Rossi Emanuela, Morabito Alessandro, De Maio Ermelinda, Di Rella Francesca, Esposito Giuseppe, Gravina Adriano, Labonia Vincenzo, Landi Gabriella, Nuzzo Francesco, Pacilio Carmen, Piccirillo Maria Carmela, D'Aiuto Giuseppe, D'Aiuto Massimiliano, Rinaldo Massimo, Botti Gerardo, Gallo Ciro, Perrone Francesco, de Matteis Andrea
Clinical Trials Unit, National Cancer Institute of Naples, Via Mariano Semmola, 80131, Napoli, Italy.
J Clin Oncol. 2008 Jan 10;26(2):264-70. doi: 10.1200/JCO.2007.13.5319. Epub 2007 Dec 17.
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).
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-beta-estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), Delta4-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.
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.
Letrozole in combination with triptorelin induces a more intense estrogen suppression than tamoxifen + triptorelin in premenopausal patients with early breast cancer.
在一项正在进行的3期试验（激素辅助治疗对骨的影响研究）中，比较来曲唑+曲普瑞林或他莫昔芬+曲普瑞林对绝经前早期乳腺癌患者进行6个月辅助治疗的内分泌效应。
前瞻性收集了81名绝经前女性的激素数据，其中30名被分配接受他莫昔芬+曲普瑞林治疗，51名被分配接受来曲唑+曲普瑞林+/-唑来膦酸治疗。在基线和治疗6个月后测量血清17-β-雌二醇（E2）、促卵泡激素（FSH）、促黄体生成素（LH）、Δ4-雄烯二酮、睾酮、硫酸脱氢表雄酮、孕酮、促肾上腺皮质激素（ACTH）和皮质醇。对于每种激素，通过Wilcoxon-Mann-Whitney精确检验比较治疗组之间的6个月值。
两组患者的中位年龄均为44岁。与他莫昔芬+曲普瑞林相比，来曲唑+曲普瑞林（+/-唑来膦酸）对中位E2血清水平（P = 0.0008）、LH水平（P = 0.0005）和皮质醇血清水平（P < 0.0001）的抑制作用更强。两组患者的中位FSH血清水平均受到抑制，但接受来曲唑治疗的患者中这种抑制作用较低，这些患者的中位FSH血清水平显著更高（P < 0.0001）。两组患者在睾酮、孕酮、ACTH、雄烯二酮和硫酸脱氢表雄酮方面未观察到显著差异。
在绝经前早期乳腺癌患者中，来曲唑联合曲普瑞林比他莫昔芬+曲普瑞林能更强烈地抑制雌激素。
