| General information |
| Database: | DB00814 |
| Objective: | Erlotinib is clinically effective in patients with non small cell lung cancer (non small cell lung cancer) who have adenocarcinoma, are never or limited former smokers, or have EGFR mutant tumors. they investigated the efficacy of erlotinib alone or in combination with chemotherapy in patients with these characteristics. |
| Authors: | J nne PA, et al |
| Title: | Randomizedphase II trial of erlotinib alone or with carboplatin and paclitaxel in patients who were never or light former smokers with advanced lung adenocarcinoma: CALGB 30406 trial. |
| Journal: | J Clin Oncol. |
| Year: | 2012 |
| PMID: | 22547605 |
| Trial Design |
| Clinical Trial Id: | NCT00126581 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced lung adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | erlotinib with carboplatin + paclitaxel |
| Study Type: | Randomizedphase II trial |
| Key Patients Feature: | Patients with advanced non small cell lung cancer (adenocarcinoma) who were epidermal growth factor receptor tyrosine kinase inhibitor and chemotherapy naive never or light former smokers (smokers of > 100 cigarettes and less than and equal to 10 pack years and quit more than and equal to 1 year ago) |
| Biomarker: | EGFR mutation |
| Biomark Analysis: | In arm A, response rate (70% v 9%), PFS (14.1 v 2.6 months), and overall survival (OS; 31.3 v 18.1 month) favored EGFRmutant patients. In arm B, response rate (73% v 30%), PFS (17.2 v 4.8 months), and OS (38.1 v 14.4 months) favored EGFRmutant patients. |
| Control Group Info: | erlotinib verus erlotinib with carboplatin and paclitaxel |
| Treatment Info: | patients were randomly assigned to continuous erlotinib or in combination with carboplatin and paclitaxel (ECP) for six cycles followed by erlotinib alone. |
| Primary End Point: | progression free survival (PFS). |
| Secondary End Point: | NA |
| Patients Number: | 181 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | In arm A, response rate (70% v 9%); In arm B, response rate (73% v 30%) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | PFS was similar (5.0 v 6.6 months; P = .1988) in patients randomly assigned to erlotinib alone (arm A; n = 81) or to ECP (arm B; n = 100). |
| Median OS A vs. C: | In arm A, overall survival (OS; 31.3 v 18.1 month) favored EGFRmutant patients. In arm B, OS (38.1 v 14.4 months) favored EGFRmutant patients. |
| Adverse Event(agent arm): | The most common reason for treatment discontinuation in both arms was progressive disease: 61 patients (75%) in arm A and 71 patients (71%) in arm B. |
| Conclusions: | Erlotinib and erlotinib plus chemotherapy have similar efficacy in clinically selected populations of patients with advanced non small cell lung cancer. EGFR mutations identify patients most likely to benefit. |