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J Thorac Oncol. 2017 Jul;12(7):1161-1166. doi: 10.1016/j.jtho.2017.02.012. Epub 2017 Feb 24.

Alectinib for Patients with ALK Rearrangement-Positive Non-Small Cell Lung Cancer and a Poor Performance Status (Lung Oncology Group in Kyushu 1401).

Author information

1
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
2
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
3
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
4
Department of Respiratory Medicine, Kumamoto Regional Medical Center, Kumamoto, Japan.
5
Department of Clinical Oncology, Tokyo Medical and Dental University, Tokyo, Japan; Department of Respiratory Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
6
Department of Respiratory Medicine, Iwate Prefectural Central Hospital, Morioka, Japan.
7
Department of Respiratory Medicine, Steel Memorial Yawata Hospital, Kita-Kyushu, Japan.
8
Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.
9
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
10
Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
11
Department of Respiratory Medicine, Kesen-numa City Hospital, Kesen-numa, Japan.
12
Division of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
13
Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
14
Department of Thoracic Medical Oncology, Oita Prefectural Hospital, Oita, Japan.
15
Department of Respiratory Medicine, Fukuoka University Chikushi Hospital, Chikushino, Japan.
16
Clinical Research Support Center Kyushu, Fukuoka, Japan.
17
Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.
18
Division of Clinical Pharmacology and Translational Research, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Tokyo, Japan.
19
Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.
20
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.

Abstract

INTRODUCTION:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

Alectinib is a treatment option for patients with ALK rearrangement-positive NSCLC and a poor PS.

KEYWORDS:

ALK rearrangement; Alectinib; NSCLC; Pharmacokinetics; Poor performance status

PMID:
28238961
DOI:
10.1016/j.jtho.2017.02.012
[Indexed for MEDLINE]
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