www.usatoday.com reported:
One of the most promising new approaches for fighting breast cancer took a stunning setback Thursday when a major study showed that a bone-building drug did not stop cancer from returning or extend life for most women fighting the disease.
Hopes that these drugs could also prevent cancer soared after a study two years ago found Zometa cut the risk of cancer recurrence by 30% in younger women forced into early menopause by hormone treatments they received.
The excitement grew last year, when a large study found that women who were not cancer patients and were taking daily bisphosphonate pills to prevent bone problems were about one-third less likely to develop breast cancer.
The new study was meant to be definitive. It tested Zometa in 3,360 women of all ages in seven countries who had breast cancer that had spread to lymph nodes. All received standard cancer treatments, and half also got periodic infusions of Zometa for five years.
After five years of follow up, about 400 women in each group had died or suffered a recurrence.
Side effects are a concern: 26 women on Zometa — 1 to 2% of the group — developed confirmed or suspected cases of jawbone decay, a serious problem long linked to bisphosphonates. Blood clots in the lung also were more common among those on Zometa, although not significantly so, Coleman said.
Zometa's role in cancer prevention remains uncertain, said Dr. Peter Ravdin of the University of Texas Health Science Center at San Antonio, one of the organizers of the cancer conference.
"There are some indications that in some patients it may still have value," but the side effect profile "certainly means that this drug shouldn't be given without confidence that it will cause benefit," he said.
Studies testing other bisphosphonate drugs for breast cancer will have results in a year or two.
Breast cancer is the most common major cancer in women. About 207,000 new cases and nearly 40,000 deaths from it are expected in the United States this year.
www.bloomberg.com reported:
Novartis AG’s effort to add $1 billion in sales to its bone-repair drug Zometa with an extra approval in breast cancer stalled yesterday when the treatment failed to stop tumors from returning in a study.
Zometa combined with standard treatments didn’t slow the disease or prolong life, according to a 3,360-patient study presented at the San Antonio Breast Cancer Symposium in Texas. An earlier, smaller study showed Zometa users were 32 percent less likely to have their cancer recur after five years.
Based on the new findings, Novartis, of Basel, Switzerland, will withdraw U.S. and European applications for Zometa approval to prevent breast cancer relapse. The company is reviewing whether a new trial is needed to refile for clearance. Positive results could have boosted Zometa sales as much as $1 billion in 2015, said Fabian Wenner, an analyst at UBS AG in Zurich.
“The data is a disappointment,” Andrew Weiss, an analyst at Bank Vontobel in Zurich said in an interview today. “Zometa was set to lose patent protection, so it’s not a bitter loss.”
Zometa has patent protection until 2013; a new application for use in breast cancer could have added three additional years in that indication, Wenner said.
“The trial casts real doubts on whether there is a role for Zometa in preventing recurrence of breast cancer,” said Eric Winer, chief of the division of women’s cancer at the Dana- Farber Cancer Institute in Boston, in an interview. Doctors prescribing Zometa to block the return of tumors “should stop or at least question that practice.”
Zometa, given as an infusion, also is sold at a lower dose under the name Reclast or Aclasta to treat osteoporosis. It belongs to a group of drugs called bisphosphonates that help maintain bone strength and may also fight cancer by stimulating immune cells, choking off the growth of blood vessels that feed tumors, and causing malignant cells to self-destruct.
“Bisphosphonates are commonly used to treat osteoporosis caused by breast cancer,” said Sharon Giordano, an oncologist at the University of Texas’ MD Anderson Cancer Center in Houston, in a telephone interview. “The million-dollar question is whether or not these drugs will also be effective in preventing breast cancer recurrences.”
About a half million women in the U.S. and Europe are diagnosed annually with breast cancer, and after treatment about 11 percent have their cancer return within five years.
Azure Study
A five-year study, dubbed Azure, compared Zometa added to chemotherapy to the other drugs alone. The main goal was to prolong the time women survived without tumors recurring. Novartis provided grant money to researchers at the University of Sheffield in England, who conducted the study.
In the study, 404 of the women getting Zometa and 403 of those on a placebo in addition to standard care developed invasive disease. A total of 243 Zometa patients and 276 on a placebo died, the researchers found. There were 17 confirmed cases of osteonecrosis of the jaw, a devastating side effect that causes the jawbones to die, and nine possible cases.
Zometa did show a benefit for the oldest women, those at least five years beyond menopause, increasing overall survival rates by 29 percent compared to those getting only chemotherapy. More work is needed to determine if that finding should change breast cancer care, researchers said.
Older Women
“This isn’t a treatment for everybody,” said Robert Coleman, an oncologist at Weston Park Hospital in Sheffield, England, and the study’s lead researcher, in a telephone interview. “But there is this group of older women that are behaving so differently we don’t think it’s a chance finding.”
Novartis will withdraw its applications for approval of Zometa to prevent the recurrence of breast cancer in the U.S. and Europe, and plans to refile after discussing the Azure trial results with regulators, said Herve Hoppenot, head of oncology at Novartis. The company originally sought clearance based on the results of the earlier trial out of Austria.
“The future of the application itself is really unknown at this point,” Hoppenot said in a telephone interview. “We don’t know what the regulators will ask us to do. We need to define the group where it is beneficial. What the data tell us is that it will be a subgroup.”
Kayla Wharton - Mrs. North Texas International
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