| General information |
| Database: | DB00836 |
| Objective: | Erlotinib prolongs survival in patients with advanced non small cell lung cancer (non small cell lung cancer). they report the results of a randomized, phase II study of erlotinib alone or intercalated with chemotherapy (CT + erlotinib) in chemotherapyna ve patients with advanced non small cell lung cancer who were positive for epidermal growth factor receptor (EGFR) protein expression and/or with high EGFR gene copy number. |
| Authors: | Hirsch FR, et al |
| Title: | A randomized, phase II, biomarkerselected study comparing erlotinib to erlotinib intercalated with chemotherapy in firstline therapy for advanced non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2011 |
| PMID: | 21825259 |
| Trial Design |
| Clinical Trial Id: | NCT00294762 |
| Agent: | erlotinib
|
| 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: | erlotinib intercalated with chemotherapy |
| Study Type: | A randomized, phase II, biomarkerselected study |
| Key Patients Feature: | sufficient tumor tissue sample for EGFR testing; histologically or cytologically advanced (ie, stages IIIB or IV) non small cell lung cancer; radiologically measurable or evaluable disease; and adequate organ function |
| Biomarker: | EGFR, KRAS mutation, EGFR fluorescent in situ hybridization and immunohistochemistry, and Ecadherin and vimentin protein levels were also assessed. |
| Biomark Analysis: | Patients with tumors harboring EGFR activating mutations fared better on erlotinib alone (median PFS, 18.2 months v 4.9 months for CT + erlotinib). |
| Control Group Info: | erlotinib versus erlotinib intercalated with chemotherapy |
| Treatment Info: | patients were randomly assigned to either erlotinib 150 mg daily orally until disease progression (PD) occurred or to chemotherapy with paclitaxel 200 mg/m(2) intravenously (IV) and carboplatin dosed by creatinine clearance (AUC 6) IV on day 1 intercalated with erlotinib 150 mg orally on days 2 through 15 every 3 weeks for four cycles followed by erlotinib 150 mg orally until PD occurred (CT + erlotinib). |
| Primary End Point: | 6month progression free survival (PFS); |
| Secondary End Point: | response rate, PFS, and survival. |
| Patients Number: | 143 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 19% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.6 months (95% confidence interval [CI] 2.6-NA, n = 4) |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common adverse event was skin rash (81% [grades 3 to 4, 9%] in erlotinib arm and 76% [grades 3 to 4, 4%] in the chemotherapy plus erlotinib arm |
| Conclusions: | The feasibility of a multicenter biomarkerdriven study was demonstrated, but neither treatment arms exceeded historical controls. This study does not support combined chemotherapy and erlotinib in firstline treatment of EGFRselected advanced non small cell lung cancer, and the patients with tumors harboring EGFR mutations had a better outcome on erlotinib alone. |