Anant Ramaswamy, MD, discusses a phase 2 multicenter clinical trial evaluating the efficacy of capecitabine plus irinotecan versus irinotecan monotherapy in advanced gallbladder cancer.
Anant Ramaswamy, MD, a medical oncologist with Tata Memorial Hospital in Mumbai, India, discusses a phase 2 multicenter clinical trial evaluating the efficacy of capecitabine (Xeloda) plus irinotecan versus irinotecan monotherapy in advanced gallbladder cancer.
The prospective superiority trial randomized patients to eitherthe doublet arm of capecitabine plus irinotecan or the monotherapy arm with irinotecan. Accrual was completed in January 2020 and the data reflect a median follow-up of 6 months, says Ramaswamy. The primary end point of the study was overall survival (OS) at 6-months, though the doublet arm was not able to achieve the primary endpoint of superior OS, as compared with irinotecan monotherapy. The median OS were similar in both arms at 5.16 months in the doublet cohort (95% CI, 4.26-6.06) and 6.28 months (95% CI, 4.25-8.3) in the single-agent irinotecan cohort, respectively. This suggeststhat irinotecan is as efficacious as the doublet therapy in this phase of second-line treatment for advanced gallbladder cancers, Ramaswamy adds.
Besides OS in this fragile cohort of patients, there was very little difference in quality of life (QOL) between the 2 arms. The doublet arm required more dose modifications (27%) than those in the monotherapy arm (9%). In terms of the primary endpoint, as well as secondary end points, the findings from this study confirmed that irinotecan is likely as efficacious as the doublet therapy, concludes Ramaswamy.