A nonrandomized clinical trial recently published on JAMA Oncology suggests that omission of breast surgery in selected patients after neoadjuvant systemic therapy may be feasible, with no recurrences.
The study was a single-arm, prospective, phase 2 nonrandomized clinical trial conducted at 7 medical centers in the US, including 50 women 40 years or older with HER2-positive or triple-negative invasive breast cancer who showed residual breast lesions after neoadjuvant systemic therapy of less than 2 cm on imaging. Since neoadjuvant systemic therapy has been associated with pathologic complete response in up to 60% of breast cancers, authors wanted to investigate if avoidance of breast surgery in patients selected with image-guided vacuum assisted biopsy could be feasible. Patients with clinically node-negative disease at diagnosis and no residual cancer underwent whole-breast radiotherapy; patients with initial documented nodal disease and a breast pathologic complete response underwent targeted axillary dissection; those with residual cancer had standard breast and axillary surgery. Patients were monitored with physical examinations and mammography every 6 months. At a median follow-up of 55.4 months, the ipsilateral breast tumor recurrence rate was 0% and disease-free and overall survival rates were 100% for patients without breast surgery. This management strategy may offer a viable alternative to surgery in a subset of patients with favorable tumor biology and excellent response to therapy, carefully and accurately selected by radiologic and pathologic assessment. As authors conclude, «Our 5-year analysis of the trial demonstrated that this new paradigm for the management of highly selected patients with HER2-positive and triple-negative breast cancer is both safe and effective. Selective avoidance of breast surgery after neoadjuvant systemic therapy may be feasible and may inform additional warranted clinical trials in breast cancer treatment de-escalation research. More confirmatory studies are necessary before this new approach alters surgical practice».
A nonrandomized clinical trial recently published on JAMA Oncology suggests that omission of breast surgery in selected patients after neoadjuvant systemic therapy may be feasible, with no recurrences.
The study was a single-arm, prospective, phase 2 nonrandomized clinical trial conducted at 7 medical centers in the US, including 50 women 40 years or older with HER2-positive or triple-negative invasive breast cancer who showed residual breast lesions after neoadjuvant systemic therapy of less than 2 cm on imaging. Since neoadjuvant systemic therapy has been associated with pathologic complete response in up to 60% of breast cancers, authors wanted to investigate if avoidance of breast surgery in patients selected with image-guided vacuum assisted biopsy could be feasible. Patients with clinically node-negative disease at diagnosis and no residual cancer underwent whole-breast radiotherapy; patients with initial documented nodal disease and a breast pathologic complete response underwent targeted axillary dissection; those with residual cancer had standard breast and axillary surgery. Patients were monitored with physical examinations and mammography every 6 months. At a median follow-up of 55.4 months, the ipsilateral breast tumor recurrence rate was 0% and disease-free and overall survival rates were 100% for patients without breast surgery. This management strategy may offer a viable alternative to surgery in a subset of patients with favorable tumor biology and excellent response to therapy, carefully and accurately selected by radiologic and pathologic assessment. As authors conclude, «Our 5-year analysis of the trial demonstrated that this new paradigm for the management of highly selected patients with HER2-positive and triple-negative breast cancer is both safe and effective. Selective avoidance of breast surgery after neoadjuvant systemic therapy may be feasible and may inform additional warranted clinical trials in breast cancer treatment de-escalation research. More confirmatory studies are necessary before this new approach alters surgical practice».