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Response and Outcomes of Maintenance Avelumab After Platinum-Based Chemotherapy (PBC) in Patients With Advanced Urothelial Carcinoma (aUC): “Real World” Experience
Journal article   Peer reviewed

Response and Outcomes of Maintenance Avelumab After Platinum-Based Chemotherapy (PBC) in Patients With Advanced Urothelial Carcinoma (aUC): “Real World” Experience

Dimitra Rafailia Bakaloudi, Rafee Talukder, Genevieve Ihsiu Lin, Dimitrios Makrakis, Leonidas N. Diamantopoulos, Nishita Tripathi, Neeraj Agarwal, Roubini Zakopoulou, Aristotelis Bamias, Jason R. Brown, …
Clinical genitourinary cancer, Vol.21(5), pp.584-593
10/01/2023
DOI: 10.1016/j.clgc.2023.06.008
PMCID: PMC11289267
PMID: 37414620

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Abstract

Platinum-based chemotherapy (PBC) followed by avelumab switch maintenance in nonprogressors is standard first line (1L) treatment for advanced urothelial carcinoma (aUC). We describe clinical features and outcomes in a “real-world’ cohort treated with avelumab maintenance for aUC. This was a retrospective cohort study of patients (pts) who received 1L switch maintenance avelumab after no progression on PBC for aUC. We calculated progression-free survival (PFS) and overall survival (OS) from initiation of maintenance avelumab. We also described OS and PFS for specific subsets using Cox regression and observed response rate (ORR). A total of 108 pts with aUC from 14 sites treated with maintenance avelumab were included. There was a median of 6 weeks1-30 from end of PBC to avelumab initiation; median follow-up time from avelumab initiation was 8.8 months (1-42.7). Median [m]PFS was 9.6 months (95%CI 7.5-12.1) and estimated 1-year OS was 72.5%. CR/PR (vs. SD) to 1L PBC (HR = 0.33, 95% CI 0.13-0.87) and ECOG PS 0 (vs. ≥1), (HR = 0.15, 95% CI 0.05-0.47) were associated with longer OS. The presence of liver metastases was associated with shorter PFS (HR = 2.32, 95% CI 1.17-4.59). ORR with avelumab maintenance was 28.7% (complete response 17.6%, partial response 11.1%), 29.6% stable disease, 26.9% progressive disease as best response (14.8% best response unknown). Results seem relatively consistent with findings from JAVELIN Bladder100 trial and recent “real world” studies. Prior response to platinum-based chemotherapy, ECOG PS 0, and absence of liver metastases were favorable prognostic factors. Limitations include the retrospective design, lack of randomization and central scan review, and possible selection/confounding biases. Based on JAVELINBladder100 trial, avelumab maintenance was approved for patients with advanced urothelial carcinoma (aUC) without progression on first-line platinum-based chemotherapy. We examined patient characteristics, prognostic factors and outcomes in patients who received avelumab switch maintenance in a “real-world” (outside trials) setting. Our results appear similar with those from the clinical trial and recent “real world” studies.
Bladder Cancer Immunotherapy Anti-PD(L)1 Immune Checkpoint Inhibitors Urinary tract cancer

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