Division of Experimental Oncology/Unit of Urology URI, IRCCS Ospedale San Raffaele, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy.
Acta Oncol. 2021 Dec;60(12):1589-1596. doi: 10.1080/0284186X.2021.1978539. Epub 2021 Sep 17.
There are little and inconsistent data from clinical practice on time on treatment with the androgen receptor-targeted drugs (ART) abiraterone and enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC). We assessed time on treatment with ART and investigated predictors of time on treatment.
Time on treatment with ART in men with mCRPC in the patient-overview prostate cancer (PPC), a subregister of the National Prostate Cancer Register (NPCR) of Sweden, was assessed by use of Kaplan-Meier plots and Cox regression. To assess the representativity of PPC for time on treatment, a comparison was made with all men in NPCR who had a filling for ART in the Prescribed Drug Registry.
2038 men in PPC received ART between 2015 and 2019. Median time on treatment in chemo-naïve men was 10.8 (95% confidence interval 9.1-13.1) months for abiraterone and 14.1 (13.5-15.5) for enzalutamide. After the use of docetaxel, time on treatment was 8.2 (6.5-12.4) months for abiraterone and 11.1 (9.8-12.6) for enzalutamide. Predictors of a long time on treatment with ART were long duration of ADT prior to ART, low serum levels of PSA at start of ART, absence of visceral metastasis, good performance status, and no prior use of docetaxel. PPC captured 2522/6337 (40%) of all men in NPCR who had filled a prescription for ART. Based on fillings in the Prescribed Drug Registry, men in PPC had a slightly longer median time on treatment with ART compared to all men in NPCR, 9.6 (9.1-10.3) vs. 8.6 (6.3-9.1) months.
Time on treatment in clinical practice was similar or shorter than that in published RCTs, due to older age, poorer performance status and more comorbidities.
在转移性去势抵抗性前列腺癌(mCRPC)男性中,雄激素受体靶向药物(ART)阿比特龙和恩扎卢胺的治疗时间在临床实践中数据较少且不一致。我们评估了 ART 治疗时间,并探讨了治疗时间的预测因素。
使用 Kaplan-Meier 图和 Cox 回归评估了瑞典国家前列腺癌登记处(NPCR)子登记处——前列腺癌患者概述(PPC)中 mCRPC 男性的 ART 治疗时间。为了评估 PPC 对治疗时间的代表性,与 Prescribed Drug Registry 中接受 ART 治疗的所有 NPCR 男性进行了比较。
2038 名 PPC 男性在 2015 年至 2019 年间接受了 ART 治疗。在未接受化疗的男性中,阿比特龙的中位治疗时间为 10.8(95%置信区间 9.1-13.1)个月,恩扎卢胺为 14.1(13.5-15.5)个月。在使用多西他赛后,阿比特龙的治疗时间为 8.2(6.5-12.4)个月,恩扎卢胺为 11.1(9.8-12.6)个月。ART 治疗时间长的预测因素包括 ART 前 ADT 持续时间长、ART 起始时 PSA 血清水平低、无内脏转移、良好的表现状态和无先前使用多西他赛。PPC 捕获了 NPCR 中接受 ART 治疗的所有男性的 2522/6337(40%)。根据 Prescribed Drug Registry 的用药记录,与 NPCR 中的所有男性相比,PPC 中的男性 ART 治疗时间中位数略长,分别为 9.6(9.1-10.3)个月和 8.6(6.3-9.1)个月。
由于年龄较大、表现状态较差和合并症较多,临床实践中的治疗时间与发表的 RCT 相似或更短。