التفاصيل البيبلوغرافية
| العنوان: |
Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results. |
| المؤلفون: |
Ueno, Makoto, Ikeda, Masafumi, Sasaki, Takashi, Nagashima, Fumio, Mizuno, Nobumasa, Shimizu, Satoshi, Ikezawa, Hiroki, Hayata, Nozomi, Nakajima, Ryo, Morizane, Chigusa |
| المصدر: |
BMC Cancer; 11/16/2020, Vol. 20 Issue 1, pN.PAG-N.PAG, 1p |
| مصطلحات موضوعية: |
BILIARY tract cancer, PLATELET-derived growth factor receptors, GALLBLADDER cancer, FIBROBLAST growth factor receptors, VASCULAR endothelial growth factors, JAPANESE people |
| مستخلص: |
Background: Biliary tract cancer (BTC) has a poor prognosis and lacks a standardized second-line therapy. Vascular endothelial growth factor (VEGF), fibroblast growth factor receptor (FGFR) 4, and platelet-derived growth factor receptor (PDGFR) are highly expressed in BTC. Therefore, lenvatinib (a known inhibitor of VEGF receptors 1-3, FGFRs 1-4, and PDGFR-α) was evaluated for second-line treatment of BTC.Methods: In this single-arm, multicenter, open-label, phase 2 study, patients with BTC received lenvatinib 24 mg orally once daily in 28-day cycles. The primary endpoint was objective response rate (ORR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), PFS rate at 12 weeks, disease control rate, clinical benefit rate, safety and pharmacokinetic profiles.Results: Twenty-six Japanese patients were enrolled and treated; 3 had a confirmed partial response per investigator assessment and per independent imaging review (IIR); ORR was 11.5% (90% confidence interval [CI]: 3.2-27.2). Median PFS was 3.19 months (95% CI: 2.79-7.23) per investigator assessment and 1.64 months (95% CI: 1.41-3.19) per IIR. Median OS was 7.35 months (95% CI: 4.50-11.27). Grade ≥ 3 treatment-emergent adverse events (TEAEs) occurred in 21 patients (80.8%) and included hypertension (n = 10 [38.5%]), proteinuria (n = 3 [11.5%]), palmar-plantar erythrodysesthesia (n = 3 [11.5%]), decreased appetite (n = 3 [11.5%]), and anemia (n = 3 [11.5%]). Two deaths occurred due to TEAEs between treatment initiation and 30 days after last dose, but neither were considered treatment related.Conclusions: Lenvatinib demonstrated antitumor activity in BTC, with a tolerable safety profile, and should be further evaluated as potential second-line therapy for this difficult to treat population.Trial Registration: ClinicalTrials.gov NCT02579616 . Date of registration: October 19, 2015. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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