Toxicity of locoregional radiotherapy in combination with bevacizumab in patients with non-metastatic breast cancer (TOLERAB): Final long-term evaluation
Toxicity of locoregional radiotherapy in combination with bevacizumab in patients with non-metastatic breast cancer (TOLERAB): Final long-term evaluation
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DOI：
10.1371/journal.pone.0221816
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发表时间：
2019-08-30
期刊：
影响因子：
3.7
通讯作者：
Kirova, Youlia
中科院分区：
文献类型：
--
作者：
Clement-Zhao, Alice;Tanguy, Marie-Laure;Kirova, Youlia
背景和目的关于贝伐单抗(B)联合局部放射治疗(RT)的安全性，目前可获得的数据很少。本研究的目的是评价同步放疗和同步放疗在非转移性乳腺癌中的5年远期毒性。材料和方法这项多中心前瞻性研究包括参加3期临床试验的非转移性乳腺癌患者，评价同期放疗和单纯放疗的疗效。所有患者均接受新辅助或辅助化疗和常规分割乳房或胸壁放疗，并加或不加区域淋巴结放疗。B组给予等量的5 mg/kg，每周1次，连服1年。分别于放疗结束后1、3、5年进行安全性评价。结果纳入2007年11月至2010年4月收治的患者。中位随访时间为60个月(12-73个月)，46例患者有5年的晚期毒性数据。大多数肿瘤为三阴性(68.8%)，肿瘤大小<2 cm(41.3%)，结节状态阴性(50.8%)。中位总剂量为15000 mg，中位疗程为11.2个月。未观察到3级毒性。仅8例出现1~2级毒性反应：1级淋巴水肿3例(6.5%)，1级疼痛2例(4.3%)，2级淋巴水肿1例(2.2%)，1级纤维化1例(2.2%)。5年总生存率为93.8%，无瘤生存率为89%，无局部复发生存率为93.1%。结论非转移性乳腺癌患者可接受B期放疗和局部放疗的5年毒副反应。未观察到3级毒性。
Background and purposeFew data are available concerning the safety of bevacizumab (B) in combination with locoregional radiation therapy (RT). The objective of this study was to evaluate the 5-year late toxicity of concurrent B and RT in non-metastatic breast cancer.Materials and methodsThis multicentre prospective study included non-metastatic breast cancer patients enrolled in phase 3 clinical trials evaluating B with concurrent RT versus RT alone. All patients received neoadjuvant or adjuvant chemotherapy and normofractionated breast or chest wall RT, with or without regional lymph node RT. B was administered at an equivalent dose of 5 mg/kg once a week for 1 year. The safety profile was evaluated 1, 3 and 5 years after completion of radiotherapy.ResultsA total of 64 patients were included between November 2007 and April 2010. Median followup was 60 months (12-73) and 5-year late toxicity data were available for 46 patients. The majority of tumours were triple-negative (68.8%), tumour size < 2cm (41.3%) with negative nodal status (50.8%). Median total dose of B was 15,000mg and median duration was 11.2 months. No grade >= 3 toxicity was observed. Only 8 patients experienced grade 1-2 toxicities: n = 3 (6.5%) grade 1 lymphedema, n = 2 (4.3%) grade 1 pain, n = 1 (2.2%) grade 2 lymphedema, n = 1 (2.2%) grade 1 fibrosis. Five-year overall survival was 93.8%, diseasefree survival was 89% and locoregional recurrence-free survival was 93.1%.ConclusionConcurrent B and locoregional RT are associated with acceptable 5-year toxicity in patients with non-metastatic breast cancer. No grade >= 3 toxicity was observed.