Citations

Background: Since its first description in 2012, the Goldilocks procedure has become an option for immediate breast reconstruction, particularly for obese patients who are poor candidates for traditional implant or autologous reconstruction. In this work, the authors performed a longitudinal study of patients who underwent mastectomy with Goldilocks reconstruction to assess the incidence of additional surgical procedures, and to assess surgical outcomes and patient satisfaction. Methods: A retrospective review of patients who underwent mastectomy with the Goldilocks procedure only at Mayo Clinic Rochester between January of 2012 and September of 2019 was performed. Demographics, complications, additional breast procedures performed to attain the final results, and patient-reported outcomes using the BREAST-Q were recorded. Univariate and multivariable analyses were performed to identify statistical associations and risk factors. Results: Sixty-three patients (108 breasts) were included. Mean age was 57.8 years. Mean body mass index was 37.6 kg/m2. Median follow-up time after the mastectomy with the Goldilocks procedure was 15 months. The major complication rate within the first 30 days was 9.3 percent. Forty-four breasts (40.7 percent) underwent additional surgery. Dyslipidemia was significantly associated with an increased risk of additional surgery (adjusted hazard ratio, 2.00; p = 0.045). Scores in the four BREAST-Q domains were not statistically different between patients who had additional procedures and those who did not. Conclusions: Based on the results, the authors recommend a thorough preoperative discussion with patients who are candidates for the Goldilocks procedure to explore all options for reconstruction and their expectations, because it is crucial to reduce the necessity for additional operations in this high-risk population. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Background: Panniculectomy is a commonly performed body contouring procedure to address skin laxity and its related complications. This study aimed to assess clinical outcomes of abdominal panniculectomy and identify predictors of complications at a tertiary academic healthcare center. Methods: A retrospective review of patients who underwent panniculectomy between January 2010 and January 2020 at our institution was performed. Exclusion criteria were a history of prior panniculectomy or abdominoplasty. Patient characteristics and clinical outcomes were collected. Univariate and multivariable analyses were performed to assess the risk factors of complications. Results: The mean age in the included 238 patients was 51.7 ± 12.7 years, and the mean body mass index (BMI) at the time of panniculectomy was 33 ± 7.5 kg/m 2 . Median resection weight was 2.7 kg (range: 0.15–14.6) and median length of hospital stay was 2 days (range: 0–24). Mean follow-up time was 50 ± 37 months. The rate of major complications was 22.3%. Revision surgery was performed in 3.4% of the cases. Multivariable analyses demonstrated that increase in BMI ( P = 0.007) and active smoking ( P = 0.026) were significantly associated with increased odds of major complication, and increase in BMI ( P = 0.0004), history of venous thromboembolism ( P = 0.034) and having a concomitant ventral hernia repair ( P = 0.0044) were significantly associated with having a length of hospital stay of 3 days or more. Conclusions: Panniculectomy is generally safe to perform, with major postoperative complication rate of 22.3% in our series. Increase in BMI and active smoking were significantly associated with having a major complication. Higher BMI, concomitant hernia repair, and a history of venous thromboembolism were associated with length of hospital stay of 3 days or more.

Venous thromboembolism (VTE) is a major complication in all patients with cancer. Compared with the general population, patients with multiple myeloma (MM) have a 9-fold increase in VTE risk, likely because of their malignancy, its treatments, and other additional patient-related factors. In MM, thromboembolism events tend to occur within 6 months of treatment initiation, regardless of treatment regimen; however, the use of immunomodulatory agents such as thalidomide or lenalidomide, especially in combination with dexamethasone or multiagent chemotherapy, is known to create a significant risk for VTE. Currently, official recommendations for VTE prophylaxis in MM outlined in various national guidelines or multidisciplinary society panels are based on expert opinion, because data from randomized controlled trials are scarce. Large studies which have mainly focused on the efficacy of thromboprophylaxis in patients with cancer at higher risk for VTE either had a very low representation of patients with MM, or excluded them all together, limiting our ability to draw evidence-based conclusions on how to effectively protect MM population from VTE. In this brief perspective, we highlight some of the greatest challenges that have hampered the field concerning the availability of high-quality clinical trial data for the formulation of best VTE prophylaxis strategies in patients with newly diagnosed MM, as well as the rationale for the latest updates in the NCCN Guidelines on this topic.

