福巴替尼治疗胆管癌的疗效分析

Introduction: Forbatinib showed an overall response rate (ORR) of 42% in patients with previously treated locally advanced or metastatic cholangiocarcinoma, and the patient's median duration of response (mDoR) was close to 10 months, showing a good therapeutic effect. Forbatinib, an FGFR inhibitor, has shown good efficacy and tolerability in the treatment of cholangiocarcinoma patients carrying specific FGFR2 gene mutations.

Indications

It is a highly selective, irreversible, oral FGFR inhibitor. FGFR contains a group of receptor tyrosine kinases that play a key role in cell proliferation, differentiation, migration and survival. It has an inhibitory effect on FGFR1-4, and has shown significant efficacy in the treatment of cholangiocarcinoma carrying FGFR2 gene fusions or other rearrangements.

Efficacy data analysis

In a key phase II clinical trial FOENIX-CCA2, forbatinib showed an objective effective rate of 42% in the treatment of FGFR2 fusion/rearranged intrahepatic cholangiocarcinoma (iCCA), with a median efficacy maintenance time of 9.7 months, a median disease progression-free time of 9 months, and a median overall survival time of 21 months. In a non-prespecified follow-up analysis performed 8 months after the primary analysis, the overall study population had an ORR of 41.7%, a DCR of 82.5%, a median DoR of 9.5 months, a median PFS of 8.9 months, and a median OS of 20 months.

Medication Guide

Forbatinib is an oral tablet with a recommended dose of 20 mg (five 4 mg tablets), usually taken once daily with food or on an empty stomach. Take it at about the same time every day. Futibatinib should be taken exactly as directed. Do not take more or less than the dose prescribed by your doctor, nor should you take it more often than prescribed by your doctor.

Forbatinib needs to be swallowed whole. Do not split, chew or crush it before taking it. If you vomit after taking forbatinib, do not take another dose and just continue with your regular dosing schedule.

Notes

1. Forbatinib may cause irritation and dry eyes. During treatment, artificial tears or lubricating eye drops should be used to prevent or treat dry eyes. Your doctor will order eye exams before and during your treatment with forbatinib to look for more serious eye problems.

2. Women need to take a pregnancy test before starting treatment and use contraceptive measures to prevent pregnancy during treatment and at least 1 week after the last dose. If male patients, contraceptive measures should be used during treatment and for 1 month after the last dose.

3. If you are breastfeeding, please tell your doctor. Breastfeeding should not be done while taking forbatinib and for 1 week after the last dose.