Pathology - Posters D
Introduction: The introduction of immune checkpoint inhibitors (ICI) has dramatically changed the treatment paradigm for metastatic urothelial carcinoma (UC). Due to their strict eligibility criteria, clinical trials include highly selected patient cohorts, and so do not broadly represent real-world population outcomes.
Aims: In this multicentric, retrospective study we aimed to investigate real-world data to assess the effectiveness of the two widely used ICI agents (pembrolizumab and atezolizumab) and to evaluate the prognostic value of routinely available clinicopathological and laboratory parameters.
Materials and methods: Clinical and follow-up data from patients with UC who received pembrolizumab or atezolizumab between January 2017 and December 2021 at 6 uro-oncology centers were retrospectively evaluated. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and duration of response (DOR) were used as endpoints. Kaplan-Meier estimates, and Cox proportional hazard models were used to assess time-to-event endpoints, while Chi-square test was used to evaluate radiographic response.
Results: Data from 210 eligible UC patients (n=76 atezolizumab, n=134 pembrolizumab) were analysed. Most patients had ECOG PS 0–1 (83.3%) and primary tumor in the bladder was predominant (81.9%). The median OS and PFS of patients were 13.6 months (95% CI: 9.4-17.7 months) and 5.9 months (95% CI: 3.9-7.8 months), respectively. Complete response, partial response and stable disease rates were 6%, 29% and 22%, respectively. Impaired ECOG-PS, the presence of visceral, liver, or bone metastases, and baseline hemoglobin levels (>10 g/dl) as well as the Bellmunt risk factors category proved to be independent prognostic factors for shorter OS and poor DCR. Second-line atezolizumab treatment in our real-world cohort provided substantially higher (35%) ORR and better survival (17 months) compared to the respective randomized clinical trials (14.5% ORR, 7.9 months OS).
Conclusions: According to our results atezolizumab and pembrolizumab are effective treatment options for a broad range of advanced UC patients. Our results confirmed the prognostic value of a series of risk factors such as radical surgery, ECOG PS, liver, visceral, bone or lymph-node only metastases, NLR, hemoglobin, albumin, and eGFR levels.
Funding: Ministry for Innovation and Technology in Hungary Grant Number: K139059. New National Excellence Program. Grant Numbers: ÚNKP-21-5-SE-3 . János Bolyai Research Scholarship of the Hungarian Academy of Sciences (BO/00451/20/5). M.V. was supported by a SE 250+ scholarship.