Cited by 505Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentHER2/EGFR in Cancer Research

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First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy

Inoue, Akira, Kobayashi, Kunihiko, Usui, Kazuhiro, Maemondo, Makoto, Okinaga, Shoji, Mikami, Iwao, Ando, Masahiro, Yamazaki, Koichi, Saijo, Yasuo, Gemma, Akihiko, Miyazawa, Hitoshi, Tanaka, Tomoaki, Ikebuchi, Kenji, Nukiwa, Toshihiro, Morita, Satoshi, Hagiwara, Koichi·2009·Journal of Clinical Oncology

DOI 10.1200/jco.2008.18.7658

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Abstract

Purpose This multicenter phase II study was undertaken to investigate the efficacy and feasibility of gefitinib for patients with advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations without indication for chemotherapy as a result of poor performance status (PS). Patients and Methods Chemotherapy-naïve patients with poor PS (patients 20 to 74 years of age with Eastern Cooperative Oncology Group PS 3 to 4, 75 to 79 years of age with PS 2 to 4, and ≥ 80 years of age with PS 1 to 4) who had EGFR mutations examined by the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method were enrolled and received gefitinib (250 mg/d) alone. Results Between February 2006 and May 2007, 30 patients with NSCLC and poor PS, including 22 patients with PS 3 to 4, were enrolled. The overall response rate was 66% (90% CI, 51% to 80%), and the disease control rate was 90%. PS improvement rate was 79% (P < .00005); in particular, 68% of the 22 patients improved from ≥ PS 3 at baseline to ≤ PS 1. The median progression-free survival, median survival time, and 1-year survival rate were 6.5 months, 17.8 months, and 63%, respectively. No treatment-related deaths were observed. Conclusion This is the first report indicating that EGFR mutation-positive patients with extremely poor PS benefit from first-line gefitinib. Because there previously has been no standard treatment for these patients with short life expectancy other than best supportive care, examination of EGFR mutations as a biomarker is recommended in this patient population.

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Self-citation

Authors: Inoue, A., Kobayashi, K., Usui, K., Maemondo, M., Okinaga, S., Mikami, I., Ando, M., Yamazaki, K., Saijo, Y., Gemma, A., Miyazawa, H., Tanaka, T., Ikebuchi, K., Nukiwa, T., Morita, S., & Hagiwara, K.
Affiliations: Tohoku University (JP)
ORCID: Inoue, Akira
Kobayashi, Kunihiko
Usui, Kazuhiro
Maemondo, Makoto
Saijo, Yasuo
Gemma, Akihiko
Miyazawa, Hitoshi
Tanaka, Tomoaki
Ikebuchi, Kenji
Nukiwa, Toshihiro
Morita, Satoshi
Hagiwara, Koichi
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2009-03-20
Volume: 27
Issue: 9
Pages: 1394-1400
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2008.18.7658
OpenAlex: W2111191667
Cited by: 505
References: 32
Citations by year: 2026: 2 · 2025: 6 · 2024: 10 · 2023: 18 · 2022: 22 · 2021: 33 · 2020: 25 · 2019: 22 · 2018: 29 · 2017: 35 · 2016: 34 · 2015: 31 · 2014: 30 · 2013: 43 · 2012: 41
FWCI: 45.89
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Keywords: gefitinib, advanced non-small cell lung cancer, EGFR mutation, first-line therapy, poor performance status, chemotherapy-naive patients, EGFR mutation testing, overall response rate, progression-free survival, best supportive care
MeSH terms: Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Middle Aged, Mutation, Prospective Studies, Young Adult, ErbB Receptors

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First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy

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