The
conventional approach to fighting breast cancer is to deploy all the tools
modern medicine has to offer. Surgery to excise the tumor is considered a
critically important step, along with drugs, radiation, and hormone treatments
and immunotherapy when appropriate.
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A new study
questions that approach, suggesting surgery may not always be necessary for all
patients. The study, an early-stage clinical trial, found that a carefully
selected group of patients who responded remarkably well to chemotherapy could
skip surgery altogether.
Fifty patients
older than 40 with two types of breast cancer and early-stage disease were
enrolled in the trial.
All patients
underwent chemotherapy, followed by biopsies to determine whether their tumors
had responded well to the treatment. Thirty-one patients — about 60 percent —
responded remarkably well and were able to forgo surgery, the researchers
found.
The participants
went on to receive radiation treatment and were still in remission after a
median follow-up period of two years and two months, said Dr Henry Kuerer, the
principal investigator of the study, which was published last month in Lancet
Oncology.
The elimination
of surgery for invasive breast cancer is “the ultimate form of
breast-conserving therapy”, he said.
Breast surgery can
lead to complications like infections, and even breast-conserving procedures
like lumpectomy can change the shape of the breast, leave scars or
indentations, a tugging sensation, or lasting nerve pain.
“Breast cancer is
so common, and there are always going to be people who would rather not have
surgery,” said Kuerer, a professor of breast surgical oncology at the
University of Texas MD Anderson Cancer Center in Houston.
Some patients
prefer radical surgery even if it does not improve survival, he noted, while
for others even a minor procedure to remove the tumor can be emotionally
grueling, even if it goes well.
The work is part
of an approach to cancer treatment called de-escalation: an effort to
individualize treatment to a specific subtype of the disease, achieving the
same results with less treatment and fewer interventions.
Some women with
breast cancer are able to forgo chemotherapy if gene tests determine that it
will not be helpful and other drugs are available, sparing them short-term side
effects and long-term complications; some lung cancer patients are also able to
forgo chemotherapy. Breast-conserving lumpectomy rather than mastectomy is also
part of de-escalation, as is forgoing surgery altogether, as in this trial. In
a separate clinical trial, Kuerer is also examining whether radiation is always
necessary.
“What I really
appreciate about the study is that it takes the next step and asks a bold
question: How do we take all the advances that we’ve made in more tailored and
specific cancer therapy, and convert that to reducing the number and types of
interventions any one patient needs to incur?” said Karen Knudsen, the CEO of
the American Cancer Society. “Asking whether we can scale back surgery is a
reasonable next consideration for the future of cancer care.”
Pamela Romero,
who participated in the trial and was deemed eligible to skip surgery, had
traveled from her home in New Iberia, Louisiana, to MD Anderson in 2018 to get
a second opinion shortly after discovering a small lump near her breast bone.
Her tumor was HER2-positive and about the size of a grape.
A HER2-positive
tumor contains cells with receptors for human epidermal growth factor 2. Only
women with HER2-positive tumors and triple-negative tumors, which contain cells
that lack receptors that respond to estrogen, progesterone, and human epidermal
growth factor 2, were included in the trial.
“The doctor
asked, ‘How do you feel about surgery?’ and I said, ‘I’m scared to death of
it,’” Romero, 66, recalled in an interview. “I said, ‘If I can get rid of the
cancer without having surgery, I’m all for it.’”
She had never had
surgery before, she said: “I did not want to be put under, or go under the
knife.”
After four
chemotherapy infusions, Romero said, the doctor told her that the tumor had
shrunk by about 85 percent, and that she could avoid surgery if she wanted to.
After two more treatments, the regimen was complete.
Romero underwent
radiation treatment and immunotherapy, and recently marked her third
anniversary of completing treatment, remaining disease-free.
While the
surgery-free regimen appears so far to have been successful, the trial included
only a small number of carefully screened women, and they have been followed
for a median period of 26 months.
It is a
significant period of time, especially for the specific types of cancer
studied, which tend to recur within the first few years. Still, experts said a
larger trial with a comparison group would be needed to see if changes in
medical practice are warranted.
“The big picture
is that this is a tiny study,” said Dr Monica Morrow, the chief of breast
surgery at Memorial Sloan Kettering Cancer Center in New York. “It is in no way
definitive. It will in no way change practice.”
The patients in
the trial had small tumors and would have qualified for breast-conserving
lumpectomy surgery, along with biopsies of the sentinel lymph nodes, she said.
“That’s hourlong
outpatient surgery,” she said. “You can get it done, and yes, you will have
some discomfort and soreness.” But women who get lumpectomies would not have
been candidates for major surgeries, like mastectomy, in the first place, she
added.
Patients in the
trial who qualified to skip surgery had undergone biopsies to determine whether
they had what is called a pathological complete response, meaning a lack of any
signs of cancer in tissue samples. Only those who had a complete response to
chemotherapy were permitted to defer surgery.
Improved
chemotherapy agents have increased response rates significantly, and 60 percent
to 80 percent of patients with triple-negative or HER2-positive breast tumors
manage to avoid surgery. But certain image-guided biopsies can produce errors,
including false-negative results, and must be carried out under strict
protocols to achieve high levels of accuracy.
Kuerer said the
results of the new trial were promising, but cautioned that surgery was still
necessary for most breast cancer patients. “It’s important for patients to know
that this is the very beginning of a new type of treatment for select
patients,” he said.
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