| General information |
| Database: | DB01017 |
| Objective: | Erlotinib is an epidermal growth factor receptor tyrosine kinase inhibitor that significantly increases survival for patients with previously treated advanced non small cell lung cancer. Epidermal growth factor receptor tyrosine kinase inhibitors have been reported to be particularly effective in Asian patients and may have a distinct safety profile in this population compared with nonAsian patients. they report safety and efficacy data from a subpopulation of East/SouthEast (E/SE) Asian patients enrolled in a global, openlabel, phase IV trial of erlotinib (Tarceva Lung Cancer Survival Treatment study). |
| Authors: | Mok T, et al |
| Title: | Efficacy and safety of erlotinib in 1242 East/SouthEast Asian patients with advanced non small cell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2010 |
| PMID: | 20808255 |
| 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 global, openlabel, phase IV trial |
| Key Patients Feature: | Patients who had previously failed on chemotherapy or radiotherapy, or were unsuitable for these treatments |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were treated with oral erlotinib (150 mg/d) until disease progression or unacceptable toxicity. |
| Primary End Point: | RR, PFS, OS and adverse event |
| Secondary End Point: | NA |
| Patients Number: | 1242 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 27% versus 10%, respectively (p < 0.0001). |
| Disease Control Rate: | 78% versus 66%, respectively (p < 0.0001). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.78 months versus 2.92 months, respectively (hazard ratio = 0.66, p < 0.0001). |
| Median OS A vs. C: | 14.7 months versus 6.8 months, respectively (hazard ratio = 0.57, p < 0.0001). |
| Adverse Event(agent arm): | Safety data were available for all 1242 E/SE Asian patients of whom 532 (43%) had one or more AE regardless of causality. Seventeen percent of patients experienced an erlotinibrelated AE (other than the most frequently occurring AEs predefined in the protocol; Table 4); of these patients, 87% had an AE that was grade 1 or 2 in severity. Only 31 (2%) patients had an SAE considered to be related to treatment. These included gastrointestinal disorders (diarrhea or abdominal pain) and skin and subcutaneous tissue disorders (includes rash; Table 5). ILD occurred in two patients (0.16%); one patient had grade 2 ILD that resolved spontaneously and the other patient had grade 4 ILD that did not improve despite treatment withdrawal. This patient subsequently had respiratory failure and died. Both cases were considered to be erlotinib related. |
| Conclusions: | Erlotinib is an effective and welltolerated treatment for Asian patients with advanced non small cell lung cancer. |