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- Title
Toxicity of locoregional radiotherapy in combination with bevacizumab in patients with non-metastatic breast cancer (TOLERAB): Final long-term evaluation.
- Authors
Clément-Zhao, Alice; Tanguy, Marie-Laure; Cottu, Paul; De La Lande, Brigitte; Bontemps, Patrick; Lemanski, Claire; Baumann, Pierre; Savignoni, Alexia; Levy, Christelle; Peignaux, Karine; Reynaud-Bougnoux, Agnès; Gobillion, Aline; Kirova, Youlia
- Abstract
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 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%. Conclusion: 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.
- Subjects
BREAST cancer; ADJUVANT treatment of cancer; RADIOTHERAPY; PROGRESSION-free survival; LYMPH nodes
- Publication
PLoS ONE, 2019, Vol 14, Issue 8, p1
- ISSN
1932-6203
- Publication type
Article
- DOI
10.1371/journal.pone.0221816