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)

Kazuhiko Yamada, Koichi Takayama, Satoru Kawakami, Kouichi Saruwatari, Ryotaro Morinaga, Taishi Harada, Naoko Aragane, Shuya Nagata, Junji Kishimoto, Yoichi Nakanishi, Yukito Ichinose

研究成果: Contribution to journalArticle査読

11 被引用数 (Scopus)

抄録

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.

本文言語英語
論文番号hyt056
ページ(範囲)629-635
ページ数7
ジャーナルJapanese journal of clinical oncology
43
6
DOI
出版ステータス出版済み - 6 2013

All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 放射線学、核医学およびイメージング
  • 癌研究

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