Thema: Presse: Efaproxiral may improve survival in patients with metastases
Presse: Efaproxiral may improve survival in patients with metastases
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02.03.2006 20:54:39
Cancer News
Cancer News Article
Efaproxiral May Improve Survival in Patients with Brain Metastases from Breast Cancer Receiving Radiation Therapy
A multi-center trial has demonstrated that the addition of efaproxiral to whole brain radiation improves the survival of patients with metastases to the brain from breast cancer. The details of this randomized trial appeared in the January 2006 issue of the Journal of Clinical Oncology .[1]
Metastases to the brain are a frequent complication of many cancers, especially cancers of the lung and breast. In some cases surgery or local irradiation can be used with some effect. However, most patients with metastases to the brain require whole brain radiation for palliation. It has been postulated that one of the reasons tumors of the brain respond poorly is hypoxia, which leads to relative resistance. Efaproxiral is a synthetic allosteric modifier that changes the conformational structure of hemoglobin binding, which results in greater oxygen diffusion and an increase in the partial pressure of oxygen in tissues.
This drug has undergone phase I testing and has been shown to be relatively well tolerated. A phase II study of efaproxiral plus oxygen in glioblastoma multiforme showed promising results.[2] A phase II study in patients with non-small cell lung cancer (NSCLC) with locally advanced disease receiving radiation therapy and chemotherapy also showed promising results.[3]
In the current study, 515 patients with brain metastases from solid tumors were randomly allocated to receive whole brain radiation with or without efaproxiral and oxygen. They reported a median survival time of 4.4 months for the control group and 5.4 months for the efaproxiral group. For patients with NSCLC or breast cancer, the median survival of the control group was 4.4 months compared to 6.0 months for the efaproxiral group. The use of efaproxiral reduced the risk of death by 49% while there did not appear to be a benefit in patients with NSCLC. They also report improved objective response rates in patients with breast cancer.
A separate study published ahead of print on January 27, 2006 in the International Journal of Radiation Oncology and Physics documented the improved response rates associated with efaproxiral at 3 and 6 month evaluations.[4] The most common side effect was hypoxia which was reversible. These authors concluded that efaproxiral was only promising in patients with breast cancer with brain metastases and a phase III randomized trial in this patient population has been started.
Comments: This study strongly suggests that the subset of patients with breast cancer appeared to benefit from efaproxiral. Based on this data Allos Therapeutics, Inc has announced global trade names which will be Efaproxyn in the United States and Revaproxyn in Europe.
Related News:
New Agent May Decrease Hypoxia and Improve Responses in Glioblastoma Multiforme (7/18/2002)
References
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[1] Suh JH, Baldassarre S, Nabid A, Kresl JJ, et al. Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases. Journal of Clinical Oncology. 2006;24:106-114.
[2] Kleinberg L, Grossman SA, Carson K, et al. Survival of patients with newly diagnosed Glioblastoma Multiforme treated with RSR13 and radiotherapy: Results of a phase II new approaches to the Brain Tumor Therapy CNS Consortium Safety and Efficacy study. Journal of Clinical Oncology. 2002;20:3149-3155.
[3] Choy H, Nabid A, Stea B, et al. Phase II multicenter study of induction chemotherapy followed by concurrent efaproxiral (RSR13) and thoracic radiotherapy for patients with locally advanced non-small-cell lung cancer. Journal of Clinical Oncology . 2005;23:5918-5928.
[4] Stea B, Suh JH, Boyd AP, et al. Whole-brain radiotherapy with or without efaproxiral for the treatment of brain metastases: Determinants of response and its prognostic value for subsequent survival. International Journal of Radiation Oncology Biology Physics . 2006 Jan 27;[epub ahead of print].
© 1998-2006 CancerConsultants.com All Rights Reserved.
Cancer News Article
Efaproxiral May Improve Survival in Patients with Brain Metastases from Breast Cancer Receiving Radiation Therapy
A multi-center trial has demonstrated that the addition of efaproxiral to whole brain radiation improves the survival of patients with metastases to the brain from breast cancer. The details of this randomized trial appeared in the January 2006 issue of the Journal of Clinical Oncology .[1]
Metastases to the brain are a frequent complication of many cancers, especially cancers of the lung and breast. In some cases surgery or local irradiation can be used with some effect. However, most patients with metastases to the brain require whole brain radiation for palliation. It has been postulated that one of the reasons tumors of the brain respond poorly is hypoxia, which leads to relative resistance. Efaproxiral is a synthetic allosteric modifier that changes the conformational structure of hemoglobin binding, which results in greater oxygen diffusion and an increase in the partial pressure of oxygen in tissues.
This drug has undergone phase I testing and has been shown to be relatively well tolerated. A phase II study of efaproxiral plus oxygen in glioblastoma multiforme showed promising results.[2] A phase II study in patients with non-small cell lung cancer (NSCLC) with locally advanced disease receiving radiation therapy and chemotherapy also showed promising results.[3]
In the current study, 515 patients with brain metastases from solid tumors were randomly allocated to receive whole brain radiation with or without efaproxiral and oxygen. They reported a median survival time of 4.4 months for the control group and 5.4 months for the efaproxiral group. For patients with NSCLC or breast cancer, the median survival of the control group was 4.4 months compared to 6.0 months for the efaproxiral group. The use of efaproxiral reduced the risk of death by 49% while there did not appear to be a benefit in patients with NSCLC. They also report improved objective response rates in patients with breast cancer.
A separate study published ahead of print on January 27, 2006 in the International Journal of Radiation Oncology and Physics documented the improved response rates associated with efaproxiral at 3 and 6 month evaluations.[4] The most common side effect was hypoxia which was reversible. These authors concluded that efaproxiral was only promising in patients with breast cancer with brain metastases and a phase III randomized trial in this patient population has been started.
Comments: This study strongly suggests that the subset of patients with breast cancer appeared to benefit from efaproxiral. Based on this data Allos Therapeutics, Inc has announced global trade names which will be Efaproxyn in the United States and Revaproxyn in Europe.
Related News:
New Agent May Decrease Hypoxia and Improve Responses in Glioblastoma Multiforme (7/18/2002)
References
--------------------------------------------------------------------------------
[1] Suh JH, Baldassarre S, Nabid A, Kresl JJ, et al. Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases. Journal of Clinical Oncology. 2006;24:106-114.
[2] Kleinberg L, Grossman SA, Carson K, et al. Survival of patients with newly diagnosed Glioblastoma Multiforme treated with RSR13 and radiotherapy: Results of a phase II new approaches to the Brain Tumor Therapy CNS Consortium Safety and Efficacy study. Journal of Clinical Oncology. 2002;20:3149-3155.
[3] Choy H, Nabid A, Stea B, et al. Phase II multicenter study of induction chemotherapy followed by concurrent efaproxiral (RSR13) and thoracic radiotherapy for patients with locally advanced non-small-cell lung cancer. Journal of Clinical Oncology . 2005;23:5918-5928.
[4] Stea B, Suh JH, Boyd AP, et al. Whole-brain radiotherapy with or without efaproxiral for the treatment of brain metastases: Determinants of response and its prognostic value for subsequent survival. International Journal of Radiation Oncology Biology Physics . 2006 Jan 27;[epub ahead of print].
© 1998-2006 CancerConsultants.com All Rights Reserved.
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