| General information |
| Database: | DB00752 |
| Objective: | This multicenterphase II study was undertaken to investigate the efficacy and feasibility of gefitinib for patients with advanced non small cell lung cancer (non small cell lung cancer) harboring epidermal growth factor receptor (EGFR) mutations without indication for chemotherapy as a result of poor performance status (PS). |
| Authors: | Inoue A, et al |
| Title: | Firstline gefitinib for patients with advanced non small cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy |
| Journal: | J Clin Oncol. |
| Year: | 2009 |
| PMID: | 19224850 |
| 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 harboring epidermal growth factor receptor mutations |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a multicenterphase II study |
| Key Patients Feature: | Chemotherapyna ve patients with poor PS (patients 20 to 74 years of age with Eastern Cooperative Oncology Group PS 3 to 4, 75 to 79 years of age with PS 2 to 4, and >or= 80 years of age with PS 1 to 4) who had EGFR mutations examined by the peptide nucleic acidlocked nucleic acid polymerase chain reaction clamp method were enrolled |
| Biomarker: | EGFR mutationpositive |
| Biomark Analysis: | This is the first report indicating that EGFR mutationpositive patients with extremely poor PS benefit from firstline gefitinib |
| Control Group Info: | single arm |
| Treatment Info: | pts received gefitinib (250 mg/d) alone. |
| Primary End Point: | overall response rate (ORR) |
| Secondary End Point: | toxicity, PFS, and overall survival (OS) |
| Patients Number: | 30 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 66% (90% CI, 51% to 80%) |
| Disease Control Rate: | 90% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.5 months |
| Median OS A vs. C: | 17.8 months |
| Adverse Event(agent arm): | The most frequent adverse event with severity of grade 2 or worse was AST/ALT elevation (Table 3), and all affected patients improved within a few months of modification of the treatment. One patient experienced grade 4 interstitial lung disease that resolved after corticosteroid pulse therapy (methylprednisolone 1 g/d for 3 days). Most of the other toxicities observed were mild or moderate. There was no treatmentrelated death. Two patients died within 30 days after initiation of gefitinib as a result of rapid disease progression. Toxicity was comparable to that observed in patients with PS 0 to 2 in the previous studies and was considered acceptable. |
| Conclusions: | This is the first report indicating that EGFR mutationpositive patients with extremely poor PS benefit from firstline gefitinib. Because there previously has been no standard treatment for these patients with short life expectancy other than best supportive care, examination of EGFR mutations as a biomarker is recommended in this patient population. |