In the JAVELIN Bladder 100 phase 3 trial, avelumab first-line maintenance + best supportive care (BSC) prolonged overall survival (OS) and progression-free survival (PFS) versus BSC alone in patients with advanced urothelial carcinoma (advanced UC) without progression after first-line platinum-based chemotherapy.
To report post hoc analyses of subgroups defined by the duration of first-line chemotherapy and interval before maintenance.
Patients with advanced UC without progression after four to six cycles of platinum-based chemotherapy and a 4-10-wk interval after chemotherapy (n = 700) were randomized to receive avelumab + BSC or BSC alone. Subgroups were defined by duration (quartile [Q]) and estimated number of cycles of chemotherapy, and interval between chemotherapy and maintenance. The median follow-up was >19 mo in both arms.
OS (primary endpoint), PFS, and safety were assessed.
Hazard ratios (95% confidence interval) for OS with avelumab + BSC versus BSC alone were as follows: by chemotherapy duration-<Q1: 0.65 (0.42-1.02), Q1-Q2: 0.79 (0.50-1.27), Q2-Q3: 0.74 (0.50-1.10), and >Q3: 0.63 (0.39-1.00); by number of cycles-four cycles: 0.69 (0.48-1.00), five cycles: 0.98 (0.57-1.71), and six cycles: 0.66 (0.47-0.92); and by interval-4-<6 wk: 0.75 (0.54-1.04), 6-<8 wk: 0.67 (0.43-1.06), and 8-10 wk: 0.69 (0.47-1.02). Results were similar for PFS. Safety was similar across subgroups. All analyses were exploratory.
Post hoc analyses of OS and PFS in subgroups defined by first-line chemotherapy duration and interval before maintenance were generally consistent with the results in the overall population, with similar safety findings. Prospective trials are warranted to confirm these findings.
Avelumab maintenance treatment helped patients with advanced urothelial cancer without disease progression after at least four cycles of prior chemotherapy, and who started maintenance treatment at least 4 wk after chemotherapy, to live longer.
European urology. 2023 Sep 13 [Epub ahead of print]
Srikala S Sridhar, Thomas Powles, Miguel Á Climent Durán, Se Hoon Park, Francesco Massari, Antoine Thiery-Vuillemin, Begoña P Valderrama, Anders Ullén, Norihiko Tsuchiya, Jeanny B Aragon-Ching, Shilpa Gupta, Daniel P Petrylak, Joaquim Bellmunt, Jing Wang, Robert J Laliberte, Alessandra di Pietro, Nuno Costa, Petros Grivas, Cora N Sternberg, Yohann Loriot
Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. Electronic address: Srikala.Sridhar@uhn.ca., Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK., Department of Medical Oncology, Instituto Valenciano de Oncología, València, Spain., Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea., Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy., Department of Medical Oncology, University Hospital Jean Minjoz, Besançon Cedex, France., Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain., Department of Pelvic Cancer, Genitourinary Oncology Unit, Karolinska University Hospital, Solna, Sweden; Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden., Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan., Inova Schar Cancer Institute, Fairfax, VA, USA., Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA., Yale Cancer Center, New Haven, CT, USA., Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA., Pfizer, Cambridge, MA, USA., Pfizer srl, Milano, Italy., Pfizer, Porto Salvo, Portugal., University of Washington, Fred Hutchinson Cancer Center, Seattle, WA, USA., Hematology/Oncology, Meyer Cancer Center, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY, USA., Gustave Roussy, Department of Cancer Medicine, INSERMU981, Université Paris-Saclay, Villejuif, France.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/37714742