Safety of Targeted Axillary Dissection After Neoadjuvant Therapy in Patients With Node-Positive Breast Cancer.

Importance: The increasing use of neoadjuvant systemic therapy (NST) has led to substantial pathological complete response rates in patients with initially node-positive, early breast cancer, thereby questioning the need for axillary lymph node dissection (ALND). Targeted axillary dissection (TAD) is feasible for axillary staging; however, data on oncological safety are scarce. Objective: To assess 3-year clinical outcomes in patients with node-positive breast cancer who underwent TAD alone or TAD with ALND. Design, Setting, and Participants: The SenTa study is a prospective registry study and was conducted between January 2017 and October 2018. The registry includes 50 study centers in Germany. Patients with clinically node-positive breast cancer underwent clipping of the most suspicious lymph node (LN) before NST. After NST, the marked LNs and sentinel LNs were excised (TAD) followed by ALND according to the clinician's choice. Patients who did not undergo TAD were excluded. Data analysis was performed in April 2022 after 43 months of follow-up. Exposure: TAD alone vs TAD with ALND. Main Outcomes and Measures: Three-year clinical outcomes were evaluated. Results: Of 199 female patients, the median (IQR) age was 52 (45-60) years. A total of 182 patients (91.5%) had 1 to 3 suspicious LNs; 119 received TAD alone and 80 received TAD with ALND. Unadjusted invasive disease-free survival was 82.4% (95% CI, 71.5-89.4) in the TAD with ALND group and 91.2% (95% CI, 84.2-95.1) in the TAD alone group (P = .04); axillary recurrence rates were 1.4% (95% CI, 0-54.8) and 1.8% (95% CI, 0-36.4), respectively (P = .56). Adjusted multivariate Cox regression indicated that TAD alone was not associated with an increased risk of recurrence (hazard ratio [HR], 0.83; 95% CI, 0.34-2.05; P = .69) or death (HR, 1.07; 95% CI, 0.31-3.70; P = .91). Similar results were obtained for 152 patients with clinically node-negative breast cancer after NST (invasive disease-free survival: HR, 1.26; 95% CI, 0.27-5.87; P = .77; overall survival: HR, 0.81; 95% CI, 0.15-3.83; P = .74). Conclusions and Relevance: These results suggest that TAD alone in patients with mostly good clinical response to NST and at least 3 TAD LNs may confer survival outcomes and recurrence rates similar to TAD with ALND.

Total mesometrial resection (TMMR) for cervical cancer FIGO IB-IIA: first results from the multicentric TMMR register study.

OBJECTIVE: The surgical concept of total mesometrial resection (TMMR) and therapeutic lymphadenectomy (tLNE) for the treatment of early cervical cancer is based on the ontogenetic cancer field model. Unicentric data show excellent locoregional control rates without adjuvant chemoradiation. However, there are so far no prospective, multicentric data supporting the method. METHODS: The multicentric TMMR register study was designed to answer the question whether the concept of TMMR+tLNE could be transferred to different centers and surgeons without compromising the outstanding oncologic results described in a unicentric setting. RESULTS: In 116 patients with cervical cancer stages IB-IIA, (International Federation of Gynecology and Obstetrics [FIGO] 2018), who underwent TMMR/tLNE, 25.0% were lymph node-positive. pT stages were pT1a in 3 patients (2.6%), pT1b1 in 82 (70.7%), pT1b2 in 18 (15.5%), pT2a in 4 (3.5%) and pT2b in 9 (7.8%). The overall recurrence rate was 7.8% in a median follow-up time of 24 months (6-80). Locoregional recurrences occurred in 6.0% of patients. One patient (0.9%) died from the disease during the observation period. CONCLUSION: These are the first multicentric data on the surgical concept of TMMR and tLNE for the treatment of cervical cancer FIGO IB-IIA. We were able to reproduce the excellent oncologic data described for the method albeit with a relatively short median observation time. A randomized controlled trial seems warranted to definitely establish TMMR+tLNE as the method of choice for the treatment of early cervical cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01819077.