The Axitinib metastatic renal cell tumor activity
Being studied drug axitinib (under development by Pfizer), in Phase II clinical study for metastatic renal cell tumor activity, the study, published in the October 22 Lacent Oncology; researchers say , some of the reaction can be sustained for a long time, but the findings in a follow-up study confirmed these research projects in progress
Axitinib is an oral high titer, and vascular endothelial growth factor receptor first, second and third selective inhibitor activity and has been shown to be effective against thyroid and pancreatic cancer; these two potential The research indications currently a Phase III clinical trial sponsored by the manufacturer.
This is sponsored by the manufacturer, for the study of renal cell carcinoma, Olivier Rixe physicians perform by the Pitie-Salpetriere Hospital in Paris, France, the study included 52 has been transferred, and at least one cytokine-based therapy (interferon alpha, interleukin 2, or both) refractory patients, these patients have received axitinib, a dose of 5 mg twice a day dosing; However, eight patients because of an adverse reaction (2 patients developed diarrhea, severe fatigue in two patients; another one patients had gastrointestinal discomfort, dehydration, muscle aches, gout), another seven patients because the second grade of high blood pressure and lowering the dose.
By the researchers evaluated the overall response was 44.2%, of which two patients showed complete response and 21 patients had partial responses; researchers comment, certain reactions seen in a very short time ( 12 patients in the treatment of the first 30 days and 65 days there is reaction), but still slow response of some patients, 9 patients with reactions at 90 and 403 days, the other two patients completely The reaction takes place in the first 246 days and 362 days. However, the researchers said, 12 of the 23 patients began to respond, but after disease progression; reaction length of time from 4.2 to 26.5 months, an average of 23 months.
Rixe, MD, and his colleagues said that the past use of cytokine-based therapy but a poor response in patients with renal cell tumors, disease progression need an average of 15.7 months, and this, together with a response rate of 44.2% is significant ; They added that the use of the drug required for disease progression, compared to other drugs is longer; the team, said 22 patients after starting the drug, stable disease for up to 8 weeks, including 13 patients had stable disease for up to 24 weeks or more, these results show that the drug has clinical benefits, even if the tumor did not significantly reduce the patient is; They concluded that, although the need for randomized controlled trials to confirm these results, it Axitinib suffering from metastatic renal cell tumor patients might be a potential drug treatment.
Rixe, MD, and his colleagues said that the toxicity of the drugs can be dealt with, and no hematologic toxicity; most frequently reported adverse reactions were diarrhea, hypertension, fatigue, nausea, sore throat, and these adverse reactions are dose adjustment and supportive therapy, or a combination of both used to treat; They pointed out that hypertension is an expected adverse reactions of these drugs, as well as similar drugs, such as bevacizumab (Avastin, Genentech manufacturing); in this study axitinib treatment when patients are using, you can use the blood pressure lowering drugs to control blood pressure and stop using axitinib, blood pressure will return to normal.
In an accompanying editorial, classes in Bethesda, Maryland Marston Linehan, MD, of the National Cancer Institute to submit comments on these adverse reactions, he said that these adverse reactions than other heavy phosphatase inhibitor drugs, such as sunitinib (Sutent, Pfizer manufacturing) with, Bayer sorafenib (Nevaxar, manufacturing), these two drugs have been approved for use in the treatment of advanced kidney cancer in the United States. In addition to the less toxic potential of axitinib for a single growth factor receptor provides a single precision against the complex molecular pathways underlying opportunities, he said, it is difficult to know for what kind of raw factor receptor is the most effective.
Linehan, MD, concluded that although more research is needed, this study found that this drug, such as axitinib, has the potential to be used as second-line therapy of renal cell carcinoma cell hormone therapy invalid, and may have as with other drugs and the first line of therapy.
The Rixe physician authors as Pfizer consultant, accept the company's remuneration. Dr. Linehan said no relevant financial relationships.
Axitinib is an oral high titer, and vascular endothelial growth factor receptor first, second and third selective inhibitor activity and has been shown to be effective against thyroid and pancreatic cancer; these two potential The research indications currently a Phase III clinical trial sponsored by the manufacturer.
This is sponsored by the manufacturer, for the study of renal cell carcinoma, Olivier Rixe physicians perform by the Pitie-Salpetriere Hospital in Paris, France, the study included 52 has been transferred, and at least one cytokine-based therapy (interferon alpha, interleukin 2, or both) refractory patients, these patients have received axitinib, a dose of 5 mg twice a day dosing; However, eight patients because of an adverse reaction (2 patients developed diarrhea, severe fatigue in two patients; another one patients had gastrointestinal discomfort, dehydration, muscle aches, gout), another seven patients because the second grade of high blood pressure and lowering the dose.
By the researchers evaluated the overall response was 44.2%, of which two patients showed complete response and 21 patients had partial responses; researchers comment, certain reactions seen in a very short time ( 12 patients in the treatment of the first 30 days and 65 days there is reaction), but still slow response of some patients, 9 patients with reactions at 90 and 403 days, the other two patients completely The reaction takes place in the first 246 days and 362 days. However, the researchers said, 12 of the 23 patients began to respond, but after disease progression; reaction length of time from 4.2 to 26.5 months, an average of 23 months.
Rixe, MD, and his colleagues said that the past use of cytokine-based therapy but a poor response in patients with renal cell tumors, disease progression need an average of 15.7 months, and this, together with a response rate of 44.2% is significant ; They added that the use of the drug required for disease progression, compared to other drugs is longer; the team, said 22 patients after starting the drug, stable disease for up to 8 weeks, including 13 patients had stable disease for up to 24 weeks or more, these results show that the drug has clinical benefits, even if the tumor did not significantly reduce the patient is; They concluded that, although the need for randomized controlled trials to confirm these results, it Axitinib suffering from metastatic renal cell tumor patients might be a potential drug treatment.
Rixe, MD, and his colleagues said that the toxicity of the drugs can be dealt with, and no hematologic toxicity; most frequently reported adverse reactions were diarrhea, hypertension, fatigue, nausea, sore throat, and these adverse reactions are dose adjustment and supportive therapy, or a combination of both used to treat; They pointed out that hypertension is an expected adverse reactions of these drugs, as well as similar drugs, such as bevacizumab (Avastin, Genentech manufacturing); in this study axitinib treatment when patients are using, you can use the blood pressure lowering drugs to control blood pressure and stop using axitinib, blood pressure will return to normal.
In an accompanying editorial, classes in Bethesda, Maryland Marston Linehan, MD, of the National Cancer Institute to submit comments on these adverse reactions, he said that these adverse reactions than other heavy phosphatase inhibitor drugs, such as sunitinib (Sutent, Pfizer manufacturing) with, Bayer sorafenib (Nevaxar, manufacturing), these two drugs have been approved for use in the treatment of advanced kidney cancer in the United States. In addition to the less toxic potential of axitinib for a single growth factor receptor provides a single precision against the complex molecular pathways underlying opportunities, he said, it is difficult to know for what kind of raw factor receptor is the most effective.
Linehan, MD, concluded that although more research is needed, this study found that this drug, such as axitinib, has the potential to be used as second-line therapy of renal cell carcinoma cell hormone therapy invalid, and may have as with other drugs and the first line of therapy.
The Rixe physician authors as Pfizer consultant, accept the company's remuneration. Dr. Linehan said no relevant financial relationships.
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