Entry Detail
| General information | |
| Database: | DB00844 |
| Objective: | The prognosis for patients with extensivestage small cell lung cancer remains poor. This trial was designed to evaluate the efficacy and toxicity of maintenance sunitinib after platinumetoposide chemotherapy. |
| Authors: | Schneider BJ, et al |
| Title: | Phase II trial of sunitinib maintenance therapy after platinumbased chemotherapy in patients with extensivestage small cell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2011 |
| PMID: | 21512407 |
| 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: | smallcell lung cancer |
| Cancer Subtype: | extensive stage small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II trial |
| Key Patients Feature: | Patients who demonstrated objective tumor response or stable disease after four cycles of platinum plus etoposide chemotherapy were eligible |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Sunitinib was given at 50 mg daily for 4 weeks of a 6week cycle until disease progression or unacceptable toxicity. |
| Primary End Point: | 4month progression free survival (PFS) rate from initiation of sunitinib. |
| Secondary End Point: | NA |
| Patients Number: | 16 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 82% |
| Disease Control Rate: | 100% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.5 months (95% confidence interval [CI], 0.83.1). Median PFS from the start of chemotherapy were 6.2 months (95% CI, 4.16.5). |
| Median OS A vs. C: | Median overall survival from the start of chemotherapy 8.2 months (95% CI, 6.214.7). |
| Adverse Event(agent arm): | NA |
| Conclusions: | Sunitinib did not seem to maintain disease stability after response to chemotherapy. Sunitinib was discontinued in half of patients due to toxicity or request to stop therapy. Although disease stability with sunitinib was noted in four patients, this approach does not seem to warrant further clinical study. |