体重指数对绝经后雌激素受体阳性乳腺癌患者延长芳香化酶抑制治疗的预后关系：SOLE试验的回顾性分析
Prognostic relation of body mass index on extended aromatase inhibition treatment in postmenopausal patients with estrogen receptor positive breast cancer: A retrospective analysis of the SOLE trial.
作者信息
Biganzoli Giacomo, Isnaldi Edoardo, Richard François, Marano Giuseppe, Boracchi Patrizia, Maetens Marion, Floris Giuseppe, Neven Patrick, Jerusalem Guy, Munzone Elisabetta, Hitre Erika, Gombos Andrea, Thompson Alastair, Aebi Stefan, Kammler Roswitha, Dell'Orto Patrizia, Viale Giuseppe, Regan Meredith M, Colleoni Marco, Biganzoli Elia, Desmedt Christine
机构信息
Unit of Medical Statistics, Biometry and Epidemiology, Department of Biomedical and Clinical Sciences (DIBIC) "L. Sacco" & DSRC, LITA Vialba campus, University of Milan, Milan, Italy.
KU Leuven, Department of Oncology, Laboratory for Translational Breast Cancer Research, Leuven, Belgium.
出版信息
Eur J Cancer. 2025 Jun 3;222:115438. doi: 10.1016/j.ejca.2025.115438. Epub 2025 Apr 17.
BACKGROUND
Obesity is associated with a greater risk of developing distant recurrences in patients with estrogen receptor-positive (ER+) breast cancer. This association is however poorly investigated in patients treated with extended endocrine treatment (ET). We therefore evaluated the prognostic role of BMI in the SOLE trial, where postmenopausal patients, after having completed 4-6 years of adjuvant ET, were treated with 5 additional years of continuous or intermittent letrozole.
PATIENTS & METHODS: We considered the 3606 patients with ER+ /HER2- lymph node-positive BC with available BMI from the SOLE trial (NCT00553410). Distant-recurrence free interval (DRFI) was the main endpoint, and breast cancer-free interval (BCFI), disease-free survival (DFS) and overall survival (OS) secondary endpoints. Adjusted risk ratios (RR) for distant metastases were estimated with crude cumulative incidence models.
RESULTS
38.6 % of the patients were underweight or normal weight, 36.5 % overweight and 24.9 % obese. BMI was associated with age, tumor size, number of positive lymph nodes, menopausal status and type of prior ET. In the adjusted analyses, the prognostic value of BMI was dependent on prior ET and extended ET arm (second-order interaction p-value<0.001 for DRFI, BCFI and DFS, but not for OS). For instance, in patients treated with both a selective estrogen receptor modulator and an aromatase inhibitor in the first five years, obesity, as compared to normal-weight, was associated with better (RR=0.61, 95 %CI: 0.42-0.90) and worse (RR=2.31, 95 %CI: 1.41-3.78) outcomes in the adjusted models, in patients treated with continuous and intermittent letrozole in the extended ET, respectively.
CONCLUSION
We observed that the prognostic relation of BMI changes according to the type of adjuvant ET and mode of administration of extended AI. This warrants further investigation.
背景
肥胖与雌激素受体阳性（ER+）乳腺癌患者发生远处复发的风险增加有关。然而，在接受延长内分泌治疗（ET）的患者中，这种关联的研究较少。因此，我们在SOLE试验中评估了BMI的预后作用，该试验中绝经后患者在完成4至6年的辅助ET后，再接受5年的连续或间歇性来曲唑治疗。
患者与方法
我们纳入了SOLE试验（NCT00553410）中3606例有可用BMI数据的ER+ /HER2-淋巴结阳性乳腺癌患者。远处复发无间隔期（DRFI）是主要终点，无乳腺癌间隔期（BCFI）、无病生存期（DFS）和总生存期（OS）是次要终点。采用粗累积发病率模型估计远处转移的调整风险比（RR）。
结果
38.6%的患者体重过轻或正常，36.5%超重，24.9%肥胖。BMI与年龄、肿瘤大小、阳性淋巴结数量、绝经状态及既往ET类型有关。在调整分析中，BMI的预后价值取决于既往ET和延长ET组（DRFI、BCFI和DFS的二阶交互p值<0.001，但OS无此情况）。例如，在前五年同时接受选择性雌激素受体调节剂和芳香化酶抑制剂治疗的患者中，在调整模型中，肥胖与正常体重相比，在分别接受延长ET中连续和间歇性来曲唑治疗的患者中，结局更好（RR=0.61，95%CI：0.42-0.90）和更差（RR=2.31，95%CI：1.41-3.78）。
结论
我们观察到BMI的预后关系根据辅助ET的类型和延长AI的给药方式而变化。这值得进一步研究。
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