WEDNESDAY, Aug. 19 (HealthDay News) -- In a phase III clinical trial, gefitinib was superior to carboplatin-paclitaxel in extending survival for patients with non-small-cell lung cancer, particularly those patients with epidermal growth factor receptor (EGFR) gene mutations, according to a study published online Aug. 19 in the New England Journal of Medicine.
Tony S. Mok, M.D., of the Chinese University of Hong Kong, and colleagues assigned 1,217 patients with advanced pulmonary adenocarcinoma, who had not been previously treated and were nonsmokers or former light smokers, to receive either a daily 250-mg dose of gefitinib or calculated doses of carboplatin plus paclitaxel. The study end point was progression-free survival at 12 months.
At study end point, the researchers found that the progression-free survival rate with gefitinib was 24.9 percent compared to 6.7 percent with the carboplatin-paclitaxel combination treatment. The gefitinib group demonstrated better survival in the 261 patients who tested positive for the EGFR mutation (hazard ratio for progression or death with gefitinib, 0.48), while the carboplatin-paclitaxel group had a better survival rate among the 176 patients without the mutation (hazard ratio with gefitinib, 2.85). For gefitinib, the most common adverse events were rash and diarrhea, while for carboplatin-paclitaxel, they were neurotoxic effects, neutropenia, and alopecia.
"Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia. The presence in the tumor of the EGFR gene is a strong predictor of a better outcome with gefitinib," the authors write.
The study was supported by AstraZeneca, and a number of the study authors reported receiving consulting and lecture fees from several pharmaceutical companies.