Outcomes of First-Line Abiraterone Acetate or Enzalutamide for Older Adults With Metastatic Castration-Resistant Prostate Cancer According to Use of Upfront Docetaxel for Metastatic Castration-Sensitive Prostate Cancer in an International Multicenter Registry: A SPARTACUSS—Meet-URO 26 Study

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2024-08-09 DOI:10.1016/j.clgc.2024.102185
Giuseppe Fotia , Calogero Saieva , Richard Lee-Ying , Anna Patrikidou , Pier Vitale Nuzzo , Elisa Zanardi , Sabrina Rossetti , Matthew Davidsohn , Marc Eid , Talal El Zarif , Heather McClure , Gian Paolo Spinelli , Alessandra Damassi , Veronica Murianni , Charles Vauchier , Thiago Martins Oliveira , Andrea Malgeri , Mikol Modesti , Ricardo Pereira Mestre , Loana Valenca , Edoardo Francini
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Abstract

Background

Managing metastatic castration-resistant prostate cancer (mCRPC) in men aged ≥ 75 is challenging due to limited data. Regardless of age, in real-world clinical practice, most mCRPC still derive from failure of androgen deprivation therapy (ADT) with or without docetaxel (D) for metastatic castration-sensitive prostate cancer (mCSPC). As abiraterone acetate plus prednisone (AA) and enzalutamide (Enza) are common first-line treatments for mCRPC. The impact of prior use of D for mCSPC on the efficacy and safety of AA or Enza in this older population remains unclear.

Methods

A cohort of patients aged ≥ 75 years starting AA or Enza as first-line therapy for mCRPC from January 2015 to April 2019 was identified from the registries of 10 institutions. Patients were categorized into 2 groups based on previous use of D for mCSPC. Primary endpoints were cancer-specific survival (CSS) from AA or Enza start, CSS from ADT onset, and safety. We used Kaplan–Meier method to estimate the endpoints distribution, including median values with 95% confidence intervals (95% CI).

Results

Of the 337 patients identified, 24 (7.1%) received ADT+D and 313 (92.9%) received ADT alone for mCSPC. Median follow-up from AA/Enza start was 18.8 months. Median CSS from ADT or AA/Enza was not significantly different between ADT+D and ADT alone cohorts (71.9 vs. 52.7 months, P = .97; 25.4 vs. 27.2 months, P = .89, respectively). No statistically significant difference in adverse events (AEs) of any grade rate (58.3% vs. 52.1%, respectively; P = .67) or grade ≥ 3 (12.5% vs. 15.7%, respectively; P = 1.0) was found between ADT+D and ADT alone cohorts.

Conclusions

Despite the innate limitations of a retrospective design and relatively small size of the ADT+D cohort, this analysis suggests that elderly men receiving AA or Enza as first-line therapy for mCRPC have similar survival outcomes and tolerability, regardless of previous D for mCSPC.

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一项国际多中心登记研究显示,根据转移性钙化敏感性前列腺癌患者前期使用多西他赛的情况,转移性钙化耐药前列腺癌老年患者一线使用醋酸阿比特龙或恩杂鲁胺的疗效:SPARTACUSS-Meet-URO 26 研究。
背景:由于数据有限,治疗年龄≥75岁男性的转移性抗性前列腺癌(mCRPC)具有挑战性。无论年龄大小,在实际临床实践中,大多数 mCRPC 仍源于雄激素剥夺疗法(ADT)联合或不联合多西他赛(Docetaxel)治疗转移性阉割敏感性前列腺癌(mCSPC)的失败。醋酸阿比特龙加泼尼松(AA)和恩扎鲁胺(Enza)是治疗mCRPC的常见一线疗法。在这一老年群体中,先前使用D治疗mCSPC对AA或Enza的疗效和安全性的影响仍不清楚:从 10 家机构的登记簿中确定了 2015 年 1 月至 2019 年 4 月期间开始接受 AA 或 Enza 作为 mCRPC 一线治疗的年龄≥ 75 岁的患者队列。根据既往使用 D 治疗 mCSPC 的情况,将患者分为 2 组。主要终点为从 AA 或 Enza 开始的癌症特异性生存率 (CSS)、从 ADT 开始的 CSS 以及安全性。我们采用 Kaplan-Meier 法估算终点分布,包括中位值和 95% 置信区间 (95%CI):在确定的 337 例患者中,24 例(7.1%)接受了 ADT+D,313 例(92.9%)接受了 ADT 单药治疗 mCSPC。从 AA/Enza 开始的中位随访时间为 18.8 个月。从 ADT 或 AA/Enza 开始的中位 CSS 在 ADT+D 和 ADT 单独治疗组之间无显著差异(分别为 71.9 个月 vs. 52.7 个月,P = .97; 25.4 个月 vs. 27.2 个月,P = .89)。ADT+D组和单纯ADT组在任何等级的不良事件(AEs)发生率(分别为58.3% vs. 52.1%;P = .67)或等级≥3(分别为12.5% vs. 15.7%;P = 1.0)方面均无统计学差异:结论:尽管ADT+D队列存在回顾性设计和规模相对较小的先天局限性,但这项分析表明,老年男性在接受AA或Enza作为mCRPC一线治疗时,无论之前是否接受过mCSPC D治疗,其生存结果和耐受性都相似。
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来源期刊
ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
自引率
2.10%
发文量
464
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