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- Title
Phase II Trial of Erlotinib for Japanese Patients With Previously Treated Non-small-cell Lung Cancer Harboring EGFR Mutations: Results of Lung Oncology Group in Kyushu (LOGiK0803).
- Authors
Yamada, Kazuhiko; Takayama, Koichi; Kawakami, Satoru; Saruwatari, Kouichi; Morinaga, Ryotaro; Harada, Taishi; Aragane, Naoko; Nagata, Shuya; Kishimoto, Junji; Nakanishi, Yoichi; Ichinose, Yukito
- Abstract
Objective Erlotinib has been reported to be useful for treatment of non-small-cell lung cancer harboring mutation of the epidermal growth factor receptor gene EGFR-mt. However, no prospective trial has yet assessed the utility of erlotinib in Japanese patients. Methods Patients with EGFR-mt (exon 19/21) non-small-cell lung cancer who had previously received one to two chemotherapy regimens were enrolled in this trial. Erlotinib was initially administered at a dose of 150 mg/day orally until disease progression or unacceptable toxicities occurred. The primary endpoint was the objective response rate. Results Twenty-six patients were enrolled between February 2009 and January 2011. Objective response was observed in 14 patients (53.8%, 95% confidence interval: 33.4–73.4%), and the disease control rate reached 80.8% (95% confidence interval: 60.7–93.5%). After a median follow-up time of 17.3 months (range: 5.8–29.5 months), the median progression-free survival was 9.3 months (95% confidence interval: 7.6–11.6 months). The median survival time is yet to be determined. Major toxicities were skin disorder and liver dysfunction; most episodes were grade 2 or less, and all were tolerable. Only one patient with grade 3 skin rash discontinued the study. No patients developed interstitial lung disease, and there were no treatment-related deaths. Conclusions This prospective study is the first to have investigated the usefulness of erlotinib in Japanese patients with previously treated EGFR-mt non-small-cell lung cancer. Although this trial could not meet the primary endpoint, erlotinib was well tolerated and showed clinical benefit such as promising disease control rate or progression-free survival in this population, similar to gefitinib.
- Publication
Japanese Journal of Clinical Oncology, 2013, Vol 43, Issue 6, p629
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hyt056