Citations

AbstractPurposeTo study the feasibility of using the Integral Quality Monitoring (IQM) system for routine quality assurance (QA) of photon beams.MethodsThe IQM system is a commercially available dose delivery verification tool, which consists of a spatially sensitive large area transmission ion chamber, mounted on the Linac collimator, and a calculation algorithm to predict the signals in response to radiation beams. By comparing the measured and predicted signals the system verifies the accuracy of beam delivery. The ion chamber unit is a battery powered system including a dual‐electrometer, temperature and pressure sensors, and inclinometers. The feasibility of using the IQM system for routine QA tests was investigated by measuring constancy values of beam parameters, with specially designed tests fields, and comparing them with those determined by a conventional system.ResultsThe sensitivity of the beam output constancy measurements by the IQM system was found to agree with those measured by a Farmer type ion chamber placed in water phantoms to within 0.1% for typical daily output variation of ± 0.5% and ± 1%. The beam symmetry was measured with a 4 cm × 4 cm aperture at multiple off‐axis distances and was found to have a highly linear relationship with those measured in a water phantom scan for intentionally introduced asymmetry between ‐3% and +3%. The beam flatness was measured with a two‐field ratio method and was found to be linearly correlated with those measured by water phantom scan. The dosimetric equivalent of a picket fence test performed by the IQM system can serve as a constancy check of the multileaf collimator (MLC) bank positioning test.ConclusionsThe IQM system has been investigated for constancy measurements of various beam parameters for photon beams. The results suggest that the system can be used for most of the routine QA tests effectively and efficiently.

Abstract Background:Presacral tumors are a rare entity typically treated with an open surgical approach. A limited number of minimally invasive resections have been described. Aim of the study was to evaluate the safety and efficacy of robotic resection of presacral tumors. Methods: This was a retrospective single system analysis, conducted at a quaternary referral academic healthcare system, and included all patients who underwent a robotic excision of a presacral tumor between 2015 and 2023. Outcomes of interest were operative time, estimated blood loss, complications, length of stay, margin status, and recurrence rates. Results: Sixteen patients (11 females, 5 males) were included. Median age of the cohort was 51 years (range 25-69). Median operative time was 197 minutes (range 98-802). Median estimated blood loss was 40 ml, ranging from 0 to 1800 ml, with one patient experiencing conversion to open surgery after uncontrolled hemorrhage. Urinary retention was the only post-operative complication that occurred in 3 patients (19%) and was solved within 30 days in all cases. Median length of stay was one day (range 1-6). Median follow-up was 6.7 months (range 1-110). All tumors were excised with appropriate margins, but one benign and one malignant tumor recurred (12.5%). Ten tumors were classified as congenital (one was malignant), two were mesenchymal (both malignant), and five were miscellaneous (one malignant). Conclusions:Robotic resection of select presacral pathology is feasible and safe. Further studies must be conducted to determine complication rates, outcomes, and long-term safety profiles.

Background: The Schnur scale used body surface area (BSA) to determine the amount of breast tissue resection in reduction mammaplasty, resulting in a greater requirement of breast weight removal in patients with larger BSA. The authors aimed to demonstrate BSA variance among women with similar mastectomy weights and the range of mastectomy weights among women with comparable BSAs. Methods: A retrospective chart review of patients who underwent mastectomy from October of 2021 to June of 2022 was performed. Patients were included if they underwent skin-sparing or nipple-sparing mastectomy with a minimum specimen weight of 700 g. Patient’s BSA, body mass index (BMI), mastectomy weight, and Schnur weight requirement (SWR) were collected. Results: A total of 130 patients (194 breasts) were included. There was significant variance in mean BSA, BMI, SWR, and SWR-to–mastectomy weight ratio among women with similar mastectomy weights. BSA varied by as much as 0.82 units, BMI varied by as much as 32 kg/m2, and SWR varied by as much as 1365 g within the same mastectomy weight group. There was also significant variance in mastectomy weights among women with comparable BSA, especially in BSA groups greater than 2.20, with the greatest range in mastectomy weights being 1684 g. Conclusions: Analysis of mastectomy patients showed no predictable relationship between BSA and breast weight. There was significant variance in the BSA of patients with similar breast weights, and conversely in breast weights of patients with comparable BSA. Therefore, strict adherence to the Schnur weight requirement can prevent patients with macromastia from receiving breast reductions.

