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| |  Axitinib Shows Promise for Renal Cell Cancer Patients Refractory to Sunitinib, Sorafenib, and Cytokines: Presented at ASCO By Cameron Johnston CHICAGO -- June 5, 2008 -- Patients with metastatic, clear-cell, renal cell carcinoma who are refractory to sorafenib, with or without interferon, and to sunitinib alone or in combination with sorafenib have shown a good response to therapy when treated with oral, twice-daily axitinib (AG-013736), researchers reported here at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting. The study results suggest that axitinib could offer some therapeutic benefit for these patients, who will have exhausted virtually all other options for treatment, according to researcher Janice Dutcher, MD, Our Lady of Mercy Medical Center, New York, New York. The study was based on a post-hoc analysis of a prior open-label, phase 2 study. In that study, patients had undergone nephrectomy and had had unacceptable toxicities and/or disease progression, Dr. Dutcher said in a presentation on May 31. All patients had been previously treated with sunitinib and sorafenib (group 1, n = 14), sorafenib plus cytokines (group 2, n = 29), or sorafenib alone (group 3, n = 15). A small number of patients also had received other therapies and were excluded from this analysis. Patients were offered axitinib alone at a starting dose of 5 mg BID, which could be titrated or reduced as necessary. Patients were treated at an average dose of 5 mg BID (range, 2.5-8.6 mg) for a median of 4 months (range, 0.01-13 months). At a median of 10.3 months of follow-up, the objective response rate was 7% in group, 28% in group 2, and 27% in group 3. Median progression-free survival rates for the 3 groups were 7.1 months, 9 months, and 7.7 months, respectively. Partial responses were seen in 1 out of 14 patients in group 1; 8 out of 29 patients in group 2; and in 4 out of 16 patients in group 3. Stable disease of more than 6 months' duration was seen in 8, 10, and 2 patients in the 3 groups, respectively. Overall survival was 11.5 in group 1 and 9.2 months in group 2. Median overall survival for those who had received prior sorafenib/cytokine therapy (group 2) had not been reached at the time of the presentation, but was at least 18.5 months. Grade 3 and 4 toxicities include hand-foot syndrome (16%), fatigue (14.5%), hypertension (14.5%), and diarrhoea (10%). None of the patients developed haematological toxicities; 3 patients developed grade III lymphopenia. These data indicate that the oral agent axitinib was effective, with at least some antitumour activity in patients with advanced renal cell carcinoma who have already failed other therapies. The treatment effect was most pronounced among patients who had already been treated with the combination of sorafenib plus cytokine therapy. However, no conclusions can be drawn about the more widespread use of this drug, due to the limited patient numbers, the researchers said. Adverse events were comparable to what has been seen with the drug in other studies and were mostly mild to moderate in severity. A randomised, phase 3 study investigating the use of axitinib as second-line therapy in patients with advanced renal cell carcinoma is being planned. Funding for this study was provided by Pfizer Oncology.
[Presentation title: Sequential Axitinib (AG-013736) Therapy of Patients (Pts) With Metastatic Clear Cell Renal Cell Cancer (RCC) Refractory to Sunitinib and Sorafenib, Cytokines and Sorafenib, or Sorafenib Alone. Abstract 5127]
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