Mandal Swarnendu, Tarigopula Vivek, Kumaraswamy Santosh, Das Manoj Kumar, Tripathy Sambit, Barik Kalandi, Nayak Prasant
Department of Urology and Renal Transplant, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
Department of Urology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Indian J Urol. 2024 Jul-Sep;40(3):174-178. doi: 10.4103/iju.iju_459_23. Epub 2024 Jul 1.
Combination of abiraterone with androgen deprivation therapy (ADT) has better survival outcomes than ADT alone in metastatic Hormone-sensitive prostate cancer (mHSPC) in the Western population. In this prospective (Clinical Trials Registry-India [CTRI] registered) observational study, we present the comparative oncological outcomes of ADT alone and ADT + abiraterone in Indian patients, which is not available currently.
This study (CTRI-number-CTRI/2020/07/026545) included newly diagnosed mHSPC patients from January 2020 to June 2023 in a tertiary care hospital, urology department. Patients fulfilling inclusion criteria were advised ADT with abiraterone (A + ADT), and those not affording received ADT monotherapy (ADT). The primary endpoint was overall survival (OS). Secondary outcomes included prostate-specific antigen (PSA) decline >90%, radiographic progression-free survival (rPFS), and PSA progression-free survival (pPFS).
Out of 278 patients with mHSPC, 163 patients were excluded and 115 were analyzed (ADT = 40 vs. A + ADT = 75). After a median follow-up of 20.3 months, 11 of 40 (27.5%) in ADT-only arm and 15 of 75 (20%) in ADT + abiraterone arm had died (Hazard-ratio of death 0.72; 95% confidence interval 0.68-0.88; < 0.001). A PSA decline of >90% was seen in 85% in the ADT alone group and 93.3% in the ADT + abiraterone group. Significantly better outcomes of the ADT + abiraterone were seen in the secondary endpoints of rPFS ( < 0.001) and pPFS ( < 0.001). The OS benefit was 28% reduction in risk of death in our study versus 37% and 38% in STAMPEDE and LATITUDE, respectively. pPFS and rPFS were also poorer in Indian subsets.
Abiraterone with ADT improves OS, PSA response, rPFS, and pPFS in the Indian population akin to the Western data but with poorer OS, rPFS, and PSA progression-free survival on comparison.
在西方人群的转移性激素敏感性前列腺癌（mHSPC）中，阿比特龙与雄激素剥夺疗法（ADT）联合使用比单独使用ADT具有更好的生存结果。在这项前瞻性（印度临床试验注册中心[CTRI]注册）观察性研究中，我们展示了印度患者单独使用ADT和ADT+阿比特龙的肿瘤学比较结果，目前尚无此类数据。
本研究（CTRI编号-CTRI/2020/07/026545）纳入了2020年1月至2023年6月在一家三级护理医院泌尿外科新诊断的mHSPC患者。符合纳入标准的患者接受ADT联合阿比特龙治疗（A+ADT），而那些负担不起的患者接受ADT单一疗法（ADT）。主要终点是总生存期（OS）。次要结局包括前列腺特异性抗原（PSA）下降>90%、影像学无进展生存期（rPFS）和PSA无进展生存期（pPFS）。
在278例mHSPC患者中，163例被排除，115例进行分析（ADT组40例 vs. A+ADT组75例）。中位随访20.3个月后，ADT单药治疗组40例中有11例（27.5%）死亡，ADT+阿比特龙组75例中有15例（20%）死亡（死亡风险比0.72；95%置信区间0.68-0.88；<0.001）。单独使用ADT组85%的患者PSA下降>90%，ADT+阿比特龙组为93.3%。在rPFS（<0.001）和pPFS（<0.001）的次要终点方面，ADT+阿比特龙组的结果明显更好。在我们的研究中，OS获益为死亡风险降低28%，而在STAMPEDE和LATITUDE研究中分别为37%和38%。印度亚组的pPFS和rPFS也较差。
阿比特龙联合ADT可改善印度人群的OS、PSA反应、rPFS和pPFS，与西方数据相似，但相比之下OS、rPFS和PSA无进展生存期较差。
