Association of Axillary Dissection With Systemic Therapy in Patients With Clinically Node-Positive Breast Cancer.

Importance: The role of axillary lymph node dissection (ALND) to determine nodal burden to inform systemic therapy recommendations in patients with clinically node (cN)-positive breast cancer (BC) is currently unknown. Objective: To address the association of ALND with systemic therapy in cN-positive BC in the upfront surgery setting and after neoadjuvant chemotherapy (NACT). Design, Setting, and Participants: This was a prospective, observational, cohort study conducted from August 2018 to June 2022. This was a preplanned study within the phase 3 randomized clinical OPBC-03/TAXIS trial. Included were patients with confirmed cN-positive BC from 44 private, public, and academic breast centers in 6 European countries. After NACT, residual nodal disease was mandatory, and a minimum follow-up of 2 months was required. Exposures: All patients underwent tailored axillary surgery (TAS) followed by ALND or axillary radiotherapy (ART) according to TAXIS randomization. TAS removed suspicious palpable and sentinel nodes, whereas imaging-guidance was optional. Systemic therapy recommendations were at the discretion of the local investigators. Results: A total of 500 patients (median [IQR] age, 57 [48-69] years; 487 female [97.4%]) were included in the study. In the upfront surgery setting, 296 of 335 patients (88.4%) had hormone receptor (HR)-positive and Erb-B2 receptor tyrosine kinase 2 (ERBB2; formerly HER2 or HER2/neu)-negative disease: 145 (49.0%) underwent ART, and 151 (51.0%) underwent ALND. The median (IQR) number of removed positive lymph nodes without ALND was 3 (1-4) nodes compared with 4 (2-9) nodes with ALND. There was no association of ALND with the proportion of patients undergoing adjuvant chemotherapy (81 of 145 [55.9%] vs 91 of 151 [60.3%]; adjusted odds ratio [aOR], 0.72; 95% CI, 0.19-2.67) and type of systemic therapy. Of 151 patients with NACT, 74 (51.0%) underwent ART, and 77 (49.0%) underwent ALND. The ratio of removed to positive nodes was a median (IQR) of 4 (3-7) nodes to 2 (1-3) nodes and 15 (12-19) nodes to 2 (1-5) nodes in the ART and ALND groups, respectively. There was no observed association of ALND with the proportion of patients undergoing postneoadjuvant systemic therapy (57 of 74 [77.0%] vs 55 of 77 [71.4%]; aOR, 0.86; 95% CI, 0.43-1.70), type of postneoadjuvant chemotherapy (eg, capecitabine: 10 of 74 [13.5%] vs 10 of 77 [13.0%]; trastuzumab emtansine-DM1: 9 of 74 [12.2%] vs 11 of 77 [14.3%]), or endocrine therapy (eg, aromatase inhibitors: 41 of 74 [55.4%] vs 36 of 77 [46.8%]; tamoxifen: 8 of 74 [10.8%] vs 6 of 77 [7.8%]). Conclusion: Results of this cohort study suggest that patients without ALND were significantly understaged. However, ALND did not inform systemic therapy recommendations.

Trends in use of neoadjuvant systemic therapy in patients with clinically node-positive breast cancer in Europe: prospective TAXIS study (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).

PURPOSE: The aim of this study was to evaluate clinical practice heterogeneity in use of neoadjuvant systemic therapy (NST) for patients with clinically node-positive breast cancer in Europe. METHODS: The study was preplanned in the international multicenter phase-III OPBC-03/TAXIS trial (ClinicalTrials.gov Identifier: NCT03513614) to include the first 500 randomized patients with confirmed nodal disease at the time of surgery. The TAXIS study's pragmatic design allowed both the neoadjuvant and adjuvant setting according to the preferences of the local investigators who were encouraged to register eligible patients consecutively. RESULTS: A total of 500 patients were included at 44 breast centers in six European countries from August 2018 to June 2022, 165 (33%) of whom underwent NST. Median age was 57 years (interquartile range [IQR], 48-69). Most patients were postmenopausal (68.4%) with grade 2 and 3 hormonal receptor-positive and human epidermal growth factor receptor 2-negative breast cancer with a median tumor size of 28 mm (IQR 20-40). The use of NST varied significantly across the countries (p < 0.001). Austria (55.2%) and Switzerland (35.8%) had the highest percentage of patients undergoing NST and Hungary (18.2%) the lowest. The administration of NST increased significantly over the years (OR 1.42; p < 0.001) and more than doubled from 20 to 46.7% between 2018 and 2022. CONCLUSION: Substantial heterogeneity in the use of NST with HR+/HER2-breast cancer exists in Europe. While stringent guidelines are available for its use in triple-negative and HER2+ breast cancer, there is a need for the development of and adherence to well-defined recommendations for HR+/HER2-breast cancer.

