Abstract
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 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%.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.
Highlights
Neoangiogenesis plays a central role in tumour growth and metastasis, with the vascular endothelial growth factor (VEGF)[1] acting as a key growth factor in breast tumours
Despite the encouraging results of preliminary studies concerning the efficacy of bevacizumab in combination with chemotherapy in metastatic breast cancer[2], no clinical benefit was observed in these trials[3,5,7]
Limited data are available concerning the safety of the combination of bevacizumab and locoregional radiotherapy, with heterogeneous results: toxicity has been described in phase I and II trials in lung cancer and pancreatic cancer[8,9,10], this combination was well tolerated by patients with cervical cancer and pancreatic cancer in another phase II trial[11,12]
Summary
Neoangiogenesis plays a central role in tumour growth and metastasis, with the vascular endothelial growth factor (VEGF)[1] acting as a key growth factor in breast tumours. Despite the encouraging results of preliminary studies concerning the efficacy of bevacizumab in combination with chemotherapy in metastatic breast cancer[2], no clinical benefit was observed in these trials[3,5,7]. Limited data are available concerning the safety of the combination of bevacizumab and locoregional radiotherapy, with heterogeneous results: toxicity has been described in phase I and II trials in lung cancer and pancreatic cancer[8,9,10], this combination was well tolerated by patients with cervical cancer and pancreatic cancer in another phase II trial[11,12]. 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.
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