Cited 4 times in
A phase 1b/2 study of PF-06747775 as monotherapy or in combination with Palbociclib in patients with epidermal growth factor receptor mutant advanced non-small cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2022-12-22T02:41:15Z | - |
dc.date.available | 2022-12-22T02:41:15Z | - |
dc.date.issued | 2022-07 | - |
dc.identifier.issn | 1354-3784 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/191659 | - |
dc.description.abstract | Introduction: This Phase 1/2 study (NCT02349633) explored the safety and antitumor activity of PF-06747775 (oral, third-generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor) in patients with advanced non-small cell lung cancer after progression on an EGFR inhibitor. Methods: Phase 1 was a dose-escalation study of PF-06747775 monotherapy (starting dose: 25 mg once daily [QD]). Phase 1b/2 evaluated PF-06747775 monotherapy at recommended Phase 2 dose (RP2D; Cohort 1); PF-06747775 200 mg QD plus palbociclib (starting dose: 100 mg QD orally; Cohort 2A); and PF-06747775 monotherapy at RP2D in a Japanese lead-in cohort. Results: Sixty-five patients were treated. Median treatment duration was 40.1 weeks. Monotherapy maximum tolerated dose was not determined. Two patients in Cohort 2A had dose-limiting toxicities. The monotherapy RP2D was estimated to be 200 mg QD. Most frequently reported adverse events (AEs) were diarrhea (69.2%), paronychia (69.2%), and rash (60.0%). Most AEs were grades 1-3. Overall, objective response rate (90% confidence interval [CI]) was 41.5% (31.2-52.5%). Median (range) duration of response was 11.09 (2.70-34.57) months. Median progression-free survival (90% CI) was 8.1 (5.4-23.3) months. Conclusions: PF-06747775 had a manageable safety profile and the study design highlights important considerations for future anti-EGFR agent development. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Taylor & Francis | - |
dc.relation.isPartOf | EXPERT OPINION ON INVESTIGATIONAL DRUGS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / drug therapy | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / genetics | - |
dc.subject.MESH | ErbB Receptors / genetics | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Lung Neoplasms* / genetics | - |
dc.subject.MESH | Piperazines / therapeutic use | - |
dc.subject.MESH | Protein Kinase Inhibitors / adverse effects | - |
dc.subject.MESH | Pyridines | - |
dc.title | A phase 1b/2 study of PF-06747775 as monotherapy or in combination with Palbociclib in patients with epidermal growth factor receptor mutant advanced non-small cell lung cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Sarah B Goldberg | - |
dc.contributor.googleauthor | Dong-Wan Kim | - |
dc.contributor.googleauthor | Mark A Socinski | - |
dc.contributor.googleauthor | Timothy F Burns | - |
dc.contributor.googleauthor | Zarnie Lwin | - |
dc.contributor.googleauthor | Nuzhat Pathan | - |
dc.contributor.googleauthor | Wei Dong Ma | - |
dc.contributor.googleauthor | Joanna C Masters | - |
dc.contributor.googleauthor | Nandini Cossons | - |
dc.contributor.googleauthor | Keith Wilner | - |
dc.contributor.googleauthor | Makoto Nishio | - |
dc.contributor.googleauthor | Hatim Husain | - |
dc.identifier.doi | 10.1080/13543784.2022.2075341 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J04348 | - |
dc.identifier.eissn | 1744-7658 | - |
dc.identifier.pmid | 35657653 | - |
dc.identifier.url | https://www.tandfonline.com/doi/full/10.1080/13543784.2022.2075341 | - |
dc.subject.keyword | (5-8): advanced non-small cell lung cancer | - |
dc.subject.keyword | PF-06747775 | - |
dc.subject.keyword | epidermal growth factor receptor | - |
dc.subject.keyword | phase 1/2 study | - |
dc.subject.keyword | tyrosine kinase inhibitor | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 31 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 747 | - |
dc.citation.endPage | 757 | - |
dc.identifier.bibliographicCitation | EXPERT OPINION ON INVESTIGATIONAL DRUGS, Vol.31(7) : 747-757, 2022-07 | - |
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