Posted: Tuesday, February 22, 2022
The Meet-URO12 trial, conducted by Francesca Vignani, MD, of SCDU Oncologia, AO Ordine Mauriziano, Turin, Italy, and colleagues assessed the use of the oral PARP inhibitor niraparib combined with best supportive care in patients with urothelial carcinoma. Ultimately, maintenance niraparib plus best supportive care did not prolong survival when compared with best supportive care alone, and these findings were presented during the 2022 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (Abstract 442).
This phase II, multicenter trial enrolled 58 patients with advanced transitional cell urothelial carcinoma who did not experience disease progression after four to six cycles of first-line platinum-based chemotherapy. Participants were randomly assigned to receive niraparib plus best supportive care (n = 39) or best supportive care alone (n = 19). Via formalin-fixed paraffin-embedded tumor samples, molecular characteristics were also assessed.
The median patient age was 69, with best responses consisting of objective response and stable disease observed in 55.2% and 44.8% of patients, respectively. At a median follow-up of 8.5 months, a total of 47 progression-free survival events were recorded. The median progression-free survival was 2.1 months for participants given the combination regimen and 2.4 months for those given best supportive care alone; the 6-month progression-free survival rates were 28.2% and 26.3%, respectively.
Of 47 patients with molecular characterization information, 44.7% had aberrations in homologous recombination repair genes. In these individuals, progression-free survival was similar across both treatment arms.
Grade 3 adverse events were observed in 65.8% of individuals given niraparib plus best supportive care and 15.8% of those given best supportive care alone, with 18 patients requiring a dose reduction in niraparib. The most common treatment-related adverse events included anemia, thrombocytopenia, neutropenia, fatigue, and constipation.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.