Gefitinib with chemo ups survival in NSCLC regardless of EGFR mutation status
Intercalating and maintenance gefitinib may improve progression-free survival (PFS) and overall survival (OS) in nonsmall cell lung cancer (NSCLC) patients with unknown epidermal growth factor receptor (EGFR) mutation status, a recent study has shown.
The investigators randomized 219 NSCLC patients who achieved stable disease after treatment with gemcitabine and carboplatin to either continue chemotherapy (n=110) or receive intercalating gefitinib with chemotherapy (n=109). Only those with unknown EGFR mutation status were included, while those with gefitinib allergies were excluded.
Major outcomes of the study were PFS, OS, tumour response and adverse events (AEs). Cox proportional hazards models were used to quantify the treatment effects.
Over a median follow-up of 20.5 months, patients in the gefitinib arm showed median PFS of 9.7 months. Compared with the control arm (median PFS, 4.2 months), PFS was significantly longer in the gefitinib arm (hazard ratio [HR], 95 percent CI, 0.41; 0.31 to 0.56; p<0.001).
Similarly, the median OS in the gefitinib arm (20.1 months) was significantly longer than in the control arm (15.4 months; HR, 0.68; 0.48 to 0.97; p=0.0323). There were 63 (57.8 percent) and 61 (55.5 percent) deaths in the gefitinib and control arms, respectively.
Eight weeks after randomization, only 19.3 percent (n=21) of the gefitinib group and 0.9 percent (n=1) of the control group achieved partial remission. No patient achieved complete response.
Moreover, stable disease was reported in 62.4 percent (n=68) of patients in the gefitinib group and 71.8 percent (n=79) of those in the control group. In contrast, 15.6 percent (n=17) and 19.1 percent (n=21) experienced disease progression in the gefitinib and control groups, respectively.
The objective response rate for the gefitinib and control groups were 19.3 and 0.9 percent, respectively, with the difference reaching statistical significance (p<0.0001).