Entry Detail
| General information | |
| Database: | DB00482 |
| Objective: | The ROSORC trial, a randomised, phase II trial comparing sorafenib plus interleukin (IL2) versus sorafenib alone as firstline treatment of metastatic renal cell carcinoma (mRCC) failed to demonstrate differences in progression free survival (PFS). Updated overall survival (OS) results are reported. |
| Authors: | Procopio G, et al |
| Title: | Overall survival for sorafenib plus interleukin2 compared with sorafenib alone in metastatic renal cell carcinoma (mRCC): final results of the ROSORC trial. |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 24063860 |
| Trial Design | |
| Clinical Trial Id: | NCT00609401 |
| 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: | 14 |
| Therapeutic Combination Content: | sorafenib plus interleukin2 |
| Study Type: | prospective randomised, openlabel, multicentrephase II study |
| Key Patients Feature: | Eligible patients were aged more than and equal to 18 years, with a lifeexpectancy more than and equal to 3 months and an Eastern Cooperative Oncology Groupperformance status less than and equal to 2. They had a histologically based diagnosis of mRCC.All histologies had at least one measurable 1D lesion detected by computedtomography (CT) or magnetic resonance imaging (MRI) and were evaluatedaccording to the Response Evaluation Criteria for Solid Tumours (RECIST)criteria v.1.0 [7]. Patients had not been previously treated with systemictherapy for metastatic disease, but they could have undergone nephrectomy. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:sorafenib plus interleukin2 B:sorafenib alone |
| Treatment Info: | patients were randomised to receive sorafenib 400 mg twice daily plus subcutaneous IL2 4.5 million international units (MIU) five times per week for 6 weeks every 8 weeks (arm A) or sorafenib alone (arm B). |
| Primary End Point: | OS |
| Secondary End Point: | NA |
| Patients Number: | 128 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median PFS was 7.3 versus 6.9 months, showing a trend in favour of the combination arm (P = 0.109) |
| Median OS A vs. C: | the median OS was 38 and 33 months in arms A and B, respectively (P = 0.667). The 5year OS was 26.3% [95% confidence interval (CI) 15.9-43.5) and 23.1% (95% CI 13.2-40.5) for the combination and singleagent arm, respectively. |
| Adverse Event(agent arm): | The most common AEs were asthenia, handfoot syndrome, hypertension, and diarrhoea. Grade 3-4 AEs were documented for 38% and 25% of the patients receiving combination and singleagent treatment, respectively. |
| Conclusions: | This outcome suggests a synergistic effect of the subsequent therapies following sorafenib failure. |