Patient-reported Outcomes from JAVELIN Bladder 100: Avelumab First-line Maintenance Plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma.

In JAVELIN Bladder 100, avelumab first-line maintenance plus best supportive care (BSC) significantly prolonged overall survival (OS; primary endpoint) versus BSC alone in patients with advanced urothelial carcinoma (aUC) without disease progression with first-line platinum-containing chemotherapy.

To evaluate patient-reported outcomes (PROs) with avelumab plus BSC versus BSC alone.

A randomized phase 3 trial (NCT02603432) was conducted in 700 patients with locally advanced or metastatic urothelial carcinoma that had not progressed with first-line gemcitabine plus cisplatin or carboplatin. PROs were a secondary endpoint.

Avelumab plus BSC (n = 350) or BSC alone (n = 350).

National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBlSI-18) and EuroQol five-level EQ-5D (EQ-5D-5L) assessments were analyzed using descriptive statistics and mixed-effect models. Time to deterioration (TTD; prespecified definition: a ≥3-point decrease from baseline in the FBlSI-18 disease-related symptoms-physical subscale for two consecutive assessments) was evaluated via Kaplan-Meier analyses.

Completion rates for scheduled on-treatment PRO assessments were >90% (overall and average per assessment). Results from descriptive analyses and mixed-effect or repeated-measures models of FBlSI-18 and EQ-5D-5L were similar between arms. TTD was also similar, both in the prespecified analysis (hazard ratio 1.26 [95% confidence interval: 0.90, 1.77]) and in the post hoc analyses including off-treatment assessments and different event definitions. Limitations included the open-label design and limited numbers of evaluable patients at later time points.

Addition of avelumab first-line maintenance to BSC in patients with aUC that had not progressed with first-line platinum-containing chemotherapy prolonged OS, with a relatively minimal effect on quality of life.

In this trial of people with advanced urothelial carcinoma who had benefited from first-line chemotherapy (ie, had stable disease or reduced tumor size), treatment with avelumab maintenance plus best supportive care (BSC) versus BSC alone improved survival significantly, without compromising quality of life, as reported by the patients themselves.

European urology. 2022 May 30 [Epub ahead of print]

Petros Grivas, Evgeny Kopyltsov, Po-Jung Su, Francis X Parnis, Se Hoon Park, Yoshiaki Yamamoto, Peter C Fong, Christophe Tournigand, Miguel A Climent Duran, Aristotelis Bamias, Claudia Caserta, Jane Chang, Paul Cislo, Alessandra di Pietro, Jing Wang, Thomas Powles

Department of Medicine, Division of Medical Oncology, University of Washington, Seattle, WA, USA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, WA, USA. Electronic address: ., State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia., Chang Gung Memorial Hospital, LinKuo, Taiwan., Adelaide Cancer Centre, University of Adelaide, Adelaide, Australia., Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Yamaguchi University Hospital, Ube, Yamaguchi, Japan., The University of Auckland and Auckland City Hospital, Auckland, New Zealand., Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Paris-Est Créteil University, Créteil, France., Instituto Valenciano de Oncología, Valencia, Spain., Alexandra General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece., Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni, Italy., Pfizer, New York, NY, USA., Pfizer srl, Milano, Italy., Pfizer, Cambridge, MA, USA., Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK.