Torrisi Rosalba, Basilico Vera, Giordano Laura, Caruso Michele, Musolino Antonino, Monari Marta Noemi, Carnaghi Carlo, Santoro Armando
IRCCS Humanitas Research Hospital Medical Oncology Unit, Rozzano, Italy.
Medical Oncology Unit, Istituto Clinico Mater Domini Humanitas, Castellanza, Italy.
Breast Care (Basel). 2022 Feb;17(1):10-15. doi: 10.1159/000514445. Epub 2021 Mar 4.
Anti-Müllerian hormone (AMH) is the most reliable biomarker of ovarian reserve; however, its role in predicting ovarian recovery after chemotherapy is unclear. Administration of a GnRH analog (GnRHa) during chemotherapy significantly reduces the ovarian failure rate and increases the pregnancy rate. The available data on the behavior of AMH during concurrent administration of chemotherapy and GnRHa are inconsistent. We investigated whether concurrent administration of triptorelin and adjuvant chemotherapy might reduce the expected drop of AMH.
Eligible patients were premenopausal women aged <40 years, with a diagnosis of early breast cancer, and candidates to 4-8 cycles of adjuvant chemotherapy. Triptorelin (3.75 mg i.m.) was started before chemotherapy and administered every 4 weeks thereafter. The principal endpoint was the proportion of patients with an AMH percent change ≤50% between 12 months after chemotherapy and basal levels. The secondary endpoint was the proportion of patients achieving postchemotherapy AMH levels above the threshold of 0.2 ng/mL.
Fifty patients were enrolled, 31 of whom had blood samples available at baseline and 1 year after the end of chemotherapy. AMH decreased to nearly undetectable levels after chemotherapy and recovered after 12 months, but they did not exceed 1 tenth of the pretreatment levels. As for the secondary endpoint, 15 of the 31 patients recovered AMH levels above the threshold.
This study did not reach its principal endpoint; however, the rate of 48% of patients who recovered AMH above threshold levels favorably compared with those in studies without concurrent GnRHa, supporting a better recovery of AMH with triptorelin.
抗苗勒管激素(AMH)是卵巢储备最可靠的生物标志物;然而,其在预测化疗后卵巢恢复情况中的作用尚不清楚。化疗期间给予促性腺激素释放激素类似物(GnRHa)可显著降低卵巢衰竭率并提高妊娠率。关于化疗与GnRHa联合应用时AMH变化情况的现有数据并不一致。我们研究了曲普瑞林与辅助化疗联合应用是否可能减少预期的AMH下降。
符合条件的患者为年龄<40岁的绝经前女性,诊断为早期乳腺癌,且为4 - 8周期辅助化疗的候选者。曲普瑞林(3.75 mg,肌肉注射)在化疗前开始使用,此后每4周给药一次。主要终点是化疗后12个月与基础水平相比,AMH变化百分比≤50%的患者比例。次要终点是化疗后AMH水平达到0.2 ng/mL阈值以上的患者比例。
共纳入50例患者,其中31例在基线和化疗结束后1年有血样。化疗后AMH降至几乎不可检测水平,并在12个月后恢复,但未超过治疗前水平的十分之一。至于次要终点,31例患者中有15例AMH水平恢复至阈值以上。
本研究未达到其主要终点;然而,48%的患者AMH恢复至阈值以上的比例优于未联合应用GnRHa的研究,支持曲普瑞林可使AMH更好地恢复。