Faculty Bibliography

BACKGROUND: While most meningiomas are considered benign tumors, a subset of these tumors are characterized by a more aggressive clinical course and require multimodal treatment. Beyond surgical and radiotherapeutic options, there are no effective medical treatments available. Somatostatin receptor 2 (SSTR2) is expressed by the majority of meningiomas. 177Lu-DOTATATE is a SSTR2-targeting radionuclide that has been successful in neuroendocrine tumors. Here we report the results of the interim analysis of an ongoing clinical trial (NCT03971461) that is evaluating the effect of 177Lu-DOTATATE in treating progressive intracranial meningiomas.
METHOD(S): In this Simon two-stage design phase II study, adults with advanced intracranial meningiomas received 177Lu-DOTATATE 7.4 GBq (200 mCi) every eight weeks for four doses. 68Ga-DOTATATE PET-MRI was performed before and at the end of treatment. The primary endpoint was progression-free survival at 6 months (PFS-6). Correlative studies evaluated the association of PFS-6, objective response rate, progression-free survival, overall survival with radiographic tumor measurements, 68Ga-DOTATATE uptake on PET-MRI, SSTR2 expression in tumor, and meningioma methylation subclass.
RESULT(S): Fourteen patients (F = 11, M = 3) with progressive meningiomas (WHO I = 3, II = 10, III = 1) have been enrolled. Median age was 63.1 (range 49-78) years. All patients previously underwent tumor resection and at least one course of radiation. Treatment with 177Lu-DOTATATE was well tolerated, no treatment-limiting toxicities were observed. Six of 14 patients (42%) achieved PFS-6. Radiographically, all six patients had achieved Stable Disease. A functional alteration of tumoral SSTR2 expression by 68Ga-DOTATATE PET-MR imaging was observed in three patients.
CONCLUSION(S): Treatment with SSTR2- targeting 177Lu-DOTATATE is well tolerated. In this interim analysis, six of 14 patients achieved PFS-6. This exceeds the predefined threshold to continue to stage two of this study. This clinical trial is now open to patient enrollment at two study sites in the US

BACKGROUND:Transoral robotic surgery has been successfully used by head and neck surgeons for a variety of procedures but is limited by rigid instrumentation and line-of-sight visualization. Non-linear systems specifically designed for the aerodigestive tract are needed. Ease of use of these new systems in both training and clinical environments is critical in its widespread adoption. METHODS:Residents, fellows, and junior faculty performed four tasks on an anatomical airway mannequin using the Medrobotics FLEX™ Robotic System: expose and incise the tonsil, grasp the epiglottis, palpate the vocal processes, and grasp the interarytenoid space. These tasks were performed once a day for four days; after a 4-month time gap, subjects were asked to perform these same tasks for three more days. Time to task completion and total distance driven were tracked. In addition, a retrospective analysis was performed analyzing one attending physician's experience with clinical usage of the robot. RESULTS:13 subjects completed the initial round of the mannequin simulation and 8 subjects completed the additional testing 4 months later. Subjects rapidly improved their speed and efficiency at task completion. Junior residents were slower in most tasks initially compared to senior trainees but quickly reached similar levels of efficiency. Following the break there was minimal degradation in skills and continued improvement in efficiency was observed with additional trials. There was significant heterogeneity in the analyzed clinical cases, but when analyzing cases of similar complexity and pathology, clear decreases in overall operative times were demonstrable. CONCLUSION:Novice users quickly gained proficiency with the FLEX™ Robotic System in a training environment, and these skills are retained after several months. This learning could translate to the clinical setting if a proper training regimen is developed. The Medrobotics FLEX™ Robotic System shows promise as a surgical tool in head and neck surgery in this study.

BACKGROUND:We ascertain the role of a low cervical paraspinal skeletal muscle index (CPSMI) as a biomarker for poor treatment tolerance in patients with operable mucosal head and neck squamous cell carcinoma (HNSCC). METHODS:A prospective cohort of patients with operable HNSCC requiring microvascular reconstruction was evaluated. Low CPSMI was calculated using preoperative CT neck imaging. Poor treatment tolerance, a composite measure of incomplete therapy or severe morbidity/mortality during treatment, was the primary outcome. RESULTS:One hundred and twenty-seven patients underwent extirpative surgery with a mean age was 60.5. Poor treatment tolerance occurred in 71 (56%) patients with 21 not completing recommended adjuvant therapy and 66 having severe treatment-related morbidity. A low CPSMI was independently associated with poor treatment tolerance (OR 2.49, 95%CI 1.10-5.93) and delay to adjuvant therapy (OR 4.48, 95%CI 1.07-27.6) after adjusting for multiple confounders. CONCLUSION:Low CPSMI was independently associated with poor treatment tolerance in patients with operable HNSCC.

Surgical proctoring requires increasing resources in growing healthcare systems. In addition, travel has become less safe in the era of COVID-19. This study demonstrates surgeon satisfaction and safety with tele-proctoring in robotic gynecologic surgery. This pilot study assesses surgeon satisfaction and operative outcomes with a novel operative tele-proctoring system with a continuous two-way video-audio feed that allows the off-site surgeon to see the operating room, surgical field, and hands of the robotic surgeon. After thorough system testing, two experienced surgeons underwent tele-proctoring for hospital credentialing, completing 7 total cases. Each completed pre- and post-surveys developed from the Michigan Standard Simulation Experience Scale. Surgical characteristics were compared between tele-proctored cases and 59 historical cases proctored in-person over the last 8 years. Surgeons reported unanimous high satisfaction with tele-proctoring (5 ± 0). There were no major technologic issues. Five of the tele-proctored cases and 35 of controls were hysterectomies. Mean age was 48.2 ± 1.4 years, mean BMI was 29.6 ± 0.9 kg/m², and mean uterine weight was 152 ± 112.3 g. Two-thirds had prior abdominal surgery (P > 0.1). Tele-proctored hysterectomies were 58 ± 6.5 min shorter than controls (P = 0.001). There were no differences in EBL or complication rates (P > 0.1). Tele-proctoring resulted in high surgeon satisfaction rates with no difference in EBL or complications. Tele-mentoring is a natural extension of tele-proctoring that could provide advanced surgical expertise far beyond where we can physically reach.