Patient-reported outcomes in the phase 3 TOPAZ-1 trial of durvalumab plus chemotherapy for advanced biliary tract cancer

In the ongoing, randomized phase 3 TOPAZ-1 trial, durvalumab plus gemcitabine and cisplatin was associated with significant improvement in overall survival compared with placebo, gemcitabine, and cisplatin in patients with advanced biliary tract cancer (aBTC). Patient-reported outcomes of the trial have now been published. The proportions of patients in the durvalumab group and the placebo group who completed QLQ-C30 and QLQ-BIL21 questionnaires were high, and baseline scores were mostly similar across treatment groups. For global health status or quality of life, functioning, and symptoms, there were no significant differences between treatment groups in time to deterioration or adjusted mean changes from baseline. The authors conclude that the addition of durvalumab to gemcitabine and cisplatin did not have a detrimental effect on patient-reported outcomes.