PURPOSE Outcomes for patients with newly diagnosed multiple myeloma (NDMM) are heterogenous, with overall survival (OS) ranging from months to over 10 years. METHODS To decipher and predict the molecular and clinical heterogeneity of NDMM, we assembled a series of 1,933 patients with available clinical, genomic, and therapeutic data. RESULTS Leveraging a comprehensive catalog of genomic drivers, we identified 12 groups, expanding on previous gene expression–based molecular classifications. To build a model predicting individualized risk in NDMM (IRMMa), we integrated clinical, genomic, and treatment variables. To correct for time-dependent variables, including high-dose melphalan followed by autologous stem-cell transplantation (HDM-ASCT), and maintenance therapy, a multi-state model was designed. The IRMMa model accuracy was significantly higher than all comparator prognostic models, with a c-index for OS of 0.726, compared with International Staging System (ISS; 0.61), revised-ISS (0.572), and R2-ISS (0.625). Integral to model accuracy was 20 genomic features, including 1q21 gain/amp, del 1p, TP53 loss, NSD2 translocations, APOBEC mutational signatures, and copy-number signatures (reflecting the complex structural variant chromothripsis). IRMMa accuracy and superiority compared with other prognostic models were validated on 256 patients enrolled in the GMMG-HD6 (ClinicalTrials.gov identifier: NCT02495922 ) clinical trial. Individualized patient risks were significantly affected across the 12 genomic groups by different treatment strategies (ie, treatment variance), which was used to identify patients for whom HDM-ASCT is particularly effective versus patients for whom the impact is limited. CONCLUSION Integrating clinical, demographic, genomic, and therapeutic data, to our knowledge, we have developed the first individualized risk-prediction model enabling personally tailored therapeutic decisions for patients with NDMM.

Objectives The objective of this case study is to raise awareness of potential 123I-FP-CIT SPECT interference by lisdexafetamine dimesylate, a prodrug of d-amphetamine. Methods A 69-year-old man with Rapid Eye Movement sleep behavior disorder and mild cognitive impairment had been treated with lisdexafetamine dimesylate for attention-deficit/hyperactivity disorder. The patient had annual or biennial 123I-FP-CIT SPECT evaluations after their baseline visit at 69 years old. Nigrostriatal dopamine transporter uptake was semiquantitatively evaluated with 123I-FP-CIT SPECT using DaTQUANT 2.0 software. Lisdexafetamine dimesylate was discontinued 3 months before the sixth-year visit (76 years old) by his primary care provider. Results The patient had 4 123I-FP-CIT SPECT scans with lisdexafetamine dimesylate and 2 scans after the discontinuation of lisdexafetamine dimesylate. The DaTQUANT z-scores of the putamen declined from −1.36 at the baseline visit to −3.02 at the fifth-year visit. After the discontinuation of lisdexafetamine dimesylate, DaTQUANT z-scores of the putamen increased to −0.63 at the sixth-year visit and remained in the normal range of −0.71 at the seventh-year visit. Conclusions This case suggests that lisdexafetamine dimesylate may have a strong interference with 123I-FP-CIT SPECT, decreasing the tracer binding to the dopamine transporter and presenting false positive results.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. Two years of adjuvant abemaciclib combined with endocrine therapy (ET) resulted in a significant improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) that persisted beyond the 2-year treatment period in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative, node-positive, high-risk early breast cancer (EBC). Here, we report 5-year efficacy results from a prespecified overall survival (OS) interim analysis. In the intent-to-treat population, with a median follow-up of 54 months, the benefit of abemaciclib was sustained with hazard ratios of 0.680 (95% CI, 0.599 to 0.772) for IDFS and 0.675 (95% CI, 0.588 to 0.774) for DRFS. This persistence of abemaciclib benefit translated to continuous separation of the curves with a deepening in 5-year absolute improvement in IDFS and DRFS rates of 7.6% and 6.7%, respectively, compared with rates of 6% and 5.3% at 4 years and 4.8% and 4.1% at 3 years. With fewer deaths in the abemaciclib plus ET arm compared with the ET-alone arm (208 v 234), statistical significance was not reached for OS. No new safety signals were observed. In conclusion, abemaciclib plus ET continued to reduce the risk of developing invasive and distant disease recurrence beyond the completion of treatment. The increasing absolute improvement at 5 years is consistent with a carryover effect and further supports the use of abemaciclib in patients with high-risk EBC.

