Gefitinib (Iressa) is more effective than first-line therapy in improving survival without disease in patients with advanced nonsmall-cell lung cancer (NSCLC) and epidermal growth-factor receptor (EGFR) mutations.
The current study was conducted in 230 patients from 43 centers in Japan, all of whom were treatment naive and had advanced NSCLC with EGFR mutations. Patients were randomized to receive either gefitinib or standard chemotherapy of paclitaxel and carboplatin.
After the interim analysis of the first 200 patients, the safety monitoring committee decided to terminate the study after a significant difference in survival without disease was seen between the 2 treatment groups (P < .001).
The geiftinib group had a significantly longer median survival without disease (10.8 vs. 5.4 months, P<0.001) and a higher complete response rate (73.7% vs. 30.7%, P<0.001) than the standard chemotherapy group.
Median overall survival was also better for the gefitinib group, but the difference was not significant (30.5 vs 23.6 months). This might be due to the fact that patients who failed first-line chemotherapy were given gefitinib as their second line treatment.
In the gefitinib group, the most common adverse events were rash and elevated levels of liver enzyme. In the standard chemotherapy, they were appetite loss, neutropenia, anemia, and sensory neuropathy. Overall incidence of severe toxic effects was significantly higher among patients receiving chemotherapy than among those receiving gefitinib (71.7% vs 41.2%; P < .001).
The study showed that treatment with gefitinib resulted in longer survival without disease in patients with mutated–EGFR nonsmall-cell lung cancer but with better tolerable profile, including less hematologic toxicity and neurotoxicity.
While this is great news patients with NSCLC, it is important to note that only 15% of American lung cancer patients have an EGFR mutation and not all lung cancer patients can benefit from this treatment.
Source: N Engl J Med. 2010;362:2380-2388
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