Dautruche A, Belin L, Cottu P, Bontemps P, Lemanski C, de la Lande B, Baumann P, Missohou F, Lévy C, Peignaux K, Reynaud-Bougnoux A, Denis F, Gobillion A, Pernin V, Kirova Y
Radiotherapy department, institut Curie, 26, rue d'Ulm, 75005 Paris, France.
Biostatistics department, institut Curie, 26, rue d'Ulm, 75005 Paris, France.
Cancer Radiother. 2018 May;22(3):222-228. doi: 10.1016/j.canrad.2017.10.004. Epub 2018 Apr 9.
To determine the 3 years late toxicity among patients with non-metastatic breast cancer who received concurrent bevacizumab and locoregional radiotherapy.
This is a single-arm, multicentre, prospective study, of the toxicity of adjuvant concomitant association of bevacizumab and radiotherapy in patients with breast cancer. Toxicity was assessed by the Common Terminology Criteria for Adverse Events version 3.0 during the radiotherapy and follow-up clinics at 12 and 36 months after its completion. The study was designed to evaluate the toxicity at one year, 3 years and 5 years.
Sixty-four patients were included from October 2007 to August 2010. All of them received concurrent adjuvant radiotherapy and bevacizumab (in 24 cases after primary systemic treatment). All patients received non-fractionated radiotherapy to breast or chest wall with or without irradiation of regional lymph nodes. Early toxicity has been previously reported. Median follow-up was 46.4 months (range: 18-77 months). Median age was 53 years old (range: 23-68 years). The 3-years overall survival was 93% (range: 87-100%). Evaluation of the toxicity at 3 years was available for 67% of the patients. There was a low rate of toxicity: 14% grade 1 pain, 9% grade 1 fibrosis, 2% grade 1 telangiectasia, 2% grade 1 paresis, 7% grade 1 lymphedema and 2% grade 3 lymphedema. No grade 4 toxicity was observed. No patient had a left ventricular ejection fraction below 50% at 3 years.
Concurrent bevacizumab with locoregional radiotherapy is associated with acceptable 3-years toxicity in patients with breast cancer.
确定接受贝伐单抗与局部区域放疗联合治疗的非转移性乳腺癌患者的3年迟发性毒性。
这是一项单臂、多中心、前瞻性研究，旨在探讨乳腺癌患者辅助性联合使用贝伐单抗与放疗的毒性。在放疗期间以及放疗结束后12个月和36个月的随访门诊中，采用不良事件通用术语标准3.0评估毒性。该研究旨在评估1年、3年和5年时的毒性。
2007年10月至2010年8月共纳入64例患者。所有患者均接受了辅助性同步放疗和贝伐单抗治疗（24例在接受原发性全身治疗后）。所有患者均接受了针对乳腺或胸壁的非分割放疗，部分患者还接受了区域淋巴结照射。早期毒性已在之前报道过。中位随访时间为46.4个月（范围：18 - 77个月）。中位年龄为53岁（范围：23 - 68岁）。3年总生存率为93%（范围：87% - 100%）。67%的患者可进行3年时的毒性评估。毒性发生率较低：14%为1级疼痛，9%为1级纤维化，2%为1级毛细血管扩张，2%为1级轻瘫，7%为1级淋巴水肿，2%为3级淋巴水肿。未观察到4级毒性。3年时无患者左心室射血分数低于50%。
对于乳腺癌患者，贝伐单抗与局部区域放疗联合使用时，3年毒性可接受。
