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Pooled analysis of CNS response to alectinib in two studies of pretreated patients with ALK-positive non-small-cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | Gadgeel, Shirish M. | - |
dc.contributor.author | Shaw, Alice T. | - |
dc.contributor.author | Govindan, Ramaswamy | - |
dc.contributor.author | Gandhi, Leena | - |
dc.contributor.author | Socinski, Mark A. | - |
dc.contributor.author | Camidge, D. Ross | - |
dc.contributor.author | De Petris, Luigi | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Chiappori, Alberto | - |
dc.contributor.author | Moro-Sibilot, Denis L. | - |
dc.contributor.author | Duruisseaux, Michael | - |
dc.contributor.author | Crino, Lucio | - |
dc.contributor.author | De Pas, Tommaso | - |
dc.contributor.author | Dansin, Eric | - |
dc.contributor.author | Tessmer, Antje | - |
dc.contributor.author | Yang, James Chih-Hsin | - |
dc.contributor.author | Han, Ji-Youn | - |
dc.contributor.author | Bordogna, Walter | - |
dc.contributor.author | Golding, Sophie | - |
dc.contributor.author | Zeaiter, Ali | - |
dc.contributor.author | Ou, Sai-Hong Ignatius | - |
dc.date.accessioned | 2020-04-27T11:12:54Z | - |
dc.date.available | 2020-04-27T11:12:54Z | - |
dc.date.created | 2018-08-21 | - |
dc.date.issued | 2016-12 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.34 No.34, pp.4079-4085 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 45166 | - |
dc.identifier.uri | https://hdl.handle.net/10371/165292 | - |
dc.description.abstract | Purpose Alectinib has shown activity in the CNS in phase I and II studies. To further evaluate this activity, we pooled efficacy and safety data from two single-arm phase II studies (NP28761 and NP28673; ClinicalTrials.gov identifiers: NCT01871805 and NCT01801111, respectively) in patients with ALK-positive non-small-cell lung cancer (NSCLC). Patients and Methods Both studies included patients with ALK-positive NSCLC who had previously received crizotinib; all patients received alectinib 600 mg twice per day. The primary end point in both studies was independent review committee (IRC)-assessed objective response rate (ORR; by Response Evaluation Criteria in Solid Tumors [ RECIST] version 1.1). Additional end points (all by IRC) included CNS ORR (CORR), CNS disease control rate (CDCR), and CNS duration of response (CDOR). Results One hundred thirty-six patients had baseline CNS metastases (60% of the overall study populations); 50 patients (37%) had measurable CNS disease at baseline. Ninety-five patients (70%) had prior CNS radiotherapy; 55 patients completed the CNS radiotherapy more than 6 months before starting alectinib. Median follow-up time was 12.4 months (range, 0.9 to 19.7 months). For patients with baseline measurable CNS disease, IRC CORR was 64.0% (95% CI, 49.2% to 77.1%), CDCR was 90.0% (95% CI, 78.2% to 96.7%), and median CDOR was 10.8 months (95% CI, 7.6 to 14.1 months). For patients with measurable and/or nonmeasurable baseline CNS disease, IRC CORR was 42.6% (95% CI, 34.2% to 51.4%), CDCR was 85.3% (95% CI, 78.2% to 90.8%), and median CDOR was 11.1 months (95% CI, 10.3 months to not evaluable). CORR was 35.8% (95% CI, 26.2% to 46.3%) for patients with prior radiotherapy (n = 95) and 58.5% (95% CI, 42.1% to 73.7%) for patients without prior radiotherapy (n = 41). As previously reported, alectinib was well tolerated, regardless of baseline CNS disease. Conclusion Alectinib showed good efficacy against CNS metastases, in addition to systemic activity, in crizotinib-refractory ALK-positive NSCLC. (C) 2016 by American Society of Clinical Oncology | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Pooled analysis of CNS response to alectinib in two studies of pretreated patients with ALK-positive non-small-cell lung cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1200/JCO.2016.68.4639 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000388929900006 | - |
dc.identifier.scopusid | 2-s2.0-84995877117 | - |
dc.citation.endpage | 4085 | - |
dc.citation.number | 34 | - |
dc.citation.startpage | 4079 | - |
dc.citation.volume | 34 | - |
dc.identifier.sci | 000388929900006 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | BRAIN METASTASES | - |
dc.subject.keywordPlus | CRIZOTINIB | - |
dc.subject.keywordPlus | CERITINIB | - |
dc.subject.keywordPlus | RESISTANCE | - |
dc.subject.keywordPlus | DISEASE | - |
dc.subject.keywordPlus | SAFETY | - |
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