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    Lenvatinib in patients with advanced grade 1/2 pancreatic and gastrointestinal neuroendocrine tumors: results of the Phase II TALENT Trial (GETNE1509)

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    Authors
    Capdevila, J.
    Fazio, N.
    Lopez, C.
    Teulé, A.
    Valle, Juan W
    Tafuto, S.
    Custodio, A.
    Reed, N.
    Raderer, M.
    Grande, E.
    Garcia-Carbonero, R.
    Jimenez-Fonseca, P.
    Hernando, J.
    Bongiovanni, A.
    Spada, F.
    Alonso, V.
    Antonuzzo, L.
    Spallanzani, A.
    Berruti, A.
    La Casta, A.
    Sevilla, I.
    Kump, P.
    Giuffrida, D.
    Merino, X.
    Trejo, L.
    Gajate, P.
    Matos, I.
    Lamarca, Angela
    Ibrahim, T.
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    Affiliation
    Vall Hebron University Hospital and Vall Hebron Institute of Oncology (VHIO), Barcelona, Spain
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Purpose: Approved systemic therapies for advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) have shown limited capacity to reduce tumor burden and no antitumor activity after progression to targeted agents (TAs). We investigated the efficacy and safety of lenvatinib in patients with previously treated advanced GEP-NETs. Patients and methods: This was a multicenter, single-arm, open-label, phase II trial with two parallel cohorts (ClinicalTrials.gov identifier: NCT02678780) involving 21 institutions in 4 European countries. Eligible patients had histologically confirmed advanced grade 1-2 pancreatic (panNET) or GI (GI-NET) NETs with documented tumor progression after treatment with a TA (panNET) or somatostatin analogs (GI-NET). Patients were treated with lenvatinib 24 mg once daily until disease progression or treatment intolerance. The primary end point was overall response rate by central radiology review. Secondary end points included progression-free survival, overall survival, duration of response, and safety. Results: Between September 2015 and March 2017, a total of 111 patients were enrolled, with 55 (panNET) and 56 (GI-NET) patients in each cohort. The median follow-up was 23 months. The overall response rate was 29.9% (95% CI, 21.6 to 39.6): 44.2% (panNET) and 16.4% (GI-NET). The median (range) duration of response was 19.9 (8.4-30.8) and 33.9 (10.6-38.3) months in the panNET and GI-NET groups, respectively. The median progression-free survival was 15.7 months (95% CI, 14.1 to 19.5). The most common adverse events were fatigue, hypertension, and diarrhea; 93.7% of patients required dose reductions or interruptions. Conclusion: We report the highest centrally confirmed response reported to date with a multikinase inhibitor in advanced GEP-NETs, with a particularly strong response in the panNET cohort. This study provides novel evidence for the efficacy of lenvatinib in patients with disease progression following treatment with other TAs, suggesting the potential value of lenvatinib in the treatment of advanced GEP-NETs.
    Citation
    Capdevila J, Fazio N, Lopez C, Teulé A, Valle JW, Tafuto S, et al. Lenvatinib in Patients With Advanced Grade 1/2 Pancreatic and Gastrointestinal Neuroendocrine Tumors: Results of the Phase II TALENT Trial (GETNE1509). JCO. 2021 May 4;JCO.20.03368
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/624028
    DOI
    10.1200/jco.20.03368
    PubMed ID
    33945297
    Additional Links
    https://dx.doi.org/10.1200/jco.20.03368
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1200/jco.20.03368
    Scopus Count
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