Prospective Multicenter Trial Assessing the Impact of Positive Peritoneal Cytology Conversion on Oncological Outcome in Patients with Endometrial Cancer Undergoing Minimally Invasive Surgery with the use of an Intrauterine Manipulator : Positive Peritoneal Cytology Conversion and Its Association with Oncological Outcome in Endometrial Cancer.

BACKGROUND: Minimally invasive surgery is the standard approach in early-stage endometrial cancer according to evidence showing no compromise in oncological outcomes, but lower morbidity compared with open surgery. However, there are limited data available on the oncological safety of the use of intrauterine manipulators in endometrial cancer. PATIENTS AND METHODS: This prospective multicenter study included patients with endometrial cancer undergoing laparoscopic staging surgery with the use of an intrauterine manipulator. We obtained three different sets of peritoneal washings: at the beginning of the surgical procedure, after the insertion of the intrauterine manipulator, and after the closure of the vaginal vault. The rate of positive peritoneal cytology conversion and its association with oncological outcomes was assessed. RESULTS: A total of 124 patients were included. Peritoneal cytology was negative in 98 (group 1) and positive in 26 (group 2) patients. In group 2, 16 patients presented with positive cytology at the beginning of the surgery (group 2a) and 10 patients had positive cytology conversion during the procedure (group 2b). Recurrence rate was significantly different among the study groups, amounting to 9.2%, 25.0%, and 60.0% for groups 1, 2a, and 2b, respectively (p < 0.001). Group 1 showed the best recurrence-free and overall survival, followed by group 2a, while patients in group 2b had the worst oncological outcomes (p = 0.002 and p = 0.053, respectively). Peritoneal cytology was an independent predictor of recurrence and death on multivariable analysis. CONCLUSION: A total of 8.1% of patients with endometrial cancer undergoing minimally invasive surgery with intrauterine manipulation showed positive peritoneal cytology conversion associated with significantly worse oncological outcome.

Tailored axillary surgery in patients with clinically node-positive breast cancer: Pre-planned feasibility substudy of TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).

AIM: We developed tailored axillary surgery (TAS) to reduce the axillary tumor volume in patients with clinically node-positive breast cancer to the point where radiotherapy can control it. The aim of this study was to quantify the extent of tumor load reduction achieved by TAS. METHODS: International multicenter prospective study embedded in a randomized trial. TAS is a novel pragmatic concept for axillary surgery de-escalation that combines palpation-guided removal of suspicious nodes with the sentinel procedure and, optionally, imaging-guided localization. Pre-specified study endpoints quantified surgical extent and reduction of tumor load. RESULTS: A total of 296 patients were included at 28 sites in four European countries, 125 (42.2%) of whom underwent neoadjuvant chemotherapy (NACT) and 71 (24.0%) achieved nodal pathologic complete response. Axillary metastases were detectable only by imaging in 145 (49.0%) patients. They were palpable in 151 (51.0%) patients, of whom 63 underwent NACT and 21 had residual palpable disease after NACT. TAS removed the biopsied and clipped node in 279 (94.3%) patients. In 225 patients with nodal disease at the time of surgery, TAS removed a median of five (IQR 3-7) nodes, two (IQR 1-4) of which were positive. Of these 225 patients, 100 underwent ALND after TAS, which removed a median of 14 (IQR 10-17) additional nodes and revealed additional positive nodes in 70/100 (70%) of patients. False-negative rate of TAS in patients who underwent subsequent ALND was 2.6%. CONCLUSIONS: TAS selectively reduced the tumor load in the axilla and remained much less radical than ALND.

Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial.

INTRODUCTION: The emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions. METHODS AND ANALYSIS: International, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm). ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles. TRIAL REGISTRATION NUMBER: NCT04293146.

A novel combined transurethral and suprapubic approach for excision of mesh at the bladder neck.

