Surgery may be unnecessary for certain women with early breast cancer
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Women with early-stage breast cancer who achieve pathologic complete response with neoadjuvant systemic chemotherapy may safely omit surgery with a low likelihood of disease recurrence, according to phase 2 study results.
The findings, published in The Lancet Oncology, should be further evaluated in additional prospective clinical trials, researchers wrote.
Background and methods
“Neoadjuvant systemic therapy yields a pathological complete response in approximately 60% of patients with triple-negative and HER2-positive breast cancer,” Judy C. Boughey, MD, chair in the division of breast and melanoma surgical oncology and program director of the Multidisciplinary Breast Surgery Fellowship at Mayo Clinic, and colleagues wrote. “A pathologic complete response to neoadjuvant systemic therapy predicts an excellent prognosis and can be accurately determined by percutaneous image-guided vacuum-assisted core biopsy.”
The multicenter, single-arm, phase 2 trial included 50 nonpregnant women (median age, 62 years; interquartile range, 55-77; 76% white) with unicentric cT1-2N0-1M0 triple-negative breast cancer (n = 21) or HER2-positive breast cancer (n = 29) and a residual breast lesion less than 2 cm on imaging after clinically standard neoadjuvant systemic therapy.
Women underwent one biopsy and skipped breast surgery if no invasive or in-situ disease was identified. All women underwent standard whole-breast radiotherapy in 15 fractions of 40 Gy or 25 fractions of 50 Gy plus a boost of seven fractions of 14 Gy.
Biopsy-confirmed ipsilateral breast tumor recurrence rate, determined by the Kaplan-Meier method assessed in the per protocol population, served as the primary outcome. Researchers additionally assessed safety among all patients who underwent vacuum-assisted core biopsy.
Median follow-up was 26.4 months.
Findings
Vacuum-assisted core biopsy identified a pathologic complete response in 31 women (62%; 95% CI, 47.2-75.4), none of whom experienced ipsilateral breast tumor recurrences, serious biopsy-associated adverse events or treatment-associated deaths.
Long-term follow-up of the study population is ongoing and researchers additionally plan to measure minimal residual disease from liquid biopsies to assess the association with pathologic complete response.
Limitations of the study included the fact that it was a high-risk, small, phase 2 trial with short, although protocol-specified, early follow-up. In addition, radiotherapy may delay and not prevent ipsilateral breast tumor recurrence, and HER2-positive hormone receptor-positive cancers even with a pathologic complete response could recur later; thus, longer follow-up is needed to validate these early promising findings, the researchers wrote.
Implications
Researchers recommended a larger randomized study to compare treatments before any changes to standard of care are considered.
This trial is a significant step toward more precise treatment to restrict morbidity of intervention without compromising patient outcome, according to an accompanying editorial by Philip M. Spanheimer, MD, assistant professor in the department of surgery, and Katherine E. Reeder-Hayes, MD, MSc, MBA, associate professor of medicine-oncology and section chief of breast oncology, both at The University of North Carolina at Chapel Hill.
“Several key questions remain about long-term outcomes and implementation across treatment settings,” they wrote. “Translational research to enrich trials for patients with a high likelihood of achieving a pathological complete response holds substantial promise to improve the feasibility of omitting surgery after neoadjuvant chemotherapy in appropriately selected patients.”
References :
- Kuerer HM, et al. Lancet Oncol. 2022;doi:10.1016/S1470-2045(22)00613-1.
- Some breast cancer patients with high responses to chemotherapy may not need surgery (press release). Available at: www.mdanderson.org/newsroom/some-breast-cancer-patients-with-high-responses-to-chemotherapy-may-not-need-surgery.h00-159543690.html. Published Oct. 25, 2022. Accessed Dec. 1, 2022.
- Spanheimer PM, et al. Lancet Oncol. 2022;doi:10.1016/S1470-2045(22)00649-0.
Perspective
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One of the main goals of presurgical treatment in breast cancer is to find no living tumor cells at the time of surgery — what we call a pCR [pathologic complete response]. Using imaging and physical examination, we are currently unable to reliably predict which patients have a PCR and could potentially avoid surgery altogether. Although this is a small study in carefully selected patients, it is an important start in potentially eliminating surgery for patients who are exceptional responders to presurgical treatment.
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