在真实世界的美国临床实践中，一线哌柏西利联合来曲唑对比来曲唑单药治疗 HR+/HER2-转移性乳腺癌的疗效比较。
Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2- metastatic breast cancer in US real-world clinical practice.
机构信息
Abramson Cancer Center, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA.
Robert H. Lurie Cancer Center of Northwestern University, Feinberg School of Medicine, Chicago, 710 N Fairbanks Ct, Suite 8-250A, Chicago, IL, 60611, USA.
出版信息
Breast Cancer Res. 2021 Mar 24;23(1):37. doi: 10.1186/s13058-021-01409-8.
BACKGROUND
Findings from randomized clinical trials may have limited generalizability to patients treated in routine clinical practice. This study examined the effectiveness of first-line palbociclib plus letrozole versus letrozole alone on survival outcomes in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor-negative (HER2-) metastatic breast cancer (MBC) treated in routine clinical practice in the USA.
PATIENTS AND METHODS
This was a retrospective observational analysis of electronic health records within the Flatiron Health Analytic Database. A total of 1430 patients with ≥ 3 months of follow-up received palbociclib plus letrozole or letrozole alone in the first-line setting between February 3, 2015, and February 28, 2019. Stabilized inverse probability treatment weighting (sIPTW) was used to balance baseline demographic and clinical characteristics. Real-world progression-free survival (rwPFS) and overall survival (OS) were analyzed.
RESULTS
After sIPTW adjustment, median follow-up was 24.2 months (interquartile range [IQR], 14.2-34.9) in the palbociclib group and 23.3 months (IQR, 12.7-34.3) in those taking letrozole alone. Palbociclib combination treatment was associated with significantly longer median rwPFS compared to letrozole alone (20.0 vs 11.9 months; hazard ratio [HR], 0.58; 95% CI, 0.49-0.69; P < 0.0001). Median OS was not reached in the palbociclib group and was 43.1 months with letrozole alone (HR, 0.66; 95% CI, 0.53-0.82; P = 0.0002). The 2-year OS rate was 78.3% in the palbociclib group and 68.0% with letrozole alone. A propensity score matching analysis showed similar results.
CONCLUSIONS
In this "real-world" population of patients with HR+/HER2- MBC, palbociclib in combination with endocrine therapy was associated with improved survival outcomes compared with patients treated with letrozole alone in the first-line setting.
TRIAL REGISTRATION
Clinicaltrials.gov; NCT04176354.
背景
随机临床试验的结果可能对常规临床实践中治疗的患者具有有限的普遍性。本研究评估了一线哌柏西利联合来曲唑与来曲唑单药治疗在美国常规临床实践中治疗激素受体阳性（HR+）/人表皮生长因子受体阴性（HER2-）转移性乳腺癌（MBC）患者的生存结局的有效性。
患者和方法
这是一项对 Flatiron Health Analytic Database 中电子健康记录的回顾性观察性分析。共有 1430 名接受≥3 个月随访的患者于 2015 年 2 月 3 日至 2019 年 2 月 28 日在一线治疗中接受了哌柏西利联合来曲唑或来曲唑单药治疗。使用稳定的逆概率治疗加权（sIPTW）来平衡基线人口统计学和临床特征。分析了真实世界无进展生存期（rwPFS）和总生存期（OS）。
结果
经过 sIPTW 调整后，哌柏西利组的中位随访时间为 24.2 个月（四分位距 [IQR]，14.2-34.9），来曲唑组为 23.3 个月（IQR，12.7-34.3）。与来曲唑单药治疗相比，哌柏西利联合治疗的中位 rwPFS 显著延长（20.0 与 11.9 个月；风险比 [HR]，0.58；95%CI，0.49-0.69；P<0.0001）。哌柏西利组未达到中位 OS，来曲唑组为 43.1 个月（HR，0.66；95%CI，0.53-0.82；P=0.0002）。哌柏西利组的 2 年 OS 率为 78.3%，来曲唑组为 68.0%。倾向评分匹配分析显示了类似的结果。
结论
在这项 HR+/HER2-MBC 患者的“真实世界”人群中，与来曲唑单药治疗相比，哌柏西利联合内分泌治疗一线治疗可改善生存结局。
试验注册
Clinicaltrials.gov；NCT04176354。
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