Ten-year survival results of a randomized trial of irradiation of internal mammary nodes after mastectomy.


Hennequin, C; Bossard, N; Servagi-Vernat, S; Maingon, P; Dubois, JB; Datchary, J; Carrie, C; Roullet, B; Suchaud, JP; Teissier, E; Lucardi, A; Gerard, JP; Belot, A; Iwaz, J; Ecochard, R; Romestaing, P; (2013) Ten-year survival results of a randomized trial of irradiation of internal mammary nodes after mastectomy. International journal of radiation oncology, biology, physics, 86 (5). pp. 860-6. ISSN 0360-3016 DOI: https://doi.org/10.1016/j.ijrobp.2013.03.021

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Abstract

To evaluate the efficacy of irradiation of internal mammary nodes (IMN) on 10-year overall survival in breast cancer patients after mastectomy. This multicenter phase 3 study enrolled patients with positive axillary nodes (pN+) or central/medial tumors with or without pN+. Other inclusion criteria were age <75 and a Karnofsky index ≥70. All patients received postoperative irradiation of the chest wall and supraclavicular nodes and were randomly assigned to receive IMN irradiation or not. Randomization was stratified by tumor location (medial/central or lateral), axillary lymph node status, and adjuvant therapy (chemotherapy vs no chemotherapy). The prescribed dose of irradiation to the target volumes was 50 Gy or equivalent. The first 5 intercostal spaces were included in the IMN target volume, and two-thirds of the dose (31.5 Gy) was given by electrons. The primary outcome was overall survival at 10 years. Disease-free survival and toxicity were secondary outcomes. T total of 1334 patients were analyzed after a median follow-up of 11.3 years among the survivors. No benefit of IMN irradiation on the overall survival could be demonstrated: the 10-year overall survival was 59.3% in the IMN-nonirradiated group versus 62.6% in the IMN-irradiated group (P=.8). According to stratification factors, we defined 6 subgroups (medial/central or lateral tumor, pN0 [only for medial/central] or pN+, and chemotherapy or not). In all these subgroups, IMN irradiation did not significantly improve overall survival. In patients treated with 2-dimensional techniques, we failed to demonstrate a survival benefit for IMN irradiation. This study cannot rule out a moderate benefit, especially with more modern, conformal techniques applied to a higher risk population.

Item Type: Article
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Non-Communicable Disease Epidemiology
PubMed ID: 23664327
Web of Science ID: 321743600018
URI: http://researchonline.lshtm.ac.uk/id/eprint/2159963

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