Marlex mesh reconstruction of the extensor mechanism following total knee arthroplasty (TKA) has demonstrated excellent early results. The purpose of the present study was to evaluate longer-term results of Marlex mesh reconstruction of the extensor mechanism in 93 TKAs. Seventy-seven reconstructions were aseptic, and 16 were performed as part of a 2-stage exchange for the treatment of infection. Mean follow-up was 8 years. Twenty-eighty patients experienced mesh failure. Seventeen failures were treated with mesh revision (8 for patellar tendon rupture, 7 for quadriceps tendon rupture, and 2 for symptomatic lengthening). The 10-year cumulative incidence of mesh revision for mesh failure was 20%. Extensor lag improved by a mean of 28°, with a mean extensor lag of 9° at most recent follow-up. At a mean follow-up of 8 years, Marlex mesh reconstruction was a durable and reliable technique to treat both aseptic and septic ruptures of the extensor mechanism. Level of Evidence: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.

Objective: Identify how surgical team members uniquely contribute to teamwork and adapt their teamwork skills during instances of uncertainty. Background The importance of surgical teamwork in preventing patient harm is well documented. Yet, little is known about how key roles (nurse, anesthesiologist, surgeon, and medical trainee) uniquely contribute to teamwork during instances of uncertainty, particularly when adapting to and rectifying an intraoperative adverse event (IAE). Methods: Audiovisual data of 23 laparoscopic cases from a large community teaching hospital were prospectively captured using OR Black Box. Human factors researchers retrospectively coded videos for teamwork skills (backup behavior, coordination, psychological safety, situation assessment, team decision-making, and leadership) by team role under 2 conditions of uncertainty: associated with an IAE versus no IAE. Surgeons identified IAEs. Results: In all, 1015 instances of teamwork skills were observed. Nurses adapted to IAEs by expressing more backup behavior skills (5.3× increase; 13.9 instances/hour during an IAE vs 2.2 instances/hour when no IAE) while surgeons and medical trainees expressed more psychological safety skills (surgeons: 3.6× increase; 30.0 instances/hour vs 6.6 instances/hour and trainees: 6.6× increase; 31.2 instances/hour vs 4.1 instances/hour). All roles expressed fewer situation assessment skills during an IAE versus no IAE. Conclusions: OR Black Box enabled the assessment of critically important details about how team members uniquely contribute during instances of uncertainty. Some teamwork skills were amplified, while others dampened when dealing with IAEs. The knowledge of how each role contributes to teamwork and adapts to IAEs should be used to inform the design of tailored interventions to strengthen interprofessional teamwork.

This commentary is a call to action for a concerted commitment and effort to transform clinical trials and enable people with cancer to participate in clinical trials closer to home. Three key strategies are identified to address major barriers: confront challenges with the interpretation of US Food and Drug Administration Form 1572 requirements (Statement of Investigator); broaden acceptance of local laboratories and imaging centers; and invest in the creation of effective, sustainable partnerships between research centers and local providers.