PhD Scientific Days 2023

Budapest, 22-23 June 2023

Pathology - Posters D

Efficacy of Immune Checkpoint Inhibitor Therapy for Advanced Urothelial Carcinoma in Real-Life Clinical Practice: Results of a Multicentric, Retrospective Study

Melinda Váradi1, Orsolya Horváth2, Orsolya Módos1, Tamás Fazekas1, Camilla Grunewald3, Günter Niegisch3, Ulrich Krafft4, Viktor Grünwald4, Boris Hadaschik4, Anikó Maráz5, Andrea Furka6,7, Miklós Szűcs1, Péter Nyirády1, Tibor Szarvas1,4

1 Department of Urology, Semmelweis University, Budapest, Hungary
2 Department of Genitourinary Medical Oncology and Pharmacology, National Institute of Oncology, Budapest
3 Department of Urology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany.
4 Department of Urology, University of Duisburg-Essen, Essen, Germany
5 Department of Oncotherapy, University of Szeged, Szeged, Hungary.
6 Miskolc Department of Oncology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.
7 Department of Clinical Radiology, Faculty of Health Care, Institute of Practical Methodology and Diagnostics, University of Miskolc, Miskolc, Hungary.

Text of the abstract

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.