The NCCN Guidelines for Multiple Myeloma provide recommendations for diagnosis, initial workup, treatment, follow-up, and supportive care for patients with various plasma cell neoplasms, including multiple myeloma. These NCCN Guidelines Insights highlight some of the important updates/changes specific to the treatment of patients with multiple myeloma in the 2022 version of the guidelines.

TPS489 Background: Tucatinib (TUC), a highly selective HER2-directed TKI approved in multiple regions for HER2+ metastatic breast cancer, is being investigated as a novel therapy for patients (pts) with metastatic colorectal cancer, gastric cancer, and other GI tumors. Preclinical and clinical data have shown HER2-targeted agents may improve clinical outcomes. In xenograft models of HER2+ and HER2-mutated tumors, dual targeting of HER2 with TUC + trastuzumab (Tras) showed superior activity to either agent alone (Kulukian 2020). Interim results from the MOUNTAINEER study have shown promising activity for TUC + Tras in HER2+ colorectal cancer. In 23 response-evaluable pts, an objective response rate (ORR) of 52% was observed with a median progression-free survival (PFS) of 8.1 months (mo) (Strickler 2019). The prognosis for pts with biliary tract cancers (BTCs) remain poor, and treatment options are limited. Given that approximately 12%-15% of BTC pts are HER2+, and 1%-8% have HER2 mutations, TUC + Tras warrants further evaluation in this patient population. The SGNTUC-019 basket study (NCT04579380) is evaluating TUC + Tras in pts with previously treated, locally advanced, unresectable or metastatic solid tumors including BTC that display HER2 overexpression/amplification or activating mutations. We describe the design of the BTC cohort. Methods: SGNTUC-019 is a multi-cohort, open-label, international Phase 2 study. Pts must be ≥18 years old; have an ECOG PS of ≤1; have adequate hepatic, hematological, renal, and cardiac functions; and have no previous exposure to HER2-directed therapy. BTC pts must have progressed on or after ≥1 previous line of treatment. The HER2+ BTC cohort will enroll 12 response-evaluable pts. If >2 responses are observed, the cohort will be expanded to 30 pts. HER2-mutated BTC patients may also be enrolled in a 30 pts cohort for other HER2-mutated solid tumors. The primary objective is antitumor activity with confirmed ORR as the primary endpoint. Secondary efficacy endpoints include disease control rate, duration of response, PFS, and OS. For eligibility, HER2 alterations can be demonstrated by HER2 overexpression/amplification in tumor tissue by prior IHC/ISH, or by HER2 amplification/mutation in a prior or on-study NGS assay of ctDNA or prior tissue NGS assay. Pts will receive TUC 300 mg orally twice a day and Tras 8 mg/kg intravenously on Cycle 1 Day 1 then 6 mg/kg every 21 days from Cycle 2 Day 1. Disease assessments per RECIST 1.1 are every 6 weeks for the first 24 weeks, then every 12 weeks. Quality of life will be evaluated every 2 cycles using EQ-5D-5L. Sites are currently enrolling within the US, EU and Asia-Pacific. Clinical trial information: NCT04579380.

