First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy
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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Patients with PS 3-4 may also receive an EGFR TKI because they are likely to obtain clinical benefit similar to patients with good PS.
“Patients with PS 3-4 may also be offered an EGFR TKI, as they are likely to receive a similar clinical benefit to patients with good PS [II, A] [113].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [113]
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- 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
- Venue
- Journal of Clinical Oncology
- Published
- 2009-03-20
- Volume
- 27
- Issue
- 9
- Pages
- 1394-1400
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- 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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