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Final Overall Survival, Safety, and Quality of Life Results From a Phase 2 Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced NSCLC
DC Field | Value | Language |
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dc.contributor.author | Wu, Yi-Long | - |
dc.contributor.author | Lu, Shun | - |
dc.contributor.author | Yang, James Chih-Hsin | - |
dc.contributor.author | Zhou, Jianying | - |
dc.contributor.author | Seto, Takashi | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.contributor.author | Su, Wu-Chou | - |
dc.contributor.author | Yamamoto, Noboru | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Paolini, Jolanda | - |
dc.contributor.author | Usari, Tiziana | - |
dc.contributor.author | Iadeluca, Laura | - |
dc.contributor.author | Wilner, Keith D. | - |
dc.contributor.author | Goto, Koichi | - |
dc.date.accessioned | 2023-03-20T08:37:17Z | - |
dc.date.available | 2023-03-20T08:37:17Z | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.issued | 2022-10 | - |
dc.identifier.citation | JTO Clinical and Research Reports, Vol.3 No.10, p. 100406 | - |
dc.identifier.issn | 2666-3643 | - |
dc.identifier.uri | https://hdl.handle.net/10371/189425 | - |
dc.description.abstract | © 2022 The AuthorsIntroduction: Crizotinib provided meaningful clinical benefit in the initial analysis of a phase 2 study in East Asian patients with advanced ROS1-positive NSCLC (NCT01945021). Nevertheless, overall survival (OS) data were immature. Here, we present the final OS, quality of life (QoL), and safety data after an additional 3 years of follow-up. Methods: In this phase 2, open-label, single-arm trial, East Asian patients with ROS1-positive advanced NSCLC who had received less than or equal to three systemic therapies previously were treated with crizotinib 250 mg twice daily on a continuous daily dosing schedule in 28-day cycles. The OS (secondary end point) was analyzed for the total population, by country, and by number of previous chemotherapy regimens. QoL and safety were also evaluated. Results: With a median duration of follow-up of 56.1 months, the median OS was 44.2 months (95% confidence interval: 32.0–not reached) for the total population (N = 127). Differences in median OS were observed among individual countries and with number of previous regimens. The improvement in QoL found in the previous analysis was maintained with the extended follow-up. Treatment-related adverse events led to crizotinib dose reductions or permanent treatment discontinuations in 17.3% and 2.4%, respectively, of the patients. Conclusions: This is the largest trial of an ALK/ROS1 inhibitor to treat patients with ROS1-positive advanced NSCLC and provides a new benchmark for OS in East Asian patients. The QoL and safety profile with long-term follow-up were consistent with previous reports and support the continued use of crizotinib in the treatment of patients with ROS1-positive advanced NSCLC. | - |
dc.language | 영어 | - |
dc.publisher | Elsevier | - |
dc.title | Final Overall Survival, Safety, and Quality of Life Results From a Phase 2 Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced NSCLC | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.jtocrr.2022.100406 | - |
dc.citation.journaltitle | JTO Clinical and Research Reports | - |
dc.identifier.wosid | 001137387800002 | - |
dc.identifier.scopusid | 2-s2.0-85140772522 | - |
dc.citation.number | 10 | - |
dc.citation.startpage | 100406 | - |
dc.citation.volume | 3 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | CELL LUNG-CANCER | - |
dc.subject.keywordPlus | ROS1 REARRANGEMENTS | - |
dc.subject.keywordPlus | ADENOCARCINOMA | - |
dc.subject.keywordPlus | QLQ-C30 | - |
dc.subject.keywordPlus | RET | - |
dc.subject.keywordAuthor | Asia | - |
dc.subject.keywordAuthor | Crizotinib | - |
dc.subject.keywordAuthor | NSCLC | - |
dc.subject.keywordAuthor | Phase 2 | - |
dc.subject.keywordAuthor | ROS1 | - |
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