INTRODUCTION AND HYPOTHESIS: Unrecognized bladder perforation of a tension-free sling is a rare situation. Removal of the intravesical sling has been done by laparotomy or transurethrally. With technique presented here we want to show a minimally invasive approach that allows complete removal of the intraluminal sling material, located at the bladder neck. METHODS: This video shows a novel combined transurethral and suprapubic approach for radical removal of the mesh. Two 3.5-mm trocars were placed suprapubically into a filled bladder. One site was used for an optic with camera and the other for a 3.5-mm grasping forceps to apply tension on the mesh to pull it out of the bladder wall while it was being excised transurethrally with a cystoscope and transurethral scissors. RESULTS: The patient's postoperative course was uneventful. At 1-month follow-up, the patient was free of dysuria and cystoscopy revealed complete healing of the mesh site. Because of recurrent stress urinary incontinence, another continence sling surgery has been performed (TVT exact). After a follow-up of 2 years, she is continent and free of dysuria. CONCLUSIONS: This novel technique provides an effective means of removing mesh perforated into the bladder, located at the bladder neck, using a combined transurethral and suprapubic approach. The technique is minimally invasive and the applied traction allows complete removal of the intraluminal part of the mesh.

A multipurpose uterine/vaginal manipulator for laparoscopic urogynecologic procedures.

INTRODUCTION AND HYPOTHESIS: The use of an appropriate uterine manipulator is key to various laparoscopic gynecologic procedures. Adequate uterine manipulation is important for total or supracervical laparoscopic hysterectomies, laparoscopic sacrocolpopexy as well as laparoscopic repair of vaginal vault prolapse. While several uterine manipulators are available to choose from, their use may be specific to certain procedures and their cost may vary as well. METHODS: This video aims to provide an introduction to a multipurpose, reusable uterine/vaginal manipulator that can be used for laparoscopic supracervical hysterectomy, laparoscopic sacrocolpopexy, laparoscopic hysteropexy as well as laparoscopic repair of vaginal vault prolapse. RESULTS: The video highlights the user-friendly, easy-to-clean, reusable, multipurpose uterine/vaginal manipulator. CONCLUSIONS: The manipulator is designed for an efficient combination of laparoscopic urogynecologic procedures and supracervical hysterectomy.

Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial.

BACKGROUND: Several studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer. METHODS: In a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil® patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage. RESULTS: Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil® and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512-895 ml]. Application of TachoSil® did not significantly reduce the total volume of axillary drainage [mean difference (MD) -110 ml, 95% CI -316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil®. The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625-35,880) with TachoSil® and 33,365 Swiss Francs (95% CI 31,771-34,961) without, p = 0.584]. In the TachoSil® group, length of stay was longer (MD 1 day, 95% CI 0.3-1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1-4) vs. 5.5 days (95% CI 2-11); p = 0.2]. CONCLUSIONS: TachoSil® reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.

A technique of laparoscopic mesh excision from the bladder after sacrocolpopexy.

Several series have demonstrated the feasibility, safety, and efficacy of laparoscopic sacrocolpopexy. Nonetheless, complications such as mesh erosion into the bladder can occur years after primary surgery, with accidental cystotomy during the primary operation appearing to be a risk factor for later mesh erosion. Over the last 10 years, we have treated 7 patients with mesh erosion into the bladder after laparoscopic sacrocolpopexy using a technique of transvesical laparoscopic partial excision of the eroded mesh. None of these 7 patients developed recurrent erosions, fistulas, or recurrent prolapse. The video demonstrates laparoscopic excision of intravesical mesh in a patient 5 years after laparoscopic sacrocolpopexy. Key steps are opening the bladder to grasp and dissect the eroded mesh; partial resection of the mesh with formation of a bladder flap; and closure of the bladder. Laparoscopy appears to be a useful tool for the treatment of this problem. Because many urogynecology units around the world have now begun to perform laparoscopic sacrocolpopexy, urogynecologists should be aware of these complications and how to treat them. The video is intended to help and encourage centers performing laparoscopic transvesical excision of mesh eroded into the bladder after sacrocolpopexy.

Laparoscopic sacrocolpopexy: demonstration of a nerve-sparing technique.

