Retrospective analysis of gefitinib versus docetaxel in never-smoking patients with previously treated non-small-cell lung cancer (NSCLC)

Abstract

17154 Background: Docetaxel has been standard for second line treatment of NSCLC. In ISEL study, subgroup analyses showed significantly longer survival in the gefitinib group than the placebo group for never-smokers and Asians. It is not clear whether gefitinib has the clinical advantage in these selected patients with NSCLC. We aimed to compare the clinical benefit of gefitinib with that of docetaxel in never smoker previously treated with chemotherapy, retrospectively. Methods: We reviewed patients from August 2002 to September 2005 in Shizuoka Cancer Center. Patients with following conditions were analyzed: NSCLC, received gefitinib or docetaxel, never-smoker, not chemo-naived. We assessed the response rate, progression free survival (PFS) and over all survival for gefitinib and docetaxel respectively. Survival curves were calculated using the Kaplan Meier-method. Prognostic factors were estimated using multivariate analysis. Results: 108 patinets were selected. 69 patients were treated with gefitinib and 39 patients were treated with docetaxel. 28 patients overlapped each other. The patients treated with gefitinib following docetaxel and those with docetaxel following gefitinib were 17 and 13, respectively. 69 patients with gefitinib: the median age, 62 years (31–79); stage IIIB/IV, 14/55; ad/sq/ others, 61/3/5; PS 0/1/2/3, 19/35/13/2; prior therapy containing platinum regimen, 58. The response rate was 36%. 39 patients with docetaxel: the median age, 63 years (31–76); stage IIIB/IV, 8/31; ad/sq/others, 29/7/3; PS 0/1/2/3, 18/19/1/1; prior therapy containing platinum regimen, 34. The response rate was 10%. Gefitinib was superior in longer median PFS (148 days vs 43 days, p = 0.0002). Over all survivals were not significant between two arms. In multivariate analysis for PFS, following factors were significant: gefitinib therapy (hazard ratio 0.375, p = 0.0002); male (hazard ratio 1.854, p = 0.0011); good performance status (hazard ratio 0.450, p = 0.0057). Conclusions: Our results suggested that gefitinib therapy is very attractive for never smoker in the point of PFS. Many patients received cross-over therapies made difficult to analyze over all survival. No significant financial relationships to disclose.