Julia Belone Lopes, Ana Elisa Sanches, Beatriz de Menezes Dobbert, Lorena Forner, João Pedro Homse Netto, Luiza Fadul, João Daniel Guedes, Fábio Fernandez, Daniel Vilarim Araujo
{"title":"Low-Dose Abiraterone in Metastatic Castration-Resistant Prostate Cancer.","authors":"Julia Belone Lopes, Ana Elisa Sanches, Beatriz de Menezes Dobbert, Lorena Forner, João Pedro Homse Netto, Luiza Fadul, João Daniel Guedes, Fábio Fernandez, Daniel Vilarim Araujo","doi":"10.1200/GO-25-00132","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Abiraterone acetate (AA) is approved for prostate cancer at a standard dose of 1,000 mg fasting. Because of a significant food effect, a lower dose (250 mg with food-AA low dose [AALD]) shows similar efficacy at 75% lower cost. In Brazil, 80% of patients rely on the public health care system, which does not cover the standard dose. Hospital de Base has been using AALD since March 2021.</p><p><strong>Materials and methods: </strong>We retrospectively reviewed patients with metastatic castration-resistant prostate cancer (mCRPC) who received AALD at any treatment line, regardless of previous chemotherapy, between March 2021 and May 2023. The primary end point was prostate-specific antigen (PSA) response rate (RR; defined as a decrease of ≥50% in PSA level after 12 weeks of treatment). Secondary end points included time to treatment failure (TTF), overall survival (OS), and PSA RR ≥50% at nadir.</p><p><strong>Results: </strong>Ninety-six patients were included. Sixty-three patients (65.6%) received AALD in mCRPC first-line. After a median follow-up of 24.4 months, 53 patients (60.2%) achieved the primary end point, and 65 (69.9%) achieved a PSA reduction of ≥50% at nadir. Patients treated with AALD pre-docetaxel in the mCRPC had a higher PSA response at 12 weeks (68.3% <i>v</i> 40%, <i>P</i> = .015) and at nadir (76.1% <i>v</i> 53.8%, <i>P</i> = .036). First-line AALD was associated with better PSA responses. The median TTF was 7.9 months and the median OS was 20.6 months. Achieving a ≥50% PSA response at 12 weeks was associated with improved TTF (13.6 <i>v</i> 4.6 months, hazard ratio [HR] = 0.37, <i>P</i> < .001) and OS (28.9 <i>v</i> 12.2 months, HR = 0.44, <i>P</i> = .004).</p><p><strong>Conclusion: </strong>AALD showed meaningful efficacy and survival outcomes. We support AALD use, especially where standard dosing is unaffordable.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"11 ","pages":"e2500132"},"PeriodicalIF":3.0000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JCO Global Oncology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1200/GO-25-00132","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/3 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: Abiraterone acetate (AA) is approved for prostate cancer at a standard dose of 1,000 mg fasting. Because of a significant food effect, a lower dose (250 mg with food-AA low dose [AALD]) shows similar efficacy at 75% lower cost. In Brazil, 80% of patients rely on the public health care system, which does not cover the standard dose. Hospital de Base has been using AALD since March 2021.
Materials and methods: We retrospectively reviewed patients with metastatic castration-resistant prostate cancer (mCRPC) who received AALD at any treatment line, regardless of previous chemotherapy, between March 2021 and May 2023. The primary end point was prostate-specific antigen (PSA) response rate (RR; defined as a decrease of ≥50% in PSA level after 12 weeks of treatment). Secondary end points included time to treatment failure (TTF), overall survival (OS), and PSA RR ≥50% at nadir.
Results: Ninety-six patients were included. Sixty-three patients (65.6%) received AALD in mCRPC first-line. After a median follow-up of 24.4 months, 53 patients (60.2%) achieved the primary end point, and 65 (69.9%) achieved a PSA reduction of ≥50% at nadir. Patients treated with AALD pre-docetaxel in the mCRPC had a higher PSA response at 12 weeks (68.3% v 40%, P = .015) and at nadir (76.1% v 53.8%, P = .036). First-line AALD was associated with better PSA responses. The median TTF was 7.9 months and the median OS was 20.6 months. Achieving a ≥50% PSA response at 12 weeks was associated with improved TTF (13.6 v 4.6 months, hazard ratio [HR] = 0.37, P < .001) and OS (28.9 v 12.2 months, HR = 0.44, P = .004).
Conclusion: AALD showed meaningful efficacy and survival outcomes. We support AALD use, especially where standard dosing is unaffordable.
目的:醋酸阿比特龙(AA)被批准用于前列腺癌,标准剂量为禁食1000mg。由于明显的食物效应,较低剂量(250毫克与食品aa低剂量[AALD])显示出相似的效果,成本降低75%。在巴西,80%的患者依赖公共卫生保健系统,该系统不包括标准剂量。基地医院自2021年3月以来一直使用AALD。材料和方法:我们回顾性分析了在2021年3月至2023年5月期间接受AALD治疗的转移性去势抵抗性前列腺癌(mCRPC)患者,无论之前是否接受过化疗。主要终点是前列腺特异性抗原(PSA)应答率(RR,定义为治疗12周后PSA水平下降≥50%)。次要终点包括治疗失败时间(TTF)、总生存期(OS)和最低时PSA RR≥50%。结果:纳入96例患者。63例(65.6%)mCRPC一线患者接受AALD治疗。中位随访24.4个月后,53例(60.2%)患者达到了主要终点,65例(69.9%)患者在最低点PSA降低≥50%。在mCRPC中接受AALD前多西紫杉醇治疗的患者在12周时(68.3% v 40%, P = 0.015)和最低点时(76.1% v 53.8%, P = 0.036)具有更高的PSA应答。一线AALD与更好的PSA反应相关。中位TTF为7.9个月,中位OS为20.6个月。在12周时达到≥50%的PSA应答与TTF (13.6 v 4.6个月,风险比[HR] = 0.37, P < 0.001)和OS (28.9 v 12.2个月,HR = 0.44, P = 0.004)的改善相关。结论:AALD具有显著的疗效和生存结局。我们支持AALD的使用,特别是在标准剂量负担不起的情况下。