations to withhold bevacizumab for at least 6 weeks before elective surgery and to wait 28 days (or until the wound was fully healed) after major surgery before recommencing bevacizumab therapy. Results: In AVADO, 221 surgical procedures (55 major, 166 minor) were performed in 155 patients. In ATHENA, 1190 surgical procedures (435 major, 755 minor) were performed in 672 patients. One bevacizumab-treated AVADO patient (0.9%) who underwent surgery experienced a grade 3 bleeding event. In ATHENA, six patients (0.9%) who underwent surgery experienced grade 3 bleeding events and one patient (0.1%) experienced a grade 4 bleeding event. No grade 5 bleeding events in patients undergoing surgery were reported in either study. One grade 3 wound-healing complication was reported in each of the AVADO arms: placebo (n = 46, 2.2%), bevacizumab 7.5 mg/kg (n = 57, 1.8%) and bevacizumab 15 mg/kg (n = 52, 1.9%). Incidence of grade 3-4 wound-healing complications in ATHENA was 2.2% and 1.3% in patients undergoing minor or major surgery, respectively. Conclusions: Surgery can be performed on patients with mBC undergoing bevacizumab therapy with a low risk of severe bleeding or wound-healing complications post surgery, if current labelling recommendations are adhered to. (C) 2011 Elsevier Ltd. All rights reserved.
引用
收藏
页码:475 / 481
页数:7
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