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PLoS One. 2019 Aug 30;14(8):e0221816. doi: 10.1371/journal.pone.0221816. eCollection 2019.

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

Author information

1
Radiotherapy Department, Institut Curie, Paris, France.
2
Biostatistics Department, Institut Curie, Paris, France.
3
Oncology Department, Institut Curie, Paris, France.
4
Radiotherapy Department, Institut Curie, Rene Huguenin Hospital, Saint Cloud, France.
5
Radiotherapy Department, CHU Jean Minjoz, Besançon, France.
6
Radiotherapy Department, Institut régional du Cancer de Montpellier, Montpellier, France.
7
Radiotherapy Department, Centre d'Oncologie de Gentilly, Nancy, France.
8
Radiotherapy Department, Centre François Baclesse, Caen, France.
9
Radiotherapy Department, Centre Georges-François Leclerc, Dijon, France.
10
Radiation Oncology Department, CHU Tours, Tours, France.

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.

PMID:
31469859
DOI:
10.1371/journal.pone.0221816
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Conflict of interest statement

The authors have declared that no competing interests exist.

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