Abstract
Prognosis of patients with advanced extrahepatic cholangiocarcinoma (eCCA) is poor. The current standard first-line treatment is systemic chemotherapy (CT) with gemcitabine and a platinum derivate. Additionally, endobiliary radiofrequency ablation (eRFA) can be applied to treat biliary obstructions. This study aimed to evaluate the additional benefit of scheduled regular eRFA in a real-life patient cohort with advanced extrahepatic cholangiocarcinoma under standard systemic CT. All patients with irresectable eCCA treated at University Hospital Bonn between 2010 and 2020 were eligible for inclusion. Patients were stratified according to treatment: standard CT (n = 26) vs. combination of eRFA with standard CT (n = 40). Overall survival (OS), progression free survival (PFS), feasibility and toxicity were retrospectively analyzed using univariate and multivariate approaches. Combined eRFA and CT resulted in significantly longer median OS (17.3 vs. 8.6 months, p = 0.004) and PFS (12.9 vs. 5.7 months, p = 0.045) compared to the CT only group. While groups did not differ regarding age, sex, tumor stage and chemotherapy treatment regimen, mean MELD was even higher (10.1 vs. 6.7, p = 0.015) in the eRFA + CT group. The survival benefit of concomitant eRFA was more evident in the subgroup with locally advanced tumors. Severe hematological toxicities (CTCAE grades 3 – 5) did not differ significantly between the groups. However, therapy-related cholangitis occurred more often in the combined treatment group (p = 0.031). Combination of eRFA and systemic CT was feasible, well-tolerated and could significantly prolong survival compared to standard CT alone. Thus, eRFA should be considered during therapeutic decision making in advanced eCCA.
Highlights
Prognosis of patients with advanced extrahepatic cholangiocarcinoma is poor
Despite the suggested survival benefits in the randomized phase III BILCAP trial by adjuvant administration of capecitabine for resected intrahepatic cholangiocarcinoma, high rates of disease recurrence are still contributing to a poor overall prognosis[5,6,7].The pivotal phase III ABC-02 trial established the current palliative systemic first-line chemotherapy (CT) standard with gemcitabine and cisplatin[8]
In 2021, pemigatinib, the first targeted therapy for patients with unresectable cholangiocarcinoma previously treated with fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement has been approved based on the results of the phase II FIGHT-202 t rial[10]
Summary
The current standard first-line treatment is systemic chemotherapy (CT) with gemcitabine and a platinum derivate. This study aimed to evaluate the additional benefit of scheduled regular eRFA in a real-life patient cohort with advanced extrahepatic cholangiocarcinoma under standard systemic CT. Despite the suggested survival benefits in the randomized phase III BILCAP trial by adjuvant administration of capecitabine for resected intrahepatic cholangiocarcinoma, high rates of disease recurrence are still contributing to a poor overall prognosis[5,6,7].The pivotal phase III ABC-02 trial established the current palliative systemic first-line chemotherapy (CT) standard with gemcitabine and cisplatin[8]. The aim of this study was to evaluate the benefit of concomitant eRFA in combination with systemic CT compared to CT alone in a real-life cohort of patients with advanced eCCA
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