Entry Detail
| General information | |
| Database: | DB00079 |
| Objective: | To report the clinical efficacy of sorafenib and to evaluate biomarkers associated with sorafenib clinical benefit in the BATTLE (BiomarkerIntegrated Approaches of Targeted Therapy for Lung Cancer Elimination) program. |
| Authors: | Blumenschein GR Jr, et al. |
| Title: | Comprehensive biomarker analysis and final efficacy results of sorafenib in the BATTLE trial. |
| Journal: | Clin Cancer Res |
| Year: | 2013 |
| PMID: | 24166906 |
| Trial Design | |
| Clinical Trial Id: | NCT00411671 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| 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: | The reported correlatives, and the invitro discovery and tumor testing of a geneexpression signature that was associated with sorafenib clinical benefit advance the prospects for this personalized approach. |
| Key Patients Feature: | Patients with previously treated nonsmall-cell lung cancer (non small cell lung cancer) received sorafenib until progression or unacceptable toxicity |
| Biomarker: | Prespecified biomarkers included KRAS, EGFR, and BRAF mutations, and EGFR gene copy number |
| Biomark Analysis: | Eightweek DCR was higher in patients with wildtype EGFR than patients with EGFR mutation (P = 0.012), and in patients with EGFR gene copy number gain (FISHpositive) versus patients FISHnegative (P = 0.048). In wildtype EGFR tumors, the SSS was associated with improved PFS (median PFS 3.61 months in high SSS vs. 1.84 months in low SSS; P = 0.026) but not with eightweek DCR. Increased expression of fibroblast growth factor1, NF¦ÊB, and hypoxia pathways were identified potential drivers of sorafenib resistance. |
| Control Group Info: | single arm |
| Treatment Info: | Sorafenib 400 mg twice/daily was administered orally (p.o) to patients in continuous 28day cycles until evidence of tumor progression or intolerable drugrelated toxicity. |
| Primary End Point: | Eightweek disease control rate (DCR), progression free survival (PFS), and overall survival (OS) were assessed. |
| Secondary End Point: | NA |
| Patients Number: | 98 |
| Trial Results | |
| DLT_MTD: | Sorafenib 400 mg twice/daily was administered orally (p.o) to patients in continuous 28day cycles until evidence of tumor progression or intolerable drugrelated toxicity |
| Objective Response Rate: | NA |
| Disease Control Rate: | 8week DCR:58.2% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.83 [95% confidence interval (CI), 2.043.58] |
| Median OS A vs. C: | 8.48 months (95% CI, 5.7810.97) |
| Adverse Event(agent arm): | NA |
| Conclusions: | Sorafenib demonstrates clinical activity in non small cell lung cancer, especially with wtEGFR. SSS(sorafenib sensitivity signature) was associated with improved PFS. These data identify subgroups that may derive clinical benefit from sorafenib and merit investigation in future trials. |