Entry Detail
| General information | |
| Database: | DB00863 |
| Objective: | Brain metastases frequently cause significant morbidity in patients with non small cell lung cancer (non small cell lung cancer). Sunitinib is a multitargeted inhibitor of tyrosine kinase receptors, including vascular endothelial growth factor receptors and plateletderived growth factor receptors, which has singleagent antitumor activity in refractory non small cell lung cancer. Thisphase II study evaluated the antitumor activity and safety of sunitinib in patients with pretreated non small cell lung cancer and irradiated brain metastases. |
| Authors: | Novello S, et al |
| Title: | Phase II study of sunitinib in patients with non small cell lung cancer and irradiated brain metastases. |
| Journal: | J Thorac Oncol. |
| Year: | 2011 |
| PMID: | 21610524 |
| Trial Design | |
| Clinical Trial Id: | NCT00372775 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | advanced cancer with brain metastasis |
| Cancer Subtype: | non small cell lung cancer with irradiated brain metastases |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, singlearm, phase II study |
| Key Patients Feature: | Male or female patients aged 18 years or older with histologically or cytologically proven non small cell lung cancer and radiologically confirmed brain metastases less than and equal to 4 cm in any linear direction were enrolled. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received sunitinib 37.5 mg on a continuous daily dosing schedule |
| Primary End Point: | progression free survival. |
| Secondary End Point: | overall survival, patientreported outcomes, and safety, including risk of intracranial hemorrhage (ICH) associated with focal neurological deficit. |
| Patients Number: | 64 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | 15.1 weeks (95% CI: 8.4-15.8). |
| Median PFS A vs. C: | 9.4 weeks (90% confidence interval [CI]: 7.513.1) |
| Median OS A vs. C: | 25.1 weeks (95% CI: 13.435.5) |
| Adverse Event(agent arm): | The most common grade 3/4 AEs were dyspnea and fatigue (six patients [9%] and five patients [8%], respectively). Other AEs of interest included hypertension (n = 12 [19%]) and one event of hypothyroidism (grade 2). Treatmentrelated nonhematologic grade 4 AEs occurred in three patients: oral pain, oropharyngeal pain, and dysphagia (n = 1), hemoptysis (n = 1), and pulmonary embolism (n = 1). Grade 3/4 hematologic laboratory abnormalities are shown in TABLE 3 |
| Conclusions: | Sunitinib administration on a continuous daily dosing schedule in patients with non small cell lung cancer and brain metastases was safe and manageable, with no increased risk of ICH. |