Entry Detail
| General information | |
| Database: | DB00487 |
| Objective: | Axitinib is a potent and selective secondgeneration inhibitor of vascular endothelial growth factor receptors 1, 2 and 3. The efficacy and safety of axitinib in Japanese patients with metastatic renal cell carcinoma were evaluated. |
| Authors: | Ueda T, et al |
| Title: | Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomizedphase 3 AXIS trial. |
| Journal: | Jpn J Clin Oncol. |
| Year: | 2013 |
| PMID: | 23630366 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | axitinib |
| Target: | Macrophage colonystimulating factor 1 Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced clear cell renal carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a twoarm, multicenter, openlabel, randomized, controlledphase III clinical trial |
| Key Patients Feature: | key eligibility criteria were aged 18 years (20 years in Japan)or older; histologically or cytologically confirmed mRCC ofclearcell subtype; Response Evaluation Criteria in SolidTumors (RECIST, v1.0)defined progressive disease afterone prior systemic firstline regimen; ECOG performancestatus 0 or 1; adequate bone marrow, hepatic and renalfunction; baseline proteinuria , 2t by urine dipstick or, 2 g/24 h urine collection; and no uncontrolled hypertension, i.e. blood pressure (BP) 140/90 mmHg at baseline(prior antihypertensive medications were permitted). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sorafenib |
| Treatment Info: | patients enrolled in the randomizedphase III trial of axitinib versus sorafenib after failure of one prior systemic therapy for metastatic renal cell carcinoma. |
| Primary End Point: | IRCassessed PFS, was achieved in Japanese patients. |
| Secondary End Point: | ORR and PROs, supported the finding that axitinib improved efficacy over sorafenib in Japanese patients. |
| Patients Number: | 723 |
| Trial Results | |
| DLT_MTD: | The common allcausality adverse events (all grades) in Japanese patients were dysphonia (68%), hypertension (64%), handfoot syndrome (64%) and diarrhea (56%) for axitinib, and handfoot syndrome (86%), hypertension (62%) and diarrhea (52%) for sorafenib. |
| Objective Response Rate: | In the overall population, IRCassessed ORR was 19.4 vs. 9.4%, respectively (P = 0.0001) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median progression free survival in Japanese patients was 12.1 months (95% confidence interval 8.6 to not estimable) for axitinib and 4.9 months (95% confidence interval 2.8-6.6) for sorafenib (hazard ratio 0.390; 95% confidence interval 0.130-1.173; stratified onesided P 0.0401). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The common allcausality adverse events (all grades) in Japanese patients were dysphonia (68%), hypertension (64%), hand-foot syndrome (64%) and diarrhea (56%) for axitinib, and hand-foot syndrome (86%), hypertension (62%) and diarrhea (52%) for sorafenib. |
| Conclusions: | Axitinib is efficacious and well tolerated in Japanese patients with previously treated metastatic renal cell carcinoma, consistent with the results in the overall population, providing a new targeted therapy for these Japanese patients. |