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: ジャーナルへの寄稿記事

10 引用 (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.

元の言語英語
記事番号hyt056
ページ(範囲)629-635
ページ数7
ジャーナルJapanese journal of clinical oncology
43
発行部数6
DOI
出版物ステータス出版済み - 6 1 2013

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Non-Small Cell Lung Carcinoma
Lung
Mutation
Confidence Intervals
Disease-Free Survival
erbB-1 Genes
Interstitial Lung Diseases
Erlotinib Hydrochloride
Exanthema
Disease Progression
Liver Diseases
Exons
Prospective Studies
Drug Therapy
Skin
Survival
Therapeutics
Population

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

これを引用

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

:: Japanese journal of clinical oncology, 巻 43, 番号 6, hyt056, 01.06.2013, p. 629-635.

研究成果: ジャーナルへの寄稿記事

Yamada, K, Takayama, K, Kawakami, S, Saruwatari, K, Morinaga, R, Harada, T, Aragane, N, Nagata, S, Kishimoto, J, Nakanishi, Y & Ichinose, Y 2013, '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)', Japanese journal of clinical oncology, 巻. 43, 番号 6, hyt056, pp. 629-635. https://doi.org/10.1093/jjco/hyt056
Yamada, Kazuhiko ; Takayama, Koichi ; Kawakami, Satoru ; Saruwatari, Kouichi ; Morinaga, Ryotaro ; Harada, Taishi ; Aragane, Naoko ; Nagata, Shuya ; Kishimoto, Junji ; Nakanishi, Yoichi ; Ichinose, Yukito. / 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). :: Japanese journal of clinical oncology. 2013 ; 巻 43, 番号 6. pp. 629-635.
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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)",
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.",
author = "Kazuhiko Yamada and Koichi Takayama and Satoru Kawakami and Kouichi Saruwatari and Ryotaro Morinaga and Taishi Harada and Naoko Aragane and Shuya Nagata and Junji Kishimoto and Yoichi Nakanishi and Yukito Ichinose",
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T1 - Phase II trial of erlotinib for Japanese patients with previously treated non-small-cell lung cancer harboring EGFR mutations

T2 - Results of lung oncology group in Kyushu (LOGiK0803)

AU - Yamada, Kazuhiko

AU - Takayama, Koichi

AU - Kawakami, Satoru

AU - Saruwatari, Kouichi

AU - Morinaga, Ryotaro

AU - Harada, Taishi

AU - Aragane, Naoko

AU - Nagata, Shuya

AU - Kishimoto, Junji

AU - Nakanishi, Yoichi

AU - Ichinose, Yukito

PY - 2013/6/1

Y1 - 2013/6/1

N2 - 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.

AB - 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.

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