부산대학교 도서관

Objective: First-line (IL) maintenance avelumab prolonged overall survival (OS) in patients with advanced urothelial carcinoma (aUC) in JAVELIN Bladder 100. OS was measured from maintenance initiation in patients with disease control following IL platinum-based therapy (PBT). The OS impact of maintenance for the IL PBT-treated population is unknown since it was not measured from IL initiation, nor can it be benchmarked with other IL therapies. To characterize the OS impact of maintenance avelumab, we used an oncology simulation model to estimate the OS of maintenance-eligible and -ineligible patients with aUC from IL PBT initiation. Methods: We developed a simulated cohort of IL PBT-treated patients with aUC, including those who did and did not receive maintenance avelumab. Eligibility was assessed at 5.6 months post IL PBT initiation based on the JAVELIN trial design. Among the lL-treated population, 58% (95% credible interval [CrI] 49-67%) were projected to be eligible (calculated from contemporary phase 3 trials); of those, 85% were assumed to receive maintenance. The model estimated median OS (mOS) among a maintenance-ineligible simulated cohort which when combined with the maintenance-eligible cohort yielded an estimated OS in the overall maintenance-intended population from IL PBT initiation. Results: Approximately half of the modeled IL PBT-treated population received maintenance. Estimated mOS was 10.1 months (95% CrI 7.5-13.5) for the maintenance-ineligible cohort, 29.3 months (95% CrI 24.8-33.9) for the maintenance-eligible, received maintenance cohort, and 15.9 months (95% CrI 13.2-19.1) in the overall maintenance-intended, IL PBT-treated population, including those eligible and ineligible for maintenance. Conclusion: The model shows that maintenance avelumab has a modest impact on OS in the overall IL PBT-treated population of patients with aUC. While maintenance avelumab improves OS for eligible patients, a large proportion of the maintenance-intended population may not receive maintenance due to ineligibility or physician/patient choice. Keywords: maintenance eligibility, maintenance avelumab, oncology simulation model, overall survival, urothelial carcinoma
Introduction The National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) guidelines recommend platinum-based therapy (PBT) for first-line (1L) treatment of patients with advanced urothelial carcinoma (aUC) [...]