427 Background: Derazantinib, a potent anti- FGFR1-3 oral kinase inhibitor, has shown clinically meaningful anti-tumor activity (21%), durable responses (median, 6.4 months), and progression-free survival (median, 8.0 months) in patients (pts) with FGFR2 fusion (FGFR2F)-positive intrahepatic cholangiocarcinoma (iCCA), and with a manageable toxicity profile. Herein, we report an interim analysis of the clinical efficacy data of derazantinib for pts with iCCA harboring FGFR2 mutations or amplifications (FGFR2M/A), a potential therapeutic option currently not addressed by FGFR inhibitors. Methods: Study FIDES-01 enrolls in a dedicated cohort pts with FGFR2M/A+ advanced iCCA who received previous chemotherapy. Pts receive 300 mg derazantinib daily until disease progression, death or intolerance. The primary endpoint is the proportion of pts alive and free of disease progression at 3 months (PFS3; RECIST 1.1, central imaging review) using a Simon’s two-stage sample-size minimizing statistical design. The interim analysis population comprises 23 pts dosed (intention to treat) who had at least one post-baseline tumor assessment (or clinical progression, or died) by June 3, 2021, using investigator assessments based on RECIST 1.1. Results: To date, 28 pts have been enrolled and dosed. FGFR2M/A observed in these pts included missense point mutations (78%), other short variants (11%) and amplifications (11%). Transition from stage 1 to stage 2 of the study was achieved earlier than planned after 8 (67%) of 12 pts were assessed as PFS3 based on central imaging review. In 23 pts included in this interim analysis for efficacy, the best overall response (investigator assessment) was confirmed partial response in two (8.7%) and stable disease in additional 15 pts (65.2%), resulting in a disease control rate of 73.9% (95% CI, 51.6–89.8). Using Kaplan-Meier analyses, the median PFS was 7.3 months (95%CI, 3.5–16.7) and the probability of being progression-free at 3 months and at 6 months were 76.3% (95%CI, 51.9–89.4) and 50.3% (95%CI, 21.7–73.4), respectively. Clinically meaningful anti-tumor efficacy was observed across all types of genetic aberrations. The safety profile of derazantinib in FGFR2M/A+ iCCA pts was consistent with that previously reported for FGFR2F+ iCCA pts. Conclusions: This interim data in study FIDES-01 suggest that derazantinib treatment provides clinical benefit to pts with advanced iCCA harboring FGFR2M/A who progressed after at least one line of standard chemotherapy. To our knowledge, this is the first report of clinically meaningful anti-tumor efficacy in a prospectively planned cohort of iCCA pts harboring FGFR2M/A. The study is ongoing to accrue 43 patients, assessing derazantinib as a therapeutic option for FGFR2M/A+ iCCA pts after disease progression on first-line treatment. Clinical trial information: NCT03230318.

Abstract Background Tranexamic acid (TXA) has gained increasing recognition as a valuable pharmacologic agent within plastic surgery. Objectives The aim of this study was to investigate the value and safety profile of both intravenous and topically administered TXA in the setting of bilateral reduction mammaplasty. Methods A retrospective review was performed to identify consecutive patients who underwent bilateral reduction mammaplasty for symptomatic macromastia (January 2016-July 2021). Pertinent preoperative, intraoperative, and postoperative details were collected/reviewed. Primary outcome measures included hematoma requiring surgical evacuation and clinically significant/symptomatic seroma formation mandating percutaneous aspiration. Patients taking anticoagulation/antiplatelet medication or those with a history of thromboembolic diseases were excluded. Patients who had received TXA were compared to a historical control group who did not receive TXA within the same consecutive cohort. Results A total of 385 consecutive patients (770 breasts) were included. TXA was used in 514 (66.8%) cases (topical, 318 [61.9%]; intravenous, 170 [33.1%]; intravenous and topical, 26 [5.1%]). Neither seroma nor hematoma were impacted/reduced with TXA (P > 0.05). Increased age (hazards ratio, 1.06 per 1-year increase; 95% CI, 1.004-1.118) significantly increased the risk of hematoma (P = 0.032). The use of drains significantly decreased the risk of seroma (P < 0.0001). Increased BMI increased the risk of seroma (hazards ratio, 1.16 per 1-kg/m2 increase; 95% CI, 1.06-1.26; P = 0.0013). The use of TXA did not impact drain duration. Conclusions This study, the largest to date on the use of IV and topical TXA, did not find any reduction in risk when using TXA in breast reduction surgery. Level of Evidence: 3

AbstractBackgroundDue to duty hour regulations, patient safety and inadequate operative time simulation have become a necessary part of surgical education and training in residency. Currently, there is no formal adoption of simulators for the use of surgical education or assessment in hand surgery. This literature review analyzes that the simulation techniques established thus far in hand surgery.MethodsA comprehensive literature search was performed on PubMed. Search results were filtered by title and abstract to isolate articles that were relevant to simulation in hand surgery. Articles that were nonspecific to the hand, non‐English and cadaveric were excluded. Additional articles were identified through references from the initial search.ResultsA total of 1192 articles were yielded from the initial query. After the application of the inclusion criteria, this was narrowed down to 28 articles. Another 8 additional articles were excluded as they did not pertain to the hand although the simulators could be adapted for hand surgery. A total of 20 articles were included in this study.ConclusionsSurgical simulation is a growing and essential field of surgical education. Simulators in hand surgery are limited and require further research and validation. Like other surgical subspecialties, hand surgery may benefit from the adoption of an official simulation curriculum for the assessment of residents and enhancement of technical skills.