Gefitinib treatment is highly effective in non-small-cell lung cancer patients failing previous chemotherapy in Taiwan: A prospective phase II study

Gefitinib has shown activity in the treatment of non-small-cell lung cancer (NSCLC) patients who failed previous platinum-based combination chemotherapy and/or taxane treatment. Recently, gefitinib was documented to be more effective in an East Asian population, as well. Thus, we performed a gefitinib trial in Taiwanese patients to assess the efficacy of this regimen. Treatment consisted of gefitinib 250 mg one tablet daily until disease progression. Thirty-six patients were enrolled from January 2003 to September 2004. Gefitinib was second-line treatment in 10, third-line in 15, fourth-line in 9, and fifth-line in 2. All patients were evaluable for toxicity profile and response rate. After 8 weeks of treatment, three patients had a complete response (CR) and nine had a partial response (PR), with an overall response rate of 33.3% (95% confidence interval 17.9% - 48.7%). All treatment-related toxicities were few and mild in severity, except that one patient suffered from reversible grade 3 interstitial pneumonitis. The median time to disease progression was 4.7 months, and the median survival was 9.5 months. The one-year survival rate was 45.1%. Survival was significantly better in those who responded to treatment (CR and PR) than in those who did not (median 20.1 vs. 4.7 months, p=0.0002). Survival was also better in those who demonstrated disease control using gefitinib (CR, PR, and stable disease) than in those who did not (14.1 vs. 1.4 months, p < 0.0001). The authors conclude that daily gefitinib treatment has high activity, is well tolerated, and provides very good survival in Taiwanese NSCLC patients who have failed previous chemotherapy, especially in those who responded to gefitinib treatment or those whose disease was controlled by gefitinib treatment.