Breast Cancer Studies Conflict

[Guest guest]

http://www.abcnews.go.com/sections/living/DailyNews/breastcancer990415.html

W A S H I N G TO N, April 15 —

Major research on

bone marrow transplants cast new confusion on

an experimental therapy considered a last resort

for advanced breast cancer. Only one of the five

studies found the costly and arduous treatment

helped women live longer, but several suggested

it might help patients stay relapse-free for

longer.

For women considering transplant therapy, the studies

released today give no easy answers — because the five

treatments attacked tumors in different ways and involved

studies of women at different stages of breast cancer.

The long-awaited studies sparked furious debate.

Advocates of transmplants argue that the studies are

conflicting and the results preliminary. They point to

patients who are alive years after treatment. Critics say the

studies show thousands of women may have undergone

costly, painful and risky operations needlessly.

Amid the confusion, the National Cancer Institute is

struggling to explain that because the studies are so

different, doctors and insurance companies cannot conclude

that transplant therapy doesn’t work.

“We are not closing the door,” stressed Dr.

Abrams, head of breast cancer clinical trials at the NCI,

which is funding 15 additional studies to try to get better

answers.

Transplants and Clinical Trials

At issue is giving ultrahigh doses of chemotherapy, five to

20 times higher than normal, to women with advanced

breast cancer. Those high doses destroy women’s bone

marrow and thus are fatal without a transplant of either

bone marrow or marrow-restoring stem cells.

Transplants do help other cancers, such as lymphoma,

but have never been proved effective for breast cancer,

despite demand from desperate patients.

Where all sides agreed today was that breast cancer

patients should not have transplants unless they enroll in

clinical trials, where patients are closely monitored by

specialists striving to provide the latest treatments. Some

12,000 U.S. breast cancer patients have had transplants this

decade, but few were in clinical trials.

“The trials show no benefit,” contends Fran Visco of

the influential National Breast Cancer Coalition. So she said

for women who don’t qualify for a clinical trial, “our

recommendation would be not to” try transplant therapy.

Doctors must ensure that patients understand the

studies’ limitations, stressed Dr. Avigan of Beth

Israel-Deaconness Hospital in Boston.

“What I will say to patients is, ‘If you’re the kind of

person who feels going through a difficult procedure is not

something you want to do unless you’re sure it’s better,

then this is not something to do,‘” he said. But for patients

willing to gamble on an experimental therapy in a clinical

trial, “then this is an option we should at least explore.”

Studies from Around the World

The studies released today, from the United States,

Scandinavia, South Africa and France, examined metastatic

breast cancer — tumors that have recurred and spread to

other organs — and “high-risk primary cancer,” where

tumors have advanced to 10 or more lymph nodes before

women are even diagnosed.

Only 22 percent of metastatic patients survive five

years. Some 43,000 Americans will die of breast cancer

this year.

Only the South African study of high-risk patients found

a survival benefit: More than five years after treatment, 17

percent of transplant patients had died, compared with 35

percent of patients on standard therapy. Plus, fewer

transplanted women suffered cancer relapses. That study

used some drugs not tried on Americans.

A three-year U.S. study found no survival difference.

But 25 percent fewer transplant patients relapsed,

suggesting transplants might improve quality of life. The

study will monitor patients for another three years to see if

ultimately transplant patients live any longer.

That study also had an intriguing twist: Both the

transplant patients and “standard” patients in that trial

were

20 percent less likely to die than doctors had expected

based on death rates from regular hospitals. Why? The

“standard” patients actually got a little higher chemotherapy

dose than most patients ever do, leaving some doctors

wondering if they routinely undertreat women.

There was no transplant benefit for women whose

cancer had metastasized. The largest of the studies, one

done in the United States, did use the chemotherapy drugs

and dosages most widely tried with transplants worldwide.

Now the NCI is trying to determine whether other drugs

would work better, or if small subgroups of women might

still benefit.