Entry Detail
| General information | |
| Database: | DB00501 |
| Objective: | arcomatoid renal cell cancer (RCC) is a distinct histological variant of RCC that is associated with rapid progression and a poor prognosis. The optimal treatment for patients with sarcomatoid RCC remains to be defined. Gemcitabine plus doxorubicine (GD) has shown some efficacy, however durability of response is limited. they carried out a prospective, openlabel study to investigate the efficacy and safety of sorafenib in patients after GD failure in sarcomatoid RCC. |
| Authors: | Staehler M, et al |
| Title: | Sorafenib after combination therapy with gemcitabine plus doxorubicine in patients with sarcomatoid renal cell carcinoma: a prospective evaluation. |
| Journal: | Eur J Med Res. |
| Year: | 2010 |
| PMID: | 20696639 |
| 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 carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Sorafenib gemcitabine +doxorubicine |
| Study Type: | a prospective, openlabel study |
| Key Patients Feature: | Study participants were treatmentna ve patients withmetastatic RCC confirmed by high resolution computerized tomography (Ct) scans. all patients had previous nephrectomy, pure sarcomatoid RCC, based onadvanced immunhohistochemical evaluation by a single pathologist, and progressive disease determined byimaging over at least one month. Patients had to havean Eastern Cooperative oncology group (ECoG)performance status of 0 or 1, normal cardiac and organic function, assessed by electrocardiography(ECG), and normal serum analysis was mandatory |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Fifteen patients with pure sarcomatoid RCC and objective progressive disease were treated with GD (gemcitabine 1500 mg/m2, doxorubicine 50 mg/m2 administered by weekly intravenous infusion) until progression of disease. Subsequently 9 patients were switched to sorafenib (400 mg twice daily). |
| Primary End Point: | Tumor response, TTP, toxicities |
| Secondary End Point: | NA |
| Patients Number: | 15 |
| Trial Results | |
| DLT_MTD: | Diarrhea and hypertensionwere the most common side effects. |
| Objective Response Rate: | Six patients died from progressive diseaseprior to being switched to sorafenib.nine patients were treated with sorafenib. one patienthad a partial remission (fig. 1) lasting for 3months and four patients experienced stable diseasewith a duration of 3 to 9 months. |
| Disease Control Rate: | NA |
| Median Time to Progression: | Median time to progression (ttP) under GD was 6.6 months (range 0.8 - 8 months). Median ttP for the 9 patients switched to sorafenib was 10.9 months (range 0.6 - 25.5 months). |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | among the nine patients treated with sorafenib overall survival (oS) from initial diagnosis was 36.4 months and oS from diagnosis of metastatic disease was 8.0months. |
| Adverse Event(agent arm): | NA |
| Conclusions: | Chemotherapy with GD was ineffective in our patients with pure sarcomatoid RCC. Subsequent antiangiogenic treatment using the multityrosine kinase inhibitor sorafenib resulted in additional progression free survival in 5 of 9 patients. Further evaluation of targeted antiangiogenic agents for the treatment of sarcomatoid RCC is warranted. |