Abstract
ObjectivePrognosis of patients with irresectable cholangiocarcinoma is still poor. The ABC-02 trial established the current first line (1L) standard systemic chemotherapy (CT) with gemcitabine/platinum derivate for advanced cholangiocarcinoma. However, the majority of patients needed therapy adaptions. Thus, the aim of this study was to evaluate 1L and second line (2L) therapy regimens and the impact of therapy adaptions in an unselected real-life cohort of patients with advanced cholangiocarcinoma.Materials and MethodsThis is a single institution retrospective analysis of patients with irresectable cholangiocarcinoma who were treated with gemcitabine/platinum derivate from 2010 to 2018. Overall survival (OS), progression-free survival (PFS) and toxicity were analyzed for all patients, especially with regard to CT de-escalation.ResultsFifty-eight patients receiving gemcitabine/platinum derivate were included in the analysis. Median OS and PFS were 12.2 and 6.9 months. Interestingly, 41 patients (71%) needed therapy de-escalation. However, despite reduced CT exposition, there was no-significant difference in OS (10.8 months vs. 15.6 months, p = 0.127), and patients suffered from less adverse events during CT. 21 (36%) patients reached 2L CT, most often with FOLFIRI (57%). Survival beyond the end of 1L CT was 7.1 months with 2L CT vs. 2.9 months with BSC.ConclusionIn our study, the combination of gemcitabine/platinum derivate showed similar OS and PFS as randomized prospective phase II/III trials. Therapy regimen adaptions were needed in the majority of patients. However, individualized modifications of the therapy regimen allowed better tolerance as well as continuation of therapy and did not significantly influence median OS. Furthermore, our study revealed a potential survival benefit with 2L CT for selected patients.
Highlights
Biliary tract cancer (BTC), including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder carcinoma, represents about 3% of all gastrointestinal malignancies
In the Western world, BTC is a rare disease with an incidence of 2-3/ 100,000 cases per year, but mortality rates have been increasing in the last decades, in line with increasing incidence of iCCA [1,2,3,4]
This is a single institution retrospective analysis of patients with irresectable cholangiocarcinoma who were treated with gemcitabine/platinum derivate in 1L therapy from 2010 to 2018
Summary
Biliary tract cancer (BTC), including intrahepatic and extrahepatic cholangiocarcinoma (iCCA, eCCA) and gallbladder carcinoma, represents about 3% of all gastrointestinal malignancies. In the Western world, BTC is a rare disease with an incidence of 2-3/ 100,000 cases per year, but mortality rates have been increasing in the last decades, in line with increasing incidence of iCCA [1,2,3,4]. Very promising information on the molecular classification and discovery of actionable mutations and genetic alterations in cholangiocarcinoma was published, enabling novel personalized therapeutic options for some patients. The majority of patients with advanced cholangiocarcinoma is negative for these biomarkers and can only be treated with chemotherapy
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