Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results.

BMC Cancer
Makoto UenoChigusa Morizane

Abstract

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. 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. 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...Continue Reading

References

Nov 20, 2003·European Journal of Surgical Oncology : the Journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology·A GiatromanolakiE Sivridis
Dec 20, 2011·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Jun Ho YiHo Yeong Lim
Jun 27, 2012·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Sirintip BoonjaraspinyoNarong Khuntikeo
Feb 26, 2014·Biochemical and Biophysical Research Communications·Yun-Fei XuYu-Xin Chen
Feb 12, 2015·The New England Journal of Medicine·Martin SchlumbergerSteven I Sherman
May 21, 2015·Cancer Research and Treatment : Official Journal of Korean Cancer Association·Joon Oh ParkHo Yeong Lim
Oct 27, 2015·BMC Cancer·Georgi AtanasovSven Jonas
Nov 11, 2016·Chinese Clinical Oncology·Lorena Marcano-BonillaLewis R Roberts
Apr 25, 2019·Cancer Management and Research·Noor-Ul-Ain TariqJuan W Valle
Oct 1, 2019·Annals of Oncology : Official Journal of the European Society for Medical Oncology·C MorizaneUNKNOWN members of the Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG)
Jan 29, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·C MorizaneUNKNOWN members of the Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG)
May 13, 2020·International Journal of Hyperthermia : the Official Journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group·Giovanni BrandiCarla Serra
Jun 4, 2020·Anticancer Research·Alessandro RizzoGiovanni Brandi

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Citations

Feb 22, 2021·Cancer Treatment and Research Communications·Alessandro RizzoGiovanni Brandi
Apr 1, 2021·Expert Review of Gastroenterology & Hepatology·Alessandro RizzoGiovanni Brandi
May 11, 2021·Expert Opinion on Investigational Drugs·Stefania De LorenzoFrancesco Tovoli
Jun 3, 2021·Journal of Clinical Medicine·Sudha KodaliRafik M Ghobrial
Oct 10, 2021·The Lancet. Gastroenterology & Hepatology·Audrey E KamRachna T Shroff

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