Objective: To evaluate the efficacy of sequential administration of gefitinib and docetaxel in the second-line therapy for advanced non-small cell lung cancer (NSCLC).
Methods: Eighty-two patients with advanced NSCLC who had received both gefitinib and docetaxel treatment were divided into 2 groups: Group A (n = 17) that were treated with gefitinib first and then crossed over to docetaxel treatment when progressive disease (PD) occurred as second-line treatment, and Group B (n = 65) that were treated with docetaxel first, and then crossed over to gefitinib treatment when PD occurred.
Results: The response rate of gefitinib in phase I (duration before crossover) was 27.7%, not significantly different from that in phase II (duration after crossover) (29.4%, P > 0.05). The response rate of docetaxel in phase I was 13.8%, not significantly different from that in phase II (5.9%, P > 0.05). Gefitinib showed an efficacy superior to docetaxel after adjusting the sequence of these two agents (28.0% vs 12.2%, chi2 = 5.46, P = 0.02). The time to progression (TTP) of gefitinib was 6.0 months, significantly longer than that of docetaxol (4.0 months, P = 0.00). Though no statistically significant survival difference was seen between these two groups, stratified analysis showed that the median survival time of the patients with the Eastern Cooperative Oncology Group (ECOG) = 2 in Group A was 13.0 months, significantly longer than that in Group B (6.0 months, P = 0.01). The adverse events (AEs), including skin rash and diarrhea were all generally tolerable. The incidence of AEs was similar in these two groups.
Conclusion: Although no impact was found in the efficacy and survival between these two different sequential administration of gefitinib and docetaxel for patients with advanced NSCLC, but the patients with poor performance status may get longer survival if they receive treatment of gefitinib first crossed-over to docetaxel.
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