Some breast cancer patients who respond highly to chemotherapy may not need surgery

According to a new study by researchers at the University of Texas MD Anderson Cancer Center, patients with early-stage breast cancer who have a pathologically complete response (pCR) to neoadjuvant chemotherapy may be able to skip surgery and receive standard radiation therapy with a low
chance of disease recurrence.

Results from a phase II trial, published today in The Lancet Oncology, evaluate the likelihood of
breast cancer recurrence in patients who receive complete remission after chemotherapy and radiotherapy.
After a median follow-up of 26.
4 months, all 31 patients had a complete response to chemotherapy and no recurrence
of breast tumors.

Dr Henry Kuerer, Professor of Oncology in Breast Surgery and Lead Investigator, said: "The ultimate form of breast-preserving treatment is the complete elimination of breast surgery
for invasive disease.
"This study adds new evidence to a growing body of evidence that in some cases, new drugs can completely eradicate cancer, and very early results suggest that we can safely operate on this specific subset of women with breast cancer
.
"

This is the first modern prospective trial
in which patients with early-stage breast cancer who respond well to chemotherapy do not operate.
State-of-the-art breast imaging-guided, vacuum-assisted core biopsy (VACB) shows high response
.
These results build on Kuererer's previous research using a biopsy protocol developed by MD Anderson to accurately identify patients
who achieve pCR after chemotherapy.
These patients, known as "special responders," have a lower risk of breast cancer recurrence and are candidates to avoid breast surgery
.

Improved chemotherapy drugs have significantly improved pCR rates, with patients with triple-negative or HER2-positive breast cancer now achieving pCR
in 60 to 80 percent of cases.
Combining these high response rates with selective image-guided VACAB and rigorous histological processing improves physicians' ability to
determine which patients may not require surgery.

The multicenter trial enrolled 50 patients with early-stage triple-negative or HER2-positive breast cancer older than 40 years with residual breast lesions of less than 2 cm
on imaging after standard chemotherapy.
Patients undergo 1 image-guided VACB
.
If the biopsy reveals no disease, breast surgery is omitted and the patient continues standard general breast radiation
.

The mean age of participants was 60.
4 years; Twenty-one cases were triple-negative breast cancers and 29 were HER2-positive breast cancers
.
Thirty-eight participants were white, 10 were black, and 2 were of other races/ethnicities
.
VACB identified pCR
in 31 patients.
No serious biopsy-related adverse events or treatment-related deaths occurred
.

"For now, standard breast cancer surgery is still necessary," Kuerer said
.
"While these results are remarkable and very promising, it is important for patients to know that this is the beginning
of a new type of treatment for specific patients.
" Longer follow-up and further studies
are needed before this approach can be incorporated into conventional breast cancer treatment.
”

Researchers will continue to track the long-term outcomes
of trial participants.
As a second goal of the study, the researchers are also measuring minimal residual disease in liquid biopsies to determine whether they are associated
with pCR.

Although this is a small, non-randomized study, it shows the feasibility
of this approach.
Larger randomised studies to directly compare the two treatments
are needed before changing the standard of care can be considered.

This study was funded
by the National Cancer Institute/National Institutes of Health (P30 CA016672, UL1 RR024148), PH and Fay Etta Robinson Distinguished Professor of Cancer Research, and the MD Anderson Clinical Research Grant Program.
Kuerer reports that he collects consulting fees from Merck, works as an editor for NEJM Group, and collects royalties
from McGraw-Hill Specialties and Elsevier Publishing.
The full list of co-authors and their information can be found
here.