Radiotherapy Department, Institut Curie, Paris, France.
Biostatistics Department, Institut Curie, Paris, France.
PLoS One. 2019 Aug 30;14(8):e0221816. doi: 10.1371/journal.pone.0221816. eCollection 2019.
Few 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.
This 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.
A total of 64 patients were included between November 2007 and April 2010. Median follow-up 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%, disease-free survival was 89% and locoregional recurrence-free survival was 93.1%.
Concurrent B and locoregional RT are associated with acceptable 5-year toxicity in patients with non-metastatic breast cancer. No grade ≥3 toxicity was observed.
关于贝伐珠单抗（B）联合局部区域放射治疗（RT）的安全性数据很少。本研究的目的是评估非转移性乳腺癌患者接受同期 B 和 RT 治疗后的 5 年晚期毒性。
这项多中心前瞻性研究纳入了参加评估 B 联合同期 RT 与单纯 RT 治疗非转移性乳腺癌的 3 期临床试验的患者。所有患者均接受新辅助或辅助化疗及适形分割乳腺或胸壁 RT，联合或不联合区域淋巴结 RT。B 以 5mg/kg 的等效剂量每周 1 次，持续 1 年。在放疗完成后 1、3 和 5 年时评估安全性。
共有 64 例患者于 2007 年 11 月至 2010 年 4 月入组。中位随访时间为 60 个月（12-73），46 例患者可获得 5 年晚期毒性数据。大多数肿瘤为三阴性（68.8%），肿瘤大小<2cm（41.3%），淋巴结状态阴性（50.8%）。B 的总剂量中位数为 15000mg，持续时间中位数为 11.2 个月。未观察到≥3 级毒性。仅 8 例患者发生 1-2 级毒性：3 例（6.5%）为 1 级淋巴水肿，2 例（4.3%）为 1 级疼痛，1 例（2.2%）为 2 级淋巴水肿，1 例（2.2%）为 1 级纤维化。5 年总生存率为 93.8%，无病生存率为 89%，局部区域无复发生存率为 93.1%。
非转移性乳腺癌患者接受贝伐珠单抗联合局部区域放射治疗后的 5 年毒性可接受，未观察到≥3 级毒性。
