<p>Efficacy and Safety of Apatinib Treatment for Patients with Advanced Intrahepatic Cholangiocarcinoma</p>

Abstract

Purpose Effective treatment options for intrahepatic cholangiocarcinoma (ICC) are limited. This study was intended to explore the efficacy and safety of apatinib in advanced ICC with lymph node metastasis or distant metastasis. Patients and Methods The efficacy and toxicity of apatinib were evaluated in patients with ICC between November 2017 and March 2020 at the Second Affiliated Hospital of Anhui Medical University. Survival analysis was estimated using Kaplan–Meier method. Results Ten patients with advanced ICC were enrolled. The median progression-free survival (PFS) was 3.0 months (95% CI: 1.450–4.550). No patient achieved a complete response (CR). One patient gained partial response (PR), and 6 patients had stable disease (SD). The objective response rate (ORR) was 10%, and the disease control rate (DCR) was 70%. The common treatment-related adverse events were hypertension (20%), proteinuria (30%), hand and foot syndrome (10%) or emesis (10%). No grade 3/4 toxicities occurred. Toxicities were mild and tolerable. Conclusion Apatinib is potentially an effective treatment option with tolerable toxicities for patients with advanced ICC.

Efficacy and Safety of Apatinib Treatment for Advanced Cholangiocarcinoma After Failed Gemcitabine-Based Chemotherapy: An Open-Label Phase II Prospective Study

“…Additionally, fewer AEs occurred in another study assessing apatinib for advanced cholangiocarcinoma, but similar findings have also been obtained for curative effect (rate of DCR 62.5% and the median PFS 95 days observed in our cohort versus the DCR rate 70.0% and the median PFS 3.0 months in that study). The difference in result might be explained by the fact that the dosage (250 mg/day) in that study was lower than in our study (500 mg/day), which may have affected the treatment response ( 39 ). Thus far, there has been no more robust evidence for the effect of the dose of apatinib set at 500 mg per day for the treatment of cholangiocarcinoma.…”

“…A prospective open-label phase II study (NCT03251443) indicated that apatinib as non-first-line therapy has promising anti-tumor activity, with ORR 11.5%, DCR 50.0%, and median PFS 2.0 months, for the pretreated advanced biliary tract cancers ( 35 ). Likewise, in another study of second-line apatinib monotherapy, ORR was 10.0% ( 36 ).…”