Entry Detail
| General information | |
| Database: | DB00988 |
| Objective: | Thisphase II study evaluated the activity of combined treatment with interferon alfa2b and sorafenib, a Raf and multiple receptor tyrosine kinase inhibitor, in patients with advanced renal carcinoma. |
| Authors: | Ryan CW, et al |
| Title: | Sorafenib with interferon alfa2b as firstline treatment of advanced renal carcinoma: a phase II study of the Souththeyst Oncology Group. |
| Journal: | J Clin Oncol. |
| Year: | 2007 |
| PMID: | 17664477 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 15 |
| Therapeutic Combination Content: | Sorafenib with interferon alfa2b |
| Study Type: | a phase II study of the Souththeyst Oncology Group |
| Key Patients Feature: | Eligible patients had metastatic or unresectable renal carcinoma with a clearcell component, no prior systemic therapy, performance status 0 to 1, and measurable disease. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Treatment consisted of interferon alfa2b 10 x 10(6) U subcutaneously three times weekly and sorafenib 400 mg orally bid |
| Primary End Point: | confirmed Response Evaluation Criteria in Solid Tumors response rate. |
| Secondary End Point: | NA |
| Patients Number: | 62 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 19% |
| Disease Control Rate: | 69% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7 months (95% CI, 4 to 11 months) |
| Median OS A vs. C: | 17 months |
| Adverse Event(agent arm): | The toxicity profile of the regimen was dominated by adverse events commonly attributed to interferon, including fatigue, anorexia, rigors/chills, leukopenia, and fever. Diarrhea, reported in 63% of patients, was a potentially overlapping toxicity between the two agents. Handfoot syndrome was reported in 16% of patients. Seven grade 4 toxicities were reported, including hyponatremia (n = 3), alkaline phosphatase (n = 1), confusion (n = 1), thrombosis/embolism (n = 1), and secondary malignancy (n = 1), which was a rapidlygrowing keratoacanthoma requiring radiation therapy. One patient died as a result of grade 5 hypotension several hours after receiving the first injection of interferon but before receiving any sorafenib. |
| Conclusions: | The confirmed response rate for the combination of sorafenib and interferon in advanced renal carcinoma is greater than expected with either interferon or sorafenib alone. The toxicity of this combination is dominated by adverse events common to interferon that limit further development of this regimen |