Taking Cancer Drug With Food May Cut Costs

By Alan Mozes
HealthDay Reporter
Tuesday, July 17, 2007; 12:00 AM

TUESDAY, July 17 (HealthDay News) -- Taking a pricey breast cancer drug called lapatinib (Tykerb) with food rather than on an empty stomach may improve its absorption by the body -- lowering the doses needed and greatly cutting costs for patients, a new study shows.

In a commentary published in the Aug. 10 issue of theJournal of Clinical Oncology, Drs. Mark Ratain and Ezra Cohen, of the University of Chicago, suggest that taking the recently approved medication with food -- particularly high-fat food -- cuts the dosage needed by at least 60 percent.

Ratain -- a professor of medicine and associate director for clinical sciences in UC's Cancer Research Center -- joined Cohen (from the hematology/oncology section of UC's department of medicine) to highlight the findings of a study presented in March at the American Society for Clinical Pharmacology and Therapeutics.

The study, which neither Ratain or Cohen was involved in, revealed that 500 milligrams of Tykerb taken with food appears to be as effective as 1,250 milligrams of the drug taken on an empty stomach, the current prescription protocol.

"What we have here is this unique situation where patients are shelling out more than they need to take a drug in a suboptimal manner," said Ratain.

The current regimen of five 250 milligram tablets per day, taken on an empty stomach, costs about $2,900 per month. But simply taking the pills with food could save the patient about $1,740 per month in drug expenses, a real "value meal" for patients, according to the experts.

Both Ratain and Cohen cautioned that physicians and patients should not alter Tykerb treatment protocols until further research substantiates these findings.

The drug's maker, GlaxoSmithKline (GSK), offered a much stronger warning in a statement released Tuesday, in which they called Ratain's and Cohen's commentary "speculative," with the "potential to be misunderstood and misused by clinicians and patients."

"While dosing Tykerb with food has been found to increase absorption, food effects are highly variable and hard to predict," the company said. "Taking Tykerb with food could result in increased side effects and decreased efficacy. Additionally, concurrent medicines that patients may be taking, including capecitabine, must be considered. Each medicine has its own potential for drug and food interactions. Therefore, it is imperative that patients follow the current FDA approved Tykerb dosing and administration recommendations without food."

Tykerb was approved for use against breast cancer by the U.S. Food and Drug Administration in March of this year. The oral tablet was developed by the GSK for patients battling a specific type of advanced-stage breast cancer, in which HER2 -- a protein that promotes tumor growth -- is expressed.

According to the American Cancer Society, every year approximately 180,000 American women are diagnosed with breast cancer. Annually, upwards of 10,000 women are projected to die from the advanced stage, HER2-positive version of the disease.

The new treatment was approved for use in combination with another medication known as capecitabine (or Xeloda), for cases in which a range of other drugs, such as Herceptin, have ceased to be effective.

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