| General information |
| Database: | DB01019 |
| Objective: | Erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) is an oral, epidermal growth factor receptor tyrosine kinase inhibitor that has antitumor activity and good tolerability in non small cell lung cancer (non small cell lung cancer). In particular, higher response rates have been reported in Asian patients than in theystern patients. The aim of this study conducted by the Korean Cancer Study Group was to evaluate the efficacy and tolerability of erlotinib monotherapy as a palliative treatment for advanced non small cell lung cancer patients in Korea. |
| Authors: | Uhm JE, et al |
| Title: | Erlotinib monotherapy for stage IIIB/IV non small cell lung cancer: a multicenter trial by the Korean Cancer Study Group. |
| Journal: | J Thorac Oncol. |
| Year: | 2009 |
| PMID: | 19687764 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| 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: | a multicenter trial by the Korean Cancer Study Group |
| Key Patients Feature: | Patients with histologically or cytologically confirmed stage IIIB or IV non small cell lung cancer including recurrent or metastatic disease, with performance status from 0 to 3, were eligible either if they had received any anticancer treatment except epidermal growth factor receptor inhibitors or if were unsuitable for chemotherapy because of poor performance status. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Enrolled patients were treated with oral erlotinib at a dose of 150 mg daily until disease progression or development of intolerable toxicity. |
| Primary End Point: | ORR, DCR, PFS, OS, ans adverse event |
| Secondary End Point: | NA |
| Patients Number: | 120 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 24.20% |
| Disease Control Rate: | 56.70% |
| Median Time to Progression: | 2.7 months (95% CI, 2.23.2) |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 12.9 months (95% CI, 6.918.8) |
| Adverse Event(agent arm): | The most common adverse event was skin rash (78% of which grade 3 or 4 skin rash occurred in 13.3% of the patients). |
| Conclusions: | Erlotinib monotherapy showed significant antitumor activity and an acceptable tolerability profile as a palliative treatment in advanced non small cell lung cancer patients in Korea, especially in females, never smokers, and patients with adenocarcinoma histology. |