奥地利维也纳大学医学院Michael Gnant团队研究了绝经后乳腺癌辅助芳香化酶抑制剂治疗的持续时间对患者预后的影响。该项研究成果发表在2021年7月28日出版的《新英格兰医学杂志》上。

对于绝经后的激素受体阳性乳腺癌患者，芳香化酶抑制剂辅助治疗的最有效持续时间尚不清楚。

在这项前瞻性、3期临床试验中，研究组招募绝经后激素受体阳性乳腺癌患者，她们均接受了5年的辅助内分泌治疗，将其随机分为两组，分别接受芳香化酶抑制剂阿那曲唑治疗2年（2年组，共7年）或5年（5年组，共10年）。主要终点是无病生存。主要分析包括所有仍在参与试验且在随机分组后2年未复发的患者（即2年组治疗结束时）。次要终点为总生存率、对侧乳腺癌、第二原发癌和临床骨折。

在3484名被纳入试验的女性中，3208名在随机分组后延长阿那曲唑治疗的前2年仍在试验中，没有疾病进展。这些女性在8年的主要分析数据集中，每个治疗组中有335名女性发生疾病进展或死亡，风险比为0.99。大多数次要终点组间无差异，亚组分析未显示任何特定亚组间的差异。5年组的临床骨折风险显著高于2年组，风险比为1.35。

研究结果表明，对于接受了5年辅助内分泌治疗的绝经后激素受体阳性乳腺癌妇女，延长5年的激素治疗与延长2年相比没有任何临床益处，但与更高的骨折风险相关。

附：英文原文

Title: Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer

Author: Michael Gnant, M.D.,, Florian Fitzal, M.D.,, Gabriel Rinnerthaler, M.D.,, Guenther G. Steger, M.D.,, Sigrun Greil-Ressler, M.D.,, Marija Balic, M.D.,, Dietmar Heck, M.D.,, Raimund Jakesz, M.D.,, Josef Thaler, M.D.,, Daniel Egle, M.D.,, Diether Manfreda, M.D.,, Vesna Bjelic-Radisic, M.D.,, Ursula Wieder, M.D.,, Christian F. Singer, M.D.,, Elisabeth Melbinger-Zeinitzer, M.D.,, Ferdinand Haslbauer, M.D.,, Paul Sevelda, M.D.,, Harald Trapl, M.D.,, Viktor Wette, M.D.,, Kerstin Wimmer, M.D.,, Simon P. Gampenrieder, M.D.,, Rupert Bartsch, M.D.,, Stephanie Kacerovsky-Strobl, M.D.,, Christoph Suppan, M.D.,, Christine Brunner, M.D.,, Christine Deutschmann, M.D.,, Lidija Soelkner, M.Sc.,, Christian Fesl, Ph.D.,, and Richard Greil, M.D.

Issue&Volume: 2021-07-28

Abstract:

Background

For postmenopausal women with hormone-receptor–positive breast cancer, the most effective duration for adjuvant therapy with an aromatase inhibitor remains unclear.

Methods

In this prospective, phase 3 trial, we randomly assigned postmenopausal women with hormone-receptor–positive breast cancer who had received 5 years of adjuvant endocrine therapy to receive the aromatase inhibitor anastrozole for an additional 2 years (2-year group, receiving a total of 7 years) or an additional 5 years (5-year group, receiving a total of 10 years). The primary end point was disease-free survival. The primary analysis included all the patients who were still participating in the trial and who had no recurrence 2 years after randomization (i.e., when treatment in the 2-year group had ended). Secondary end points were overall survival, contralateral breast cancer, second primary cancer, and clinical bone fracture.

Results

Among the 3484 women who were enrolled in the trial, 3208 remained in the trial without disease progression after the first 2 years of extended anastrozole treatment following randomization. Among these women, disease progression or death occurred in 335 women in each treatment group in the primary-analysis set at 8 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P=0.90). No between-group differences occurred in most secondary end points, and subgroup analyses did not indicate differences in any particular subgroup. The risk of clinical bone fracture was higher in the 5-year group than in the 2-year group (hazard ratio, 1.35; 95% CI, 1.00 to 1.84).

Conclusions

In postmenopausal women with hormone-receptor–positive breast cancer who had received 5 years of adjuvant endocrine therapy, extending hormone therapy by 5 years provided no benefit over a 2-year extension but was associated with a greater risk of bone fracture.

DOI: NJ202107293850506

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2104162