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AACR-EORTC-NCI:- Lovastatin Holds Promise For Treatment In Head And Neck, Cervical Cancers By Ed Susman Special to DG News MIAMI BEACH, FL -- November 1, 2001 -- The cholesterol-lowering drug lovastatin appears to show some promise for treating patients with head and neck and cervical cancers. This finding was reported by Canadian researchers at the 12th annual joint meeting of the American Association for Cancer Research, the European Organization for Research and Treatment of Cancer and the National Cancer Institute of the United States. Jennifer Knox, MD, a staff oncologist at Princess Margaret Hospital, University of Toronto, in Ontario, Canada, said that in her Phase 1 trial, five of 20 patients who were administered lovastatin after other therapies failed to control their disease were able to achieve long-term stable disease. "Four of these patients have maintained stable disease for greater than three months," Dr. Knox said. "And, one man, who had advanced head and neck cancer, has had stable disease for more than a year. He has been able to return to work and has shown other physical improvements." However, she added, none of the patients' tumors has shown any shrinkage. "In these cases, most of the people die from their disease within three to six months," she said, "so we are encouraged by these preliminary results." Patients in the trial were given prolonged administration of lovastatin following recurrence or development of metastatic squamous cell carcinoma of the head and neck or of the cervix. Lovastatin, a specific and reversible competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, has a long history as a cholesterol-lowering agent. However, in vitro and in vivo studies have suggested that lovastatin may have pro-apoptotic and potent cytotoxicity against cancer cell lines. Dr. Knox and colleagues attempt to explore the toxicity and pharmacokinetics of lovastatin administered on a prolonged oral schedule. The first two groups of five patients received lovastatin at 5 and 10 mg/kg/day for two weeks, and then spent one week off medication before continuing the cycles; the next two groups were dosed at 7.5 mg/kg for 21 days, before taking a week off medication. Patients have completed as many as 12 cycles of treatment. The researchers did note a transient Grade 3 creatine kinase increase in three patients that led the doctors to reduce the dose. Dr. Knox said the patients who experienced the rise in creatine kinase did not exhibit any symptoms. No further toxicities were noted. Pharmacokinetic analysis revealed that steady state plasma concentrations of lovastatin were reached by days 4-8 with drug cleared after the 7-day break. LDL cholesterol levels demonstrate a nadir to 50 percent of baseline by day 14 with uniform recovery to greater than 80 percent of baseline by the start of each subsequent cycle. Dr. Knox said that the patients did not experience undesired weight loss. She added that the preliminary data was encouraging enough for the researchers to go ahead with a Phase II trial to determine the effectiveness of lovastatin at the 7.5mg/kg/day dose. E-mail this page to a friend or colleague! To print, use this version