Entry Detail
| General information | |
| Database: | DB00460 |
| Objective: | They investigated the efficacy of sunitinib, a multikinase VEGF inhibitor, in patients with relapsed/refractory GE/oesophageal cancer. |
| Authors: | Wu C, et al |
| Title: | a phase II and pharmacodynamic study of sunitinib in relapsed/refractory oesophageal and gastrooesophageal cancers. |
| Journal: | Br J Cancer. |
| Year: | 2015 |
| PMID: | 26151457 |
| Trial Design | |
| Clinical Trial Id: | NCT00702884 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | esophageal cancer and esophagusgastroesophageal junction cancer |
| Cancer Subtype: | esophageal or GE cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | phase II and pharmacodynamic study |
| Key Patients Feature: | Patients were required to have unresectable pathologically confirmed oesophageal or GE cancer, measurable diseaseper RECIST 1.0, no 42 lines of prior palliative therapy, no priorantiVEGF therapy, ECOG performance status of p1, no cardiacdysrhythmias, normal or wellcontrolled blood pressure, normal orwellcontrolled thyroid function, and no warfarin. |
| Biomarker: | NA |
| Biomark Analysis: | Serum VEGFA and C levels, tumour complement factor B (CFB) gene expression, and DCEMRI correlated with clinical benefit, defined as SD or better as best response. |
| Control Group Info: | single arm |
| Treatment Info: | Patients received sunitinib 37.5 mg orally daily and imaged every 6 weeks. Exploratory correlative analysis included serum growth factors, tumour gene expression and dynamic contrastenhanced magnetic resonance imaging (DCEMRI). |
| Primary End Point: | progression free survival (PFS) at 24 weeks. |
| Secondary End Point: | NA |
| Patients Number: | 25 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | the duration of best response for the patients was 23 and 72 weeks. Ten patients (42%) had stable disease (SD) for >10 weeks. Overall response rate is 13%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7 weeks (95% CI: 5.6-11.4 weeks) |
| Median OS A vs. C: | 17 weeks (95% CI: 8.9-25.3 weeks) |
| Adverse Event(agent arm): | Most common grade 3/4 toxicities included fatigue (24%), anaemia (20%) thrombocytopenia (16%), and leucopenia (16%). No patients discontinued therapy due to toxicity. |
| Conclusions: | Sunitinib is well tolerated but only a select subgroup of patients benefited. Serum VEGFA and C may be early predictors of benefit. On this study, patients with clinical benefit from sunitinib had higher tumour CFB expression, and thus has identified CFB as a potential predictor for efficacy of antiangiogenic therapy. These findings need validation from future prospective trials. |