A group of prominent cancer doctors is planning a novel assault on high drug costs, using clinical trials to show that many oncology medications could be taken at lower doses or for shorter periods without hurting their effectiveness. As Exhibit A, they point to their pilot study involving Zytiga, a widely prescribed drug for advanced prostate cancer. Cutting the standard dose of Zytiga by three-quarters was as effective as taking the full amount — as long as patients swallowed the medication with a low-fat breakfast rather than on an empty stomach, as directed by the label.
The initiative is the latest response to rising concerns over “financial toxicity,” the economic devastation that can be wrought by the high cost of cancer care. With new oncology therapies routinely debuting at more than $100,000 a year, “lots of people are worried about developing drugs that people can’t get,” said Leonard Saltz of Memorial Sloan Kettering Cancer Center in New York, who helped organize the new group. The effort is also an acknowledgment that, despite President Trump’s grousing about high drug prices earlier this year, they’re unlikely to change soon.
The doctors’ initial study with Zytiga illustrates their thinking. The randomized trial enrolled 72 prostate-cancer patients, with half taking the recommended standard dose of 1,000 milligrams on an empty stomach and the other half taking 250 milligrams with a low-fat breakfast, such as cereal with skim milk.
Despite the big difference in dosages, there was no difference in the drug’s activity, as measured by prostate-specific-antigen levels in each group. In addition, the length of time before the disease worsened was the same for both groups, about 14 months. The oncologists intend to repeat the study with many more patients.
Ratain said food can increase or decrease the absorption rate, or bioavailability, of some drugs. Zytiga has an especially large “food effect”; taking it with a low-fat meal can increase its level in the blood by four to seven times. But many oral cancer drugs, including Zytiga, stipulate that patients should fast because that’s how they were tested.
Zytiga’s manufacturer is not convinced by the pilot study, warning against taking a lower dose with food. “Use of food as a way to increase bioavailability in patients with cancer could present problems and risks,” the drug’s manufacturer, Janssen, said in a statement. “Given the variation in the content and composition of meals, the recommendation is to take Zytiga exactly as described in the prescribing information.”
Some doctors also dislike the idea of changing the way drugs are administered for cost reasons. Benjamin Davies, an assistant professor of urology at the University of Pittsburgh School of Medicine, said he thinks many cancer drugs are too expensive. But cutting back on their dosage “seems like a backwards approach,” he said. “We should address drug prices directly. To suggest that we can’t regulate or legislate our way out of this problem is a wrong assumption.”
The key, Lichter told the trade publication the Cancer Letter, is in running trials to gather the data. “As a patient, I’d want to know that I can safely take this lower dose and not sacrifice any of the benefits.”