The sessions’ invited discussant, Imane H. El Dika, MD, Assistant Attending Physician at Memorial Sloan Kettering Cancer Center, New York, said the results of the two trials in advanced biliary tract cancer were clear, and did not change the current standard of care of durvalumab combined with gemcitabine/cisplatin, based on the results of the TOPAZ trial.1
“SWOG 1815 is an important negative phase III trial…. The addition of nab-paclitaxel to gemcitabine and cisplatin does not improve overall survival over gemcitabine plus cisplatin in the front-line setting, and it increases toxicity,” she said. “In IMbrave151, two experimental arms were tested, and there was no clear signal to move either arm forward. The gemcitabine/cisplatin/durvalumab combination remains a standard front-line treatment.”
SWOG 1815 did demonstrate some “interesting trends that are hypothesis-generating,” specifically, the longer overall survival in locally advanced disease and in gallbladder tumors, Dr. El Dika said. “The signal from selected patient subsets is worthy of further evaluation.”
Regarding the phase II IMbrave151 trial, Dr. El Dika noted that it explored a new and interesting therapeutic mechanism in biliary tract cancer. “But with the limitation of having a small sample size and a lack of statistical power, we can say that both arms did not compare favorably to historical controls,” she noted.
“This brings me to the point of clinical equipoise. We as clinicians have a genuine desire to give the best to our patients and to offer treatments based on earlier data while we wait for more confirmatory analysis. We just learned we need to validate the data before doing that. Based on the available results,” she concluded, “I don’t think there is enough signal to move this [bevacizumab/atezolizumab/cisplatin/gemcitabine] forward or to offer this treatment.”
DISCLOSURE: Dr. El Dika reported no conflicts of interest.
1. Oh DY, He AR, Qin S, et al: Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid. June 1, 2022 (early release online).
Biliary tract cancer is particularly difficult to treat, with a median overall survival of about 1 year with standard-of-care gemcitabine-based regimens. Advanced biliary tract cancer is an area of significant unmet need because of its aggressive nature, limited treatment options, and poor...