Toxicity of locoregional radiotherapy in combination with bevacizumab in patients with non-metastatic breast cancer (TOLERAB): Final long-term evaluation

{Background and purpose 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. Materials and methods 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. Results A 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