Key Findings at a Glance

• Paradigm Shift: A new study hints at a potential new paradigm for teh management of select patients with HER2-positive and triple-negative breast cancers, according to dr. Henry Kuerer of MD anderson Cancer Center.
• Surgery Avoidance: Women with HER2-positive or triple-negative breast cancer who achieve a complete response to neoadjuvant systemic therapy (NST) may safely avoid surgery.
• Excellent Outcomes: A five-year study showed no recurrences in patients who skipped surgery after NST.
• Quality of Life Improvement: Patients reported increased decisional comfort and improved overall health-related quality of life.

The Study: A Closer Look

Researchers at the University of Texas MD Anderson Cancer Center are exploring a groundbreaking approach to breast cancer treatment.The study, published in
JAMA Oncology
, suggests that for some women with specific types of breast cancer, surgery might not be necessary after a complete response to chemotherapy [[research link]].

The study focused on 50 women, aged 40 or older (median age 62), with HER2-positive (58%) or triple-negative (42%) invasive breast cancer. All participants had residual breast lesions of less than 2 cm after neoadjuvant systemic therapy (NST). Neoadjuvant therapy is systemic treatment given before surgery to shrink the tumor and reduce the risk of recurrence [[1]].

After NST, the women underwent an image-guided vacuum-assisted biopsy (VAB) using a 9G needle, with a minimum of 12 cores obtained.This precise biopsy technique, developed at MD Anderson, allows doctors to accurately sample the area where the cancer had shrunk.

Utilizing this technique, the false-negative rate was less than 5%, with an accuracy of 98%.

Dr.Henry Kuerer, MD Anderson Cancer Center

Of those biopsied, 31 patients (62%) showed a pathologic complete response (pCR), meaning no invasive or in situ disease was detected. this included eight patients with initial nodal metastases who achieved axillary pCR after targeted axillary node dissection. These patients then received whole-breast radiotherapy with a boost but did not undergo breast surgery. The remaining 19 patients, who showed residual cancer on VAB, underwent standard breast and axillary surgery.

The Results: A Promising Outlook

After a median follow-up of 55.4 months, none of the 31 patients who avoided surgery experienced ipsilateral breast tumor recurrence.The disease-free and overall survival rates for this group were both 100%.

Dr. Kuerer emphasized the rigorous monitoring involved in the study.

There was no guesswork with this new paradigm for the management of meticulously selected patients after neoadjuvant systemic therapy. We followed these patients extremely closely at six-month intervals with imaging and physical examinations and were delighted that none of the patients had a recurrence, as we had already predicted, as no residual breast cancer was noted on the needle biopsy.

Dr. Henry Kuerer, MD Anderson Cancer Center

Traditionally, surgical management is the standard practice for invasive breast cancer. All 31 patients in this study would have undergone surgery had they not participated in the trial.

Patient Experience: Comfort and Quality of Life

The study also examined the women’s feelings about participating in the trial. At the beginning, participants reported relatively high comfort levels with their decision to forego surgery, with a mean baseline Decisional Regret Scale score of 15.2 out of 100. After five years,this score substantially decreased to 2.5, indicating increased decisional comfort over time.

Overall health-related quality of life,including physical,social/family,emotional,functional,and breast cancer-specific well-being,also improved significantly during the follow-up period.

Dr. Kuerer believes that avoiding unneeded treatments can significantly benefit patients.

I think that most patients would prefer avoiding therapies that are not essential for their well-being and preventing complications such as pain syndrome, swelling of the arm, infection, adverse cosmetic outcomes, and even, for some patients, psychological trauma from breast cancer surgery.

Dr. Henry Kuerer, MD Anderson Cancer Center

The Future: Further Research Needed

While the results are promising, Dr. Kuerer stresses the need for further clinical trials before surgical omission becomes standard practice.He emphasizes the importance of strict eligibility criteria and technical protocols.

I think it is essential that VAB is the only biopsy method at this time to utilize all the criteria we established in our foundational trials to select patients safely. There have been other biopsy trials looking at the accuracy in determining a pathological complete response, but they did not ensure technical accuracy, used a needle size that was too small without appropriately sampling the residual region, and did not include the extensive microscopic evaluation of the small portions of tissue to ensure no carcinoma cells.

Dr. Henry Kuerer, MD Anderson Cancer Center

The researchers have expanded the clinical trial to include 100 patients at MD Anderson Cancer Center. The protocol is also being investigated in South Korea in the Optimist study, which is currently recruiting patients.