| General information |
| Database: | DB00761 |
| Objective: | To evaluate the efficacy and safety of gefitinib plus simvastatin (GS) versus gefitinib alone (G) in previously treated patients with advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Han JY, et al |
| Title: | A randomizedphase II study of gefitinib plus simvastatin versus gefitinib alone in previously treated patients with advanced non small cell lung cancer. |
| Journal: | Clin Cancer Res. |
| Year: | 2011 |
| PMID: | 21411446 |
| Trial Design |
| Clinical Trial Id: | NCT00452244 |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gefitinib + simvastatin |
| Study Type: | A randomizedphase II study |
| Key Patients Feature: | previously treated patients with advanced non small cell lung cancer. |
| Biomarker: | epidermal growth factor receptor (EGFR) mutant status |
| Biomark Analysis: | In exploratory subgroup analysis, GS showed higher RR (40% vs. 0%, P = 0.043) and longer PFS (3.6M vs. 1.7M, P = 0.027) compared with G alone in patients with wildtype epidermal growth factor receptor (EGFR) nonadenocarcinomas. |
| Control Group Info: | gefitinib plus simvastatin versus gefitinib alone |
| Treatment Info: | patients were randomly assigned to G alone (250 mg/d, n = 54) or GS (250 and 40 mg/d, respectively, n = 52). One cycle was 4 weeks of treatment. Therapy was continued until disease progression or intolerable toxicity was observed. |
| Primary End Point: | response rate (RR) |
| Secondary End Point: | toxicity, progression free survival (PFS), and overall survival (OS) |
| Patients Number: | 106 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 38.5% (95% CI, 25.351.7) for GS and 31.5% (95% CI, 19.143.9) for G |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.3 months [M] (95% CI, 1.45.2M) for GS and 1.9M (95% CI, 1.02.8M) for G |
| Median OS A vs. C: | 13.6M (95% CI, 7.120.1M) for GS and 12.0M (95% CI, 7.816.2M) for G. |
| Adverse Event(agent arm): | Adverse events in both arms were generally mild and mainly consisted of skin rashes. |
| Conclusions: | Although no superiority of GS to G was demonstrated in this unselected non small cell lung cancer population, GS showed higher RR and longer PFS compared with G alone in patients with wildtype EGFR nonadenocarcinomas. Simvastatin may improve the efficacy of gefitinib in that subgroup of gefitinibresistant non small cell lung cancer patients. |