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Prognostic Value of Extracapsular Tumor Spread for Locoregional Control in Premenopausal Patients With Node-Positive Breast Cancer Treated With Classical Cyclophosphamide, Methotrexate, and Fluorouracil: Long-Term Observations From International Breast Cancer Study Group Trial VI

From the Department of Radiation Oncology, and the Institute of Medical Oncology, Inselspital; IBCSG Coordinating Center, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona, Mendrisio, Lugano, Switzerland; IBCSG Statistical Center, Dana-Farber Cancer Institute; Harvard School of Public Health; Frontier Science and Technology Research Foundation, Boston, MA; West Swedish Breast Cancer Study Group, Sahlgrenska University Hospital, Göteborg; Department of Surgery, SU/Moelndal's Hospital, Moelndal, Sweden; The Institute of Oncology, Ljubljana, Slovenia; Department of Surgery, The Royal Melbourne Hospital, Melbourne; The Cancer Council Australia and University of Sydney, Australia; Centro di Riferimento Oncologico, Aviano; Oncologia Medica-Spedali Civili, Brescia; and European Institute of Oncology, Milan, Italy. (Dr Gruber is currently with the Institute of Radiation Oncology, Kantonsspital, Aarau, Switzerland)

Address reprint requests to Günther Gruber, MD, Institute of Radiation Oncology, Kantonsspital Aarau, Tellstrasse, CH-5001 Aarau, Switzerland; e-mail: guenther.gruber{at}ksa.ch

PURPOSE: We sought to determine retrospectively whether extracapsular spread (ECS) might identify a subgroup that could benefit from radiotherapy after mastectomy, especially patients with 1 to 3 positive lymph nodes (LN1-3+).

PATIENTS AND METHODS: We randomized 1,475 premenopausal women with node-positive breast cancer to three, six, or nine courses of "classical" CMF (cyclophosphamide, methotrexate, and fluorouracil). After a review of all pathology forms, 933 patients (63%) had information on the presence or absence of ECS. ECS was present in 49.5%. The median follow-up was 10 years.

RESULTS: In univariate analyses, ECS was associated with worse disease-free survival (DFS) and overall survival (OS). In multivariate analyses adjusting for tumor size, vessel invasion, surgery type, and age group, ECS remained significant (DFS: hazard ratio, 1.61; 95% CI, 1.34 to 1.93; P < .0001; OS: 1.67; 95% CI, 1.34 to 2.08; P < .0001). However, ECS was not significant when the number of positive nodes was added. The locoregional failure rate ± distant failure (LRF ± distant failure) within 10 years was estimated at 19% (± 2%) without ECS, versus 27% (± 2%) with ECS. The difference was statistically significant in univariate analyses, but not after adjusting for the number of positive nodes. No independent effect of ECS on DFS, OS, or LRF could be confirmed within the subgroup of 382 patients with LN1-3+ treated with mastectomy without radiotherapy.

CONCLUSION: Our results do not support an independent prognostic value of ECS, nor its use as an indication for irradiation in premenopausal patients with LN1-3+ treated with classical CMF. However, we could not examine whether extensive ECS is of prognostic importance.

Supported by the Swiss Group for Clinical Cancer Research, Frontier Science and Technology Research Foundation, The Cancer Council Australia, Australian New Zealand Breast Cancer Trials Group, National Cancer Institute (CA-75362), Swedish Cancer Society, Cancer Association of South Africa, Foundation for Clinical Research of Eastern Switzerland. We further acknowledge the initial support provided by the Ludwig Institute for Cancer Research and the Cancer League of Ticino.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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