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Clinical Trial
. 2017 Feb;22(1):70-78.
doi: 10.1007/s10147-016-1039-0. Epub 2016 Sep 22.

Final overall survival in JO22903, a phase II, open-label study of first-line erlotinib for Japanese patients with EGFR mutation-positive non-small-cell lung cancer

Noboru Yamamoto  1 , Koichi Goto  2 , Makoto Nishio  3 , Kenichi Chikamori  4 , Toyoaki Hida  5 , Makoto Maemondo  6 , Nobuyuki Katakami  7 , Toshiyuki Kozuki  8 , Hiroshige Yoshioka  9 , Takashi Seto  10 , Kosei Tajima  11 , Tomohide Tamura  12
Affiliations
Clinical Trial

Final overall survival in JO22903, a phase II, open-label study of first-line erlotinib for Japanese patients with EGFR mutation-positive non-small-cell lung cancer

Noboru Yamamoto et al. Int J Clin Oncol. 2017 Feb.

Erratum in

Abstract

Background: In Japan, the clinical efficacy of erlotinib monotherapy in epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer was demonstrated in the phase II JO22903 trial, which reported a median progression-free survival of 11.8 months. Here we report final overall survival data from JO22903.

Methods: JO22903 (JapicCTI-101085) was a single-arm, multicenter, phase II, open-label, non-randomized study of first-line erlotinib monotherapy in EGFR mutation-positive non-small-cell lung cancer. Eligible patients (≥20 years) with stage IIIB/IV or recurrent non-small-cell lung cancer and confirmed activating mutations of EGFR (exon 19 deletion or L858R point mutation in exon 21) received oral erlotinib 150 mg/day until disease progression or unacceptable toxicity. The primary endpoints were progression-free survival and safety; overall survival was a secondary endpoint.

Results: At the final analysis, 102 patients were included in the modified intent-to-treat population and 103 in the safety population. Median follow-up was 32.3 months. Median overall survival was 36.3 months (95 % confidence interval 29.4-not reached). Subgroup analyses of overall survival suggested that the presence of brain metastases was a negative prognostic factor (median overall survival 22.7 months, 95 % confidence interval 19.6-29.4). The impact on overall survival of using versus not using EGFR tyrosine kinase inhibitors in any line of treatment following disease progression was unclear (median 32.8 versus 36.3 months, respectively). No new safety issues were observed.

Conclusion: In this survival update, single-agent erlotinib achieved a median overall survival of more than 3 years in patients with EGFR mutation-positive non-small-cell lung cancer.

Keywords: EGFR mutations; Erlotinib; First line; Japanese patients; Non-small-cell lung cancer (NSCLC); Overall survival.

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Conflict of interest statement

Noboru Yamamoto received honoraria from AstraZeneca, Eli Lilly, Pfizer and Chugai Pharmaceutical. He also received research funding from Daiichi-Sankyo, Kyowa-Kirin, Chugai Pharmaceutical, Eli Lilly, Takeda, Quintiles, Bristol-Myers Squibb, Astellas, Taiho, Pfizer, Novartis and Eisai. Koichi Goto received research funding from Chugai Pharmaceutical. Makoto Nishio received honoraria from Chugai Pharmaceutical, Boehringer Ingelheim and AstraZeneca. He also received research funding from Chugai Pharmaceutical and AstraZeneca. Kenichi Chikamori received honoraria from Chugai Pharmaceutical. He also received research funding from Chugai Pharmaceutical and Bristol-Myers Squibb. Toyoaki Hida received honoraria from Chugai Pharmaceutical, Taiho, AstraZeneca and Boehringer Ingelheim. He also received research funding from Chugai Pharmaceutical, Taiho, AstraZeneca, Boehringer Ingelheim, Clovis Oncology and Astellas. Makoto Maemondo received honoraria from Chugai Pharmaceutical, AstraZeneca and Boehringer Ingelheim. He also received research funding from Chugai Pharmaceutical, AstraZeneca and Boehringer Ingelheim. Nobuyuki Katakami received honoraria and research funding from Chugai Pharmaceutical. Toshiyuki Kozuki received honoraria from Chugai Pharmaceutical, AstraZeneca, Eli Lilly, Pfizer, Kyowa Kirin, Sanofi, Taiho and Roche. He also received research funding from Chugai Pharmaceutical, Bristol-Myers Squibb and Pfizer. Hiroshige Yoshioka received honoraria from Boehringer Ingelheim, Eli Lilly and Chugai Pharmaceutical. He also received research funding from Chugai Pharmaceutical, Novartis, Takeda, Pfizer, Merck-Serono, Eli Lilly and Kyowa Kirin. Takashi Seto received honoraria and lecture fees from Chugai Pharmaceutical. Kosei Tajima is an employee of Chugai Pharmaceutical. Tomohide Tamura received honoraria from Chugai Pharmaceutical, Taiho, Ono, Eli Lilly, Eisai, Yakult Honsha, Boehringer Ingelheim and Bristol-Myers Squibb.

Figures

Fig. 1
Fig. 1
Overall survival with a erlotinib monotherapy in the modified ITT population and b by EGFR mutation type
Fig. 2
Fig. 2
Overall survival by CNS progression
Fig. 3
Fig. 3
Overall survival by post-PD therapy with a second-line platinum doublet chemotherapy and b EGFR TKI in any line
See this image and copyright information in PMC

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