Originally published as JCO Early Release 10.1200/JCO.2006.09.0118 on June 4 2007

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Plasma Testosterone and Prognosis of Postmenopausal Breast Cancer Patients

Andrea Micheli, Elisabetta Meneghini, Giorgio Secreto, Franco Berrino, Elisabetta Venturelli, Adalberto Cavalleri, Tiziana Camerini, Maria G. Di Mauro, Elena Cavadini, Giuseppe De Palo, Umberto Veronesi, Franca Formelli

From the Department of Preventive and Predictive Medicine; Scientific Directorate; and Chemoprevention Unit, Fondazione IRCCS "Istituto Nazionale dei Tumori"; and the European Institute of Oncology, Milan, Italy

Address reprint requests to Andrea Micheli, PhD, Fondazione IRCCS "Istituto Nazionale dei Tumori," Via Venezian 1, 20133 Milan, Italy; e-mail: andrea.micheli{at}istitutotumori.mi.it

Purpose High endogenous testosterone is associated with increased breast cancer (BC) risk. We designed this study specifically to assess the long-term prognostic role of testosterone in a cohort of postmenopausal BC patients.

Patients and Methods We considered 194 postmenopausal women, operated on for early BC (T1-2N0M0), who never received chemotherapy or hormonal therapy, and who participated in a fenretinide BC prevention trial as untreated controls. Blood samples were collected 3 months (median) after surgery; plasma samples, stored at –80°C, were radioimmunoassayed for testosterone. Median follow-up was 14 years. The main end point was any cancer event. Event-free survival was estimated by the Kaplan-Meier method. Hazard ratios (HRs) of events by testosterone level were estimated by the Cox model, adjusting for age, tumor size, and histology.

Results Patients with high testosterone ( 0.40 ng/mL, median of distribution) had significantly lower event-free survival than those with low testosterone (log-rank P = .004). The adjusted HR of patients with high versus low testosterone was 2.05 (95% CI, 1.28 to 3.27). High testosterone was also associated with a significantly higher risk of BC events (relapse and second primary) with an adjusted HR of 1.77 (95% CI, 1.06 to 2.96). Eleven second primaries (non-BC) occurred in the high-testosterone group, four in the low-testosterone group.

Conclusion High plasma testosterone strongly predicts poorer prognosis in postmenopausal BC patients not administered adjuvant therapy. Testosterone levels should be determined as part of the prognostic work-up.

published online ahead of print at www.jco.org on June 4, 2007.

Supported by the Italian Association for Cancer Research (ref. 47/03) and the US National Cancer Institute, US Department of Health and Human Services, National Institutes of Health, and the Italian National Research Council.

Presented in part at the Reunião do Grupo para a Epidemiologia e o Registro do Cancro nos Países de Língua Latina, May 4-6, 2005, Lisbon, Portugal.

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

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