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International Journal of Clinical Oncology
Published in: International Journal of Clinical Oncology 1/2017

Open Access 01-02-2017 | Original Article

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

Authors: Noboru Yamamoto, Koichi Goto, Makoto Nishio, Kenichi Chikamori, Toyoaki Hida, Makoto Maemondo, Nobuyuki Katakami, Toshiyuki Kozuki, Hiroshige Yoshioka, Takashi Seto, Kosei Tajima, Tomohide Tamura

Published in: International Journal of Clinical Oncology | Issue 1/2017

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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.
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Metadata
Title
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
Authors
Noboru Yamamoto
Koichi Goto
Makoto Nishio
Kenichi Chikamori
Toyoaki Hida
Makoto Maemondo
Nobuyuki Katakami
Toshiyuki Kozuki
Hiroshige Yoshioka
Takashi Seto
Kosei Tajima
Tomohide Tamura
Publication date
01-02-2017
Publisher
Springer Japan
Published in
International Journal of Clinical Oncology / Issue 1/2017
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI
https://doi.org/10.1007/s10147-016-1039-0

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