| General information |
| Database: | DB00824 |
| Objective: | Patients with stage IV non small cell lung cancer (non small cell lung cancer) who progress through firstline therapy have poor progression free survival (PFS) and overall survival (OS), most commonly failing in original sites of gross disease. Cytoreduction with stereotactic body radiation therapy (SBRT) may help systemic agents delay relapse. |
| Authors: | Iyengar P, et al |
| Title: | Phase II trial of stereotactic body radiation therapy combined with erlotinib for patients with limited but progressive metastatic non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2014 |
| PMID: | 25349291 |
| 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: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | stereotactic body radiation therapy combined with erlotinib |
| Study Type: | phase II study |
| Key Patients Feature: | pts had stage IV non small cell lung cancer with no more than six sites of extracranial disease who failed early systemic chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were able to receive SBRT and concurrent erlotinib until disease progression. After erlotinib commencement, SBRT with equipotent fractionation was delivered to all sites of disease. |
| Primary End Point: | PFS, OS, and other end points were evaluated. |
| Secondary End Point: | NA |
| Patients Number: | 24 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 14.7 months |
| Median OS A vs. C: | 20.4 months |
| Adverse Event(agent arm): | NA |
| Conclusions: | Use of SBRT with erlotinib for unselected patients with stage IV non small cell lung cancer as a second or subsequent line therapy resulted in dramatic changes in patterns of failure, was well tolerated, and resulted in high PFS and OS, substantially greater than historical values for patients who only received systemic agents. |