Gemcitabine-cisplatin plus pembrolizumab combo feasible in advanced BTC

The addition of pembrolizumab to the combination of gemcitabine and cisplatin does not appear to worsen the health-related quality of life (HRQoL) in patients with advanced biliary tract cancer (BTC), results of the phase III KEYNOTE-966 study have shown.

A total of 1,069 participants were randomized to gemcitabine plus cisplatin with pembrolizumab (n=533) or gemcitabine plus cisplatin with placebo (n=536). Of these, >87 percent in both arms completed the questionnaires from baseline to week 18. Least squares mean changes were comparable between groups for all domains from baseline to week 18.

Likewise, time to confirmed deterioration estimates did not significantly differ between arms, including for global health status/QoL (median not reached [NR] in the pembrolizumab arm vs 21.2 months in the placebo arm; hazard ratio [HR], 0.86, 95 percent confidence interval [CI], 0.70‒1.07), jaundice (NR vs NR; HR, 1.20, 95 percent CI, 0.94‒1.54), and pain (NR vs NR; HR, 0.79, 95 percent CI, 0.59‒1.05).

“HRQoL was maintained after adding pembrolizumab to gemcitabine plus cisplatin, further supporting this regimen as a first-line treatment option for advanced BTC,” the investigators said.

In KEYNOTE-966, the investigators assessed HRQoL using the EORTC Core Quality of Life Questionnaire (QLQ-C30), EORTC QLQ-BIL21, and EQ-5D-5L questionnaires. They compared data from the latest time point with ≥60-percent completion and ≥80-percent compliance (week 18) to baseline.

Least squares means for change from baseline to week 18 were compared using a constrained longitudinal analysis model in six prespecified domains: QLQ-C30 global health status/quality of life, physical functioning, and role functioning; QLQ-BIL21 pain and jaundice scores, and EQ-5D-5L visual analogue score.

Finally, a stratified Cox proportional hazard model with randomization stratification factors was used to assess between-group difference in time to confirmed deterioration.