OP20 Three year-survival outcomes after neoadjuvant pembrolizumab and radical cystectomy: Final results from the PURE-01 study

ESMO Open

article

T.C. De Padua¹  G. Basile²  E. Morea³  D. Raggi¹  P. Giannatempo⁴  L. Marandino¹  R. Colombo²  M. Colecchia⁵  R. Lucianò⁵  M. Bandini²  M. Moschini²  A. Briganti²  F. Montorsi²  A. Necchi¹ 

[1] Department of Medical Oncology, San Raffaele Hospital;Department of Urology, Urological Research Institute ,(URI), San Raffaele Hospital;Vita-Salute San Raffaele University;Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori;Department of Pathology, San Raffaele Hospital

关键词: Neoadjuvant;    Urothelial Cancer;    Immunotherapy;   

DOI  :  10.1016/j.esmoop.2022.100709

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Background: Survival outcomes of patients with muscle-invasive bladder cancer(MIBC) treated with neoadjuvant pembrolizumab before radical cystectomy (RC)within the PURE-01 study (NCT02736266) showed promising results. Herein, wereport the three year-survival outcomes.Methods: The intention-to-treat (ITT) population included 155 patients, whereaspatients receiving neoadjuvant pembrolizumab and RC without additional chemotherapy were 125. Median follow-up was calculated using the reverse Kaplan-Meirmethod. Event-free survival (EFS) was defined as the time from the first cycle ofpembrolizumab to radiographic disease progression precluding RC, initiation ofneoadjuvant chemotherapy (NAC), recurrence after RC, or death from any cause.Other end points were recurrence-free survival (RFS) and overall survival (OS).Multivariable Cox regression analyses (MVA) evaluated clinical and biomarkers predictors of events after treatment.Results: Overall, 143 (92.3%) patients underwent RC, 57 patients (39.9%) achieved anypT0ypN0 and 83 patients (58%) achieved a pathologic downstaging to ypT1/a/isypN0. After a median [interquartile range (IQR)] follow-up of 39 (30-47) months,three-year EFS was 74.4% [95% confidence interval (CI): 67.8-81.7] in the ITT. The 36-month OS in the ITT population was 83.8% (95% CI: 77.8- 90.2). Within the cohort ofpatients who did not receive additional chemotherapy (n¼125), three-year RFS (95%CI) was 96.3% (91.6- 100) for ypT0ypN0, 96.1% (89-100) for ypT1/a/is ypN0, 74.9%(60.2-93) for ypT2-4ypN0, and 58.3% (36.2-94.1) for ypTanyypN+. According withbiomarker analysis, 36-months EFS rates were 89% (82.5-96) and 78.2% (68.4-89.4) inthose patients with CD8+10% (n¼82) and <10% (n¼60), respectively. Overall, 8patients refused RC, of those 5 achieved ypT0, 1 ypTa and 1 had MIBC at secondTURBT. To date none had relapse. Higher PD-L1 CPS [hazard ratio (HR): 0.98, 95% CI:0.96-0.99; P¼0.01] was associated with lower rates of events, while cT3-4 (HR: 2.55,95% CI: 1.18-5.51; P¼0.02) was associated with higher rates of events at MVA.Conclusions: The three-year PURE-01 survival results confirm the prolonged efficacyof neoadjuvant pembrolizumab in MIBC. Biomarkers confirmed their clinical utility toidentify those patients who may benefit the most from neoadjuvant pembrolizumab.

【 授权许可】

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