Omission of surgery may be possible for women with early-stage breast cancer who are “exceptional responders” to neoadjuvant systemic therapy (NST), according to researchers.

The researchers found that patients who had a pathological complete response (pCR) to NST, as indicated by image-guided vacuum-assisted core biopsy (VACB), could forgo surgery and remain recurrence-free for more than 2 years.

These results, from a phase 2 study, were published in The Lancet Oncology


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This single-arm study (ClinicalTrials.gov Identifier: NCT02945579) enrolled non-pregnant patients with unicentric cT1-2N0-1M0 triple-negative breast cancer or HER2-positive breast cancer and a residual breast lesion less than 2 cm on imaging after standard NST. 

Patients underwent 1 image-guided VACB. If no invasive or in situ disease was found, the patients could forgo surgery. Patients then underwent standard whole-breast radiotherapy (40 Gy in 15 fractions or 50 Gy in 25 fractions) plus a boost (14 Gy in 7 fractions). 

The cohort included 50 patients who underwent VACB after NST. The median age at baseline was 62 years (range, 55-77), all patients were women, and 76% were White. Triple-negative disease was seen in 42% of patients, 22% had HER2-positive/hormone receptor-negative disease, and 36% had HER2-positive/hormone receptor-positive disease.

There were 31 patients (62%) who had a pCR to NST per VACB and did not undergo surgery. At a median follow-up of 26.4 months, there were no ipsilateral breast tumor recurrences in these patients. 

There were 19 patients who did not achieve a pCR and therefore underwent standard surgery. There were no recurrences in this group either. 

The recurrence-free survival and overall survival rates were both 100%. 

“To our knowledge, this study is the first modern, prospective trial of omission of surgery in patients with early-stage breast cancer … who are exceptional responders to NST as indicated by state-of-the art breast imaging-guided VACB,” the researchers wrote. 

“The protocol-specified early results of this trial suggest that this new potential treatment approach appears promising. Long-term data to corroborate the early results of this trial … are necessary before this novel de-escalated treatment approach can become standard of care in this patient population.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Kuerer HM, Smith BD, Krishnamurthy S, et al. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy:A multicentre, single-arm, phase 2 trial. Lancet Oncol. Published online October 25, 2022. doi:10.1016/S1470-2045(22)00613-1