Howard A. Burris, MD, highlighted previous findings of the phase 3 TOPAZ-1 trial assessing durvalumab plus gemcitabine and cisplatin vs placebo plus gemcitabine and cisplatin in advanced biliary tract cancer and patient-reported outcomes data that were presented at 2022 ASCO.
In an interview with CancerNetwork® during the 2022 American Society of Clinical Oncology Annual Meeting, Howard A. Burris, MD, president and chief medical officer of Sarah Cannon as well as an associate of Tennessee Oncology, discussed the safety profile as well as patient-reported outcomes from the phase 3 TOPAZ-1 trial (NCT03875235) of gemcitabine and cisplatin plus either durvalumab (Imfinzi) or placebo in advanced biliary tract cancer (BTC).1
In addition to improved overall survival (OS) and progression-free survival (PFS), the active therapy arm was well tolerated and yielded no difference in time to deterioration of quality-of-life, which further supports the use of the regimen in patients with BTC.
TOPAZ-1 was a clinical trial studying the addition of durvalumab, the PD-1 inhibitor, to the standard chemotherapy regimen of gemcitabine and cisplatin in the treatment of unresectable cholangiocarcinoma or biliary [tract cancer]. In that clinical trial, we showed a statistically significant improvement in overall survival.2
In addition to statistically significant outcomes, one of the factors we look at [is whether] we have a positive effect on quality of life and the [patient’s] ability to handle the regimen with the adverse effects, or toxicity profile. Interestingly, the most impressive survival differences, an objective outcome, was the fact that at 2 years, 25% of patients were alive in the arm that received durvalumab with chemotherapy vs 10% in the group of patients who received chemotherapy alone. After the initial 8 cycles of chemotherapy—patients, in general, tend to receive 6 to 8 cycles—patients received maintenance durvalumab or maintenance placebo. That duration of survival difference points in the direction that patients were able to tolerate the regimen and able to stay on study.