Jean-Marc Classe, MD, PhD
Results of a clinical trial show that an axillary lymph node dissection (ALND) can be avoided for patients with large, operable tumors in the breast, no clinical signs of cancer in the axillary nodes before being treated with neoadjuvant chemotherapy, and no signs of cancer following a sentinel lymph node biopsy (SLNB) during surgery. These findings were presented at the 2016 San Antonio Breast Cancer Symposium.
According to Jean-Marc Classe, MD, PhD, who was an investigator on the trial, researchers wanted to assess the feasibility and safety of the less invasive procedure of SLNB for patients treated with neoadjuvant chemotherapy for a large breast cancer, due to the high risk for serious complications and long-term sequelae associated with ALND.
“ALND, which is an invasive surgical procedure in which many of the lymph nodes in the armpit are removed, is often performed to check whether a patient’s cancer has spread outside the breast after neoadjuvant chemotherapy,” explained Classe in a statement.
The trial enrolled 590 patients with large, operable breast tumors who had no cancer in the lymph nodes, as determined by axillary sonography with fine-needle cytology. The patients received neoadjuvant chemotherapy and then underwent surgery and SLNB.
Cancer cells were found in the SLNB samples of 139 patients, who then underwent ALND. In 432 patients, there were no cancer cells detected in the SLNB samples. Follow-up was available for 416 of those patients, with the median follow-up at 35.8 months.
The disease-free survival at 3 years in patients who had no cancer in the SLNB sample, and therefore had not received ALND, was 94.8%. One patient had homolateral axillary lymph node relapse. Of 9 other relapses, 3 were metastatic, while 6 were recurrences in the breasts. Overall survival was 98.7%.
“We found that for patients with no proof of cancer in the axillary lymph nodes before neoadjuvant chemotherapy, SLNB during the surgery after neoadjuvant chemotherapy was safe because those who had a negative SNLB and did not have an ALND had a very low risk of an axillary relapse at 3 years after surgery,” stated Classe, head of surgery at the Institut de Cancerologie de l’Ouest René Gauducheau in Nantes, France.
“We had expected more axillary lymph node relapses than we observed, so this is very exciting and will hopefully mean that more patients are spared the potential complications of invasive ALND.”
“The disease-free and overall survival results we observed for the patients who underwent only an SLNB after neoadjuvant chemotherapy are comparable with the historical survival rates for patients in this situation who have ALND rather than SLNB,” said Classe. “Therefore, an ALND could be avoided by patients who have no signs of cancer in the axillary lymph nodes following a sonographic axillary assessment prior to neoadjuvant chemotherapy and SLNB during surgery after neoadjuvant chemotherapy.”
Longer follow-up of the patients is needed, Classe said, to further confirm the safety of SLNB in these patients.
Classe JM, Loaec C, Alran S, et al. Sentinel node detection after neoadjuvant chemotherapy in patient without previous axillary node involvement (GANEA 2 trial): follow-up of a prospective multi-institutional cohort. Presented at: 2016 San Antonio Breast Cancer Symposium; December 6-10, 2016; San Antonio, TX. Abstract S2-07.