Entry Detail
| General information | |
| Database: | DB00081 |
| Objective: | assessed the efficacy and safety of sorafenib, an oral multikinase inhibitor, in combination with carboplatin and paclitaxel in chemotherapyna ve patients with unresectable stage IIIB or IV non small cell lung cancer |
| Authors: | Scagliotti G, et al |
| Title: | Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non small cell lung cancer. |
| Journal: | J Clin Oncol |
| Year: | 2010 |
| PMID: | 20212250 |
| Trial Design | |
| Clinical Trial Id: | NCT00300885 |
| 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: | a histologic or cytologic diagnosis of clinical stage IIIB (limited to malignant pleural or pericardial effusion) or stage IV non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | CP+sorafenib |
| Study Type: | a multicenter, randomized, placebocontrolled, phase III trial in non small cell lung cancer¡ªEvaluation of Sorafenib, Carboplatin, and Paclitaxel Efficacy (ESCAPE) |
| Key Patients Feature: | Chemotherapyna ve patients (age more than and equal to 18 years) with a histologic or cytologic diagnosis of clinical stage IIIB (limited to malignant pleural or pericardial effusion) or stage IV non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | CP+placebo(n = 462, arm B) on days 2 to 19 |
| Treatment Info: | patients were randomly assigned to receive up to six 21day cycles of carboplatin area under the curve 6 and paclitaxel 200 mg/m(2) (CP) on day 1, followed by either sorafenib 400 mg twice a day (n = 464, arm A) or placebo (n = 462, arm B) on days 2 to 19. The maintenancephase after CP consisted of sorafenib 400 mg or placebo twice a day. |
| Primary End Point: | overall survival (OS); |
| Secondary End Point: | progression free survival and tumor response. |
| Patients Number: | 926 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The study was terminated after the interim analysis concluded that the study was highly unlikely to meet its primary end point(PFS) |
| Median OS A vs. C: | 10.7 vs 10.6 [HR] = 1.15; 95% CI, 0.94 to 1.41; P = .915;A prespecified exploratory analysis revealed that patients with squamous cell histology had greater mortality in arm A than in arm B (HR = 1.85; 95% CI, 1.22 to 2.81). |
| Adverse Event(agent arm): | Main grade 3 or 4 sorafenibrelated toxicities included rash (8.4%), handfoot skin reaction (7.8%), and diarrhea (3.5%). |
| Conclusions: | No clinical benefit was observed from adding sorafenib to CP chemotherapy as firstline treatment for non small cell lung cancer. |