| General information |
| Database: | DB00788 |
| Objective: | The aim of this study was to evaluate the efficacy and safety of Erlotinib in Japanese patients with previously treated non small cell lung cancer (non small cell lung cancer). Available tumor biopsy samples were analyzed to examine relationships between biomarkers and clinical outcome |
| Authors: | Kubota K, et al |
| Title: | Efficacy and safety of erlotinib monotherapy for Japanese patients with advanced non small cell lung cancer: a phase II study. |
| Journal: | J Thorac Oncol. |
| Year: | 2008 |
| PMID: | 19057270 |
| 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: | openlabelphase II trial |
| Key Patients Feature: | stage III/IV non small cell lung cancer patients who had progressive disease after at least one prior platinumbased chemotherapy regimen |
| Biomarker: | Analysis of epidermal growth factor receptor gene mutations in exon 1821 by direct sequencing was performed in tumor tissue specimens obtained at the first diagnosis. |
| Biomark Analysis: | Only 7 patients had samples available for mutation analysis. Three patients who had deletion mutations on exon 19 (del E746A750 or del S752I759) exhibited objective response. |
| Control Group Info: | single arm |
| Treatment Info: | Erlotinib was administered at a dose of 150 mg/d orally until disease progression or intolerable toxicity |
| Primary End Point: | the objective response rate (ORR) to erlotinib treatment (150 mg/d). |
| Secondary End Point: | disease control rate (DCR), response duration, time to progression, overall survival (OS), quality of life (QoL), and safety. |
| Patients Number: | 60 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 28.30% |
| Disease Control Rate: | 50.00% |
| Median Time to Progression: | 77 days (95% CI: 55-166 days) |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 14.72 months (95% CI: 11.07-20.57 months; 19 censored cases) and the 1year survival rate was 56.5% (95% CI: 43.9-69.1%) |
| Adverse Event(agent arm): | Treatmentrelated AEs were observed in all patients, and there were 24 serious AEs in 18 patients (29%). AEs led to discontinuation of erlotinib in 11 patients (18%), including 3 due to ILDlike events, 2 due to ALT elevation, and one each due to rash, paronychia, punctate keratitis, dyspnea/hypoxia, pneumonia and fever/inflammatory neck swelling, and to dose interruptions in 30 patients (48.4%). While the main reasons for the dose interruptions were rash (n = 15; 24.2%) and diarrhea (n = 4; 6.5%), only one patient with rash had to discontinue treatment, and no patients had to discontinue because of diarrhea or any other digestive toxicity. Fourteen patients (23%) had dose reductions due to AEs, mostly due to rash (n = 9; 15%). |
| Conclusions: | Erlotinib is efficacious in Japanese patients with previously treated non small cell lung cancer. The toxicity profile was similar to that in theystern patients, except for a somewhat higher incidence of skin disorders and interstitial lung disease. Further studies are needed to determine the relationship bettheyen epidermal growth factor receptor mutations and outcomes with Erlotinib in Japanese patients. |