The army in breast cancer. how to avoid axillary lymphadenectomy in patients with positive clinical axilla.

Resumen El tratamiento del cáncer de mama en las últimas décadas, ha evolucionado con una tendencia cada vez más conservadora, siendo la cirugía de la axila, la que probablemente esté sufriendo más cambios en los últimos años. En la cirugía de la axila, la biopsia selectiva del ganglio centinela, ha sustituido a la linfadenectomía axilar (LA) en el tratamiento del cáncer de mama con axila clínica y radiológica negativa ( cN0 ) , en pacientes con ganglio centinela positivo( pN1) que cumplan criterios del estudio ACOSOG Z0011 y, en la actualidad, en determinados grupos de pacientes con ganglios positivos en el diagnóstico (cN1) tras recibir quimioterapia neoadyuvante. Estudios como el NSABP B-32 publicaron una tasa de identificación del ganglio centinela de 97,1% y una tasa de falsos negativos del 9,8%, sin diferencias significativas en recurrencia local ni supervivencia entre el grupo de BSGC sólo, y el seguido de LA tras 8 años de seguimiento. Posteriormente, surgen estudios en los que se analiza la observación clínica como opción a la LA en pacientes con ganglio centinela metastático. El ensayo Z0011constituye el estudio de referencia para la discusión del abandono de la LA. Por último, y dado el alto porcentaje de respuestas patológicas completas (pCR ),en la mama y ganglios axilares tras quimioterapia neoadyuvante, se plantea no realizarla en pacientes cN1 con pCR en la axila. En definitiva, en la actualidad hay que justificar la práctica de la linfadenectomía axilar la paciente con cáncer de mama.

Application of the ACOSOG Z0011 criteria to Chinese patients with breast cancer: a prospective study

Background Although the ACOSOG Z0011 study showed that axillary lymph node dissection (ALND) could be avoided in a specific population of sentinel lymph node-positive patients, it is not widely accepted by Chinese surgeons. We conducted a prospective single-arm study to confirm whether or not the results of Z0011 are applicable to Chinese patients. Methods Patients conforming to the Z0011 criteria were prospectively enrolled at the Peking University People’s Hospital Breast Center from November 2014 to June 2019. The clinicopathological features of the study group were compared with those of the Z0011 study group. Lymphedema after surgery, the incidence of local-regional recurrence, and survival were analyzed. Results One hundred forty-two patients who met the Z0011 eligibility criteria were enrolled in this study; 115 underwent sentinel lymph node biopsy (SLNB) alone. Compared with the Z0011 trial, younger patients were included (median age, 52 [26–82] years vs 54 [25–90] years; P = 0.03). For clinical T stage, tumor histology, hormone status, lymphovascular invasion, and the number of positive sentinel lymph nodes (SLNs), no statistically significant differences were observed. More patients received adjuvant chemotherapy and endocrine therapy in this study (90.85% vs 58.0% and 80.99% vs 46.6% respectively, P <0.001). A similar percentage of patients received radiotherapy, but more nodal radiotherapy procedures were carried out in our study (54.5% vs 16.9%). After a median follow-up of 29 months, only 1 patient (0.9%) had ipsilateral breast tumor recurrence, and no regional recurrence occurred. Conclusion Our study showed that it is achievable to avoid ALND in patients eligible for Z0011 in China. Trial registration ClinicalTrials.gov. Registration number NCT03606616. Retrospectively registered on 31 July 2018.

Potential Impact of the Z0011 Trial on the Omission of Axillary Dissection: A Retrospective Cohort Study

Objective To evaluate the number of patients with early-stage breast cancer who could benefit from the omission of axillary surgery following the application of the Alliance for Clinical Trials in Oncology (ACOSOG) Z0011 trial criteria. Methods A retrospective cohort study conducted in the Hospital da Mulher da Universidade Estadual de Campinas. The study population included 384 women diagnosed with early-stage invasive breast cancer, clinically negative axilla, treated with breast-conserving surgery and sentinel lymph node biopsy, radiation therapy, chemotherapy and/or endocrine therapy, from January 2005 to December 2010. The ACOSOG Z0011 trial criteria were applied to this population and a statistical analysis was performed to make a comparison between populations. Results A total of 384 patients underwent breast-conserving surgery and sentinel lymph node biopsy. Of the total number of patients, 86 women underwent axillary lymph node dissection for metastatic sentinel lymph nodes (SNLs). One patient underwent axillary node dissection due to a suspicious SLN intraoperatively, thus, she was excluded from the study. Among these patients, 82/86 (95.3%) had one to two involved sentinel lymph nodes and met the criteria for the ACOSOG Z0011 trial with the omission of axillary lymph node dissection. Among the 82 eligible women, there were only 13 cases (15.9%) of lymphovascular invasion and 62 cases (75.6%) of tumors measuring up to 2 cm in diameter (T1). Conclusion The ACOSOG Z0011 trial criteria can be applied to a select group of SLN-positive patients, reducing the costs and morbidities of breast cancer surgery.