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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

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dc.contributor.authorGadgeel, Shirish M.-
dc.contributor.authorShaw, Alice T.-
dc.contributor.authorGovindan, Ramaswamy-
dc.contributor.authorGandhi, Leena-
dc.contributor.authorSocinski, Mark A.-
dc.contributor.authorCamidge, D. Ross-
dc.contributor.authorDe Petris, Luigi-
dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorChiappori, Alberto-
dc.contributor.authorMoro-Sibilot, Denis L.-
dc.contributor.authorDuruisseaux, Michael-
dc.contributor.authorCrino, Lucio-
dc.contributor.authorDe Pas, Tommaso-
dc.contributor.authorDansin, Eric-
dc.contributor.authorTessmer, Antje-
dc.contributor.authorYang, James Chih-Hsin-
dc.contributor.authorHan, Ji-Youn-
dc.contributor.authorBordogna, Walter-
dc.contributor.authorGolding, Sophie-
dc.contributor.authorZeaiter, Ali-
dc.contributor.authorOu, Sai-Hong Ignatius-
dc.date.accessioned2020-04-27T11:12:54Z-
dc.date.available2020-04-27T11:12:54Z-
dc.date.issued2016-12-
dc.identifier.citationJournal of Clinical Oncology, Vol.34 No.34, pp.4079-4085-
dc.identifier.issn0732-183X-
dc.identifier.other45166-
dc.identifier.urihttps://hdl.handle.net/10371/165292-
dc.description.abstractPurpose 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.titlePooled analysis of CNS response to alectinib in two studies of pretreated patients with ALK-positive non-small-cell lung cancer-
dc.typeArticle-
dc.contributor.AlternativeAuthor김동완-
dc.identifier.doi10.1200/JCO.2016.68.4639-
dc.citation.journaltitleJournal of Clinical Oncology-
dc.identifier.scopusid2-s2.0-84995877117-
dc.citation.endpage4085-
dc.citation.number34-
dc.citation.startpage4079-
dc.citation.volume34-
dc.identifier.urlhttp://ascopubs.org/doi/10.1200/JCO.2016.68.4639-
dc.identifier.rimsid45166-
dc.identifier.sci000388929900006-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorKim, Dong-Wan-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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