Background: Cholangiocarcinoma (CCA) is a rare malignant disease of the biliary tract with an increasing incidence and a high mortality worldwide. Systematic data on epidemiological trends, treatment strategies, and in-hospital mortality of CCA in Germany are largely missing. However, the evaluation and careful interpretation of these data could help to further improve the treatment strategies and outcome of CCA patients in the future. Methods: Standardized hospital discharge data from the German Federal Statistical Office were used to evaluate epidemiological and clinical trends as well as the in-hospital mortality of CCA in Germany between 2010 and 2019. Results: A total of 154,515 hospitalized CCA cases were included into the analyses. The number of cases significantly increased over time (p < 0.001), with intrahepatic CCA (62.5%) being the most prevalent tumor localization. Overall, in-hospital mortality was 11.4% and remained unchanged over time. In-hospital mortality was significantly associated with patients’ age and tumor localization. The presence of clinical complications such as (sub)acute liver failure, acute respiratory distress syndrome (ARDS), or acute renal failure significantly increased in-hospital mortality up to 77.6%. In-hospital mortality was significantly lower among patients treated at high annual case volume centers. Finally, treatment strategies for CCA significantly changed over time and showed decisive differences with respect to the hospitals’ annual case volume. Conclusions: Our data provide a systematic overview on hospitalized CCA patients in Germany. We identified relevant clinical and epidemiological risk factors associated with an increased in-hospital mortality that could help to further improve framework conditions for the management of CCA patients in the future.
Background The prognosis of patients with advanced biliary tract cancer (BTC) who have progressed on gemcitabine plus cisplatin is dismal. Trifluridine/tipiracil (FTD/TPI) and irinotecan have proven efficacy in different gastrointestinal malignancies. We therefore hypothesized that this combination might improve the therapeutic outcome in patients with BTC after failure of first line treatment. Methods TRITICC is an interventional, prospective, open-label, non-randomised, exploratory, multicentre, single-arm phase IIA clinical trial done in 6 sites with expertise in managing biliary tract cancer across Germany. A total of 28 adult patients (aged ≥ 18 years) with histologically verified locally advanced or metastatic biliary tract cancer (including cholangiocarcinoma and gallbladder or ampullary carcinoma) with documented radiological disease progression to first-line gemcitabine based chemotherapy will be included to receive a combination of FTD/TPI plus irinotecan according to previously published protocols. Study treatment will be continued until disease progression according to RECIST 1.1 criteria or occurrence of unacceptable toxicity. The effect of FTD/TPI plus irinotecan on progression-free survival will be analyzed as primary endpoint. Safety (according to NCI-CTCAE), response rates and overall survival are secondary endpoints. In addition, a comprehensive translational research program is part of the study and might provide findings about predictive markers with regard to response, survival periods and resistance to treatment. Discussion The aim of TRITICC is to evaluate the safety and efficacy of FTD/TPI plus irinotecan in patients with biliary tract cancer refractory to previous Gemcitabine based treatment. Trial registration EudraCT 2018–002936-26; NCT04059562
TPS4176 Background: Biliary tract cancers (BTC) currently account for ̃15% of all primary liver cancers and ̃3% of gastrointestinal malignancies. Gemcitabine/Cisplatin has been the standard of care in the first-line therapy of BTC for a decade. Despite recently some survival benefit has been shown in adding a checkpoint inhibitor, further lines of treatment are only poorly defined. In the ABC-06 phase-3 study, second-line FOLFOX demonstrated a moderate but significant improvement of survival and might be regarded as a standard of care. The combination of liposomal Irinotecan and 5-FU infusion pump also improved survival after first line therapy. Both mentioned second-line regimens are based on limited evidence and questionable generalizability. Thus, there is a high need for novel treatment concepts in patients without targetable genetic alterations. Trifluridine/tipiracil (FTD/TPI) is a orally active, antimetabolite agent comprised of trifluridine, a thymidine-based nucleoside analogue, and tipiracil, a potent thymidine phosphorylase inhibitor. Recent reports provided evidence of an antitumor activity of FTD/TPI plus Irinotecan as well in patients with BTC. Therefore, the TRITICC trial was designed to evaluate the safety and efficacy of FTD/TPI plus irinotecan in patients with BTC refractory to previous Gemcitabine based treatment. Methods: TRITICC (NCT04059562) is an interventional, prospective, open-label, non-randomized, exploratory, multicenter, single-arm phase IIA clinical trial that evaluates the safety and efficacy of FTD/TPI (25 mg/m² body surface area (BSA), BID, orally on days 1-5 followed by a 9-days recovery period from day 6 trough day 14 of each 14-days treatment cycle) plus irinotecan (on day 1 of each cycle at a dose of 180 mg/m2) in adult patients with histologically verified locally advanced or metastatic BTC (including cholangiocarcinoma and gallbladder or ampullary carcinoma) with documented radiological disease progression to first-line gemcitabine based chemotherapy. A total of 28 patients is planned to be enrolled in 6 sites across Germany. Study treatment will be continued until disease progression according to RECIST 1.1 criteria or occurrence of unacceptable toxicity. The effect of FTD/TPI plus irinotecan on progression-free survival will be analyzed as primary endpoint. Safety (according to NCI-CTCAE), response rates and overall survival are secondary endpoints. In addition, a comprehensive translational research program is part of the study and might provide findings about predictive markers with regard to response, survival periods and resistance to treatment. Currently, 3 out of the planned 6 German study sites are opened for recruitment and 6 patients have been enrolled. The primary study endpoint is estimated to be evaluated in 2023. Clinical trial information: NCT04059562.
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