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A Phase 1 study of gefitinib combined with durvalumab in EGFR TKI-naive patients withEGFRmutation-positive locally advanced/metastatic non-small-cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | Creelan, Benjamin C. | - |
dc.contributor.author | Yeh, Tammie C. | - |
dc.contributor.author | Kim, Sang-We | - |
dc.contributor.author | Nogami, Naoyuki | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Chow, Laura Q. M. | - |
dc.contributor.author | Kanda, Shintaro | - |
dc.contributor.author | Taylor, Rosemary | - |
dc.contributor.author | Tang, Weifeng | - |
dc.contributor.author | Tang, Mei | - |
dc.contributor.author | Angell, Helen K. | - |
dc.contributor.author | Roudier, Martine P. | - |
dc.contributor.author | Marotti, Marcelo | - |
dc.contributor.author | Gibbons, Don L. | - |
dc.date.accessioned | 2022-04-20T10:27:51Z | - |
dc.date.available | 2022-04-20T10:27:51Z | - |
dc.date.created | 2021-02-02 | - |
dc.date.created | 2021-02-02 | - |
dc.date.created | 2021-02-02 | - |
dc.date.issued | 2021-01-19 | - |
dc.identifier.citation | British Journal of Cancer, Vol.124 No.2, pp.383-390 | - |
dc.identifier.issn | 0007-0920 | - |
dc.identifier.other | 122024 | - |
dc.identifier.uri | https://hdl.handle.net/10371/179091 | - |
dc.description.abstract | Background EGFR tyrosine kinase inhibitors (TKIs) induce cytolysis and release of tumour proteins, which can stimulate antigen-specific T cells. The safety and efficacy of durvalumab and gefitinib in combination for TKI-naive patients with advancedEGFRm NSCLC was evaluated. Methods This Phase 1 open-label, multicentre trial (NCT02088112) was conducted in 56 patients with NSCLC. Dose expansion permitted TKI-naive patients, primarily with activating L858R or Ex19delEGFRm. Arms 1 + 1a received concurrent therapy; Arm 2 received 4 weeks of gefitinib induction followed by concurrent therapy. Results From dose escalation, the recommended dose of durvalumab was 10 mg/kg Q2W with 250 mg QD gefitinib. Pharmacokinetics were as expected, consistent with inhibition of soluble PD-L1 and no treatment-emergent immunogenicity. In dose expansion, 35% of patients had elevated liver enzymes leading to drug discontinuation. In Arms 1 + 1a, objective response rate was 63.3% (95% CI: 43.9-80.1), median progression-free survival (PFS) was 10.1 months (95% CI: 5.5-15.2) and median response duration was 9.2 months (95% CI: 3.7-14.0). Conclusions Durvalumab and gefitinib in combination had higher toxicity than either agent alone. No significant increase in PFS was detected compared with historical controls. Therefore, concurrent PD-L1 inhibitors with gefitinib should be generally avoided in TKI-naive patients withEGFRm NSCLC. | - |
dc.language | 영어 | - |
dc.publisher | Nature Publishing Group | - |
dc.title | A Phase 1 study of gefitinib combined with durvalumab in EGFR TKI-naive patients withEGFRmutation-positive locally advanced/metastatic non-small-cell lung cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1038/s41416-020-01099-7 | - |
dc.citation.journaltitle | British Journal of Cancer | - |
dc.identifier.wosid | 000575032800002 | - |
dc.identifier.scopusid | 2-s2.0-85092048603 | - |
dc.citation.endpage | 390 | - |
dc.citation.number | 2 | - |
dc.citation.startpage | 383 | - |
dc.citation.volume | 124 | - |
dc.identifier.sci | 000575032800002 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | EXPRESSION | - |
dc.subject.keywordPlus | OSIMERTINIB | - |
dc.subject.keywordPlus | ASSOCIATION | - |
dc.subject.keywordPlus | INHIBITORS | - |
dc.subject.keywordPlus | DOCETAXEL | - |
dc.subject.keywordPlus | NIVOLUMAB | - |
dc.subject.keywordPlus | AFATINIB | - |
dc.subject.keywordPlus | THERAPY | - |
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