Entry Detail
| General information | |
| Database: | DB00592 |
| Objective: | Bevacizumab ((BEV) has become a mainstay of treating recurrent glioblastoma, but eventual tumor resistance is expected. Targeting multiple growthassociated signaling pathways may result in more effective treatment than targeting VEGF alone. |
| Authors: | Kreisl TN, et al |
| Title: | Continuous daily sunitinib for recurrent glioblastoma |
| Journal: | J Neurooncol. |
| Year: | 2013 |
| PMID: | 23086433 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | Tumors of the nervous system |
| Cancer Subtype: | glioma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | phase IIstudy |
| Key Patients Feature: | Patients older than 18 years with histologically confirmedintracranial GBM or gliosarcoma were eligible. Patientsmust have progressed after standard radiation and temozolomide therapy, observed on a contrastenhanced perfusion MRI or CT within 14 days of registration, and on afiveday stable dose of steroids. Patients enrolled to theBEVresistant arm must have progressed while treated withBEV. Additional eligibility criteria included Karnofskyperformance status (KPS) equal to or greater than 60, andnormal end organ and marrow function. At least 4 weeksmust have elapsed from last treatment with radiationtherapy, 6 weeks from BEV, 6 weeks from nitrosoureas, 3 weeks from procarbazine, 2 weeks from vincristine, 1 week from noncytotoxic agents, 4 weeks from any othercytotoxic therapy, and 2 weeks from any investigationalagent. Concurrent use of other standard chemotherapeuticsor investigational agents was not allowed. |
| Biomarker: | BEV exposure |
| Biomark Analysis: | Median overall survival was 9.4 months [95 % CI 6.1521.90] in the BEVna ve cohort and 4.37 months [95 % CI 3.026.21] in the BEVresistant cohort. 3/29 patients (10 %) of the BEVna ve, and 0/27 BEVresistant patients achieved radiographic response. |
| Control Group Info: | single arm |
| Treatment Info: | pts were treated with sunitinib 37.5 mg daily in thisphase II study. Response evaluations were performed at baseline and at the end of every 4 week cycle. |
| Primary End Point: | Sixmonth progression free survival (PFS6) |
| Secondary End Point: | health related quality of life measures and FDGPET correlatives with patient outcomes. |
| Patients Number: | 63 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | PFS6 was 10.4 % [95 % CI 3.2-33.8] in the BEVna ¡§ve cohort and 0 % in the BEVresistant cohort. |
| Median OS A vs. C: | 9.4 months [95 % CI 6.15-21.90] in the BEVna ¡§ve cohort and 4.37 months [95 % CI 3.02-6.21] in the BEVresistant cohort. |
| Adverse Event(agent arm): | The most common hematological toxicities were thrombocytopeina, leukopenia, and neutropenia. The most common nonhematological toxicities were transaminitis, low thyroid hormone, and hypertension. Grade C3 events occurring in C10 % of patients were leukopenia, neutropenia, lymphopenia, thrombocytopenia, and hypophosphatemia. |
| Conclusions: | Continuous daily sunitinib did not prolong progression free survival in BEVna?ve nor BEVresistant patients with recurrent glioblastoma. |