JAVELIN Bladder 100: Long-term Patient-Reported Outcomes

Prolonged avelumab first-line maintenance treatment (at least 12 months) is associated with stable patient-reported outcomes (PROs) for those with advanced urothelial carcinoma (aUC), according to long-term outcomes of the phase 3 JAVELIN Bladder 100 trial presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium.

Prior data readouts of the JAVELIN Bladder 100 study showed avelumab first-line maintenance plus best supportive care (BSC) significantly prolongs overall survival compared with BSC alone in patients with aUC who had not progressed on first-line platinum-based chemotherapy. Health-related quality of life (QOL) was reportedly maintained.

Petros Grivas, MD, PhD, and colleagues reported long-term exploratory PRO analyses in the overall avelumab-plus-BSC arm (any treatment duration) and in the subgroup with at least 12 months of avelumab treatment. PROs were a secondary end point assessed at baseline, on day 1 of each 4-week cycle, at end of treatment/withdrawal, and up to 90 days post-treatment. Researchers used the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 and EuroQol 5 Dimensions 5 Levels to measure PROs.

As of the data cutoff (June 4, 2021), the median follow-up in the avelumab arm (n=350) was 38 months and at least 24 months in all patients. The median duration of treatment was 5.8 months. In patients treated for at least 12 months (n=118), baseline characteristics were similar to those in the overall avelumab-plus-BSC arm, except for a higher proportion with an Eastern Cooperative Oncology Group performance status of 0 (70.3% vs 60.9%, respectively) and lower proportion with visceral metastases (47.5% vs 54.6%, respectively).

Dr. Grivas and colleagues noted that in both treatment arms, completion rates for both PRO instruments among evaluable patients were greater than 80% at all time points during treatment.

On average, PRO scores remained stable throughout treatment, and no clinically relevant changes from baseline were observed. Among those treated for at least 12 months, approximately 75% reported no change or a decrease in treatment side effects throughout 24 months of treatment.

Dr. Grivas and colleagues concluded that prolonged avelumab first-line maintenance is associated with stable PROs, indicating preservation of QOL in patients with aUC. “The results further support the use of avelumab first-line maintenance until progression or unacceptable toxicity as standard of care with level 1 evidence in patients with aUC who are progression-free after platinum-based chemotherapy,” they wrote.