KeepHealthCare.ORG – Study: Less usage of Roche breast-cancer drug OK
Treating breast-cancer patients with an expensive Roche Holding AG drug for six months instead of 12 reduced the medication’s heart-related side effects and its costs without sacrificing its effectiveness in preventing relapses, a new study found.
The study, funded by the U.K. National Institute for Health Research, was conducted on more than 4,000 women in the early stages of an aggressive type of breast cancer known as HER2-positive.
Herceptin, which generated about $7 billion in global sales for Roche last year, has vastly improved treatment for HER2-positive breast cancer since it hit the market in 1998, particularly when used to prevent disease recurrence after breast surgery. In the U.S., the drug costs $76,700 for 12 months of treatment.
The standard course of treatment for Herceptin after surgery has been 12 months, based on clinical trials conducted by Roche’s Genentech unit. But the drug can weaken the heart muscle and cause other cardiac problems, leading some women to stop taking it. The drug’s prescribing label, approved by the U.S. Food and Drug Administration, recommends treatment for one year.
Still, there has been some debate among doctors over the optimal length of treatment with Herceptin. A Roche-sponsored study and one by the French National Cancer Institute, both released in 2012, suggested one year was best. But researchers have continued to study shorter durations.
The U.K. researchers began their study in 2007. About half the women were assigned to receive six months of Herceptin treatment, and the other half 12 months.
The study found that 89.4% of the women who took Herceptin for six months were free of disease four years after the start of treatment, versus 89.8% for women who received 12 months of treatment.
The shorter duration also appeared to cut cardiac toxicity. About 4% of patients receiving six months of therapy stopped treatment due to cardiac problems, versus 8% of patients in the 12-month group.
“The headline result is that six months is as good as 12 months,” Helena Earl, the study’s lead investigator and professor of clinical cancer medicine at the U.K.’s University of Cambridge, said on a conference call with reporters Wednesday held by the American Society of Clinical Oncology.
The oncology group released a summary of the Herceptin study along with nearly 5,000 other cancer trials Wednesday, ahead of planned presentations at its annual meeting in Chicago in early June.
Reducing the treatment duration by half “cut down on the number of people who had to stop treatment by half,” said Bruce Johnson, president of the oncology society and an oncologist at the Dana-Farber Cancer Institute in Boston. “We certainly anticipate this will have an effect on cost as well.”
Courtney Siekirk, spokeswoman for Roche’s Genentech unit, said the new study should be viewed in the context of prior studies that didn’t show that shorter treatment was better. She added that the one-year treatment presented in the FDA-approved prescribing label for Herceptin is based on several studies testing that duration.
Write to Peter Loftus at [email protected]