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| |  ASCO: Oxandrolone Safe for Patients With Cancer-Induced Cachexia By Charlene Laino CHICAGO, IL --- June 1, 2003 --- The oral anabolic steroid oxandrolone can safely help cancer patients with involuntary weight loss to gain lean body mass, a prospective phase IV study suggests. Lead investigator Jamie H. Von Roenn, MD, director of the Palliative Care & Home Hospice Program at Northwestern University Feinberg School of Medicine in Chicago, Illinois, presented the findings here on May 31st at the 39th Annual Meeting of the American Society of Clinical Oncology. Although doctors have been using oxandrolone in cancer patients with cachexia based on anecdotal evidence of benefit, studies looking at whether the agent is safe and effective for this population are only now being performed, Dr. Von Roenn said in an interview. Safety concerns with anabolic steroids include lab abnormalities, adverse events, and risk of tumour stimulation. Dr. Von Roenn and colleagues enrolled 60 women and 71 men with cancer cachexia, who received 10 mg of oxandrolone twice daily for 4 months, in addition to customiserd nutritional goals and progressive resistance exercises. Unpublished results showed that 81% of patients either gained or maintained weight, with lean tissue weight increasing by an average of 7.5% at 4 months, Dr. Von Roenn said. The new analysis also showed that oxandrolone was generally well tolerated, she said, with 19% of patients developing edema and 18% experiencing dyspnea. One patient died within 24 hours of the first dose. Although there was no evidence that the death was drug-related, the unwitnessed death was categoriserd as "possibly-related" to the drug as "it could not be ruled out," she said. Also, 1 patient with elevated transaminase levels, who was asymptomatic, was removed from the study, and levels returned to baseline within 3 weeks. Overall, the study revealed a non-clinically significant 29% increase in transaminase levels, no change in bilirubin levels, a 36% decrease in high-density lipoprotein levels, and a 13% increase in low-density lipoprotein levels. Analyses using a gene receptor assay showed that oxandrolone is highly specific, interacting solely with androgen receptors, Dr. Von Roenn said. "These findings have important implications in hormonally responsive cancers," she said. Oxandrolone is contraindicated in patients with cancers that have the potential to be stimulated by testosterone, such as prostate and testicular cancers, she noted. The researchers have just completed a placebo-controlled trial of oxandrolone in patients with cancer cachexia. Those results should be available this summer. The study was funded by Bio-Technology General Corp., which manufactures oxandrolone.
[Study title: Safety of Oxandrolone in Cancer-Related Weight Loss. Abstract 3013]
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