Dec. 11--Patients with metastatic breast cancer who respond to chemotherapy are
unlikely to see any additional benefits from surgery or radiation therapy,
according to leaders of a new clinical trial.
The randomized, controlled study, which was presented Wednesday at the San
Antonio Breast Cancer Symposium, was intended to settle a long-running dispute
among oncologists about the best way to treat women whose tumors had spread to
other parts of their bodies, said Dr. Rajendra Badwe, director of the Tata
Memorial Hospital in Mumbai, India.
"For a surgeon like myself, knowing when to do surgery is important," said
Badwe, who led the trial. "But even more important is knowing when not to do
The message may come as welcome news to some breast cancer patients, who now
have medical evidence on their side if they opt to take a pass on painful,
invasive procedures that aren't likely to extend their lives. But for other
women with metastatic disease, the message that there's not much they can do
beyond chemotherapy is sure to be unsettling, patient advocates said.
"It can be very disheartening for a woman diagnosed with Stage IV breast cancer
to learn that surgery is not recommended for her," said Musa Mayer, a breast
cancer survivor who operates the website AdvancedBC.org. "She may see this as a
message of futility."
In the United States, Canada and Europe, roughly 5% to 10% of all breast cancer
patients are diagnosed after their tumors have already spread. In the developing
world, where access to medical care isn't as good, 10% to 20% of patients have
metastatic disease by the time they're diagnosed.
Researchers conducting experiments in animals and studying the clinical records
of human patients have sometimes observed an association between the surgical
removal of primary cancer tumors and the rapid growth of secondary tumors in
other areas of the body.
The cause of this phenomenon, which does not occur in all cases, remains
unclear. Oncologists have offered several possible explanations, including the
hypothesis that as the body recovers from surgery, it releases growth factors
that accelerate the development of new tumors. Others speculate that the primary
tumor itself may somehow inhibit the growth of distant metastases, and that this
influence is lost when the tumor is removed.
Cancer specialists are split over how to deal with this potential problem. If
chemotherapy is already working, some doctors recommend against further
treatment with surgery or radiation unless there is bleeding or ulceration, a
sign that a tumor is causing serious problems and needs to be removed
immediately. Other doctors say the risk of accelerating new tumor growth is only
theoretical, and that surgery increases patient survival.
"We've had a house divided," Badwe said. "Some say surgery is inappropriate,
while others say it saves lives."
So Badwe and his colleagues set out to examine whether surgery and radiation
actually did extend a patient's survival. They enrolled 350 Indian women who
were diagnosed with metastatic breast cancer and who also showed a positive
response to chemotherapy.
Among the volunteers, 177 continued treatment with chemotherapy only and 173 had
partial or complete removal of their breast and removal of nearby lymph nodes,
followed by radiotherapy.
Seventeen months later, 218 of the patients had died -- 107 from the
chemotherapy-only group and 111 from the surgery and radiation group. Overall
survival after two years of follow-up was 43% among the chemotherapy patients
and 40% for the patients who had more aggressive treatment.
Statistically speaking, the outcomes for both groups were the same, the authors
concluded. "We found there was no difference in overall survival," Badwe said.
Dr. Courtney Vito, a surgical oncologist at the City of Hope cancer center in
Duarte who wasn't involved in the study, said the findings were significant,
especially in light of advances in drug treatments.
"We've actually been able to see drugs completely resolve small distant
metastases and all that's left is in the breast," she said. "Well, what do you
do with those women?"
Vito agreed with Badwe that oncologists were split into two camps when it came
to the issue of surgical removal of primary tumors, but that she did not think
the new study would end the long-running debate.
"This study reinforces my own personal bias" to leave the primary tumor alone,
Vito said. "But for people in the camp that think stage IV mastectomy is
valuable, this probably will not be enough" to convince them to skip surgery.
Efforts to conduct similar studies in the United States have encountered serious
problems enrolling patients, she said.
"Women who believe that removing their breast will help them don't want to be
randomized and let the trial decide if they get surgery or not," Vito said.
"It's the same for patients that don't want to get surgery. ... Some people say
a study like this would never be able to be done and it looks like these authors
have done it and come up with an answer."
Mayer, the breast cancer survivor, said the trial appeared to be the first
high-quality evidence to address the issue, although she wondered just how women
would respond to news that surgery wouldn't help them.
"For many women, a simple lumpectomy or mastectomy offers the satisfaction that
the cancer in her breast is gone," she said. "This is not a small thing, even
for a woman who realizes that there are metastatic sites of cancer elsewhere in
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