Impact of adjuvant hormonotherapy on radiation-induced breast fibrosis according to the individual radiosensitivity: results of a multicenter prospective French trial
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Céline Bourgier1, Florence Castan1, Olivier Riou1, Tan-Dat Nguyen2, Karine Peignaux3, Claire Lemanski1, Jean-Léon Lagrange4, Youlia Kirova5, Eric Lartigau6, Yazid Belkacemi4, Sofia Rivera7, Georges Noël8, Sébastien Clippe9, Françoise Mornex10, Christophe Hennequin11, Sophie Gourgou1, Muriel Brengues1, Pascal Fenoglietto1, Esat Mahmut Ozsahin12 and David Azria1
1Institute de Recherche en Cancérologie de Montpellier, Inserm U1194, Université de Montpellier, Institut Régional du Cancer de Montpellier, Montpellier, France
2Institute Jean Godinot, Reims, France
3Centre GF Leclerc, Dijon, France
4AP-HP Henri Mondor, Créteil, France
5Institute Curie, Paris, France
6Centre Oscar Lambret, Lille, France
7Gustave Roussy, Villejuif, France
8Centre Paul Strauss, Strasbourg, France
9Centre Marie Curie, Valence, France
10Centre Hospitalier Lyon Sud, Pierre Bénite, France
11AP-HP Saint-Louis, Paris, France
12Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
David Azria, email: [email protected]
Keywords: radiotherapy; breast cancer; hormonotherapy; individual radiosensitivity; late effects
Received: November 30, 2017 Accepted: February 25, 2018 Epub: March 02, 2018 Published: March 20, 2018
Background: To evaluate risk of severe breast fibrosis occurrence in patients treated by breast-conserving surgery, adjuvant radiotherapy and hormonotherapy (HT) according to individual radiosensitivity (RILA assay).
Results: HT– and RILAhigh were the two independent factors associated with improved breast-fibrosis free survival (BFFS). BFFS rate at 36 months was lower in patients with RILAlow and HT+ than in patients with RILAhigh and HT– (75.8% and 100%, respectively; p = 0.004, hazard ratio 5.84 [95% confidence interval (CI) 1.8–19.1]). Conversely, BFFS at 36 months was comparable in patients with RILAhigh and HT+ and in patients with RILAlow and HT– (89.8% and 93.5%, respectively; p = 0.39, hazard ratio 1.7 [95% CI 0.51–5.65]), showing that these two parameters influenced independently the occurrence of severe breast fibrosis. BFFS rate was not affected by the HT type (tamoxifen or aromatase inhibitor) and timing (concomitant or sequential with radiotherapy).
Conclusions: HT and RILA score independently influenced BFFS rate at 36 months. Patients with RILAhigh and HT– presented an excellent BFFS at 36 months (100%).
Materials and methods: Breast Fibrosis-Free Survival (BFFS) rate was assessed relative to RILA categories and to adjuvant HT use (HT+ and HT–, respectively) in a prospective multicentre study (NCT00893035) which enrolled 502 breast cancer patients (456 evaluable patients). Breast fibrosis was recorded according to CTCAE v3.0 grading scale; RILA score was defined according to two categories (<12%: RILAlow; ≥12%: RILAhigh).
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