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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
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2022-11-24T00:44:22Z | - |
dc.date.available | 2022-11-24T00:44:22Z | - |
dc.date.issued | 2021-05 | - |
dc.identifier.issn | 0008-543X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190926 | - |
dc.identifier.uri | https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.33385 | - |
dc.description.abstract | Background: 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.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Wiley | - |
dc.relation.isPartOf | CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Brain Neoplasms / secondary | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung / drug therapy* | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung / genetics | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung / mortality | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung / pathology | - |
dc.subject.MESH | Circulating Tumor DNA | - |
dc.subject.MESH | Confidence Intervals | - |
dc.subject.MESH | Drug Administration Schedule | - |
dc.subject.MESH | ErbB Receptors / antagonists & inhibitors | - |
dc.subject.MESH | ErbB Receptors / genetics* | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms / drug therapy* | - |
dc.subject.MESH | Lung Neoplasms / genetics | - |
dc.subject.MESH | Lung Neoplasms / mortality | - |
dc.subject.MESH | Lung Neoplasms / pathology | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Mutation | - |
dc.subject.MESH | Piperazines / administration & dosage | - |
dc.subject.MESH | Piperazines / adverse effects | - |
dc.subject.MESH | Piperazines / therapeutic use* | - |
dc.subject.MESH | Progression-Free Survival | - |
dc.subject.MESH | Protein Kinase Inhibitors / therapeutic use | - |
dc.subject.MESH | Pyrimidines / administration & dosage | - |
dc.subject.MESH | Pyrimidines / adverse effects | - |
dc.subject.MESH | Pyrimidines / therapeutic use* | - |
dc.subject.MESH | Treatment Failure | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Keunchil Park | - |
dc.contributor.googleauthor | Pasi A Jӓnne | - |
dc.contributor.googleauthor | Dong-Wan Kim | - |
dc.contributor.googleauthor | Ji-Youn Han | - |
dc.contributor.googleauthor | Ming-Fang Wu | - |
dc.contributor.googleauthor | Jong-Seok Lee | - |
dc.contributor.googleauthor | Jin-Hyoung Kang | - |
dc.contributor.googleauthor | Dae Ho Lee | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Chong-Jen Yu | - |
dc.contributor.googleauthor | Yong Kek Pang | - |
dc.contributor.googleauthor | Enriqueta Felip | - |
dc.contributor.googleauthor | Hyunjin Kim | - |
dc.contributor.googleauthor | Eunhye Baek | - |
dc.contributor.googleauthor | Young Su Noh | - |
dc.identifier.doi | 10.1002/cncr.33385 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J00434 | - |
dc.identifier.eissn | 1097-0142 | - |
dc.identifier.pmid | 33434335 | - |
dc.subject.keyword | T790M | - |
dc.subject.keyword | epidermal growth factor receptor | - |
dc.subject.keyword | non-small cell lung cancer | - |
dc.subject.keyword | olmutinib | - |
dc.subject.keyword | tyrosine kinase inhibitor | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 127 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | 1407 | - |
dc.citation.endPage | 1416 | - |
dc.identifier.bibliographicCitation | CANCER, Vol.127(9) : 1407-1416, 2021-05 | - |
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