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Time-Dependent Relevance of Steroid Receptors in Breast Cancer

From the Unità Operativa Determinanti Biomolecolari nella Prognosi e Terapia; Statistica Medica e Biometria; Unità di Chirurgia Ginecologica; Unità di Anatomia Patologica, Istituto Nazionale per lo Studio e la Cura dei Tumori; Istituto di Statistica Medica e Biometria, Università degli Studi; and Centro per lo Studio della Patologia Cellulare, Consiglio Nazionale delle Ricerche, Milan, Italy.

Address reprint requests to Danila Coradini, PhD, Unità Operativa Determinanti Biomolecolari nella Prognosi e Terapia, Istituto Nazionale Tumori, Via Venezian 1, 20133 Milan, Italy; email coradini @istitutotumori.mi.it.

PURPOSE: To analyze the time-dependent prognostic role of the investigated variables, considered, when appropriate, on a continuous scale, for the purpose of evaluating and describing the interrelationships between clinically relevant patient and tumor characteristics (age, size and histology, and estrogen receptor [ER] and progesterone receptor content) and the risk of new disease manifestation.

PATIENTS AND METHODS: We applied a flexible statistical model to a case series of 1,793 patients with axillary lymph node–negative breast cancer with a minimal potential follow-up of 10 years. To avoid a potential confounding effect of adjuvant treatment, only patients given local-regional therapy until relapse were considered.

RESULTS: ER content and tumor size (adjusted for all the other covariates) showed a time-dependent relationship with the risk of new disease manifestations. In particular, ER content failed to show a prognostic effect within the first years of follow-up; thereafter, a positive association with risk of relapse was observed. For tumor size, within the first years of follow-up, the risk of relapse was directly related to size for only tumors up to 2.5 cm in diameter; thereafter, the impact on prognosis progressively decreased.

CONCLUSION: The availability of a long follow-up on a large breast cancer series, as well as the use of innovative statistical approaches, allowed us to explore the functional relation between steroid receptors and clinical outcome and to generate a hypothesis on the involvement of ER in favoring long-term metastasis development.

D.C. and M.G.D. contributed equally to the planning and execution of this article.

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