Four RCTs were included in the review (2,257 patients, range 141 to 1,466). One trial was phase II and three were phase III. One RCT scored 3 on the Jadad scale and three RCTs scored 2.
There was no statistically significant difference in overall or progression-free survival between the gefitinib and docetaxel groups (four RCTs). Gefitinib was associated with a significantly higher response rate (RR 1.58, 95% CI 1.02 to 2.45, NNT 23; four RCTs) and quality of life (Functional Assessment of Cancer Therapy-Lung RR 1.55, 95% CI 1.27 to 1.88; 1,598 patients and Trial Outcome Index RR 1.86, 95% CI 1.43 to 2.42; 1,458 patients). There was no significant difference between the groups in symptom improvement. Gefitinib was associated with significantly less grade 3 or 4 neutropenia (OR 0.02, 95% CI 0.01 to 0.03; 2,053 patients) and fatigue (OR 0.47, 95% CI 0.32 to 0.70; 2,223 patients) but more rashes (OR 2.87, 95% CI 1.24 to 6.63; 2,223 patients). Rates of nausea, vomiting and diarrhoea were comparable.
There was significant heterogeneity for response rate (p=0.06) but not for other outcomes. No publication bias was detected.