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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorYamamoto, Nobuyuki
dc.contributor.authorHayashi, Hidetoshi
dc.contributor.authorPlanchard, David
dc.contributor.authorMorán, Teresa
dc.contributor.authorGregorc, Vanesa
dc.contributor.authorDowell, Jonathan
dc.contributor.authorCedres Perez, Susana
dc.date.accessioned2021-10-28T09:28:37Z
dc.date.available2021-10-28T09:28:37Z
dc.date.issued2020-10
dc.identifier.citationYamamoto N, Hayashi H, Planchard D, Morán T, Gregorc V, Dowell J, et al. A randomized, phase 2 study of deoxyuridine triphosphatase inhibitor, TAS-114, in combination with S-1 versus S-1 alone in patients with advanced non-small-cell lung cancer. Invest New Drugs. 2020 Oct;38:1588–1597.
dc.identifier.issn1573-0646
dc.identifier.urihttp://hdl.handle.net/11351/6478
dc.description5-fluorouracil; Non-small-cell lung cancer; Progression-free survival
dc.description.abstractIntroduction TAS-114 is a potent inhibitor of deoxyuridine triphosphatase, which is a gatekeeper protein preventing uracil and 5-fluorouracil (5-FU) misincorporation into DNA. TAS-114 has been suggested to enhance the antitumor activity of 5-FU. This randomized, phase 2 study investigated TAS-114 plus S-1 (TAS-114/S-1) vs. S-1 in non-small-cell lung cancer (NSCLC) patients. Methods Patients with advanced NSCLC, previously treated with ≥ 2 regimens, were randomized 1:1 to receive TAS-114 (400 mg)/S-1 (30 mg/m2) or S-1 (30 mg/m2). Progression-free survival (PFS, independent central review) was the primary endpoint. Secondary endpoints included disease control rate (DCR), overall survival (OS), overall response rate (ORR), and safety. Results In total, 127 patients received treatment. Median PFS was 3.65 and 4.17 months in the TAS-114/S-1 and S-1 groups, respectively (hazard ratio [HR] 1.16, 95% confidence interval [CI] 0.71–1.88; P = 0.2744). DCR was similar between groups (TAS-114/S-1 80.3%, S-1 75.9%) and median OS was 7.92 and 9.82 months for the TAS-114/S-1 and S-1 groups, respectively (HR 1.31, 95% CI 0.80–2.14; P = 0.1431). The ORR was higher in the TAS-114/S-1 group than the S-1 group (19.7% vs. 10.3%), and more patients with tumor shrinkage were observed in the TAS-114/S-1 group. Incidence rates of anemia, skin toxicities, and Grade ≥ 3 treatment-related adverse events were higher in the TAS-114/S-1 group compared with the monotherapy group. Conclusions Although the TAS-114/S-1 combination improved the response rate, this did not translate into improvements in PFS. Clinical Trial Registration No. NCT02855125 (ClinicalTrials.gov) registered on 4 August 2016.
dc.language.isoeng
dc.publisherSpringer
dc.relation.ispartofseriesInvestigational New Drugs;38
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectPulmons - Càncer - Quimioteràpia
dc.subject.meshCarcinoma, Non-Small-Cell Lung
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.mesh/therapeutic use
dc.titleA randomized, phase 2 study of deoxyuridine triphosphatase inhibitor, TAS-114, in combination with S-1 versus S-1 alone in patients with advanced non-small-cell lung cancer
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1007/s10637-020-00930-5
dc.subject.decscarcinoma de pulmón de células no pequeñas
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.subject.decs/uso terapéutico
dc.relation.publishversionhttps://doi.org/10.1007/s10637-020-00930-5
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Yamamoto N] Third Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Wakayama Prefecture 641- 8509, Japan. [Hayashi H] Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan. [Planchard D] Department of Medical Oncology, Thoracic Group, Institut Gustave Roussy, 114 rue Édouard- Vaillant, Villejuif Cedex 94805, France. [Morán T] Medical Oncology, Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Bellaterra, Spain. B-ARGO, Carretera de Canyet s/n, Badalona, Barcelona 08916, Spain. [Gregorc V] Department of Oncology, Division of Experimental Medicine, IRCCS Ospedale San Raffaele, Via Olgettina, 60, Milano 20132, Italy. [Dowell J] Department of Internal Medicine, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA. [Cedres S] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
dc.identifier.pmid32246224
dc.identifier.wos000523083000001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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