Rethinking surgical revisions: impact of the MonarchE trial on axillary dissection in hormone-positive HER2-negative early breast cancer patients potentially eligible for abemaciclib.

INTRODUCTION: The MonarchE trial explored the use of abemaciclib, a CDK4/6 inhibitor, as an adjuvant treatment in high-risk early-stage luminal-like breast cancer. The study's inclusion criteria, especially the N2 status, may require revisiting surgical interventions, including invasive axillary lymph node dissection (ALND)-a procedure that current guidelines generally do not recommend. METHODS: We conducted a single-centre, retrospective, observational cohort study on non-metastatic breast cancer patients managed from 2002 to 2011, at the Institut Curie. Data collection involved clinical and histological characteristics plus treatment follow-up. RESULTS: Out of 8715 treated patients, 721 met the inclusion criteria. Overall, 12% (87) were classified as N2 ( ≥ 4 positive lymph nodes), thus eligible for abemaciclib per "node criterion." Tumour size, positive sentinel lymph nodes, and lobular histology showed a significant correlation with N2 status. Approximately 1000 ALNDs would be required to identify 120 N2 cases and prevent four recurrences. CONCLUSION: The MonarchE trial may significantly affect surgical practices due to the need for invasive procedures to identify high-risk patients for adjuvant abemaciclib treatment. The prospect of unnecessary morbidity demands less invasive N2 status determination methods. Surgical decisions must consider patient health and potential treatment benefits.

Collateral damage of COVID-19 pandemic: The impact on a gynecologic surgery department.

OBJECTIVE: This study focuses on changes in gynecologic surgical activity at Hospital Foch, Paris, France during the first French COVID lockdown in 2020. Additional goals include the evaluation the extent of the postponement suffered for each type of surgery and estimate the possible negative impact for patients. STUDY DESIGN: Single-center, retrospective, chart-review cohort study in the gynecology department of Hospital Foch. Comparison of all patients scheduled, postponed and operated during the first COVID lockdown (March 14, to May 11, 2020) versus the same period in 2019. Postponed surgeries were classified into 4 scheduling interval categories according to the Society of Gynecology Oncology (SGO) recommendations: urgent (without delay), semi-urgent (1-4 weeks), non-urgent (>4-12 weeks) and elective (>3 months) and evaluated to determine whether COVID-19-related delays of surgeries fell within guidelines. The potential "loss of chance" or medical risk associated with postponed surgeries was estimated according to a composite criterion including death, aggravation of expected tumor stages/grades in cancers, increase in surgical complexity compared to that initially planned, need for preoperative transfusions, start of morphine consumption during preoperative treatment for opiate-naive patients, additional hospitalization or consultations in emergency room and delay in treatment when surgery was urgent. RESULTS: During the 2020 French COVID lockdown, 61 patients had a surgical procedure and 114 were postponed; in the comparator 2019 group, 232 patients underwent surgical procedures, indicating an overall decrease of 65% of activity. Analysis of differences between the two years revealed a reduction of 64% in emergency procedures, 90% of functional pathologies, and 13% of cancers. According to SGO guidelines, the only type of surgical procedures that had excessive delay was the semi-urgent group, where time to surgery was 6.7 weeks [range 5.4-10 weeks] instead of the recommended interval of 1-4 weeks. Among postponed surgeries there were 10 patients (8.7%) with a potential "loss of chance" according to the composite criteria, all included in the semi-urgent group. CONCLUSION: The COVID 19 pandemic was responsible for a significant decrease of activity in the surgical department of Hospital Foch. Difficulty of rescheduling surgeries was responsible for an increased delay in semi-urgent operations. In almost 9% of postponed surgeries, there was a potential "loss of chance", which likely represents only the tip of iceberg of collateral damages due to COVID 19 pandemic in this surgical unit. These data show the importance of continuing to treat pathologies requiring urgent or semi-urgent surgery during pandemics.