title: Alectinib for Patients with ALK Rearrangement-Positive Non-Small Cell Lung Cancer and a Poor Performance Status (Lung Oncology Group in Kyushu 1401).
abstract: Alectinib has shown marked efficacy and safety in patients with anaplastic lymphoma receptor tyrosine kinase gene (ALK) rearrangement-positive NSCLC and a good performance status (PS). It has remained unclear whether alectinib might also be beneficial for such patients with a poor PS.
  
  
  
  Eligible patients with advanced ALK rearrangement-positive NSCLC and a PS of 2 to 4 received alectinib orally at 300 mg twice daily. The primary end point of the study was objective response rate (ORR), and the most informative secondary end point was rate of PS improvement.
  
  
  
  Between September 2014 and December 2015, 18 patients were enrolled in this phase II study. Of those patients, 12, five, and one had a PS of 2, 3, or 4, respectively, whereas four patients had received prior crizotinib treatment. The ORR was 72.2% (90% confidence interval: 52.9-85.8%). The ORR did not differ significantly between patients with a PS of 2 and those with a PS of 3 or higher (58.3% and 100%, respectively [p = 0.114]). The PS improvement rate was 83.3% (90% confidence interval: 64.8-93.1%, p < 0.0001), with the frequency of improvement to a PS of 0 or 1 being 72.2%. The median progression-free survival was 10.1 months. Toxicity was mild, with the frequency of adverse events of grade 3 or higher being low. Neither dose reduction nor withdrawal of alectinib because of toxicity was necessary.
  
  
  
  Alectinib is a treatment option for patients with ALK rearrangement-positive NSCLC and a poor PS.
authors.affiliation: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Iwama
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Goto
authors.affiliation: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Haruyasu
authors.initials: H
authors.lastname: Murakami
authors.affiliation: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Taishi
authors.initials: T
authors.lastname: Harada
authors.affiliation: Department of Respiratory Medicine, Kumamoto Regional Medical Center, Kumamoto, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Tsumura
authors.affiliation: Department of Clinical Oncology, Tokyo Medical and Dental University, Tokyo, Japan; Department of Respiratory Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Sakashita
authors.affiliation: Department of Respiratory Medicine, Iwate Prefectural Central Hospital, Morioka, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Mori
authors.affiliation: Department of Respiratory Medicine, Steel Memorial Yawata Hospital, Kita-Kyushu, Japan.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Nakagaki
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.
authors.forename: Yuka
authors.initials: Y
authors.lastname: Fujita
authors.affiliation: Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Seike
authors.affiliation: Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Bessho
authors.affiliation: Department of Respiratory Medicine, Kesen-numa City Hospital, Kesen-numa, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Ono
authors.affiliation: Division of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
authors.forename: Akihito
authors.initials: A
authors.lastname: Okazaki
authors.affiliation: Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Akamatsu
authors.affiliation: Department of Thoracic Medical Oncology, Oita Prefectural Hospital, Oita, Japan.
authors.forename: Ryotaro
authors.initials: R
authors.lastname: Morinaga
authors.affiliation: Department of Respiratory Medicine, Fukuoka University Chikushi Hospital, Chikushino, Japan.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Ushijima
authors.affiliation: Clinical Research Support Center Kyushu, Fukuoka, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Shimose
authors.affiliation: Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Tokunaga
authors.affiliation: Division of Clinical Pharmacology and Translational Research, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Tokyo, Japan.
authors.forename: Akinobu
authors.initials: A
authors.lastname: Hamada
authors.affiliation: Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Nakanishi
authors.affiliation: Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Sugio
authors.affiliation: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. Electronic address: okamotoi@kokyu.med.kyushu-u.ac.jp.
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002227:Carbazoles / Q000494:pharmacology / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000494:pharmacology / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D002227:Carbazoles; D010880:Piperidines; D047428:Protein Kinase Inhibitors; C582670:alectinib
keywords: ALK rearrangement; Alectinib; NSCLC; Pharmacokinetics; Poor performance status