According to a press release from Alfacell Corporation, the addition of ONCONASE® (ranpirnase) to Adriamycin® (doxorubicin) improves survival over doxorubicin alone in patients with inoperable mesothelioma.
Malignant pleural mesothelioma is a rare cancer that develops in the tissue that covers the lungs and lines the interior of the chest. It is often caused by chronic exposure to asbestos. The majority of patients are not diagnosed until the disease has progressed to an advanced stage and treatment with surgery or radiation is not an option. Patients with this disease often have a decreased quality of life due to symptoms such as shortness of breath, cough, pain, fatigue, and the inability to eat.
Mesothelioma is fairly resistant to most therapies, including surgery, chemotherapy, and radiation therapy. Therefore, finding a chemotherapy regimen or new therapeutic approaches that can improve quality of life or survival is essential for improving care in this population.
ONCONASE is an agent that is meant to target cancerous cells while sparing healthy cells from side effects. ONCONASE is taken into cancerous cells, where it kills the cell through various processes. ONCONASE is not yet approved by the U.S. Food and Drug Administration (FDA).
Researchers recently conducted a clinical trial to evaluate the addition of ONCONASE to doxorubicin compared with doxorubicin alone in the treatment of inoperable mesothelioma. This trial included 143 patients. Results are below:
- Median survival was improved by two months with the addition of ONCONASE (12 months for patients treated with ONCONASE/doxorubicin compared with only 10 months for those treated with doxorubicin alone).
- At one year 47% of patients treated with ONCONASE/doxorubicin were alive compared with only 36% of patients treated with doxorubicin only.
- The median duration of disease regression or disease stabilization was improved by seven months in the group of patients treated with ONCONASE/doxorubicin (17 months) compared to those treated with doxorubicin alone (10 months).
The researchers concluded that the addition of ONCONASE to doxorubicin improves outcomes compared to doxorubicin alone in the treatment of inoperable malignant mesothelioma. Future trials evaluating the addition of ONCONASE to more effective chemotherapy agents in the treatment of mesothelioma are warranted to determine its true clinical effectiveness.
Reference: Alfacell Corporation. Alfacell Provides Update on ONCONASE Phase IIIb Confirmatory Registration Trial; Releases First Interim Analysis Data. Available at: http://www.snl.com/irweblinkx/file.aspx?IID=4104784&FID=2237286. Accessed May 2006.