Gefitinib showed clinically meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients. At 250 mg/d, gefitinib had a favorable AE profile. Gefitinib 250 mg/d is an important, novel treatment option for patients with pretreated advanced NSCLC [corrected]

ORE PERSONS IN THE United States die from non-small cell lung cancer (NSCLC) than from breast, colorectal, and prostate cancer combined. 1 Each year, more than 60000 persons develop stages IIIB and IV NSCLC; nearly all go on to die from metastatic spread. In addition, most individuals experience symptoms caused directly by lung cancer. These symptoms are often the first manifestations of the illness and increase in frequency and severity as the disease progresses. Cough, shortness of breath, weight loss, loss of appetite, and chest tightness impair the quality of lives already cut short by NSCLC. For patients with advanced lung cancer, physical well-being and changes in quality of life correlate with survival. 2 Espe-Author Affiliations and Financial Disclosures are listed at the end of this article.

Gefitinib showed no added benefit in survival, TTP, or RR compared with standard chemotherapy alone. This large, placebo-controlled trial confirmed the favorable gefitinib safety profile observed in phase I and II monotherapy trials.

Gefitinib in combination with gemcitabine and cisplatin in chemotherapy-naive patients with advanced NSCLC did not have improved efficacy over gemcitabine and cisplatin alone. The reasons for this remain obscure and require further preclinical testing.