Healthy Skepticism Library item: 2685

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Donn J.
Drug Effective Against Early Breast Cancer
Associated Press 2005 Oct 19
http://news.yahoo.com/s/ap/20051019/ap_on_he_me/breast_cancer_drug

Keywords:
Herceptin breast cancer

Notes:

Ralph Faggotter’s Comments:
This is what happens with new drugs.
They have a honeymoon phase.
for example-
“ From the NCI press release: Study: breast cancer drug called ‘stunning,’ ‘jaw-dropping’ A drug that targets only diseased cells has proved astonishingly effective against an aggressive form of early breast cancer – a long-sought breakthrough that has doctors talking about curing thousands of women each year in this country alone. The drug, Herceptin, is already used for advanced cancer. But in three studies involving thousands of women with early-stage disease, it cut the risk of a relapse in half. Several experts used words like “revolutionary,” “stunning” and “jaw-dropping” to describe the findings. “In 1991, I didn’t know that we would cure breast cancer, and in 2005, I’m convinced we have,” exulted Dr. Jo Anne Zujewski, head of breast cancer therapeutics at the government’s National Cancer Institute. Herceptin, made by Genentech, appears to have “changed one of the most worrisome kinds of cancers into one that may have a relatively good prognosis,” said Dr. Ed Romond of the University of Kentucky. He was one of the researchers who reported findings from three Herceptin studies Thursday in The New England Journal of Medicine…. “

But others, like ‘Breast Cancer Action’ urge caution-

Barbara Brenner’s Comments:
Breast Cancer Action Strongly Concerned About New Reports on Herceptin
Breast Cancer Action has strong concerns about the latest reports on Herceptin. The studies have been relatively short (a maximum of 2 1/2 years of data) and yet researchers are glibly trumpeting the drug as a “cure.” Jeff Donn’s AP article today (10/19/05) reports: “Several experts used words like ‘revolutionary,’ ‘stunning’ and ‘jaw-dropping’ to describe the findings.’ His article also quotes a representative of the National Cancer Institute: “In 1991, I didn’t know that we would cure breast cancer, and in 2005, I’m convinced we have,’ exulted Dr. Jo Anne Zujewski, head of breast cancer therapeutics at the government’s National Cancer Institute.” (http://news.yahoo.com/s/ap/20051019/ap_on_he_me/breast_cancer_drug)“Using words here such as ‘cure’ is outrageous, and inaccurate as a way of describing these short-term trial results,” said Barbara Brenner, Executive Director of Breast Cancer, a national grassroots education and advocacy organization. “The annals of breast cancer are filled with stories like this one in which the hype hurts thousands of women and their loved ones. It is these patients, who expect the drug to benefit them, as seen with high-dose chemotherapy treatment, for example.“Even the studies’ authors admit that it’s unknown how long Herceptin needs to be taken. At price tag of $48,000 per year, that question becomes critically important, as does the issue of who will have access to the drug. After 2 1/2 years, we can’t possibly know all of the side effects (short and long term) in addition to the serious ones we already know (cardiotoxicity). As seen with drugs like tamoxifen, the entire range of side effects can take over a decade to become widely known. “Patients need responsibly vetted information, not more hype,” Brenner said.
……………………………………………………………………………………… For more on the Herceptin story see-
http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2005/10/19/national/a141038D74.DTL&type=health and the USA Today story: http://www.usatoday.com/news/health/2005-10-19-breast-cancer-drug_x.htm?csp=14

Full text:

Drug Effective Against Early Breast Cancer

By JEFF DONN, Associated Press Writer Wed Oct 19, 7:37 PM ET

A drug that targets only diseased cells has proved astonishingly effective against an aggressive form of early breast cancer – a long-sought breakthrough that has doctors talking about curing thousands of women each year in this country alone.
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The drug, Herceptin, is already used for advanced cancer. But in three studies involving thousands of women with early-stage disease, it cut the risk of a relapse in half.

Several experts used words like “revolutionary,” “stunning” and “jaw-dropping” to describe the findings.

“In 1991, I didn’t know that we would cure breast cancer, and in 2005, I’m convinced we have,” exulted Dr. Jo Anne Zujewski, head of breast cancer therapeutics at the government’s
National Cancer Institute.

However, an official at the
American Cancer Society warned that it is far too early to suggest this amounts to a cure, since the women studied were followed for only three years at the most.

Moreover, Herceptin is only for the estimated 20 percent of breast cancer cases in which tumors churn out too much of a protein known as HER2. Even then, the drug does not help everyone.

Still, Herceptin could be the biggest thing in cancer drugs since research a decade ago demonstrated the extraordinary effectiveness of tamoxifen, another medicine that transformed the treatment of the disease by homing in on cancer cells but sparing healthy ones.

Herceptin, made by Genentech, appears to have “changed one of the most worrisome kinds of cancers into one that may have a relatively good prognosis,” said Dr. Ed Romond of the University of Kentucky.

He was one of the researchers who reported findings from three Herceptin studies Thursday in The
New England Journal of Medicine. One was an international study sponsored by Herceptin’s European marketer, Roche. The others were North American studies sponsored by the National Cancer Institute.

The researchers followed a total of more than 6,500 women with early-stage breast cancer. Women received Herceptin along with the standard treatments, including surgery and chemotherapy.

In the first study, 220 women undergoing standard therapy for a year either developed breast cancer again, showed other kinds of tumors, or died. Only 127 did when Herceptin was added.

The two other studies, partly funded by Genentech, reached similar findings in their combined results. At three years, patients on Herceptin showed a disease-free survival rate that was 12 percentage points higher than without it.

The government approved the drug in 1998 for advanced breast cancer that has already spread within the body. But early-stage cases are much more common.

Many doctors are already embracing the drug for such women, cancer experts say, because details of the three studies were first publicized last spring at a medical conference.

“The strength of the evidence is so overwhelming at this point that it would be almost impossible to withhold this drug from the appropriate group of patients,” said Dr. Gabriel Hortobagyi, of the University of Texas, who is president-elect of the American Society of Clinical Oncology.

Genentech intends to apply to the U.S. government to add early-stage cancer use to Herceptin’s label, spokeswoman Colleen Wilson said. But doctors are already free to prescribe the drug for early breast cancer on their own authority.

About 200,000 women are diagnosed with breast cancer each year in this country, and 40,000 die. About 30,000 American women will probably be taking Herceptin for breast cancer within a couple of years, curing perhaps 7,000 who would otherwise relapse, some doctors predicted.

However, doctors cautioned that some women get better without Herceptin, especially when there is little evidence that the cancer is spreading within the breast. Also, a small number taking the drug suffer heart failure.

A year of Herceptin could cost $48,000 even at wholesale prices.

Tamoxifen has the same kind of benefit as Herceptin – a 50 percent reduction in risk – but works against another large class of cancer cases known as estrogen-positive.

Debbie Saslow, director of the breast cancer section of the American Cancer Society, said she was impressed by the Herceptin findings but wants to watch such patients for years. “I think it’s way too soon to talk about a cure,” she said.

It is also unclear whether Herceptin should be taken with chemotherapy drugs, soon afterward, or even years later. Herceptin appears so potent, some researchers said, that patients might someday be able to skip chemotherapy, radiation and surgery, which destroy both healthy and diseased tissue.

American sales of Herceptin leaped by two-thirds, to $215 million, in the three months ending Oct. 1, compared with the year’s first quarter, according to Genentech.

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On the Net:

New England Journal of Medicine: http://nejm.org