Pain and Health-related Quality of Life with Biweekly Versus Triweekly Cabazitaxel Schedule in Older Men with Metastatic Castration-resistant Prostate Cancer in the Multicenter, Randomized CABASTY Trial

IF 8.3 1区医学 Q1 ONCOLOGY

European urology oncology Pub Date : 2025-02-01 DOI:10.1016/j.euo.2024.07.011

Stephane Oudard , Yohann Tran , Carole Helissey , Charles Vauchier , Raffaele Ratta , Mostefa Bennamoun , Eric Voog , Ali Hasbini , Antoine Thiery-Vuillemin , Kais Aldabbagh , Carolina Saldana , Emmanuel Sevin , Eric Amela , Gunhild Von Amsberg , Nadine Houede , Dominique Besson , Susan Feyerabend , Martin Boegemann , David Pfister , Martin Schostak , Philippe Barthelemy

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引用次数: 0

Abstract

Background and objective

The CABASTY study showed that more frequent administration of a lower dose of cabazitaxel (CBZ) reduced toxicity in older men with metastatic castration-resistant prostate cancer (mCRPC), without compromising efficacy. Here, we investigated the impact of a biweekly CBZ schedule on patient-reported pain and health-related quality of life (HRQoL).

Methods

We randomized 196 patients from 25 centers (1:1, stratified by age and G8 score) to the biweekly CBZ16 (CBZ 16 mg/m²) experimental arm or the triweekly CBZ25 (CBZ 25 mg/m²) control arm (CABASTY study, NCT02961257). We assessed pain using the Numeric Pain Rating Scale and HRQoL using the Functional Assessment of Cancer Therapy—Prostate (FACT-P) questionnaire.

Key findings and limitations

A total of 141 patients were available for a pain and 160 for an HRQoL analysis. Median time to pain progression (stratified hazard ratio [HR]: 1.7, confidence interval [CI]: 0.67−4.22, p = 0.3) and median time to first opiate use (stratified HR: 1.05, CI: 0.44−2.55, p = 0.9) did not differ between arms. We did not see a significant difference in median time to deterioration of FACT-P total score between treatments (stratified HR: 0.88, CI: 0.47−1.7, p = 0.7). Interestingly, the time to onset of several adverse events was significantly longer in the biweekly CBZ16 group.

Conclusions and clinical implications

HRQoL did not significantly differ between the biweekly CBZ16 and the standard schedule. Additionally, onset of some adverse events was delayed. These results may increase health care providers’ confidence in using CBZ in older patients with mCRPC who are denied chemotherapy.

Patient summary

Androgen receptor pathway inhibitors are often preferred to taxane chemotherapy as a treatment of second or subsequent line in older metastatic castration-resistant prostate cancer patients due to more frequent treatment-related toxicities. Here, we showed that quality of life and pain did not differ significantly with an adapted schedule of cabazitaxel (CBZ), compared with the standard regimen. This CBZ schedule could increase eligibility of older patients for chemotherapy.

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在多中心随机 CABASTY 试验中，转移性钙化抵抗性前列腺癌老年男性患者的疼痛和健康相关生活质量与双周卡巴他赛和三周卡巴他赛时间表的比较

背景和目的：CABASTY研究表明，在不影响疗效的前提下，更频繁地服用低剂量卡巴他赛（CBZ）可降低转移性耐药前列腺癌（mCRPC）老年男性患者的毒性。在此，我们研究了双周 CBZ 计划对患者报告的疼痛和健康相关生活质量（HRQoL）的影响：我们将来自 25 个中心的 196 名患者随机分配到双周 CBZ16（CBZ 16 mg/m2）实验组或三周 CBZ25（CBZ 25 mg/m2）对照组（CABASTY 研究，NCT02961257）（1:1，按年龄和 G8 评分分层）。我们使用数字疼痛评分量表评估疼痛，并使用前列腺癌治疗功能评估（FACT-P）问卷评估患者的 HRQoL：共有141名患者可进行疼痛分析，160名患者可进行HRQoL分析。疼痛进展的中位时间（分层危险比 [HR]：1.7，置信区间 [C1.7，置信区间 [CI]：分层危险比[HR]：1.7，置信区间[CI]：0.67-4.22，p = 0.3）和首次使用阿片类药物的中位时间（分层危险比：1.05，置信区间[CI]：0.44-2.55，p = 0.9）在两组间没有差异。在 FACT-P 总分恶化的中位时间方面，不同治疗方案之间也没有明显差异（分层 HR：0.88，CI：0.47-1.7，P = 0.7）。有趣的是，双周CBZ16治疗组出现几种不良事件的时间明显更长：双周CBZ16治疗组与标准治疗组在HRQoL方面没有明显差异。此外，一些不良反应的发生时间有所推迟。这些结果可能会增强医疗服务提供者的信心，使他们在被拒绝化疗的老年mCRPC患者中使用CBZ。患者总结：由于与治疗相关的毒性反应更为频繁，在老年转移性阉割耐药前列腺癌患者的二线或后续治疗中，雄激素受体通路抑制剂通常比类固醇化疗更受青睐。在这里，我们的研究表明，与标准方案相比，卡巴齐他赛（CBZ）的调整方案在生活质量和疼痛方面没有显著差异。这种CBZ方案可以提高老年患者接受化疗的资格。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European urology oncology Multiple-

CiteScore

15.50

自引率

2.40%

发文量

128

审稿时长

20 days

期刊介绍： Journal Name: European Urology Oncology Affiliation: Official Journal of the European Association of Urology Focus: First official publication of the EAU fully devoted to the study of genitourinary malignancies Aims to deliver high-quality research Content: Includes original articles, opinion piece editorials, and invited reviews Covers clinical, basic, and translational research Publication Frequency: Six times a year in electronic format