It is being widely reported today that Herceptin, made by Genentech, has shown "stunning" results in the treatment of a particularly aggressive form of metastatic breast cancer. This combined with last week's news of the development of Gardasil, Merck's vaccine that is 100% effective in preventing cervical cancer, is wonderful news and should save the lives of tens of thousands of woman every year.
_________________________________________________________
Oct. 19, 2005, 11:03PM
For some women, breast cancer drug could equal a cure
'Remarkable' findings show Herceptin halves relapse risk for 1 form of disease
By TODD ACKERMAN
Copyright 2005 Houston Chronicle
A targeted drug already approved to treat an aggressive form of advanced breast cancer has proved remarkably effective at preventing tumors from recurring in early-stage patients.
The drug, Herceptin, cut the risk of relapse in half, a breakthrough that prompted experts to predict thousands of American women will be cured of breast cancer annually. Experts called the study results "stunning."
"This is probably the biggest evidence of a treatment effect I've ever seen in oncology," said Richard Gelber, a Dana-Farber Cancer Institute biostatistician who led the analysis of most of the trial participants. "It is quite remarkable."
In an editorial accompanying the three studies, published in today's edition of the New England Journal of Medicine, the University of M.D. Anderson Cancer Center's Dr. Gabriel Hortobagyi called the findings "revolutionary" and said the development of such targeted drugs "will completely alter our approach to the treatment of breast cancer."
M.D. Anderson provided some of the more than 6,500 patients with early-stage breast cancer who participated in the studies. The women had already undergone standard therapy — surgery and chemotherapy and sometimes radiation.
Used in early treatment
Herceptin only works on about 20 to 30 percent of women whose breast cancer has a particular genetic mutation, or about 40,000 U.S. women. Their tumors produce too much of a protein known as HER2, which is linked with more aggressive forms of the disease and a higher risk of breast cancer death.
The Food and Drug Administration approved Herceptin in 1998 for breast cancer that has recurred after surgery or that has spread elsewhere in the body. But the new trials were designed to investigate whether the drug would also work earlier in the course of the disease, after the tumor is removed by surgery.
Because details of the studies were first publicized last spring at a cancer conference, many doctors have already begun using Herceptin in early-stage patients, Hortobagyi said. M.D. Anderson, which has been involved in Herceptin studies from the very beginning, has made early treatment with it the standard of care since May.
Doctors are already free to prescribe Herceptin to early-stage patients on their own authority, but its maker, Genentech, plans to apply to the FDA to add such usage to the drug's label. Experts expect insurance to cover the drug, which could cost $48,000 over a year.
The three studies included an international one sponsored by Herceptin's European marketer (Roche) and two North American ones sponsored by the National Cancer Institute. Researchers followed the participants for two years.
In the first study, conducted in 39 countries, 220 women taking only standard therapy either developed breast cancer again, had another kind of tumor or died, compared with 127 women who also took Herceptin.
The two other studies found a similar reduction in death or new cancers among women who got Herceptin while receiving chemotherapy.
About 200,000 U.S. women are diagnosed with breast cancer each year, and 40,000 die. Tamoxifen, a mainstay of cancer treatment, produces the same kind of 50 percent reduction in risk, but only works against another large class of breast cancer cases known as estrogen-positive.
Herceptin, given intravenously, is designed to block a particular protein that juts out of tumor cells and spurs them to grow when activated. It is bioengineered from part of a mouse antibody, which is altered to closely resemble a human antibody.
Some side effects
On occasion, it can cause serious side effects, including heart problems. In the international trial, about 6 percent of patients stopped taking the drug because of adverse results.
The studies, in which women received treatment for both one and two years, left unclear how long patients should continue to take Herceptin.
Debbie Saslow, director of breast and gynecological cancers at the American Cancer Society, said she was impressed with the trial benefits but wants to watch them longer before pronouncing a cure.
But other doctors were so excited about Herceptin's performance in the studies they suggested that one day some breast cancer patients might no longer need chemotherapy, radiation and surgery.
"This is huge news," said Dr. JoAnne Zujewski, head of the breast cancer therapeutics at the National Cancer Institute. "It doesn't work on all HER2 breast cancers ... but for thousands of women out there, Herceptin will represent a cure."
Comments