福巴替尼片治疗胆管癌效果怎么样

Forbatinib selectively and irreversibly binds to the ATP-binding pocket of FGFR1-4, resulting in inhibition of FGFR-mediated signal transduction pathways, reduction in tumor cell proliferation, and increase in tumor cell death. Forbatinib is an investigational, oral, potent, selective, irreversible small molecule inhibitor of FGFR1, 2, 3, and 4.

An ongoing global, open-label, phase II study, FOENIX-CCA2 (NCT02052778), is investigating patients with unresectable locally advanced or metastatic iCCA with FGFR2 fusions or rearrangements.

After 67 patients were followed for at least 6 months, researchers documented an objective response rate (ORR) of 37.3%. One patient (1.5%) achieved complete response (CR), and 24 patients (35.8%) achieved partial response (PR). The median duration of response (DoR) was 8.3 months, with 37% of patients still receiving treatment.

The disease control rate (DCR) was 82.1%; the median treatment time was 2.5 months; the median progression-free survival (PFS) was 7.2 months; at 6 months, the PFS rate was 61% and the overall survival rate (OS) was 86%. At a median follow-up of 17.1 months, the median progression-free survival was 9.0 months and the overall survival was 21.7 months. Treatment of intrahepatic cholangiocarcinoma with FGFR2 fusion/rearrangement is effective and tolerable.

The U.S. FDA's approval of forbatinib for the treatment of cholangiocarcinoma is based on study TAS-101-20, a multicenter, open-label, single-arm trial. Patients received 1 mg orally once daily. The primary efficacy outcome measures were overall response rate (ORR) and duration of response (DoR), as determined by an independent review committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.42. The ORR is 95%. The median DoR (median duration of response) was 7.30 months.

Common symptoms of forbatinib include onychotoxicity, constipation, diarrhea, fatigue, dry eyes, nausea, vomiting, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, joint pain, dysgeusia, musculoskeletal pain, loss of appetite, urinary tract infection, palmar and plantar redness, swelling and dysesthesia syndrome (the palms and soles of the feet).

The above is the content of the therapeutic effect of forbatinib. For more details, you can read the drug instructions. It is recommended to follow the doctor's instructions and treat the disease symptomatically.

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References

Gandhy SU, Casak SJ, Mushti SL, Cheng J, Subramaniam S, Zhao H, Zhao M, Bi Y, Liu G, Fan J, Adeniyi O, Charlab R, Kufrin D, Thompson MD, Jarrell K, Auth D, Lemery SJ, Pazdur R, Kluetz PG, Fashoyin-Aje LA. FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements. Clin Cancer Res. 2023 Jun 8:CCR-23-1042. doi: 10.1158/1078-0432.CCR-23-1042. Epub ahead of print. PMID: 37289037.