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Abstract
BackgroundThe majority of advanced biliary tract cancer (ABTC) patients will progress after gemcitabine and cisplatin (GP) doublet therapy, while the standard second-line regimen has not been established. We conducted this study to assess the efficacy and safety of second-line irinotecan and capecitabine (XELIRI) regimen vs. irinotecan monotherapy in ABTC patients progressed on GP.MethodsSixty-four GP refractory ABTC patients were randomised to either irinotecan 180 mg/m2 on day 1 plus capecitabine 1000 mg/m2 twice daily on days 1–10 of a 14-day cycle (XELIRI-arm) or single-agent irinotecan 180 mg/m2 on day 1 of a 14-day cycle (IRI-arm). Treatments were repeated until disease progression or unacceptable toxicity occurred.ResultsA total of 60 patients were included in the analysis. For XELIRI and IRI-arms, respectively, the median PFS was 3.7 vs. 2.4 months, 9-month survival rate 60.9% vs. 32.0%, median OS 10.1 vs. 7.3 months, and disease control rate 63.3% vs. 50.0%. The most common grade 3 or 4 toxicities were leucopaenia and neutropaenia.ConclusionsThis randomised, phase II study of irinotecan-containing regimens in good PS second-line ABTC patients showed a clear benefit of XELIRI regimen over irinotecan monotherapy in prolonging PFS, with acceptable toxicity.
Highlights
Biliary tract cancer (BTC) is a rarely[1] and highly fatal malignancy with a 5-year overall survival (OS) rate of only about 10% for cholangiocarcinoma and less than 5% for gallbladder cancer.[2,3]Radical resection is the only potentially curative approach to early stage BTC
Three independent systematic reviews have provided the most comprehensive results regarding the use of second-line chemotherapy in advanced biliary tract cancer (ABTC).[19,20,21]
There was no solid evidence that indicates any clear survival benefit of the use of second-line chemotherapy, irinotecan had been preliminary evaluated as a monotherapy or as part of combination therapies in ABTC, and the median OS for second-line treatment was approximately 6–8 months.[15,16,22]
Summary
Biliary tract cancer (BTC) is a rarely[1] and highly fatal malignancy with a 5-year overall survival (OS) rate of only about 10% for cholangiocarcinoma and less than 5% for gallbladder cancer.[2,3]Radical resection is the only potentially curative approach to early stage BTC. Several studies have demonstrated the efficacy and safety of gemcitabine in ABTC.[4,5] In 2010, the combination regimen with gemcitabine plus cisplatin (GP) was shown to significantly improve the survival of patients with ABTC compared to gemcitabine alone as first-line therapy in two randomised trials (OS: 11.7 vs 8.1 months, 11.2 vs 7.7 months, respectively).[6,7] GP doublet therapy is the standard first-line regimen for ABTC. The majority of advanced biliary tract cancer (ABTC) patients will progress after gemcitabine and cisplatin (GP) doublet therapy, while the standard second-line regimen has not been established. We conducted this study to assess the efficacy and safety of second-line irinotecan and capecitabine (XELIRI) regimen vs irinotecan monotherapy in ABTC patients progressed on GP. CONCLUSIONS: This randomised, phase II study of irinotecan-containing regimens in good PS second-line ABTC patients showed a clear benefit of XELIRI regimen over irinotecan monotherapy in prolonging PFS, with acceptable toxicity
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