| General information |
| Database: | DB00111 |
| Objective: | There is strong rationale to combine temsirolimus (TEM) with Bevacizumab (BEV) for patients with advanced hepatocellular carcinoma. |
| Authors: | Knox JJ, et al |
| Title: | a phase II trial of bevacizumab plus temsirolimus in patients with advanced hepatocellular carcinoma. |
| Journal: | Invest New Drugs. |
| Year: | 2015 |
| PMID: | 25318437 |
| Trial Design |
| Clinical Trial Id: | NCT01010126 |
| Agent: | bevacizumab, temsirolimus
|
| Target: | NA
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma not amenable to surgical or regional therapies |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | temsirolimus(TEM)+Bevacizumab(BEV) |
| Study Type: | A modified twostage Simonphase II trial |
| Key Patients Feature: | pts had advanced hepatocellular carcinoma, Child Pugh A liver status and no prior systemic therapy involving the VEGF or mTOR targeted agents. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with temsirolimus 25 mg IV on Days 1, 8, 15, and 22 of a 28 day cycle and bevacizumab 10 mg/kg IV on Days 1 and 15 of the cycle. |
| Primary End Point: | Toxicity, PFS |
| Secondary End Point: | overall survival |
| Patients Number: | 28 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | the first 25 evaluable patients showed only one PR, the final data update in March 2013 demonstrated 4 confirmed PRs, a 5th unconfirmed PR |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | interim analysis of the first 25 showed 16/25 were progression free at 6 months. The final data showed 16 /26 progression free at 6 months, median PFS was 7 months |
| Median OS A vs. C: | the median OS was 14 months |
| Adverse Event(agent arm): | Drug related toxicities were common including cytopenias, fatigue, mucositis, diarrhea and mild bleeds. |
| Conclusions: | This firstline hepatocellular carcinoma trial evaluating the BEVTEM doublet reports an ORR of 19 % and OS of 14 months which is favorable but requires further study at a more optimized dose and schedule. |