Oliveira, Lúcia

Background: Chemoimmunotherapy using rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunomycin), vincristine sulfate (Oncovin), and prednisone (R-CHOP) has been the standard of care treatment of DLBCL for over 20 years. Despite its widespread usage, there is no accepted standard for the dose of prednisone in this setting which varies from fixed-dose (100 mg daily for 5 days) to different levels of BSA-adjusted dosage (ranging from 40-100 mg/m2 daily for 5 days). BSA-adjusted dosage results in high doses of prednisone administered to patients with increased body surface area which may lead to significant adverse events. We performed a systematic review and meta-analysis to determine if fixed-dose prednisone during R-CHOP therapy results in equivalent outcomes compared to BSA-adjusted dosing. Methods: A comprehensive search of several databases from each database's inception to April 29th, 2024, English language, was conducted. The databases included Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, and Daily, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. The search strategy was designed and conducted by an experienced librarian with input from the study's principal investigator. Controlled vocabulary supplemented with keywords was used to search for prospective clinical studies of R-CHOP for adult patients with untreated DLBCL. Search results were reviewed independently by 2 members of the study team for final inclusion. Discrepancies were adjudicated by a third member and reviewed by the senior author. Prednisone dosage and clinical outcomes were abstracted from the available public data. Meta-analysis was performed using the metafor package in R version 4.2.2 by applying a mixed-effects model to combine results from the multiple studies. The analysis was first conducted overall to determine the general effect, and then stratified by prednisone dose (fixed- vs. BSA-adjusted) to explore dose-dependent variations in outcomes. Results: Our search resulted in 2287 entries which were individually reviewed by the study team. A total of 30 studies with a combined sample size of 3573 treated patients fulfilled the inclusion criteria and were included in the final analysis set. Nineteen (63%) studies with a combined sample size of 1930 patients (median 155, range 12-399) used fixed-dose prednisone. Eleven (37%) studies with a combined sample size of 1643 patients (median 70, range 9-439) used BSA-adjusted dosing. Overall survival (OS) at 2 years data were available for 11 (37%) of the studies. Progression free survival (PFS) at 2 years data were available for 8 studies (27%). Overall response rate (ORR) and complete response rate (CRR) data were available for 16 (54%) and 14 (47%) of the included studies, respectively. OS at 2 years for all studies was 84% (SD 78%-91%) and did not differ between fixed-dose (88%, SD 79%-97%) and BSA-adjusted dose (82%, 73%-91%). PFS at 2 years for all studies was 77% (SD 68%-85%) and did not differ between fixed-dose (80%, SD 68%-93%) and BSA-adjusted dose (74%, SD 62%-86%). ORR for all studies was 86% (SD 79%-92%) and did not differ between fixed-dose (86%, SD 76%-96%) and BSA-adjusted dosage (84%, SD 80%-88%). CRR for all studies was 70% (SD 61%-80%) and did not differ between fixed-dose (67%, SD 54%-81%) and BSA-adjusted dose (77%, SD 64%-89%). Heterogeneity tests performed according to available clinical outcomes yielded results between 0% and 76%. Conclusion: The result of our systematic review and meta-analysis combining 30 prospective studies and a total of 3573 patients with newly diagnosed DLBCL treated with frontline R-CHOP found no difference in clinical outcomes between patients treated with fixed-dose and BSA-adjusted dose prednisone. Our findings provide scientific evidence for the widespread practice of capping prednisone at the maximum dose of 100 mg daily for 5 days, potentially avoiding unnecessary adverse effects from BSA-adjusted dosing.

