Tripathy Debu, Blum Joanne L, Karuturi Meghan S, McCune Steven, Kurian Sobha, Moezi Mehdi, Anderson Daniel, Gauthier Eric, Zhang Zhe, Montelongo Monica Z, Wang Yao, Rocque Gabrielle B
Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States.
Baylor-Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, TX 75246, United States.
Oncologist. 2024 Oct 30. doi: 10.1093/oncolo/oyae291.
Strict eligibility criteria for participation in randomized clinical trials (RCTs) often limit the generalizability of data when applied to a more heterogeneous real-world population. Thus, evidence generated directly from real-world populations, including subgroups underrepresented in RCTs, can help inform routine clinical practice. POLARIS (NCT03280303), a prospective, observational, multicenter, cohort study, evaluated patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) receiving palbociclib + endocrine therapy (ET) in routine care.
Demographics, baseline characteristics, and treatment patterns were summarized descriptively. Real-world response and clinical benefit rates, real-world progression-free survival (rwPFS), and overall survival (OS) were summarized descriptively by line of therapy and endocrine partner in the overall cohort and various subgroups.
Between January 2017 and October 2019, 1250 patients (median age of 64.0 years) initiated treatment with palbociclib-based therapy, including 901 in the first-line (1L) setting and 349 in the second-line or later (≥2L) settings. Real-world response and clinical benefit rates with palbociclib + ET were 34.0% and 69.4%, respectively, in 1L, and 21.8% and 57.9% in ≥2L. Median rwPFS was 20.9 (95% CI, 18.7-24.7) and 13.5 (10.6-17.1) months, and median OS was 48.5 (42.0-not estimable) and 37.2 (31.2-40.8) months, with 1L and ≥2L palbociclib + ET, respectively.
Outcomes in this large, heterogeneous, real-world population are generally consistent with previously reported results from clinical trials and other real-world studies, further supporting the use of palbociclib + ET in patients with HR+/HER2- ABC.
NCT03280303 (ClinicalTrials.gov).
参与随机临床试验（RCT）的严格入选标准在应用于更具异质性的真实世界人群时，常常会限制数据的可推广性。因此，直接从真实世界人群中产生的证据，包括在RCT中代表性不足的亚组的数据，有助于为常规临床实践提供参考。POLARIS（NCT03280303）是一项前瞻性、观察性、多中心队列研究，评估了在常规治疗中接受哌柏西利联合内分泌治疗（ET）的激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2-）晚期乳腺癌（ABC）患者。
对人口统计学、基线特征和治疗模式进行描述性总结。按治疗线数和内分泌联合用药情况，对整个队列及各个亚组的真实世界缓解率和临床获益率、真实世界无进展生存期（rwPFS）和总生存期（OS）进行描述性总结。
2017年1月至2019年10月期间，1250例患者（中位年龄64.0岁）开始接受基于哌柏西利的治疗，其中901例为一线（1L）治疗，349例为二线或更晚期（≥2L）治疗。哌柏西利联合ET的真实世界缓解率和临床获益率在1L治疗中分别为34.0%和69.4%，在≥2L治疗中分别为21.8%和57.9%。1L和≥2L哌柏西利联合ET的中位rwPFS分别为20.9（95%CI，18.7-24.7）和13.5（10.6-17.1）个月，中位OS分别为48.5（42.0-不可估计）和37.2（31.2-40.8）个月。
在这个大型、异质性的真实世界人群中的结果总体上与先前临床试验和其他真实世界研究报告的结果一致，进一步支持在HR+/HER2-ABC患者中使用哌柏西利联合ET。
NCT03280303（ClinicalTrials.gov）。
