First-line gefitinib for elderly patients with advanced NSCLC harboring EGFR mutations. A combined analysis of North-East Japan Study Group studies

Abstract

Objective: To assess outcomes of elderly patients with advanced NSCLC harboring an EGFR mutation treated with gefitinib, as well as safety and impact on quality of life (QoL).

Methods: We performed a retrospective analysis of pooled data from one Phase III and two Phase II studies of 71 patients aged ≥ 70 years with a performance status of 0 – 2. The main outcome measures were progression-free survival (PFS), overall survival (OS) and response rate (RR), as well as incidence of adverse events and time to 9.1% deterioration in QoL.

Results: Median PFS (14.3 vs 5.7 months, p < 0.001) and overall RR (73.2 vs 26.5%, p < 0.001) in the gefitinib group were superior to those in the standard chemotherapy group, whereas median OS was not significantly different (30.8 vs 26.4 months, p = 0.42). Elevation of aspartate transaminase and/or alanine transaminase (18.3%) was the most common adverse event, and one treatment-related death (pneumonitis) occurred. Time to 9.1% deterioration in the QoL domains of pain and dyspnea, anxiety, and daily functioning was similar between the two age groups.

Conclusion: First-line gefitinib is efficacious with acceptable toxicity in relatively fit elderly patients with advanced NSCLC harboring an EGFR mutation.

Keywords:

• EGFR tyrosine kinase inhibitors
• elderly patients
• gefitinib
• NSCLC

Acknowledgements

We thank patients and their families as well as site investigators, and Koichi Yamazaki (deceased), former associate professor of the First Department of Medicine, Hokkaido University School of Medicine. Results of this study were presented at the 2012 American Society of Clinical Oncology Annual Meeting, Chicago, IL, USA (June 1 – 5, 2012).

Declaration of interest

K Kobayashi and K Hagiwara have received research support from AstraZeneca. The NEJ002 study was supported by Grants-in-Aid from the Japan Society for Promotion of Science and the Japanese Foundation for Multidisciplinary Treatment of Cancer and a grant from the Tokyo Cooperative Oncology Group. We wish to thank William Ng for providing medical writing support, which was funded by AstraZeneca K.K. (Osaka, Japan) according to a publication support agreement. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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