PMID- 33849473 OWN - NLM STAT- MEDLINE DCOM- 20210510 LR - 20230919 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 21 IP - 1 DP - 2021 Apr 13 TI - Pembrolizumab with or without enzalutamide in selected populations of men with previously untreated metastatic castration-resistant prostate cancer harbouring programmed cell death ligand-1 staining: a retrospective study. PG - 399 LID - 10.1186/s12885-021-08156-1 [doi] LID - 399 AB - BACKGROUND: The purpose of this retrospective study was to evaluate the survival outcomes of pembrolizumab (PEM) plus enzalutamide (ENZ) versus PEM alone in selected populations of men with previously untreated metastatic castration-resistant prostate cancer (mCRPC) harbouring programmed cell death ligand-1 (PD-L1) staining. METHODS: Consecutive men with previously untreated mCRPC harbouring PD-L1 staining who underwent treatment with PEM plus ENZ (PE) or PEM alone (PA) at our medical centre from January 1, 2017, to January 31, 2021, were retrospectively identified. Follow-up was conducted monthly during the first year and then every 1 month thereafter. The primary outcomes of the study were overall survival (OS) and progression-free survival (PFS). Secondary outcomes were the frequency of key adverse events (AEs). RESULTS: In total, 302 men were retrospectively reviewed, 96 of whom were deemed to be ineligible per the exclusion criteria, leaving 206 men (PE: n = 100, median age 64 years [range, 43-85] and PA: n = 106, 65 years [range, 45-82]) who were eligible for the study. The median follow-up for both groups was 34 months (range, 2-42). At the final follow-up, the median OS was 25.1 months (95% confidence interval [CI], 22.3-27.6) in the PE group versus 18.3 months (95% CI, 16.5-20.9) in the PA group (hazard ratio [HR] 0.56; 95% CI, 0.39-0.80; p = 0.001). A marked distinction was also observed in the median PFS (6.1 months [95% CI, 4.7-7.8] for PE vs. 4.9 months for PA (95% CI, 3.2-6.4) for PA; HR 0.55, 95% CI, 0.41-0.75; p = 0.001). There were noteworthy differences in the rate of the key AEs between the two groups (72.0% for PE vs. 45.3% for PA, p < 0.001). Noteworthy differences were also detected for fatigue events (7.0% in the PE group vs. 0.9% in the PA group, p = 0.025) and musculoskeletal events (9.0% for PE vs. 0.9% for PA, p = 0.007), but these events tended to be manageable. CONCLUSIONS: Among selected populations of men with previously untreated mCRPC harbouring PD-L1 staining, PEM added to ENZ treatment may significantly increase the survival benefits compared with PEM treatment alone regardless of tumor mutation status. The safety profile for PE plus ENZ tends to be manageable. FAU - Lin, Huanyi AU - Lin H AD - Department of Urinary Surgery, The First Affiliated Hospital, Sun Yat-sen University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, China. FAU - Liu, Qilong AU - Liu Q AD - Department of Gastrointestinal Surgery, The First Affiliated Hospital, Sun Yat-sen University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, China. FAU - Zeng, Xianshang AU - Zeng X AD - Department of Orthopaedics, The First Affiliated Hospital, Sun Yat-sen University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, China. FAU - Yu, Weiguang AU - Yu W AD - Department of Orthopaedics, The First Affiliated Hospital, Sun Yat-sen University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, China. yuwg3@mail.sysu.edu.cn. FAU - Xu, Guixing AU - Xu G AD - Department of Neurosurgery, The First Affiliated Hospital, Sun Yat-sen University, No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou, 510080, China. xuguix@mail.sysu.edu.cn. LA - eng PT - Journal Article DEP - 20210413 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents, Immunological) RN - 0 (Benzamides) RN - 0 (Biomarkers, Tumor) RN - 0 (Nitriles) RN - 0 (Programmed Cell Death 1 Receptor) RN - 2010-15-3 (Phenylthiohydantoin) RN - 93T0T9GKNU (enzalutamide) RN - DPT0O3T46P (pembrolizumab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal, Humanized/administration & dosage/*therapeutic use MH - Antineoplastic Agents, Immunological/administration & dosage/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Benzamides MH - Biomarkers, Tumor MH - Humans MH - Immunohistochemistry MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Molecular Targeted Therapy MH - Neoplasm Staging MH - Nitriles MH - Phenylthiohydantoin/administration & dosage/analogs & derivatives MH - Prognosis MH - Programmed Cell Death 1 Receptor/antagonists & inhibitors/metabolism MH - Prostatic Neoplasms, Castration-Resistant/diagnosis/*drug therapy/metabolism/mortality MH - Retrospective Studies MH - Treatment Outcome PMC - PMC8045189 OTO - NOTNLM OT - Castration-resistant OT - Enzalutamide OT - Pembrolizumab OT - Prostate cancer OT - Survival COIS- The authors declare that they have no competing interests. EDAT- 2021/04/15 06:00 MHDA- 2021/05/11 06:00 PMCR- 2021/04/13 CRDT- 2021/04/14 05:34 PHST- 2021/03/01 00:00 [received] PHST- 2021/03/30 00:00 [accepted] PHST- 2021/04/14 05:34 [entrez] PHST- 2021/04/15 06:00 [pubmed] PHST- 2021/05/11 06:00 [medline] PHST- 2021/04/13 00:00 [pmc-release] AID - 10.1186/s12885-021-08156-1 [pii] AID - 8156 [pii] AID - 10.1186/s12885-021-08156-1 [doi] PST - epublish SO - BMC Cancer. 2021 Apr 13;21(1):399. doi: 10.1186/s12885-021-08156-1.