研究动态
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种族与代谢性去势敏感性前列腺癌患者治疗效果:SWOG 1216第3期试验的次级分析

Race and Treatment Outcomes in Patients With Metastatic Castration-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG 1216 Phase 3 Trial.

发表日期:2023 Aug 01
作者: Nicolas Sayegh, Umang Swami, Yeonjung Jo, Georges Gebrael, Benjamin Haaland, Shilpa Gupta, Melissa Plets, Maha H A Hussain, David I Quinn, Primo N Lara, Ian M Thompson, Neeraj Agarwal
来源: MEDICINE & SCIENCE IN SPORTS & EXERCISE

摘要:

黑人患者与白人患者相比,前列腺癌表现出更具侵袭性的疾病,并且死亡率更高。种族和社会决定因素会影响前列腺癌特异性死亡率和总生存期(OS)。然而,在先前的试验中,与白人患者相比,黑人患者并没有较差的结果,可能是因为在临床试验环境中有平等的护理资源可供利用。为了比较具有转移性去势敏感的前列腺癌(mCSPC)患者的种族在一项有大量黑人患者的3期试验中的生存差异,对患者级别的前瞻性3期随机临床试验的数据进行二次分析,包括在2013年3月1日至2017年7月15日期间入选的新诊断mCSPC患者。分析于2022年12月至2023年2月进行。接受雄激素剥夺治疗的患者被随机分配(1:1)接受奥替莫尼300毫克口服两次/日(实验组)或比卡鲁胺50毫克口服每日一次(对照组)。主要终点是OS,次要终点是无进展生存期(PFS)。在1313名参与者中,有135人(10%)为黑人,1077人(82%)为白人,两组之间种族分布均匀。与白人患者相比,黑人患者年龄较小(中位数[IQR]年龄,65.8 [60-70] vs 68.4 [62.5-74.1]岁;P= .001),并且基线前列腺特异性抗原应答率中位数(IQR)高于白人患者(54.7 [19.8-222.0] vs 26.7 [9.2-96.0] ng/mL;P< .001)。在中位随访期为4.9年的情况下,黑人和白人患者的中位PFS相似(2.3年;95% CI,1.8-1.4年 vs 2.9年;95% CI,2.5-3.3年;P= .71),及OS(5.5年;95% CI,4.8-NR vs 6.3年;95% CI,5.7-NR;P= .65)。多变量分析在调整已知预后因素后证实了相似的PFS和OS,未观察到种族和治疗之间的相互作用。通过对第一代或第二代雄激素受体信号通路抑制剂进行雄激素剥夺治疗的随机临床试验的二次分析,黑人和白人患者均表现出类似的OS和PFS。平等的护理资源可以减少黑人和白人晚期前列腺癌患者之间历史上的结果差异。ClinicalTrials.gov识别号:NCT01809691。
Black patients present with more aggressive disease and experience higher mortality than White patients with prostate cancer. Race and social determinants of health influence prostate cancer-specific mortality and overall survival (OS); however, in a previous trial, Black patients did not have inferior outcomes compared with White patients, possibly because of equitable access to care available in a clinical trial setting.To compare differences in survival outcomes of patients with metastatic castration-sensitive prostate cancer (mCSPC) by race in a phase 3 trial with a large proportion of Black patients.This secondary analysis of patient-level data of a prospective phase 3 randomized clinical trial included patients with newly diagnosed mCSPC enrolled between March 1, 2013, and July 15, 2017. Analysis was conducted between December 2022 and February 2023.Patients receiving androgen deprivation therapy were randomized (1:1) to receive either orteronel 300 mg orally twice daily (experimental group) or bicalutamide 50 mg orally daily (control group).OS, with progression-free survival (PFS) as a secondary end point.Among 1313 participants, 135 (10%) identified as Black and 1077 (82%) as White, with an equal racial distribution between groups. Black patients were younger (median [IQR] age, 65.8 [60-70] vs 68.4 [62.5-74.1] years; P = .001) and had a higher median (IQR) baseline prostate-specific antigen response rate than White patients (54.7 [19.8-222.0] vs 26.7 [9.2-96.0] ng/mL; P < .001). At a median follow-up of 4.9 years, Black and White patients had similar median PFS (2.3 years; 95% CI, 1.8-1.4 years vs 2.9 years; 95% CI, 2.5-3.3 years; P = .71) and OS (5.5 years; 95% CI, 4.8-NR vs 6.3 years; 95% CI, 5.7-NR; P = .65). The multivariable analysis confirmed similar PFS and OS after adjusting for known prognostic factors. No interaction between race and treatment was observed.In this secondary analysis of a randomized clinical trial studying androgen deprivation therapy with first- or second-generation androgen receptor pathway inhibitors, both Black and White patients demonstrated similar OS and PFS. Equitable access to care may reduce historical differences in outcomes between Black and White patients with advanced prostate cancer.ClinicalTrials.gov Identifier: NCT01809691.