BETHESDA, Md--The Oncologic Drugs Advisory Committee (ODAC) has recommended that Sclerosol (sterile aerosol talc) be approved for use in relieving fluid around the lungs (malignant pleural effusion) of patients with cancer. The sponsor for Sclerosol, Bryan Corporation (Woburn, Mass), presented nine controlled trials (six articles and three abstracts), with an average of 12 patients each, in support of the talc.
In his presentation for Byran, John F. Beamis, MD, head, Pulmonary and Critical Care Medicine, Lahey Hitchcock Clinic, Burlington, Mass, cited his study of 11 patients, showing a 90% success rate, defined as no return of fluid after 30 and 90 days based on chest x-rays. None of the patients had recurrence of malignant pleural effusion after 1 month.
When asked about the talc's origins and freedom from asbestos, Frank Abrano, president of Bryan Corporation, said that the talc comes from a mine in France and is chemically tested in Massachusetts to be sure that it is asbestos-free. He added that this talc is also used in food processing in the United States. Dr. Beamis said that not only is the talc sterile but it is delivered directly into the chest during thoracoscopy, with no systemic distribution to other organs.
Lydia Larson, PharmD, speaking for the FDA, said that the talc has been used as a pleural sclerosing agent since the 1950s. Its use declined with the availability of injectable tetracycline(Drug information on tetracycline), then increased again when tetracycline was taken off the market.
Dr. Larson searched three databases and found 12 controlled clinical trials of the talc, covering a variety of tumors, including lung, ovarian, and breast. In all articles except one, a single dose of the talc was administered.
The success rate, defined as no re-accumulation of fluid on 3 to 12 months' follow-up by x-ray, was 90% to 100% with the talc vs 40% to 50% with other therapies. The symptomatic relief rate with the talc was 9 of 9 in one study, and 6 of 7 in another. Adverse effects included a 23% incidence of fever or pain and up to a 1% incidence of infection.
Although the data on Sclerosol were mostly literature-based, and the trials had small sample sizes and a variability of doses, Dr. Larson pointed out that four of the trials were prospective randomized studies, and that the trials showed an objective measure of success in the form of chest x-rays and a consistency of results over time.