Metastasis at time of diagnosis included M0 (14%), M1a (15%), M1b (38%), and unknown (33%). At the start of platinum-based chemotherapy, 74% of patients had metastatic disease. The sites of primary tumor included upper tract UC (31%), lower tract UC (49%), upper and lower tract (3%), and unknown (8%). Seventy-six percent of patients had an ECOG performance status of 0 or 1. Sixty-four percent of patients were current or former smokers, and 78% of patients did not have a family history of bladder cancer. Additionally, 90% of patients were White, 3% were Black, 3% were Asian, and 4% were Hispanic. Regarding ethnicity, 78% were non-Hispanic/Latino, 4% were Hispanic/Latino, and 18% were unknown. The key end points of the study include real-world overall survival (OS) and progression-free survival (PFS), treatment patterns, real-world time to treatment discontinuation, real-world time to next line of treatment, reasons for treatment discontinuation, adverse effects (AEs), time to onset of immune-related AEs and high-dose steroid use, and health-care resource utilization, hospitalizations, and emergency department visits.Īmong the 160 patients analyzed in the study thus far, the median age of was 70 years (range, 40-90) and 77% were male. “We collected data from patients who received chemotherapy and then went on to avelumab switch maintenance in 37 geographically dispersed oncology practices, both community practice and academic centers, within the United States,” Grivas said. Exclusion criteria included pregnancy at the time of trial enrollment and interventional clinical trial participation during the study period. Patients were also required to have baseline and history data were available via medical records. The ongoing, retrospective PATRIOT-II study included patients with histologically confirmed locally advanced or mUC who were at least 18 years old at diagnosis and initiated avelumab maintenance after not progressing on first-line platinum-based chemotherapy. Grivas is a physician at the Seattle Cancer Care Alliance, an associate professor in the Division of Medical Oncology, University of Washington (UW) School of Medicine, clinical director of the Genitourinary Cancers Program, UW Medicine, and an associate professor in the Clinical Research Division, Fred Hutchinson Cancer Research Center, in Seattle, Washington. In an effort to describe real-world evidence of what is happening in clinical practice, we designed the PATRIOT-II study, ” lead study author Petros Grivas, MD, PhD, said in an interview with OncLive®. “We want to corroborate the findings real-world data. In June 2022, the FDA approved avelumab as maintenance treatment for patients with locally advanced or mUC that has not progressed with first-line, platinum-based chemotherapy, based on findings from the phase 3 JAVELIN Bladder 100 trial (NCT02603432). The median number of chemotherapy cycles was 5 cycles (interquartile range, 3-6), and median duration of platinum-based chemotherapy was 13 weeks (IQR, 10-17). Eleven percent had stable disease (SD), and response was unknown in 8% of patients.Īdditionally, 62.5% of patients received cisplatin-based chemotherapy, and 37.5% of patients received carboplatin-based chemotherapy. The baseline characteristics, treatment patterns, and responses to first-line platinum-based chemotherapy for patients with locally advanced or mUC receiving avelumab maintenance therapy were consistent with responses to usual therapy paradigms in the first-line induction setting, according to data presented at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium.īaseline findings showed that patients treated with first-line platinum-based chemotherapy prior to avelumab maintenance (n = 160) experienced a complete response (CR) rate of 13% and a partial response (PR) rate of 68% to chemotherapy. The ongoing, retrospective PATRIOT-II study continues to evaluate real-world outcomes and treatment patterns for maintenance avelumab (Bavencio) for the treatment of locally advanced or metastatic urothelial carcinoma (mUC).
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |