Background: Palbociclib has been approved for marketing in China. However, its effectiveness, safety, and latent variables in the Chinese population require further investigation. Methods: Information was retrieved from 397 patients with metastatic breast cancer (mBC) who received at least two cycles of palbociclib plus endocrine therapy (PAL plus ET) at eight clinical sites in China. The patients’ demographic characteristics, treatment patterns, and adverse events (AEs) were analyzed. Results: The objective response rate (ORR) and clinical benefit rate (CBR) for PAL plus ET were 28.97% and 66.25%, respectively. The median PFS was 14.2 months in the whole population. In addition to protein Ki-67 status and sensitivity to ETs, no liver metastases, fewer metastatic sites, an earlier line of therapy, and treatment combined with AI instead of FUL were also considered as independent prognostic factors for PAL treatment. Administration of PAL was generally well tolerated in patients with hormone-receptor-positive and human-epidermal-growth-factor-receptor-2-negative (HR+/HER2−) advanced breast cancer (ABC). The therapy was safe in the elderly population, which is consistent with the outcomes of the whole population and previous reports. Conclusions: In this most widely distributed study in China to date, palbociclib combined with ET proved its effectiveness for HR+/HER2− ABC treatment, and adverse events were manageable. Here, we identified some independent prognosis factors, but the mechanism by which these factors influence effectiveness requires further verification.
背景：帕博西利已在中国获批上市，但其在中国人群中的疗效、安全性及潜在影响因素仍需进一步研究。方法：本研究收集了中国八家临床中心397例接受至少两个周期帕博西利联合内分泌治疗（PAL+ET）的转移性乳腺癌（mBC）患者资料，分析其人口学特征、治疗模式及不良事件（AEs）。结果：PAL+ET治疗的客观缓解率（ORR）和临床获益率（CBR）分别为28.97%和66.25%，全人群的中位无进展生存期（PFS）为14.2个月。除Ki-67蛋白状态及内分泌治疗敏感性外，无肝转移、转移灶数量较少、较早治疗线数以及联合芳香化酶抑制剂（AI）而非氟维司群（FUL）治疗也被确定为PAL治疗的独立预后因素。帕博西利在激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2−）晚期乳腺癌（ABC）患者中总体耐受性良好，老年人群安全性特征与全人群及既往报道一致。结论：作为目前中国覆盖范围最广的相关研究，本结果证实帕博西利联合内分泌治疗对HR+/HER2−晚期乳腺癌具有明确疗效，且不良事件可控。本研究识别了若干独立预后因素，但这些因素影响疗效的具体机制仍需进一步验证。
肿瘤(癌症)患者之家