培美替尼效果好吗

In an ongoing multicenter, single-arm, phase II study (NCT04256980), adult patients with locally advanced or metastatic cholangiocarcinoma with centrally confirmed FGFR2 fusions or rearrangements and who have received ≥1 prior systemic therapy receive 13.5 mg of oral pemetinib once daily (3-week cycles; 2 weeks on, 1 week off) until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was objective response rate (ORR) as assessed by an independent radiology review committee.

Results: A total of 31 patients were enrolled. The median follow-up time was 5.1 months. Among the 30 patients with FGFR2 fusion or rearrangement evaluated for efficacy, 15 patients achieved partial response (ORR, 50.0%); 15 patients had stable disease, and the disease control rate was 100%. The median time to response was 1.4 months, the median duration of response was not reached, and the median progression-free survival was 6.3 months.

Eight of 31 patients (25.8%) experienced grade ≥3 treatment flares. Hyperphosphatemia, hypophosphatemia, nail toxicity, and eye disease were mostly

Conclusions: Encouraging antitumor activity and favorable safety profile support the use of pemetinib in previously treated Chinese patients with cholangiocarcinoma and FGFR2 rearrangements.

A post hoc analysis evaluated progression-free survival (PFS) in patients who had received first- or second-line systemic therapy for advanced/metastatic CCA (cholangiocarcinoma) prior to enrollment in the FIGHT-202 phase II study (NCT02924376).

PATIENTS AND METHODS: Patients with locally advanced or metastatic CCA with FGFR2 fusions/rearrangements (n=107), other FGF/FGFR alterations (n=20) or no FGF/FFFR alterations (n=18), and documented disease progression after at least one systemic cancer treatment prior to enrollment in FIGHT-202 were evaluated. Previous treatment and disease response data were collated from electronic case report forms. PFS was calculated for each row before systemic cancer treatment.

Results: Among patients with FGFR2 fusion/rearrangement, other FGF/FGFR changes, and no FGF/FGFR-changes, the median PFS of previous first-line systemic therapy were 5.5 months, 4.4 months, and 2.8 months, respectively; the median PFS of previous second-line systemic therapy were 4.2 months, 3.0 months, and 5.9 months. Median PFS for patients with FGFR2 fusions/rearrangements (n=65) who received second-line therapy during the FIGHT-202 trial was 7.0 months.

Conclusions: Among patients with CCA and FGFR2 fusions or rearrangements, second-line treatment with pemetinib may be associated with longer PFS compared with second-line treatment with systemic therapy received prior to study entry.

Pemetinib has a significant therapeutic effect on patients with cholangiocarcinoma. It can prolong the patient's survival period and improve the patient's quality of life. It is recommended that patients follow the doctor's instructions and take the medication and treat symptoms accordingly.

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References

[1.]shi GM, Huang Zhou J. Pemigatinib in previously treated Chinese patients with locally advanced or metastatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements: A phase II study. Cancer Med. 2023 Feb;12(4):4137-4146. doi: 10.1002/cam4.5273. Epub 2022 Sep 20. PMID: 36127767; PMCID: PMC9972033.

[2.]Bibeau K, Féliz L, Lihou CF, Ren H, Abou-Alfa GK. Progression-Free Survival in Patients With Cholangiocarcinoma With or Without FGF/FGFR Alterations: A FIGHT-202 Post Hoc Analysis of Prior Systemic Therapy Response. JCO Precis Oncol. 2022 Apr;6:e2100414. doi: 10.1200/PO.21.00414. PMID: 35544727; PMCID: PMC9200396.