根据体重指数的乳腺癌辅助化疗方案的疗效:III 期 GIM2 试验的结果。
Efficacy of adjuvant chemotherapy schedules for breast cancer according to body mass index: results from the phase III GIM2 trial.
发表日期:2024 Aug 08
作者:
F Poggio, E Blondeaux, M Tagliamento, M Perachino, S Nardin, B Conte, M Giuliano, G Arpino, M De Laurentiis, A Gravina, G Bisagni, A Rimanti, A Turletti, C Nisticò, E Magnolfi, S Gasparro, A Fabi, O Garrone, M G Alicicco, Y Urracci, P Poletti, P Correale, C Molinelli, A Fozza, F Puglisi, G Colantuoni, P Fregatti, L Boni, M Lambertini, L Del Mastro
来源:
ESMO Open
摘要:
III 期 GIM2 试验显示,与标准间隔 (SI) 化疗相比,对于淋巴结阳性早期乳腺癌女性,辅助剂量密集 (DD) 化疗可改善无病生存 (DFS) 和总生存 (OS)。公元前)。该探索性分析旨在调查本试验中根据体重指数 (BMI) 不同化疗方案的益处。该分析探讨了根据 BMI 不同化疗方案在 DFS 和 OS 方面的功效。使用单变量和多变量 Cox 比例风险模型,并根据相关预后因素进行调整。在 2091 名入组患者中,1925 名基线 BMI 已知的患者被随机分配进行 DD 与 SI 比较,因此纳入本次分析:31.6% 超重,19.3% 超重。肥胖。超重和肥胖与绝经后状态、pT > 2 和 pN > 2 肿瘤显着相关。中位随访 15.0 年(四分位距 8.4-16.3 年)后,多变量 Cox 生存模型证明不同 BMI 类别与 DFS 没有关联[调整后风险比 (adjHR) 0.96,95% 置信区间 (CI) 0.80-1.15与 BMI 或 OS 正常的患者相比,超重和肥胖患者的 adjHR 1.11,95% CI 0.91-1.35(超重和肥胖患者的 adjHR 0.90,95% CI 0.71-1.14,adjHR 1.18,95% CI 0.92-1.52)肥胖患者)。在 DFS(交互作用 P = 0.56)或 OS(交互作用 P = 0.19)方面,BMI 和治疗方案之间没有发现显着的交互作用。无论不同的 BMI 类别,均观察到 DD 化疗的生存获益,对于超重和肥胖患者的获益更为明显。对于淋巴结阳性 BC 患者,无论 BMI 如何,DD 方案均应被视为首选方案。版权所有 © 2024 作者( s)。由爱思唯尔有限公司出版。保留所有权利。
The phase III GIM2 trial showed improved disease-free survival (DFS) and overall survival (OS) with adjuvant dose-dense (DD) as compared with standard-interval (SI) chemotherapy in women with node-positive early-stage breast cancer (BC). This exploratory analysis aimed to investigate the benefit of different schedules according to body mass index (BMI) in this trial.This analysis explored the efficacy, in terms of DFS and OS, of different chemotherapy schedules according to BMI. Univariate and multivariable Cox proportional hazard models, adjusted for relevant prognostic factors, were used.Out of 2091 patients enrolled, 1925 with known baseline BMI were randomized in the DD versus SI comparison and therefore included in this analysis: 31.6% were overweight and 19.3% obese. Overweight and obesity were significantly associated with postmenopausal status, pT >2, and pN >2 tumors. After a median follow-up of 15.0 years (interquartile range 8.4-16.3 years), multivariable Cox survival models demonstrated no association of different BMI categories on DFS [adjusted hazard ratio (adjHR) 0.96, 95% confidence interval (CI) 0.80-1.15 and adjHR 1.11, 95% CI 0.91-1.35 for overweight and obese patients, respectively, compared to patients with normal BMI] or OS (adjHR 0.90, 95% CI 0.71-1.14 and adjHR 1.18, 95% CI 0.92-1.52 for overweight and obese patients, respectively). No significant interaction was found between BMI and treatment schedule in terms of DFS (Pfor interaction = 0.56) or OS (Pfor interaction = 0.19). The survival benefit of DD chemotherapy was observed irrespective of different BMI categories, with a more pronounced benefit for overweight and obese patients.In node-positive BC patients, DD schedule should be considered the preferred schedule irrespective of BMI.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.