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Vol.57 No.3 contents | Japanese/English |
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- Original Article -
The Efficacy of Ceritinib for ALK-rearranged Non-small Cell Lung Cancer Previously Treated with Alectinib -an Analysis of Japanese and Global Phase I Studies-
Gouji Toyokawa1, Haruyasu Murakami2, Kota Tokushige3, Ben Hatano3, Makoto Nishio41Department of Surgery and Science, Kyushu University, Japan, 2Division of Thoracic Oncology, Shizuoka Cancer Center, Japan, 3Oncology Development and Medical Affairs Division, Novartis Pharma K.K., Japan, 4Thoracic Center, the Cancer Institute Hospital of JFCR, Japan
Objective. We analyzed the efficacy of ceritinib in patients with ALK-rearrangement non-small cell lung cancer (ALK+NSCLC) who had a history of ALK inhibitor (ALKi) therapy including alectinib. Methods. The efficacy and safety of ceritinib in patients with ALK+NSCLC was analyzed in a Japanese phase I study. The efficacy of ceritinib was also analyzed in patients with a history of alectinib therapy in a Japanese phase I study and ASCEND-1. Results. In the Japanese phase I study, the rate of major serious adverse events was increased with ALT. The overall response rate (ORR) and disease control rate (DCR) in patients administered ceritinib 750 mg/day, the maximum tolerated and recommended dose, were 37.5% (3/8) and 75.0% (6/8), respectively. The ORR in patients who had a history of ALKi therapy was 52.9% (9/17, all patients showed a partial response [PR]), and the progression-free survival was longer than 4.2 months in these responders. An ALK secondary mutation (L1196M, I1171, I1171T) was reported in three of the nine patients who showed PR. In the Japanese phase I study and ASCEND-1, PR was confirmed in 41.7% (5/12) of patients who had a history of alectinib therapy. Conclusion. Ceritinib may be a new treatment option for ALK+NSCLC patients with a history of alectinib therapy.
key words: Ceritinib, ALK fusion gene, Non-small cell lung cancer, ALK secondary mutation, Patients previously treated with alectinib
Received: January 16, 2017
Accepted: March 24, 2017
JJLC 57 (3): 175-183, 2017
