随机化RxPONDER试验中激素受体阳性、HER2阴性、淋巴结阳性乳腺癌的种族与临床结局
Race and clinical outcomes in hormone receptor-positive, HER2-negative, node-positive breast cancer in the randomized RxPONDER trial.
作者信息
Abdou Yara, Barlow William E, Gralow Julie R, Meric-Bernstam Funda, Albain Kathy S, Hayes Daniel F, Lin Nancy U, Perez Edith A, Goldstein Lori J, Chia Stephen K L, Dhesy-Thind Sukhbinder, Rastogi Priya, Alba Emilio, Delaloge Suzette, Schott Anne F, Shak Steven, Sharma Priyanka, Lew Danika L, Miao Jieling, Unger Joseph M, Tripathy Debasish, Hortobagyi Gabriel N, Pusztai Lajos, Kalinsky Kevin
机构信息
University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
SWOG Statistics and Data Management Center, Seattle, WA, United States.
出版信息
J Natl Cancer Inst. 2025 May 1;117(5):889-897. doi: 10.1093/jnci/djae314.
BACKGROUND
The phase III RxPONDER trial has affected treatment for node-positive (1-3), hormone receptor-positive, HER2-negative breast cancer with a 21-gene recurrence score (RS) less than 26. We investigated how these findings apply to different racial and ethnic groups within the trial.
METHODS
The trial randomly assigned women to endocrine therapy (ET) or to chemotherapy plus ET. The primary clinical outcome was invasive disease-free survival (IDFS), with distant relapse-free survival (DRFS) as a secondary outcome. Multivariable Cox models were used to evaluate the association between race/ethnicity and survival outcomes, adjusting for clinicopathological characteristics, RS, and treatment.
RESULTS
A total of 4048 women with self-reported race/ethnicity were included: Hispanic (15.1%), non-Hispanic Black (NHB) (6.1%), Native American/Pacific Islander (0.8%), Asian (8.0%), and non-Hispanic White (NHW) (70%). No differences in RS distribution, tumor size, or number of positive nodes were observed by race/ethnicity. Relative to NHWs, IDFS was worse for NHB participants (5-year IDFS 91.6% vs 87.1%, HR = 1.37; 95% CI = 1.03 to 1.81) and better for Asians (91.6% vs 93.9%, HR = 0.64; 95% CI = 0.46 to 0.91). Relative to NHW, DRFS was worse for NHB participants (5-year DRFS 95.8% vs 91.0%, HR = 1.65; 95% CI = 1.17 to 2.32) and better for Asians (95.8% vs 96.7%, HR = 0.59; 95% CI = 0.37 to 0.95). Adjusting for clinical characteristics, particularly body mass index, diminished the effect of race on outcomes. Chemotherapy treatment efficacy did not differ by race/ethnicity.
CONCLUSIONS
NHB women had worse clinical outcomes compared with NHWs in the RxPONDER trial despite similar RS and comparable treatment. Our study emphasizes the persistent racial disparities in breast cancer outcomes while highlighting complex interactions among contributing factors.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT01272037.
背景
III期RxPONDER试验影响了对淋巴结阳性（1 - 3个）、激素受体阳性、人表皮生长因子受体2（HER2）阴性且21基因复发评分（RS）低于26的乳腺癌的治疗。我们研究了这些结果如何适用于试验中的不同种族和族裔群体。
方法
该试验将女性随机分配至内分泌治疗（ET）组或化疗加ET组。主要临床结局为无侵袭性疾病生存期（IDFS），远处无复发生存期（DRFS）作为次要结局。采用多变量Cox模型评估种族/族裔与生存结局之间的关联，并对临床病理特征、RS和治疗进行校正。
结果
共纳入4048名自我报告种族/族裔的女性：西班牙裔（15.1%）、非西班牙裔黑人（NHB）（6.1%）、美洲原住民/太平洋岛民（0.8%）、亚洲人（8.0%）和非西班牙裔白人（NHW）（70%）。未观察到种族/族裔在RS分布、肿瘤大小或阳性淋巴结数量方面存在差异。相对于NHW，NHB参与者的IDFS较差（5年IDFS为91.6%对87.1%，风险比[HR] = 1.37；95%置信区间[CI] = 1.03至1.81），而亚洲人则较好（91.6%对93.9%，HR = 0.64；95% CI = 0.46至0.91）。相对于NHW，NHB参与者的DRFS较差（5年DRFS为95.8%对91.0%，HR = 1.65；95% CI = 1.17至2.32），而亚洲人则较好（95.8%对96.7%，HR = 0.59；95% CI = 0.37至0.95）。对临床特征进行校正，尤其是体重指数，会减弱种族对结局的影响。化疗治疗效果在种族/族裔之间没有差异。
结论
在RxPONDER试验中，尽管RS相似且治疗相当，但NHB女性的临床结局比NHW女性更差。我们的研究强调了乳腺癌结局中持续存在的种族差异，同时突出了影响因素之间复杂的相互作用。
试验注册
ClinicalTrials.gov：NCT01272037
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