- 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;
- Grivas, Petros
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.