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Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001
DC Field | Value | Language |
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dc.contributor.author | Shaw, Alice Tsang | - |
dc.contributor.author | Riely, Gregory J. | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Camidge, David Ross | - |
dc.contributor.author | Solomon, Benjamin J. | - |
dc.contributor.author | Varella-Garcia, Marileila | - |
dc.contributor.author | Iafrate, Anthony John | - |
dc.contributor.author | Shapiro, Geoffrey I. | - |
dc.contributor.author | Usari, Tiziana | - |
dc.contributor.author | Wang, S. C. | - |
dc.contributor.author | Wilner, Keith. D. | - |
dc.contributor.author | Clark, Jeffrey W. | - |
dc.contributor.author | Ou, Sai Hong Ignatius | - |
dc.date.accessioned | 2021-01-31T08:06:21Z | - |
dc.date.available | 2021-01-31T08:06:21Z | - |
dc.date.created | 2019-11-25 | - |
dc.date.issued | 2019-07 | - |
dc.identifier.citation | Annals of Oncology, Vol.30 No.7, pp.1121-1126 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.other | 86820 | - |
dc.identifier.uri | https://hdl.handle.net/10371/171806 | - |
dc.description.abstract | Background In the ongoing phase I PROFILE 1001 study, crizotinib showed antitumor activity in patients with ROS1-rearranged advanced non-small-cell lung cancer (NSCLC). Here, we present updated antitumor activity, overall survival (OS) and safety data (additional 46.2months follow-up) for patients with ROS1-rearranged advanced NSCLC from PROFILE 1001. Patients and methods ROS1 status was determined by FISH or reverse transcriptase-polymerase chain reaction. All patients received crizotinib at a starting dose of 250mg twice daily. Results Fifty-three patients received crizotinib, with a median duration of treatment of 22.4months. At data cut-off, treatment was ongoing in 12 patients (23%). The objective response rate (ORR) was 72% [95% confidence interval (CI), 58% to 83%], including six confirmed complete responses and 32 confirmed partial responses; 10 patients had stable disease. Responses were durable (median duration of response 24.7months; 95% CI, 15.2-45.3). ORRs were consistent across different patient subgroups. Median progression-free survival was 19.3months (95% CI, 15.2-39.1). A total of 26 deaths (49%) occurred (median follow-up period of 62.6months), and of the remaining 27 patients (51%), 14 (26%) were in follow-up at data cut-off. Median OS was 51.4months (95% CI, 29.3 to not reached) and survival probabilities at 12, 24, 36, and 48months were 79%, 67%, 53%, and 51%, respectively. No correlation was observed between OS and specific ROS1 fusion partner. Treatment-related adverse events (TRAEs) were mainly grade 1 or 2, per CTCAE v3.0. There were no grade >= 4 TRAEs and no TRAEs associated with permanent discontinuation. No new safety signals were reported with long-term crizotinib treatment. Conclusions These findings serve as a new benchmark for OS in ROS1-rearranged advanced NSCLC, and continue to show the clinically meaningful benefit and safety of crizotinib in this molecular subgroup. Trial Registration Number ClinicalTrials.gov identifier NCT00585195 | - |
dc.language | 영어 | - |
dc.publisher | Oxford University Press | - |
dc.title | Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1093/annonc/mdz131 | - |
dc.citation.journaltitle | Annals of Oncology | - |
dc.identifier.wosid | 000484369900018 | - |
dc.identifier.scopusid | 2-s2.0-85069214430 | - |
dc.citation.endpage | 1126 | - |
dc.citation.number | 7 | - |
dc.citation.startpage | 1121 | - |
dc.citation.volume | 30 | - |
dc.identifier.sci | 000484369900018 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | CLINICAL ACTIVITY | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | INHIBITOR | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordAuthor | crizotinib | - |
dc.subject.keywordAuthor | non-small-cell lung cancer | - |
dc.subject.keywordAuthor | ROS1 | - |
dc.subject.keywordAuthor | overall survival | - |
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