GÉTICA 2021

28 VII FORO DE I nmunología Traslacional e INMUNOTERAPIA DEL CÁNCER The three-risk category prognostic model developed included Eastern Cooperative On- cology Group performance status, PPI use, al- bumin level, presence of liver metastases, and presence of peritoneal metastases variables and was associated with higher risk of death (HR 1/4 3.00, 95 % CI, 1.97- 4.56; P 1/4 0.0001) (Table I) (Figs. 1 and 2). Conclusions: This study confirms anti-PD-(L)1 monotherapy as a safe and effective treatment option in daily clinical practice for mUC pa- tients. It also describes the presence of perito- neal metastases as an independent prognostic factor for OS and underlines the association between PPI use and worse therapeutic out- comes. Finally, it proposes a new easy-to-use risk-assessment model for OS prediction. patients under anti-PD-(L)1 therapy in a re- al-world scenario. Results: Median OS was 7.8 months [95 % confidence interval (CI), 5.4-10.4], median pro- gression-free survival (PFS) was 2.80 months (95 % CI, 2.4-3.4), disease control rate (DCR) was 40%(95%CI, 31-49), andoverall response rate (ORR) was 24 % (95 % CI, 15-31). Presence of peritoneal metastases was associated with poor OS [hazard ratio (HR) 1/4 2.40, 95 % CI, 1.08-5.33; P 1/4 0.03]. Use of proton-pump inhibitors (PPI) was associated with poor OS (HR 1/4 1.83, 95 % CI, 1.11-3.02; P 1/4 0.02) and PFS (HR 1/4 1.94, 95 % CI, 1.22- 3.09; P 1/4 0.005), and lower DCR (OR 1/4 0.38, 95 % CI, 0.17-0.89; P 1/4 0.03) and ORR (OR 1/4 0.18, 95 % CI, 0.02-1.60; P 1/4 0.002). Table I. Bootstrap HR estimates versus initial HR estimates for the final prognosticmodel for overall survival Boostrap estimates Initial estimates Characteristics HR (95 % CI) p value HR (95 % CI) p value ECOG-PS (≥ vs. 0-1). 3.20 (1.78-7.21) 0.0003 3.20 (1.76-5.83) 0.0001 Liver metastases (yes vs. no) 2.81 (1.60-5.53) 0.001 2.81 (1.59-4.98) 0.0004 Peritoneal metastases (yes vs. no) 2.60 (1.34-5.80) 0.003 2.60 (1.40-4.83) 0.002 Albumin (< 3.5 g/dL) vs. ≥ 3.5 g/dL) 2.46 (1.26-6.99) 0.03 2.46 (1.28-4.74) 0.01 PPI use (yes vs. no) 1.64 (1.03-2.80) 0.04 1.64 (1.04-2.57) 0.03 CI: confidence interval; ECOG-PS: Eastern Cooperative Oncology Group Performance Status; HR: hazard ratio; PPI: proton-pump inhibitors.