Dutch Institute for Clinical Auditing, Rijnsburgerweg 10, Leiden, 2333AA, the Netherlands; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, the Netherlands.
Dutch Institute for Clinical Auditing, Rijnsburgerweg 10, Leiden, 2333AA, the Netherlands; Department of Medical Oncology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, De Boelelaan, 1118, Amsterdam, 1081HZ, the Netherlands.
Breast. 2021 Dec;60:263-271. doi: 10.1016/j.breast.2021.11.013. Epub 2021 Nov 17.
This study aimed to provide insights into the real-world use of palbociclib, dose reductions, and drug effectiveness in (older) patients with advanced breast cancer (BC).
Patients with advanced BC treated with palbociclib from 2017 to 2020 were included. The Kaplan-Meier method was used to calculate time to next treatment (TTNT) and overall survival (OS) for patients with or without dose reductions. These clinical outcomes were also compared in subgroup analyses for older patients (≥70 years) and younger patients (<70 years) and for patients discontinuing palbociclib early (<4 administrations).
A total of 598 patients with advanced BC were included, with a median age of 64 years. Palbociclib dose reductions occurred in 33% of all patients. Early discontinuation of palbociclib without dose reductions occurred in 23% of the patients. Patients who required a palbociclib dose reduction were older (median age 67 years vs. 63 years). Patients with dose reductions had a significantly higher TTNT of 16.9 vs. 11.4 months (p < 0.001) and median OS of 29.7 vs. 21.9 months (p = 0.003) compared to patients without dose reductions. The TTNT in older patients was significantly longer (16.9 vs. 11.6 months, p = 0.013) than younger patients, but OS was similar (20.7 vs. 26.7 months, p = 0.051).
Palbociclib dose reductions occurred in real-world practice similarly to the PALOMA-3 trial. Patients with dose reductions had no poorer outcomes compared to patients not requiring a dose reduction. Older patients treated with palbociclib had more frequent dose reductions, but this did not appear to affect OS.
本研究旨在深入了解帕博西尼在（老年）晚期乳腺癌患者中的实际应用情况，包括剂量减少和药物疗效。
纳入了 2017 年至 2020 年期间接受帕博西尼治疗的晚期乳腺癌患者。采用 Kaplan-Meier 法计算有或无剂量减少的患者的无进展治疗时间（TTNT）和总生存期（OS）。还对老年（≥70 岁）和年轻（<70 岁）患者以及早期（<4 次给药）停止帕博西尼治疗的患者进行了亚组分析，并比较了这些临床结局。
共纳入 598 例晚期乳腺癌患者，中位年龄为 64 岁。所有患者中有 33%发生帕博西尼剂量减少。有 23%的患者在未减少剂量的情况下早期停止使用帕博西尼。需要减少帕博西尼剂量的患者年龄较大（中位年龄 67 岁 vs. 63 岁）。与未减少剂量的患者相比，剂量减少的患者 TTNT 显著延长（16.9 个月 vs. 11.4 个月，p<0.001），中位 OS 也显著延长（29.7 个月 vs. 21.9 个月，p=0.003）。与年轻患者相比，老年患者的 TTNT 明显更长（16.9 个月 vs. 11.6 个月，p=0.013），但 OS 相似（20.7 个月 vs. 26.7 个月，p=0.051）。
帕博西尼在真实世界中的剂量减少与 PALOMA-3 试验相似。与无需剂量减少的患者相比，剂量减少的患者结局并未恶化。接受帕博西尼治疗的老年患者剂量减少更频繁，但这似乎并未影响 OS。
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