Dr Kuerer on the Safety, Feasibility of Omitting Surgery in Select Patients With HER2+, Triple-Negative Breast Cancer

"I do believe this model is feasible in nearly every type of breast practice across the United States. As I mentioned, we didn’t require MRI. We’re not opposed to MRI—it just wasn’t mandated for eligibility or to standardize the eligibility or biopsy procedure. The majority [of biopsies were performed using] image-guided stereotactic techniques.

Henry M. Kuerer, MD, PhD, FACS, CMQ, a professor and executive director of the Breast Programs of MD Anderson Cancer Network in the Department of Breast Surgical Oncology at The University of Texas MD Anderson Cancer Center, described the safety and feasibility of selectively eliminating surgery in patients with early-stage HER2-positive breast cancer or triple-negative breast cancer (TNBC) who achieve a pathologic complete response (pCR) following neoadjuvant systemic therapy.

Results from this phase 2 trial (NCT02945579) showed that, at a median follow-up of 55.4 months (IQR, 44.0-63.5), the study reported a 0% ipsilateral breast tumor recurrence rate among 31 evaluable patients who did not undergo surgery. Five-year disease-free survival and overall survival were both 100%, suggesting that for select patients, surgical omission may be a viable strategy with favorable oncologic outcomes.

Patients were monitored closely for safety and efficacy, Kuerer stated, adding that the primary procedural difference in this trial was the incorporation of image-guided core biopsies after neoadjuvant therapy to confirm pCR. Among 50 patients, no hematomas occurred, and only 2 grade 1 toxicities were observed—one case of nausea and one technical complication requiring a second biopsy pass.

All participants received whole-breast, hypofractionated radiotherapy with a boost to the tumor bed, he noted. The majority (75%) were clinically node-negative and received only tangential irradiation to the axillary region, avoiding both breast and axillary surgery, Kuerer detailed.

This approach may challenge the long-standing surgical paradigm in breast cancer care, Kuerer asserted. In randomized trials, equipoise, which is typically required for randomized trials and means investigators genuinely do not know which approach is better, is usually standard, Kuerer stated. However, with this novel approach of surgical omission, there is no equipoise, he said.

Accordingly, these findings underscore a potential shift toward nonoperative management in carefully selected patients.

Importantly, the study did not require breast MRI for eligibility or biopsy planning, supporting the feasibility of this model across diverse clinical settings, he said. Image-guided stereotactic techniques were predominantly used for biopsy confirmation of response, indicating that this approach may be broadly applicable in routine practice, Kuerer concluded.