Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development.

In 2022, cancer drug development continued to progress rapidly despite the lingering COVID-19 pandemic. Highlights of U.S. drug approvals for oncology indications this year include ongoing development in rare diseases and molecular subgroups, improved dosage optimization, and updated data for drugs granted accelerated approval, with confirmatory studies demonstrating verification of clinical benefit in some instances, as well as indication withdrawal when clinical benefit was not verified.

Central Nervous System Xanthoma Disseminatum: Response to 2CdA in an Adolescent.

Xanthoma disseminatum is a normolipemic non-Langerhans cell histiocytosis characterized by red-brown rubbery papules of the skin which coalesce into plaque-like lesions with symmetric involvement of face, flexor, and intertriginous areas. Less commonly, xanthoma disseminatum may affect mucosal linings, abdominal organs, and the central nervous system, leading to endocrinopathies. We report a 12-year-old adolescent with mucosal, central nervous system, and painful cutaneous lesions, further complicated by diabetes insipidus and amenorrhea. Treatment with 2-chlorodeoxyadenosine led to relief of pain and significant improvement of mucosal, central nervous system, and cutaneous lesions, with subsequent restoration of menstrual cycles.

Phantom Limb Pain in Pediatric Oncology.

Phantom limb pain (PLP) is a prevalent problem for children and adolescents undergoing amputation due to cancer treatment. The symptoms are wide ranging from sharp to tingling. PLP in children typically lasts for a few minutes but can be almost constant and can be highly distressing. This focused review describes the characteristics, epidemiology, mechanisms, and evidence-based treatment of PLP in pediatric populations, focusing on pediatric cancer. In pediatric oncology, the administration of chemotherapy is a risk factor that potentially sensitizes the nervous system and predisposes pediatric cancer patients to develop PLP after amputation. Gabapentin, tricyclic antidepressants, opiates, nerve blocks, and epidural catheters have shown mixed success in adults and case reports document potential utility in pediatric patients. Non-pharmacologic treatments, such as mirror therapy, psychotherapy, and acupuncture have also been used in pediatric PLP with success. Prospective controlled trials are necessary to advance care for pediatric patients with PLP.

Anti-K1 (Kell) Antibody Expressed in Maternal Breastmilk: A Case Report of a Neonate with Multiple Intrauterine Transfusions and Postnatal Exposure to Kell Antibody in Maternal Breastmilk.

Hemolytic disease of the fetus and newborn is a common consideration in newborn medicine, especially among the jaundiced. Maternal breastmilk provides numerous benefits to the infant, including nutrition and immunologic factors. Here, we present an infant who received three intrauterine transfusions for anemia secondary to anti-K1 (Kell), anti-C, and anti-e antibodies and whose maternal breastmilk tested positive for anti-Kell antibodies. The infant required another transfusion at 4 weeks of life for anemia. We review the pathophysiology of anti-Kell antibodies, the immunology of breast milk, and the intersection of these two topics.

Epidemiology, demographics, and outcomes of craniomaxillofacial gunshot wounds in a level I trauma center.

BACKGROUND: Gunshot injuries to the craniomaxillofacial region are a challenge to the trauma and reconstructive surgeon. Although management of these injuries has been standardized and early rather than late intervention is advocated, the patient characteristics before, during, and after have been poorly elucidated. METHODS: A prospectively maintained Level I trauma center database was queried as to gunshot wounds of the craniomaxillofacial skeleton. Over a five-year period (2007-2011), 168 patients were identified with these injuries. Charts were reviewed as to demographics, presentations, and outcomes and these were tested for significant relationships with hospital length of stay, numbers and types of procedures, morbidity, and mortality. RESULTS: Gunshot wounds to the craniofacial skeleton resulted in 71 deaths in this patient population. Those that died were significantly older, presented with a lower GCS, had a shorter LOS, and a higher INR than those that lived. Subgroup analysis of mechanism demonstrated mortality was more likely to occur as a result of self-inflicted injury in whites and due to assault in the African-American population. CONCLUSIONS: Data gathered from this study disputes some commonly held beliefs regarding the epidemiology of gunshot injuries and should allow for better characterization of which outcomes are consistent with which presentations.

Digital animation versus textbook in teaching plastic surgery techniques to novice learners.

BACKGROUND: The authors present a prospective, randomized, blinded trial comparing the educational efficacy of digital animation versus a textbook in teaching the Ivy loop technique to novice learners. METHODS: Medical student volunteers (n = 32) were anonymously videotaped as they fastened dental wire to the teeth of a skull model (preintervention analysis) and then were randomly assigned to one of two study groups. The animation and text groups (n = 16 each) were shown either a digital animation or textbook demonstrating the Ivy loop surgical technique. Volunteers were then videotaped as they performed the technique (postintervention analysis). Volunteers were then shown the educational material provided to the other study group and given a validated educational survey to compare the educational value of both materials. Preintervention and postintervention video recordings were graded using a validated surgical competency scale. Surgical performance grades, time to task completion, and educational survey scores were compared. RESULTS: Preintervention analysis performance scores did not significantly differ between the animation and text groups (10.7 [2.8] versus 11.1 [3.9]; p = 0.74), but postintervention analysis demonstrated significantly higher performance scores in the animation group (18.8 [2.9] versus 13.0 [3.5]; p < 0.001). Time to task completion was similar. The educational survey demonstrated significantly higher scores in the animation group. CONCLUSIONS: A prospective, randomized, blinded study comparing the educational efficacy of a surgical textbook to digital animation demonstrates that, in novice learners, digital animation is a more effective tool for learning the Ivy loop technique. Test takers found digital animation to be the superior educational medium.