As reported in The Lancet Oncology by Howard A. Burris III, MD, FACP, FASCO, and colleagues, a patient-reported outcome (PRO) analysis from the phase III TOPAZ-1 trial showed no “detrimental effect” with the addition of durvalumab to gemcitabine/cisplatin in patients with advanced biliary tract cancer.
An interim analysis of the trial supported the September 2022 approval of durvalumab combined with chemotherapy in this setting on the basis of improved overall survival.
Howard A. Burris III, MD, FACP, FASCO
Study Details
In the ongoing international double-blind trial, 685 patients with previously untreated, unresectable, locally advanced, or metastatic biliary tract cancer were randomly assigned between April 2019 and December 2020 to receive durvalumab (n = 341) or placebo (n = 344) in addition to gemcitabine and cisplatin. PROs were assessed in all patients who completed the EORTC 30-item Quality of Life questionnaire (QLQ-C30) and the 21-item Cholangiocarcinoma and Gallbladder Cancer Quality of Life Module (QLQ-BIL21). Time to deterioration in PROs was defined as time from random assignment to an absolute decrease of ≥ 10 points.
Key Findings
QLQ-C30 data were available for 318 patients in the durvalumab group and 328 in the placebo group, with a median follow-up of 9.9 months (interquartile range [IQR] = 6.7–14.1 months). QLQ-BIL21 data were available for 305 patients in the durvalumab group and 322 in the placebo group, with a median follow-up of 10.2 months (IQR = 6.7–14.3 months).
For global health status/quality of life on the QLQ-C30 and functional scales and symptom scales on the QLC-C30 and QLQ-BIL21, no differences in time to deterioration or adjusted mean changes in scores from baseline were observed between the durvalumab group and the placebo group. Median time to deterioration of global health status/quality of life was 7.4 months (95% confidence interval [CI] = 5.6–8.9 months) in the durvalumab group vs 6.7 months (95% CI = 5.6–7.9 months) in the placebo group (hazard ratio = 0.87, 95% CI = 0.69–1.12). Adjusted mean changes from baseline scores were 1.23 (95% CI = –0.71 to 3.16) in the durvalumab group vs 0.35 (95% CI = –1.63 to 2.32) in the placebo group.
The investigators concluded, “The addition of durvalumab to gemcitabine and cisplatin did not have a detrimental effect on patient-reported outcomes. These results suggest that durvalumab, gemcitabine, and cisplatin is a tolerable treatment regimen in patients with advanced biliary tract cancer.”
Dr. Burris III, of Sarah Cannon Research Institute, Tennessee Oncology, Nashville, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by AstraZeneca. For full disclosures of the study authors, visit thelancet.com.
