1. Response and Outcomes of Maintenance Avelumab After Platinum-Based Chemotherapy (PBC) in Patients With Advanced Urothelial Carcinoma (aUC): Real World Experience.
- Author
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Bakaloudi, Dimitra, Talukder, Rafee, Lin, Genevieve, Makrakis, Dimitrios, Diamantopoulos, Leonidas, Tripathi, Nishita, Agarwal, Neeraj, Zakopoulou, Roubini, Bamias, Aristotelis, Brown, Jason, Pinato, David, Korolewicz, James, Jindal, Tanya, Koshkin, Vadim, Murgić, Jure, Miletić, Marija, Frobe, Ana, Johnson, Jeffrey, Zakharia, Yousef, Drakaki, Alexandra, Rodriguez-Vida, Alejo, Rey-Cárdenas, Macarena, Castellano, Daniel, Buznego, Lucia, Duran, Ignacio, Carballeira, Clara, Barrera, Rafael, Marmorejo, David, McKay, Rana, Stewart, Tyler, Gupta, Shilpa, Ruplin, Andrew, Yu, Evan, Khaki, Ali, and Grivas, Petros
- Subjects
Anti-PD(L)1 ,Bladder cancer ,Immune Checkpoint Inhibitors ,Immunotherapy ,Urinary tract cancer ,Humans ,Antibodies ,Monoclonal ,Retrospective Studies ,Carcinoma ,Transitional Cell ,Platinum ,Urinary Bladder Neoplasms - Abstract
BACKGROUND: 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. MATERIALS AND METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.
- Published
- 2023