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      Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study.

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          Abstract

          Patients with non-small-cell lung cancer (NSCLC) and ALK rearrangements generally have a progression-free survival of 8-11 months while on treatment with the ALK inhibitor crizotinib. However, resistance inevitably develops, with the brain a common site of progression. More potent ALK inhibitors with consistently demonstrable CNS activity and good tolerability are needed urgently. Alectinib is a novel, highly selective, and potent ALK inhibitor that has shown clinical activity in patients with crizotinib-naive ALK-rearranged NSCLC. We did a phase 1/2 study of alectinib to establish the recommended phase 2 dose of the drug and examine its activity in patients resistant or intolerant to crizotinib.

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          Author and article information

          Journal
          Lancet Oncol.
          The Lancet. Oncology
          1474-5488
          1470-2045
          Sep 2014
          : 15
          : 10
          Affiliations
          [1 ] Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI, USA.
          [2 ] Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
          [3 ] Memorial Sloan Kettering Cancer Center, New York, NY, USA.
          [4 ] H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.
          [5 ] Swedish Medical Center, Seattle, WA, USA.
          [6 ] Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, CA USA.
          [7 ] Roche Pharmaceutical Research and Early Development Center, Roche Innovation Center New York, F Hoffmann-La Roche, New York, NY, USA.
          [8 ] Chugai Pharma USA, Berkeley Heights, NJ, USA.
          [9 ] Chugai Pharmaceuticals, Tokyo, Japan.
          [10 ] Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, CA USA. Electronic address: ignatius.ou@uci.edu.
          Article
          S1470-2045(14)70362-6
          10.1016/S1470-2045(14)70362-6
          25153538
          Copyright © 2014 Elsevier Ltd. All rights reserved.

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