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Table 1 Results of published case reports and clinical trials for TKI usage in CCA

From: Personalized prescription of tyrosine kinase inhibitors in unresectable metastatic cholangiocarcinoma

Drug Number of patients Dose Duration of treatment Outcome Side effects Refs.
Sorafenib 2 400 mg PO bid 4 months with later switch to oxaliplatin and gemcitabine; 6 month for the time of report Transient disease stabilization; decrease of tumor markers CA 125, CA 19-9, CA 27.29 Maculopapular rash, hair thinning, grade 3 thrombocytopenia (disappeared after 1-week discontinuation), hypertension, facial rush [13]
Sorafenib 1 400 mg PO bid 2 years for the time of report Stable disease with time-to-progression 5.7 month; decrease of tumor marker CA 19-9; decrease of bilirubin level and increase of liver synthesis parameters Mild diarrhea, fatigue and skin toxicity; no dose reduction or interruption were made [12]
Sorafenib 1 400 mg PO bid; 7 days cessation after 1 year and dose reduction to 200 mg 4 years for the time of report Stable disease; decrease of bilirubin level Mild diarrhea, desquamation rush. Grade 1 hand-foot syndrome, mild thrombocytopenia (required 7 days cessation) [11]
Sorafenib 44 400 mg PO bid 1.8-month median duration Median time to progression 5.6 month; median overall survival 5.7 month; disease control rate at 3 months 15.9% Mild diarrhea, fatigue, hand-foot syndrome [14]
Sorafenib 15 400 mg PO bid 3.2-month median duration Median time to progression 3.2 month; median overall survival 5.7 month; disease control rate at 3 months 73.3% Skin rush in 5 patients grade 3 hand-foot syndrome in 1 patient [15]
Sorafenib 31 400 mg PO bid 2-month median duration Disease control rate detected according suggested scheme 0%; median overall survival 9 month; median progression free survival 3 month Grades 3 and 4 toxicities in 20 patients included: thrombosis/embolism, hypertension, fatigue, bilirubin evaluation, hand-foot syndrome [16]
Sorafenib 46 400 mg PO bid From 1 to 12 months Disease control rate at 3 months 32.6%; median overall survival 4.4 month; median progression free survival 2.3 month Hand-foot syndrome, skin rush, diarrhea, fatigue and thrombocytopenia [17]
Pazopanib
Trametinib
25 Pazopanib 800 mg qd
Trametinib 2 mg qd
3-month median duration Median overall survival 6.4 month; disease control rate detected according suggested scheme 75%; median progression free survival 3.6 month Hypertension, fatigue, rash, diarrhea, nausea/vomiting, thrombocytopenia [18]