Entry Detail
| General information | |
| Database: | DB00078 |
| Objective: | To investigate efficacy and safety of sorafenib in patients with advanced lung adenocarcinoma as second or thirdline treatment after failure of epidermal growth factor receptor tyrosine kinase inhibitors (EGFRTKIs) therapy |
| Authors: | Zhou Q, et al |
| Title: | A multicenterphase II study of sorafenib monotherapy in clinically selected patients with advanced lung adenocarcinoma after failure of EGFRTKI therapy (Chinese Thoracic Oncology Group, CTONG 0805). |
| Journal: | Lung Cancer |
| Year: | 2014 |
| PMID: | 24440279 |
| Trial Design | |
| Clinical Trial Id: | NCT00922584 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced lung adenocarcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | A multicenterphase II study of sorafenib monotherapy (Chinese Thoracic Oncology Group, CTONG 0805) |
| Key Patients Feature: | Patients who were diagnosed with stage IIIB or stage IV lung adenocarcinoma, and benefited from one prior EGFRTKI therapy and then failed |
| Biomarker: | genotype of Bcl2interacting mediator of cell death (BIM) deletion polymorphism and EGFR mutation status |
| Biomark Analysis: | In 30 tumor tissues, 22 EGFR active mutations were found. The DCR had no significant difference between mutationpositive and wildtype patients (31.8% vs. 42.9%, respectively; HR, 0.622; p=0.665). |
| Control Group Info: | single arm |
| Treatment Info: | Patients received oral sorafenib 400mg twice daily continuously until disease progression or intolerable toxicity. |
| Primary End Point: | disease control rate (DCR). |
| Secondary End Point: | safety, progression free survival (PFS) and overall survival (OS). |
| Patients Number: | 64 |
| Trial Results | |
| DLT_MTD: | Patients received oral sorafenib 400mg twice daily continuously until disease progression or intolerable toxicity. |
| Objective Response Rate: | NA |
| Disease Control Rate: | 32.8%, which did not meet the predefined statistical hypothesis of 38.4% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.7 months [95% (confidence interval), 3.53.9 months] |
| Median OS A vs. C: | 7.4 months (95% CI, 5.79.2 months) |
| Adverse Event(agent arm): | Handfoot syndrome (HFS) was the predominant toxicity occurring in 71.9% of patients. Fourteen patients (21.9%) had more than and equal to grade 2 dermatologic reactions that resulted sorafenib dose reduction in three patients (4.7%). |
| Conclusions: | Sorafenib monotherapy did not achieve positive result in patients defined in our trial and they need better biomarker to determine the population who can benefit from sorafenib treatment |