Show simple item record

 
dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorPark, Keunchil
dc.contributor.authorJӓnne, Pasi A.
dc.contributor.authorKim, Dong-Wan
dc.contributor.authorHan, Ji-Youn
dc.contributor.authorWu, Ming-Fang
dc.contributor.authorLee, Jong-Seok
dc.contributor.authorFelip Font, Enriqueta
dc.date.accessioned2021-06-21T12:00:52Z
dc.date.available2021-06-21T12:00:52Z
dc.date.copyright2020
dc.date.issued2021-05-01
dc.identifier.citationPark K, Jӓnne PA, Kim D, Han J, Wu M, Lee J, et al. Olmutinib in T790M‐positive non–small cell lung cancer after failure of first‐line epidermal growth factor receptor‐tyrosine kinase inhibitor therapy: A global, phase 2 study. Cancer. 2021 May 1;127(9):1407-1416.
dc.identifier.issn1097-0142
dc.identifier.urihttp://hdl.handle.net/11351/6087
dc.descriptionEpidermal growth factor receptor; Non-small cell lung cancer; Tyrosine kinase inhibitor
dc.description.abstractBackground In this open-label, international phase 2 study, the authors assessed the efficacy and safety of olmutinib in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who had a confirmed T790M mutation and disease progression on previous epidermal growth factor receptor-tyrosine kinase inhibitor therapy. Methods Patients aged ≥20 years received once-daily oral olmutinib 800 mg continuously in 21-day cycles. The primary endpoint was the objective response rate (patients who had a confirmed best overall response of a complete or partial response), assessed by central review. Secondary endpoints included the disease control rate, the duration of objective response, progression-free survival, and overall survival. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03). Results Overall, 162 patients (median age, 63 years; women, >60%) were enrolled from 68 sites in 9 countries. At the time of database cutoff, 23.5% of enrolled patients remained on treatment. The median treatment duration was 6.5 months (range, 0.03-21.68 months). Overall, 46.3% of patients (95% CI, 38.4%-54.3%) had a confirmed objective response (all partial responses). The best overall response (the objective response rate regardless of confirmation) was 51.9% (84 patients; 95% CI, 43.9%-59.8%). The confirmed disease control rate for all patients was 86.4% (95% CI, 80.2%-91.3%). The median duration of objective response was 12.7 months (95% CI, 8.3-15.4 months). Estimated median progression-free survival was 9.4 months (95% CI, 6.9-12.3 months), and estimated median overall survival was 19.7 months (95% CI, 15.1 months to not reached). All patients experienced treatment-emergent adverse events, and 71.6% of patients had grade ≥3 treatment-emergent adverse events. Conclusions Olmutinib has meaningful clinical activity and a manageable safety profile in patients with T790M-positive non–small cell lung cancer who received previous epidermal growth factor receptor-tyrosine kinase inhibitor therapy.
dc.language.isoeng
dc.publisherWiley
dc.relation.ispartofseriesCancer;127(9)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectPulmons - Càncer - Tractament
dc.subjectMedicaments antineoplàstics
dc.subjectPrognosi
dc.subject.meshCarcinoma, Non-Small-Cell Lung
dc.subject.meshAntineoplastic Agents
dc.subject.meshProgression-Free Survival
dc.titleOlmutinib in T790M-positive non–small cell lung cancer after failure of first-line epidermal growth factor receptor-tyrosine kinase inhibitor therapy: A global, phase 2 study
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1002/cncr.33385
dc.subject.decscarcinoma de pulmón de células no pequeñas
dc.subject.decsantineoplásicos
dc.subject.decssupervivencia libre de progresión
dc.relation.publishversionhttps://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.33385
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Park K] Division of Hematology/Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. [Jӓnne PA] Lowe Center for Thoracic Oncology, The Belfer Institute for Applied Cancer Science, Dana-Farber Cancer Institute, Boston, Massachusetts. [Kim DW] Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea. [Han JY] National Cancer Center, Goyang, Republic of Korea. [Wu MF] Chung Shan Medical University Hospital, Taichung, Taiwan. [Lee JS] Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. [Felip E] Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
dc.identifier.pmid33434335
dc.identifier.wos000606964500001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record