Originally published as JCO Early Release 10.1200/JCO.2007.13.5319 on December 17 2007

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Endocrine Effects of Adjuvant Letrozole + Triptorelin Compared With Tamoxifen + Triptorelin in Premenopausal Patients With Early Breast Cancer

Emanuela Rossi, Alessandro Morabito, Ermelinda De Maio, Francesca Di Rella, Giuseppe Esposito, Adriano Gravina, Vincenzo Labonia, Gabriella Landi, Francesco Nuzzo, Carmen Pacilio, Maria Carmela Piccirillo, Giuseppe D'Aiuto, Massimiliano D'Aiuto, Massimo Rinaldo, Gerardo Botti, Ciro Gallo, Francesco Perrone, Andrea de Matteis

From the National Cancer Institute; and the Department of Medicine and Public Health, Second University of Naples, Naples, Italy

Corresponding author: Francesco Perrone, Clinical Trials Unit, National Cancer Institute of Naples, Via Mariano Semmola, 80131, Napoli, Italy; e-mail: francesco.perrone{at}uosc.fondazionepascale.it

Purpose: To compare the endocrine effects of 6 months of adjuvant treatment with letrozole + triptorelin or tamoxifen + triptorelin in premenopausal patients with early breast cancer within an ongoing phase 3 trial (Hormonal Adjuvant Treatment Bone Effects study).

Patients and Methods: Prospectively collected hormonal data were available for 81 premenopausal women, of whom 30 were assigned to receive tamoxifen + triptorelin and 51 were assigned letrozole + triptorelin ± zoledronate. Serum 17-β-estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), 4-androstenedione, testosterone, dehydroepiandrosterone-sulfate, progesterone, adrenocorticotropic hormone (ACTH), and cortisol were measured at baseline and after 6 months of treatment. For each hormone, 6-month values were compared between treatment groups by the Wilcoxon-Mann-Whitney exact test.

Results: Median age was 44 years for both groups of patients. Letrozole + triptorelin (± zoledronate) induced a stronger suppression of median E2 serum levels (P = .0008), LH levels (P = .0005), and cortisol serum levels (P < .0001) compared with tamoxifen + triptorelin. Median FSH serum levels were suppressed in both groups, but such suppression was lower among patients receiving letrozole, who showed significantly higher median FSH serum levels (P < .0001). No significant differences were observed for testosterone, progesterone, ACTH, androstenedione, and dehydroepiandrosterone between the two groups of patients.

Conclusion: Letrozole in combination with triptorelin induces a more intense estrogen suppression than tamoxifen + triptorelin in premenopausal patients with early breast cancer.

Supported in part by Associazione Italiana per la Ricerca sul Cancro. Letrozole and zoledronic acid were supplied at no cost by Novartis, Italy.

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