LJUBLJANA, Slovenia-Gefitinib (Iressa) has similar efficacy and low toxicity compared with docetaxel(Drug information on docetaxel) (Taxotere) in the second-line treatment of advanced non-small-cell lung cancer (NSCLC), results of the Second- line Indication of Gefitinib(Drug information on gefitinib) in NSCLC (SIGN) study indicate. The trial was the first to compare the two drugs in this palliative setting, said Tanja Cufer, MD, of the Institute of Oncology, Ljubljana, Slovenia, and colleagues (abstract 7035). Currently approved drugs for second- line therapy of advanced NSCLCare docetaxel, erlotinib (Tarceva), and pemetrexed(Drug information on pemetrexed) (Alimta). Striking Differences in Adverse Events Among the 139 evaluable patients in this international, phase II study, there were grade 3 and 4 adverse events in 8.9% of the patients on gefitinib vs 25.4% of those on docetaxel. Grade 3 and 4 neutropenia was 46% with docetaxel vs 1.6% with gefitinib, and leukopenia rates were 37.3% vs 0. Grade 3 and 4 rash and diarrhea, which are associated with tyrosine kinase inhibitors (TKIs), were no worse on the gefitinib arm of the trial. Symptom and QOL Benefit Symptom and quality of life (QOL) improvements were somewhat higher in the gefitinib arm. About 26% of thepatients on docetaxel experienced improvements in symptoms and in QOL. Of the patients on gefitinib, 36.9% had symptom improvement and 33.8% reported QOL improvement. Though these differences were not statistically significant, they did suggest improvement. "There does appear to be a trend toward improvement [in symptoms and QOL] in the gefitinib arm as opposed to docetaxel," said discussant Charles Rudin, MD, PhD, director of the Lung Cancer Therapeutics Program, Sidney Kimmel Comprehensive Cancer Center. Comparable Responses Response and survival rates were very similar for the two drugs. The objective response rate was 13.2% for gefitinib and 13.7% for docetaxel; median overall survival was 7.5 months for gefitinib and 7.1 months for docetaxel; and median progres-sion-free survival time was 3.0 months with gefitinib and 3.4 months with docetaxel. "I think the conclusion perhaps is not surprising...EGFR TKIs may offer improved quality of life with similar outcomes relative to cytotoxic chemotherapies for non-small-cell lung cancer," Dr. Rudin said. "So these data really are consistent with Dr. Shepherd's BR.21 study using Tarceva." Further Comparisons Warranted The investigators concluded that the findings support further comparisons of the two drugs. A phase III study, the Iressa NSCLC Trial Evaluating Response and Survival against Taxotere (INTEREST) has already been initiated, using the same design. Dr. Rudin noted that other agents under study in this population include cetuximab (Erbitux) as monotherapy, docetaxel with gefitinib, and docetaxel with bortezomib(Drug information on bortezomib) (Velcade).