Entry Detail
| General information | |
| Database: | DB00466 |
| Objective: | In this exploratory study they sought to characterize early tumor response in patients with metastatic renal cell carcinoma treated with continuous daily 37.5 mg sunitinib therapy. |
| Authors: | Horn KP, et al |
| Title: | FDG and FLTPET for Early measurement of response to 37.5 mg daily sunitinib therapy in metastatic renal cell carcinoma. |
| Journal: | Cancer Imaging. |
| Year: | 2015 |
| PMID: | 26335224 |
| Trial Design | |
| Clinical Trial Id: | NCT00694096 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | exploratory clinical trial |
| Key Patients Feature: | Inclusion criteria included: aged 18 or older, previous¡¡histological diagnosis of RCC, documented evidence of¡¡metastatic disease on contrastenhanced CT and/or MRI within 30 days with at least one measurable lesion, [10] andsuitable candidacy for standard sunitinib therapy for metastatic RCC as determined by the treating oncologist. |
| Biomarker: | NA |
| Biomark Analysis: | Baseline FDGPET tumor maximum standardized uptake values correlated inversely with overall survival (p = 0.0036). Conversely, baseline (18) Ffluorothymidine PET imaging did not have prognostic value (p = 0.56) but showed a greater early response rate at 12 weeks after initiating therapy. |
| Control Group Info: | single arm |
| Treatment Info: | patients underwent dynamic acquisition positron emission tomography (PET) imaging using (18) Ffluorodeoxyglucose (FDG) and (18) Ffluorothymidine (FLT) at baseline and early in treatment (after 1, 2, 3 or 4 weeks) with 37.5 mg continuous daily dosing of sunitinib. Semiquantitative analyses were performed to characterize the tumor metabolic (FDG) and proliferative (FLT) responses to treatment. |
| Primary End Point: | Early measurement of response to sunitinib therapy |
| Secondary End Point: | NA |
| Patients Number: | 20 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | A metabolic response was observed in 5/19 patients, however this was not observed until after two weeks of therapy were completed. Metabolic progression was observed in 2/19 patients and proliferative progression was observed in 1/19 patients. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | While preliminary in nature, these results show an immediate and sustained proliferative response follotheyd by a delayed metabolic response beginning after two weeks in metastatic renal cell carcinoma treated with a continuous daily dose of 37.5?mg sunitinib. The results provide evidence of tumor response to lotheyrdose sunitinib while also supporting the inclusion of PET imaging as a tool for early assessment in oncological clinical trials. |