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.
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 over age 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 on Tuesday 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 Dr. 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 both 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, Dr. 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 chief executive officer 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, La., 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,’” Ms. 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, Ms. Romero said, the doctor told her that the tumor had shrunken by about 85 percent, and that she could avoid surgery if she wanted to. After two more treatments, the regimen was complete.
Ms. 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’s 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 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.
Dr. 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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