College of Medicine, University of Pittsburgh, 300 Halket St., Suite 4628, Pittsburgh, PA, 15213, USA.
Pfizer Inc, New York, NY, USA.
Target Oncol. 2021 Sep;16(5):601-611. doi: 10.1007/s11523-021-00826-1. Epub 2021 Aug 2.
Limited information exists regarding tumor response to palbociclib plus an aromatase inhibitor (AI) versus AI alone in real-world practice.
To evaluate the real-world tumor response of palbociclib plus letrozole (PAL+LET) versus LET alone as first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (HR+/HER2‒ MBC) in routine US clinical practice.
This retrospective analysis included HR+/HER2‒ MBC patients who initiated PAL+LET or LET as first-line treatment between February 2015 and September 2018 in the Flatiron Health Analytics database. Patients were followed until December 2018. Real-world best tumor response (rwBTR) was determined based on physicians' assessment of radiologic evidence for change in burden of disease.
Of the 1383 eligible patients who initiated PAL+LET or LET as first-line therapy in the Flatiron database, 968 patients had ≥ 1 tumor response assessment (662 received PAL+LET and 306 received LET). The rwBTR rate (complete response+partial response) in the first-line setting was 59.8% in the PAL+LET group and 39.2% in the LET group (odds ratio 2.31 (95% CI 1.75‒3.04), P < 0.0001). After 1:1 propensity-score matching, the rwBTR rate was 58.6% in the PAL+LET group versus 39.1% in the LET group (odds ratio 2.21 (95% CI 1.50‒3.25), P < 0.0001).
This real-world analysis demonstrated that HR+/HER2‒ MBC patients were more likely to respond to PAL+LET compared to LET. These findings further showed the effectiveness of PAL+LET therapy in the real-world setting and support the combination as a standard of care for MBC.
Pfizer; NCT04176354; registered November 25, 2019.
在真实世界的实践中，关于帕博西尼联合芳香化酶抑制剂（AI）与 AI 单药治疗的肿瘤反应的信息有限。
评估帕博西尼联合来曲唑（PAL+LET）与 LET 单药作为一线治疗激素受体阳性/人表皮生长因子受体 2 阴性转移性乳腺癌（HR+/HER2‒MBC）患者的真实世界肿瘤反应，该研究在常规美国临床实践中进行。
这项回顾性分析纳入了 2015 年 2 月至 2018 年 9 月期间在 Flatiron Health Analytics 数据库中接受 PAL+LET 或 LET 作为一线治疗的 HR+/HER2‒MBC 患者。患者随访至 2018 年 12 月。根据医生对疾病负担变化的影像学评估，确定真实世界最佳肿瘤反应（rwBTR）。
在 Flatiron 数据库中，符合条件的 1383 例患者中，有 968 例患者接受了≥1 次肿瘤反应评估（662 例接受 PAL+LET，306 例接受 LET）。一线治疗中，PAL+LET 组 rwBTR 率（完全缓解+部分缓解）为 59.8%，LET 组为 39.2%（比值比 2.31（95%CI 1.75‒3.04），P<0.0001）。经过 1:1 倾向评分匹配后，PAL+LET 组 rwBTR 率为 58.6%，LET 组为 39.1%（比值比 2.21（95%CI 1.50‒3.25），P<0.0001）。
这项真实世界分析表明，与 LET 相比，HR+/HER2‒MBC 患者对 PAL+LET 更可能有反应。这些发现进一步证明了 PAL+LET 治疗在真实世界环境中的有效性，并支持该联合方案作为 MBC 的标准治疗。
辉瑞；NCT04176354；2019 年 11 月 25 日注册。
