SPADE: Design of a real-world observational study of avelumab first-line (1L) maintenance in advanced urothelial carcinoma (UC) in the Asia-Pacific (APAC) region.

Abstract

TPS577 Background: UC is a common cancer, with >200,000 new cases reported in the APAC region in 2020. In the global phase 3 JAVELIN Bladder 100 trial, avelumab 1L maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) vs BSC alone in patients with advanced UC that had not progressed with 1L platinum-containing chemotherapy (median OS, 23.8 vs 15.0 months [p=0.0036]; median PFS, 5.5 vs 2.1 months [p<0.0001]), leading to regulatory approvals worldwide and incorporation into international treatment guidelines with level 1 evidence. The objectives of the SPADE noninterventional study are to evaluate real-world patient characteristics, treatment patterns, patient-reported outcomes (PROs) and treatment outcomes with avelumab maintenance administered in patients with advanced UC without disease progression after 1L platinum-based chemotherapy in the APAC region. Methods: SPADE is a multicenter, prospective, observational study ongoing in Australia, Hong Kong, India, Japan, Republic of Korea, Singapore, Taiwan, and other countries. Overall, 286 patients with unresectable locally advanced or metastatic (stage IV) measurable UC of any histology that has not progressed with 1L platinum-containing chemotherapy, for whom avelumab 1L maintenance therapy is planned, will be enrolled. All patients will receive avelumab 800 mg intravenously every 2 weeks (or per local marketing authorization) and will be followed up for 12 months or until avelumab is discontinued. The decision to start avelumab treatment should be made in advance by the treating physician and per local clinical practice. Data collected will include patient demographics (ECOG performance status, renal function, history of UC, primary tumor location, location of metastases, and prior therapy), treatment details for 1L platinum-based chemotherapy (regimen, cycles, and response per RECIST), treatment details for avelumab 1L maintenance (interval from end of chemotherapy until initiation, duration of avelumab treatment, and planned subsequent treatment), and treatment outcomes with avelumab 1L maintenance (6- and 12-month OS and health-related quality of life). Data sources will include medical records collected during routine clinical care. Data for baseline treatment patterns will be summarized using descriptive statistics. OS will be analyzed using the Kaplan-Meier method. Health-related quality of life, including changes over time, will be measured using the EQ-5D-5L and National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index (NCCN/FACT FBISI-18) questionnaires. An interim analysis is planned after ~30% of patients have been enrolled.