Entry Detail
| General information | |
| Database: | DB00496 |
| Objective: | The treatment of advanced renal cell carcinoma has been revolutionised by targeted therapy with drugs that block angiogenesis. So far, nophase 3 randomised trials comparing the effectiveness of one targeted agent against another have been reported. they did a randomisedphase 3 study comparing axitinib, a potent and selective secondgeneration inhibitor of vascular endothelial growth factor (VEGF) receptors, with sorafenib, an approved VEGF receptor inhibitor, as secondline therapy in patients with metastatic renal cell cancer. |
| Authors: | Rini BI, et al |
| Title: | Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomisedphase 3 trial. |
| Journal: | Lancet. |
| Year: | 2011 |
| PMID: | 22056247 |
| Trial Design | |
| Clinical Trial Id: | NCT00678392 |
| Agent: | axitinib |
| Target: | Macrophage colonystimulating factor 1 Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | renal cell carcinoma with a clear cell component |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | multicentrephase III randomised controlled trial |
| Key Patients Feature: | patients 18 years or older with histologically orcytologically confi rmed renal cell carcinoma with a clearcell component. All patients had measurable disease byResponse Evaluation Criteria in Solid Tumours (RECIST, version 1.0)17 and RECISTdefi ned progressive disease asassessed by investigators after one previous systemic firstline regimen with a sunitinibbased, bevacizumab plusinterferonalfabased, temsirolimusbased, or cytokinebased regimen, which refl ected all regimens withregulatory approvals at the time of study design. Eligibilitycriteria were 2 weeks or more since end of previoussystemic treatment (4 weeks or more for bevacizumab plusinterferonalfa); Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1; life expectancy of12 weeks or more; and adequate renal, hepatic, andhaematological organ function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sorafenib |
| Treatment Info: | pts were stratified and and then randomly assigned (1:1) to either axitinib (5 mg twice daily) or sorafenib (400 mg twice daily). Axitinib dose increases to 7 mg and then to 10 mg, twice daily, were allowed for those patients without hypertension or adverse reactions above grade 2. |
| Primary End Point: | progression free survival (PFS) |
| Secondary End Point: | NA |
| Patients Number: | 723 |
| Trial Results | |
| DLT_MTD: | The most common adverse events werediarrhoea, hypertension, and fatigue in the axitinib arm, and diarrhoea, palmarplantar erythrodysaesthesia, andalopecia in the sorafenib arm. |
| Objective Response Rate: | The objective response rate as assessed by maskedindependent radiology review committee was 19% foraxitinib and 9% for sorafenib (p=0.0001), with a medianduration of response of 11 months (95% CI 7.4-notestimable) for axitinib and 10.6 months (8.8-11.5) forsorafenib |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median PFS was 6.7 months with axitinib compared to 4.7 months with sorafenib (hazard ratio 0.665; 95% CI 0.544-0.812; onesided p<0.0001). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common adverse events were diarrhoea, hypertension, and fatigue in the axitinib arm, and diarrhoea, palmarplantar erythrodysaesthesia, and alopecia in the sorafenib arm. |
| Conclusions: | Axitinib resulted in significantly longer PFS compared with sorafenib. Axitinib is a treatment option for secondline therapy of advanced renal cell carcinoma. |