| General information |
| Database: | DB00822 |
| Objective: | To investigate the antitumor activity and toxicity of the epidermal growth factor receptor (EGFR) inhibitor gefitinib (ZD1839 or Iressa; AstraZeneca Pharmaceuticals, Wilmington, DE), in patients with advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | J nne PA, et al |
| Title: | Outcomes of patients with advanced non small cell lung cancer treated with gefitinib (ZD1839, "Iressa") on an expanded access study. |
| Journal: | Lung Cancer. |
| Year: | 2004 |
| PMID: | 15084387 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an open label, expanded access program (EAP) |
| Key Patients Feature: | patients with advanced non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | oral gefitinib administered at 250 mg per day continuously until evidence of undue toxicity or disease progression |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 172 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 3.5% (95% CI; 1.4-7.1%) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 4.5 months (95% CI; 4.14.9 months). Oneyear survival was 29%. |
| Adverse Event(agent arm): | Only 3 of 154 (1.9%) patients discontinued gefitinib for toxicity; two (2/154; 1.3%) for grade 3 rash and 1 (1/154; 0.6%) for grade 3 nausea. No pulmonary toxicity was observed in our patient population. No cumulative toxicities have been observed in patients treated with gefitinib for more than and equal to 12 months. |
| Conclusions: | Gefitinib has antitumor activity, in a heterogeneous population of non small cell lung cancer patients treated on the EAP study. Treatment with gefitinib in this population is associated with a longer survival in women, those with good performance status and in patients with adenocarcinomas. These findings need to be further validated in additional clinical studies. |