Laparoscopic sacrocolpopexy is a well-established technique to treat apical vaginal prolapse. De novo micturition disorders, pelvic pain, and defecation disorders have been reported and may be due to intraoperative compromise of the superior hypogastric plexus. The video demonstrates our technique for nerve-sparing laparoscopic sacrocolpopexy. The patient is a 62-year-old woman with symptomatic stage III posthysterectomy vaginal vault prolapse. Key steps of the procedure are opening the peritoneum at the level of the promontory, identification of the fibers of the superior hypogastric plexus, deep anterior and posterior dissection with attachment of the mesh to the vagina, displacement of the nerve fibers to the left side during suturing of the mesh to the longitudinal ligament, and complete peritonealization. This technique of the identification and protection of relevant nerve structures appears to be reproducible and can be considered by surgeons who perform laparoscopic sacrocolpopexy.

Long-term follow-up of laparoscopic sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: This study evaluates the long-term results of laparoscopic sacrocolpopexy. In a prior publication, we demonstrated that laparoscopic sacrocolpopexy is a safe method with excellent anatomical results and low recurrence rates after a 12-month follow-up. This study now evaluates the long-term objectives and subjective outcomes of laparoscopic sacrocolpopexy after 5 years (mean). METHODS: From 2003 to 2007, a prospective study enrolling 101 patients was conducted to evaluate laparoscopic sacrocolpopexy as a treatment for pelvic organ prolapse. The long-term results were assessed postoperatively after 5 years by gynecological examinations, including the Pelvic Organ Prolapse Quantification (POP-Q) system and quality of life assessments using validated questionnaires. RESULTS: A total of 68 patients received a full clinical follow-up exam between July and September 2011, and 17 patients were assessed by questionnaires only. Altogether, six anatomical recurrences in the anterior, four in the posterior, and one in the apical compartment were found during the 5 years after surgery; 83.8 % of patients had no prolapse in any compartment or stage 0 prolapse according to the International Continence Society (ICS) classification. The total reoperation rate was 3.5 %. Two mesh erosions into the bladder occurred, though no vaginal erosion occurred. The preoperative quality of life index improved from 5.6 to 9.1 (12 months) and 8.3 (60 months) postoperatively, resulting in a subjective cure rate of 95.3 %. CONCLUSIONS: Laparoscopic sacrocolpopexy has demonstrated excellent anatomical and functional long-term results. With the ongoing debate about the complications of vaginal mesh surgery, laparoscopic sacrocolpopexy should be considered a favorable treatment option for patients with pelvic organ prolapse.

Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial.

OBJECTIVE: To compare surgical outcome and quality of life of robot-assisted laparoscopic hysterectomy with conventional laparoscopic hysterectomy. METHODS: For this controlled clinical trial, patients with benign indications for hysterectomy were randomized to receive either a robotic (robotic group) or conventional laparoscopic hysterectomy (conventional group). The primary end point was total operating time; secondary end points were perioperative outcome, blood loss, and the change in quality of life. RESULTS: Ninety-five patients out of 100 randomized patients completed the study. Patient age, body mass index, and uterus weight showed no significant differences between both groups. All results are given as mean (± standard deviation; median). Total operating time for the robotic group was significantly higher with 106 (± 29; 103) compared with 75 (± 21; 74) (conventional group) minutes. Blood loss, complications, analgesics use, and return to activity for both groups were comparable. The change in preoperative to postoperative quality-of-life index (quality of life measured on a linear scale from 0 to 100) was significantly higher in the robotic group, with 13 (± 10; 13) compared with 5 (± 14; 5) (conventional group). CONCLUSION: Robot-assisted laparoscopic hysterectomy and conventional laparoscopy compare well in most surgical aspects, but the robotic procedure is associated with longer operating times. Postoperative quality-of-life index was better; however, long-term, there was no difference. However, subjective postoperative parameters such as analgesic use and return to activity showed no significant difference between both groups.

Robotic versus laparoscopic hysterectomy: a review of recent comparative studies.

PURPOSE OF REVIEW: To illustrate the current stand on robotic versus conventional laparoscopic hysterectomy regarding operating times, clinical outcome and costs. RECENT FINDINGS: Only six studies were reviewed, as there are only few recent studies comparing robotic with laparoscopic hysterectomy and most are retrospective. Apart from one multicentre study with over 36  000 patients, 350 institutions and numerous surgeons, most studies were performed with few cases by one or two surgeons at one or two hospitals. Operating times for robotic hysterectomies generally were longer, ranging from 89.9 to 267  min. Surgery time for conventional laparoscopic hysterectomies was between 83 and 206  min. In all studies, clinical outcomes such as blood loss, complications or hospital stay of both the robotic and the conventional laparoscopic procedure were similar. Only two studies compared costs and both came up with very similar findings. Cost for a robot-assisted hysterectomy is approximately 2600 USD higher than that for conventional laparoscopic hysterectomy not including investment and amortization. SUMMARY: Robotic and conventional laparoscopic hysterectomy are essentially equivalent regarding surgical and clinical outcome. Operating times are slightly higher and costs are significantly higher for the robotic procedure.

Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study.

OBJECTIVE: Robotic surgery, with its technical advances, promises to open a new window to minimally invasive surgery in gynaecology. Feasibility and safety of this surgical innovation have been demonstrated in several studies, and now a critical analysis of these new developments regarding outcome and costs is in place. So far only a few studies compare robotic with conventional laparoscopic surgery in gynaecology. Our objective was to evaluate our initial experience performing total robot-assisted hysterectomy with the da Vinci surgical system and compare peri-operative outcome and costs with total laparoscopic hysterectomy. STUDY DESIGN: For this prospective matched case-control study at our institution, peri-operative data from our first 40 consecutive total robot-assisted hysterectomies for benign indications were recorded and matched 1:1 with total laparoscopic hysterectomies according to age, BMI and uterus weight. Surgical costs were calculated for both procedures. Surgeons' subjective impressions of robotics were evaluated with a self-developed questionnaire. RESULTS: No conversions to laparotomy or severe peri-operative complications occurred. Mean operating time was 109 (113; 50-170) min for the robotic group and 83 (80; 55-165) min for the conventional laparoscopic group. Mean postoperative hospitalisation for robotic surgery was 3.3 (3; 2-6) days versus 3.9 (4; 2-7) days for the conventional laparoscopic group. Average surgical cost of a robot-assisted laparoscopic hysterectomy was 4067 euros compared to 2151 euros for the conventional laparoscopic procedure at our institution. For the robotic group wider range of motion of the instruments and better ergonomics were considered to be an advantage, and lack of direct access to the patient was stated as a disadvantage. CONCLUSION: Robot-assited hysterectomy is a feasible and interesting new technique with comparable outcome to total laparoscopic hysterectomy. Operating times of total laparoscopic hysterectomy seem to be achieved quickly especially for experienced laparoscopic surgeons. However, costs of robotic surgery are still higher than for conventional laparoscopy. Randomised clinical trials need to be conducted to further evaluate benefits of this new technology for patients and surgeons and analyse its cost-effectiveness in gynaecology.

Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases.

Our prospective study evaluates laparoscopic sacrocolpopexy for vaginal vault prolapse focusing on perioperative data, objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system and postoperative quality of life using the Kings Health questionnaire. One hundred one patients completed the study. Fifty five had laparoscopic supracervical hysterectomy and sacrocolpopexy for uterine prolapse and 46 had laparoscopic sacrocolpopexy for post-hysterectomy prolapse. Median follow-up was 12 months. The subjective cure rate was 93% the objective cure rate (no prolapse in any compartment) according to the International Continence Society classification of prolapse was 98%. The main site of objective recurrence (6%) was the anterior compartment. No apical recurrences and no vaginal mesh erosion occurred. Postoperatively overall quality of life and sexual quality showed significant improvement with less than 1% de-novo dyspareunia. The procedure is recommended for experienced laparoscopic surgeons because of severe intraoperative complications like bladder or rectal injuries.

How does tension-free vaginal tape correct stress incontinence? investigation by perineal ultrasound.

Forty patients who underwent a single tension-free vaginal tape procedure were evaluated by perineal ultrasound both pre- and postoperatively in a prospective observational clinical study. The positions of the tape, bladder neck and urethra were sonographically documented at rest and during Valsalva maneuvers. During Valsalva the tape rotated towards the symphysis in all patients. Postoperative urethral angulation could be demonstrated in 36 of 40 patients. Bladder neck mobility remained unchanged after the tension-free vaginal tape procedure, and 36 of the 40 were dry according to patient questionnaires. Postoperative cough test was negative in all patients. Two points seem to be important for the functioning of the tension-free vaginal tape: a dynamic kinking of the urethra during stress, and the movement of the tape against the symphysis, compressing the tissue between the tape and the symphysis. Mobility of the bladder neck is unaffected by the single tension-free vaginal tape procedure.