Abstract
Purpose
Gefitinib is safe for the treatment of non-small cell lung cancer (NSCLC), but some patients experience toxicities and require dose reduction. The purpose of this study was to evaluate the effect of gefitinib dose reduction on survival.
Methods
We retrospectively analyzed 263 patients with NSCLC harboring sensitive epidermal growth factor receptor (EGFR) mutation. All patients had recurred or metastatic disease and received gefitinib 250 mg daily as palliative chemotherapy.
Results
Of the 263 patients, 23 had gefitinib dose reduction due to toxicities (1 due to mucositis, 5 due to skin rash, 11 due to hepatotoxicity and 6 for both skin and hepatotoxicity). In the dose reduction group, the mean dose intensity was 0.84 (range 0.48–0.98). Patients with dose reduction showed significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to those receiving the standard dose (median PFS: 14.0 vs. 10.6 months, P = 0.042, median OS: 54.5 vs. 29.6, P = 0.020). In multivariate analysis, the effect of dose reduction was not significantly associated with prolonged PFS [hazard ratio (HR) 0.619, 95 % confidence interval (CI) 0.357–1.073, P = 0.085], or OS (HR 0.625, 95 % CI 0.287–1.362, P = 0.237). However, patients receiving low-dose gefitinib tended to have superior survival outcomes compared to those receiving standard-dose gefitinib.
Conclusions
The patients experiencing gefitinib dose reduction or short-term treatment interruption due to toxicities did not show inferior survival, compared to those receiving full dose of gefitinib in NSCLC patients with EGFR mutation.
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Acknowledgments
This study was supported by grants from the Innovative Research Institute for Cell Therapy, Republic of Korea (A062260). This work was supported by the National Research Foundation of Korea (NRF) Grant funded by the Korean Government (2010-0009563). We would especially like to thank our database manager, Ju Youn Kim, for data management. We also wish to thank the members of the Seoul National University Hospital Lung Study Group.
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Sim, S.H., Keam, B., Kim, DW. et al. The gefitinib dose reduction on survival outcomes in epidermal growth factor receptor mutant non-small cell lung cancer. J Cancer Res Clin Oncol 140, 2135–2142 (2014). https://doi.org/10.1007/s00432-014-1768-2
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DOI: https://doi.org/10.1007/s00432-014-1768-2