Tue
30
Oct
A phase II trial on axitinib, a new experimental drug for treating patients with cytokine-refractory, metastatic kidney cancer who have a poor response to more traditional drugs has shown promising results according to a new study published in the The Lancet Oncology.
Professor Olivier Rixe of the University of Paris, France, and colleagues assessed the activity and safety of axitinib in a group of patients with metastatic renal-cell cancer who had failed to respond to cytokine-based treatments.
The researchers enrolled 52 patients between October 2003 and April 2004. Each patient had at least one measurable lesion that could be targeted and was given an oral dose of axitinib starting at 5 mg twice a day.
Rixe and colleagues assessed the percentage of patients who responded either completely or partially using the Response Evaluation Criteria In Solid Tumors (RECIST) method, as well as how long they took to respond, the time to progression, overall survival, safety and other measures.
In an intention to treat analysis, the study produced the following results:
* Of the 52 patients, 2 responded completely and 21 partially.
* This equated to an objective response rate of 44.2 per cent.
* The median response rate was 23.0 months (range 4.2 to 29.8 months).
* But 12 of 23 initial responders progressed with response durations of 4.2 to 26.5 months.
* Also, 22 patients showed stable disease for more than 8 weeks, with 13 of them for 24 weeks or more.
* 4 patients had early disease progression, 3 had missing response data.
* Median time to progression was 15.7 months (range 0.03 to 31.5 months).
* Median overall survival was 29·9 months (range 2·4 to 35·8 months).
* Adverse events linked to treatment included diarrhoea, hypertension, fatigue, nausea, and hoarseness.
* High blood pressure was found in 30 patients.
* Of these, all but 8 responded to blood pressure treatment. 7 of the 8 had a history of high blood pressure at enrollment.
The researchers concluded that:
"Axitinib shows clinical activity in patients with cytokine-refractory metastatic renal-cell cancer. Although 28 patients had grade 3 or grade 4 treatment-related adverse events, these adverse events were generally manageable and controlled by dose modification or supportive care, or both. Further studies are needed to confirm these findings."
Professor Olivier Rixe of the University of Paris, France, and colleagues assessed the activity and safety of axitinib in a group of patients with metastatic renal-cell cancer who had failed to respond to cytokine-based treatments.
The researchers enrolled 52 patients between October 2003 and April 2004. Each patient had at least one measurable lesion that could be targeted and was given an oral dose of axitinib starting at 5 mg twice a day.
Rixe and colleagues assessed the percentage of patients who responded either completely or partially using the Response Evaluation Criteria In Solid Tumors (RECIST) method, as well as how long they took to respond, the time to progression, overall survival, safety and other measures.
In an intention to treat analysis, the study produced the following results:
* Of the 52 patients, 2 responded completely and 21 partially.
* This equated to an objective response rate of 44.2 per cent.
* The median response rate was 23.0 months (range 4.2 to 29.8 months).
* But 12 of 23 initial responders progressed with response durations of 4.2 to 26.5 months.
* Also, 22 patients showed stable disease for more than 8 weeks, with 13 of them for 24 weeks or more.
* 4 patients had early disease progression, 3 had missing response data.
* Median time to progression was 15.7 months (range 0.03 to 31.5 months).
* Median overall survival was 29·9 months (range 2·4 to 35·8 months).
* Adverse events linked to treatment included diarrhoea, hypertension, fatigue, nausea, and hoarseness.
* High blood pressure was found in 30 patients.
* Of these, all but 8 responded to blood pressure treatment. 7 of the 8 had a history of high blood pressure at enrollment.
The researchers concluded that:
"Axitinib shows clinical activity in patients with cytokine-refractory metastatic renal-cell cancer. Although 28 patients had grade 3 or grade 4 treatment-related adverse events, these adverse events were generally manageable and controlled by dose modification or supportive care, or both. Further studies are needed to confirm these findings."
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Tuesday, October 30th, 2007 at 9:05 pm
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