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Final overall survival analysis from a study comparing first-line crizotinib versus chemotherapy in ALK-mutation-positive non-small-cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | Solomon, Benjamin J. | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Wu, Yi-Long | - |
dc.contributor.author | Nakagawa, Kazuhiko | - |
dc.contributor.author | Mekhail, Tarek | - |
dc.contributor.author | Felip, Enriqueta | - |
dc.contributor.author | Cappuzzo, Federico | - |
dc.contributor.author | Paolini, Jolanda | - |
dc.contributor.author | Usari, Tiziana | - |
dc.contributor.author | Tang, Yiyun | - |
dc.contributor.author | Wilner, Keith D. | - |
dc.contributor.author | Blackhall, Fiona | - |
dc.contributor.author | Mok, Tony S. | - |
dc.date.accessioned | 2020-04-27T11:03:06Z | - |
dc.date.available | 2020-04-27T11:03:06Z | - |
dc.date.created | 2019-06-26 | - |
dc.date.issued | 2018-08-01 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.36 No.22, pp.2251-2258 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 76829 | - |
dc.identifier.uri | https://hdl.handle.net/10371/165232 | - |
dc.description.abstract | Purpose The phase III PROFILE 1014 trial compared crizotinib with chemotherapy as first-line treatment in patients with anaplastic lymphoma kinase (ALK) -positive advanced nonsquamous non-small-cell lung cancer. Here, we report the final overall survival (OS) results. Patients and Methods Patients were randomly assigned to receive oral crizotinib 250 mg twice daily (n = 172) or intravenous pemetrexed 500 mg/m(2) plus cisplatin 75 mg/m(2) or carboplatin (area under the concentration-time curve of 5 to 6 mgmL/min) every 3 weeks for a maximum of six cycles (n = 171). Crossover to crizotinib was permitted after disease progression. OS was analyzed using a stratified log-rank test and a prespecified rank-preserving structural failure time model to account for crossover. Results Median follow-up duration for OS was approximately 46 months for both arms. In the chemotherapy arm, 144 patients (84.2%) received crizotinib in subsequent lines. Hazard ratio for OS was 0.760 (95% CI, 0.548 to 1.053; two-sided P = .0978). Median OS was not reached (NR) with crizotinib (95% CI, 45.8 months to NR) and 47.5 months with chemotherapy (95% CI, 32.2 months to NR). Survival probability at 4 years was 56.6% (95% CI, 48.3% to 64.1%) with crizotinib and 49.1% (95% CI, 40.5% to 57.1%) with chemotherapy. After crossover adjustment, there was an improvement in OS that favored crizotinib (hazard ratio, 0.346; 95% bootstrap CI, 0.081 to 0.718). The longest OS was observed in crizotinib-treated patients who received a subsequent ALK tyrosine kinase inhibitor. No new safety signals were identified. Conclusion The final analysis of the PROFILE 1014 study provides a new benchmark for OS in patients with ALK-rearranged non-small-cell lung cancer and highlights the benefit of crizotinib for prolonging survival in this patient population. | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Final overall survival analysis from a study comparing first-line crizotinib versus chemotherapy in ALK-mutation-positive non-small-cell lung cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1200/JCO.2017.77.4794 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000445665200003 | - |
dc.identifier.scopusid | 2-s2.0-85050751520 | - |
dc.citation.endpage | 2258 | - |
dc.citation.number | 22 | - |
dc.citation.startpage | 2251 | - |
dc.citation.volume | 36 | - |
dc.identifier.sci | 000445665200003 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | RETROSPECTIVE ANALYSIS | - |
dc.subject.keywordPlus | ADENOCARCINOMA | - |
dc.subject.keywordPlus | INHIBITORS | - |
dc.subject.keywordPlus | CERITINIB | - |
dc.subject.keywordPlus | ALECTINIB | - |
dc.subject.keywordPlus | PHASE-3 | - |
dc.subject.keywordPlus | TRIALS | - |
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