Howard A. Burris, MD, Talks QOL With Durvalumab/Chemo in Advanced Biliary Tract Cancer From TOPAZ-1 Trial

Video

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.

Transcript:

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.

Reference

  1. Burris HA, Okusaka T, Vogel A, et al. Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. J Clin Oncol. 2022;40(suppl 16):4070-4070. doi:10.1200/JCO.2022.40.16_suppl.4070
  2. Oh DY, He AR, Qin S, et al. A phase 3 randomized, double-blind, placebo-controlled study of durvalumab in combination with gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced biliary tract cancer (BTC): TOPAZ-1. J Clin Oncol. 2022;40(suppl 4):378. doi:10.1200/JCO.2022.40.4_suppl.378

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Recent Videos
An ongoing phase 1 trial seeks to prove XmAb819 as an effective treatment and ENPP3 as a plausible target in patients with relapsed or refractory RCC.
“The therapy is designed to prevent both CAR T-cell inactivation and to restore the anti-tumor immunity of the white blood cells that have gotten through the tumor,” said Marasco, MD, PhD.
Ongoing studies aim to combine base immunotherapy regimens with novel agents to potentially improve outcomes among patients with kidney cancer.
Investigators have found a way to reduce liver and biliary toxicity when targeting the molecule CAIX in patients with clear cell renal cell carcinoma.
Neoantigen-targeting vaccines resulted in an absence of recurrence in 9 patients with high-risk kidney cancer, according to David A. Braun, MD, PhD.
The Kidney Cancer Research Consortium may allow collaborators to form more mechanistic and scientifically driven efforts in the field.
Wayne A. Marasco, MD, PhD, stated that by targeting 2 molecules instead of 1, higher levels of tumor cell killing can be achieved in patients with clear cell renal cell carcinoma.
Leading experts in the breast cancer field highlight the use of CDK4/6 inhibitors, antibody-drug conjugates, and other treatment modalities.
Related Content