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镭-223 在未经多西紫杉醇治疗与经多西紫杉醇治疗的转移性去势抵抗性前列腺癌患者中的治疗结局:来自台湾的真实世界证据。

Treatment outcomes with radium-223 in docetaxel-naïve versus docetaxel-treated metastatic castration-resistant prostate cancer patients: Real-world evidence from Taiwan.

机构信息

Department of Urology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.

Jhong Siao Urological Hospital, Kaohsiung, Taiwan.

出版信息

Medicine (Baltimore). 2023 Feb 3;102(5):e32671. doi: 10.1097/MD.0000000000032671.

DOI:10.1097/MD.0000000000032671
PMID:36749250
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9901946/
Abstract

While radium (Ra)-223 is among the multiple, known life-prolonging treatments in bone-predominant metastatic castration-resistant prostate cancer (mCRPC), optimal treatment sequencing has not been determined, particularly in the Asia-Pacific context. Hence, we aimed to compare treatment outcomes of docetaxel-naïve and post-docetaxel mCRPC patients undergoing Ra-223 therapy in Taiwan. Using a single-center retrospective cohort design, we reviewed records of adult patients receiving Ra-223 for bone-metastatic mCRPC from 2018 to 2021. Patients were categorized into docetaxel-naïve or post-docetaxel groups based on history of docetaxel use preceding Ra-223. We compared the 2 groups in terms of all-cause death, 6-cycle treatment completion, and the following secondary outcomes: pain control, change in biochemical parameters (prostate-specific antigen, lactate dehydrogenase, alkaline phosphatase), biochemical response, and treatment-emergent adverse events. We performed total population sampling and a complete case analysis. We included 48 patients (25 docetaxel-naïve, 23 post-docetaxel) in the study. The mean follow-up duration was 12.4 months for the entire cohort. The docetaxel-naïve group exhibited a significantly lower all-cause mortality rate versus the post-docetaxel group (40.0% vs 78.3%, P = .02), as well as a significantly higher treatment completion rate (72.0% vs 26.1%, P < .01). We did not find significant differences in pain control, change in biochemical parameters, biochemical response, or hematologic treatment-emergent adverse events between the 2 groups. However, the docetaxel-naïve group had a numerically higher pain control rate, numerically greater improvements in alkaline phosphatase and prostate-specific antigen, and numerically lower rates of grade ≥ 3 neutropenia and grade ≥ 3 thrombocytopenia than the post-docetaxel group. Use of Ra-223 in docetaxel-naïve patients with mCRPC led to lower mortality and higher treatment completion than post-docetaxel use. Our study adds preliminary real-world evidence that Ra-223 may be used safely and effectively in earlier lines of treatment for bone-predominant mCRPC. Further large-scale, longer-term, and controlled studies are recommended.

摘要

虽然镭-223(Ra-223)是多种已知的延长生存期的治疗方法之一,用于治疗以骨骼为主的转移性去势抵抗性前列腺癌(mCRPC),但尚未确定最佳的治疗顺序,特别是在亚太地区。因此,我们旨在比较镭-223 治疗在台湾的未经多西紫杉醇治疗和多西紫杉醇治疗后的 mCRPC 患者的治疗结果。我们采用单中心回顾性队列设计,回顾了 2018 年至 2021 年间接受镭-223 治疗的患有骨骼转移的 mCRPC 的成年患者的记录。根据接受镭-223 治疗前多西紫杉醇的使用史,将患者分为未经多西紫杉醇治疗组或多西紫杉醇治疗后组。我们比较了两组的全因死亡、6 个周期治疗完成情况以及以下次要结局:疼痛控制、生化参数(前列腺特异性抗原、乳酸脱氢酶、碱性磷酸酶)变化、生化反应和治疗后不良事件。我们进行了总人群抽样和完全病例分析。我们纳入了 48 名患者(25 名未经多西紫杉醇治疗,23 名多西紫杉醇治疗后)。整个队列的平均随访时间为 12.4 个月。未经多西紫杉醇治疗组的全因死亡率明显低于多西紫杉醇治疗后组(40.0%比 78.3%,P =.02),治疗完成率明显更高(72.0%比 26.1%,P <.01)。两组之间的疼痛控制、生化参数变化、生化反应或血液学治疗后不良事件无显著差异。然而,未经多西紫杉醇治疗组的疼痛控制率较高,碱性磷酸酶和前列腺特异性抗原的改善程度较大,且≥3 级中性粒细胞减少症和≥3 级血小板减少症的发生率较低。在未经多西紫杉醇治疗的 mCRPC 患者中使用镭-223 治疗可降低死亡率并提高治疗完成率,高于多西紫杉醇治疗。我们的研究提供了初步的真实世界证据,表明镭-223 可安全有效地用于以骨骼为主的 mCRPC 的早期治疗线。建议进行进一步的大规模、长期和对照研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/795863bfdbf7/medi-102-e32671-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/72e2e025a0e7/medi-102-e32671-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/a1540049832c/medi-102-e32671-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/6f6c6ff10411/medi-102-e32671-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/ab384ea807a3/medi-102-e32671-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/795863bfdbf7/medi-102-e32671-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/72e2e025a0e7/medi-102-e32671-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/a1540049832c/medi-102-e32671-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/6f6c6ff10411/medi-102-e32671-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/ab384ea807a3/medi-102-e32671-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7483/9901946/795863bfdbf7/medi-102-e32671-g005.jpg

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