Successful Crizotinib-targeted Therapy of Pediatric Unresectable ERC1::ALK Fusion Sarcoma.

Anaplastic lymphoma kinase ( ALK )-fusion sarcomas are rare part of the emerging theoretically targetable tyrosine kinase RAS::MAPK pathway fusion myopericytic-ovoid sarcomas. We report our clinicopathologic and treatment experience with an ALK fusion sarcoma. A novel ELKS/RAB6-interacting/CAST family member 1 - unaligned ALK fusion infiltrative nonmetastatic low-grade sarcoma of the right hand of a 15-month-old male was treated with crizotinib, an ALK tyrosine kinase inhibitor as oral monotherapy, inducing complete radiographic and clinical resolution by 10 months and sustained response now over 12 months after elective discontinuation. Crizotinib can successfully be used to treat unresectable novel ALK fusion sarcomas.

Ensuring Intervention Fidelity of an Attention Control Arm in a Multisite Randomized Controlled Trial.

BACKGROUND: Intervention fidelity is a critical element of randomized controlled trials, yet reporting of intervention fidelity among attention control arms is limited. Lack of fidelity to attention control procedures can affect study outcomes by either overestimating or underestimating the efficacy of the intervention under examination. OBJECTIVES: This brief report describes the approach researchers took to promote fidelity to the attention control arm of a pediatric palliative care randomized controlled trial funded by the National Institutes of Health. METHODS: The Informational Meetings for Planning and Coordinating Treatment trial aims to determine the efficacy of a communication intervention that uses care team dyads (i.e., physicians partnered with nurses or advanced practice providers) to engage parents of children with cancer who have a poor prognosis in structured conversations about prognostic information, goals of care, and care planning. The intervention is compared with an attention control arm, which provides parents with structured conversations on common pediatric cancer education topics, such as talking to their child about their cancer, clinical trials, cancer treatment, side effects, and so forth. National Institutes of Health guidelines for assessing and implementing strategies to promote intervention fidelity were used to design (a) the attention control arm of a randomized controlled trial, (b) related attention control arm training, and (c) quality assurance monitoring. RESULTS: Attention control study procedures were designed to mirror that of the intervention arm (i.e., same number, frequency, and time spent in study visits). Cluster randomization was used to allocate care team dyads to one arm of the randomized controlled trial. Care team dyads assigned to the attention control arm participated in online training sessions to learn attention control procedures, the different roles of research team members, and quality assurance methods. Fidelity to attention control procedures is assessed by both the interveners themselves and a quality assurance team. DISCUSSION: Study design, training, and delivery are all critical to attention control fidelity. Baseline training often needs to be supplemented with booster training when time gaps occur between study start-up and implementation. Quality assurance procedures are essential to determine whether interveners consistently deliver attention control procedures correctly.

Varicocelectomy is associated with increases in serum testosterone independent of clinical grade.

OBJECTIVE: To determine whether the varicocele grade is related to the degree of improvement in serum testosterone levels after varicocelectomy. MATERIALS AND METHODS: We performed a retrospective review of men with a total serum testosterone level <400 ng/dL who had undergone microsurgical subinguinal varicocelectomy for infertility and/or hypogonadism. All men had clinically palpable left varicoceles and preoperative and postoperative total serum testosterone levels available. For patients with bilateral varicoceles, the greatest grade on either side was used to stratify the patients. The men with an isolated, left-side, grade I varicocele were not offered varicocelectomy. The changes in the testosterone levels were evaluated, with the results expressed as the mean ± standard error. P ≤.05 was considered statistically significant. RESULTS: A total of 59 patients had undergone bilateral varicocelectomy and 19 unilateral varicocelectomy. Overall, an increase in testosterone was seen in 65 of the 78 men (83%) in the present study. The mean follow-up was 7 months. The mean serum testosterone level increased from 308.4 to 417.5 ng/dL, with a mean increase of 109.1 ± 12.8 ng/dL (n = 78). The improvements in the serum testosterone levels were seen regardless of the clinical grade. CONCLUSION: Microsurgical varicocelectomy resulted in significant increases in the serum testosterone level, independent of the varicocele grade.