BACKGROUND: Narrative operative reports may omit or obscure data from an operation. OBJECTIVE: To develop a synoptic operative report for rectal prolapse that includes core descriptors as developed by an international consensus of expert pelvic floor surgeons. DESIGN: Descriptors for patients undergoing rectal prolapse surgery were generated through review. Members of the Pelvic Floor Disorders Consortium were recruited to participate in a 3-round Delphi process using a 9-point Likert scale. Descriptors that achieved 70% agreement were kept from the first round, and descriptors scoring 40% to 70% agreement were recirculated in subsequent rounds. A final list of operative descriptors was determined at a consensus meeting, with a final consensus meeting more than 70% agreement. SETTINGS: This survey was administered to members of the Pelvic Floor Disorders Consortium. PATIENTS: No patient data are included in this study. MAIN OUTCOME MEASURES: Descriptors meeting greater than 70% agreement were selected. RESULTS: One hundred seventy-six surgeons representing colorectal surgeons, urogynecologists, and urologists distributed throughout North America (56%), Latin America (4%), Western Europe (29%), Asia (4%), and Africa (1%) participated in the first round of Delphi voting. After 2 additional rounds and a final consensus meeting, 16 of 30 descriptors met 70% consensus. Descriptors that met consensus were surgery type, posterior dissection, ventral dissection, mesh used, type of mesh used, mesh location, sutures used, suture type, pouch of Douglas and peritoneum reclosed, length of rectum imbricated, length of bowel resected, levatoroplasty, simultaneous vaginal procedure, simultaneous gynecologic procedure, simultaneous enterocele repair, and simultaneous urinary incontinence procedure. LIMITATIONS: The survey represents the views of members of the Delphi panel and may not represent the viewpoints of all surgeons. CONCLUSIONS: This Delphi survey establishes international consensus descriptors for intraoperative variables that have been used to produce a synoptic operative report. This will help establish defined operative reporting to improve clinical communication, quality measures, and clinical research. See Video Abstract. DESARROLLO DE UN PROTOCOLO OPERATORIO SINÓPTICO DERIVADO DE CONSENSO PARA EL PROLAPSO RECTAL: UN INFORME DEL CONSORCIO DE TRASTORNOS DEL PISO PÉLVICO ANTECEDENTES: Los protocolos operativos narrativos frecuentemente pueden omitir u oscurecer datos de un procedimiento. OBJETIVO: Nuestro objetivo es desarrollar un protocolo operatorio sinóptico para el prolapso rectal que incluya descriptores básicos desarrollados por un consenso internacional de cirujanos expertos en piso pélvico. DISEÑO: Los descriptores para pacientes sometidos a cirugía de prolapso rectal se generaron mediante revisión. Se reclutó a miembros del Consorcio de Trastornos del Piso Pélvico para participar en un proceso Delphi de 3 rondas utilizando una escala Likert de 9 puntos. Los descriptores que lograron un 70% de acuerdo se mantuvieron en la primera ronda, los descriptores que obtuvieron un 40-70% de acuerdo se recircularon en rondas posteriores. Se determinó una lista final de descriptores operativos en una reunión de consenso, con una reunión de consenso final de más del 70% de acuerdo. ESCENARIO: Esta fue una encuesta administrada a miembros del Consorcio de Trastornos del Piso Pélvico. PRINCIPALES MEDIDAS DE RESULTADO: Se seleccionaron los descriptores que cumplieron más del 70% de acuerdo. RESULTADOS: Ciento setenta y seis cirujanos en representación de cirujanos colorrectales, uroginecólogos y urólogos distribuidos en América del Norte (56%), América Latina (4%), Europa Occidental (29%), Asia (4%) y África (1%) participaron en la primera ronda de votación Delphi. Después de dos rondas adicionales y una reunión de consenso final, 16 de 30 descriptores alcanzaron un 70% de consenso. Los descriptores que alcanzaron consenso fueron: tipo de cirugía, disección posterior, disección ventral, malla utilizada, tipo de malla utilizada, ubicación de la malla, suturas utilizadas, tipo de sutura, cierre del fondo de saco de Douglas y peritoneo, longitud del recto superpuesto, longitud del intestino resecado, plastía de los elevadores , procedimiento vaginal simultáneo, procedimiento ginecológico simultáneo, reparación simultánea de enterocele y procedimiento simultáneo de incontinencia urinaria. LIMITACIONES: La encuesta representa las opiniones de los miembros del panel Delphi y puede no representar los puntos de vista de todos los cirujanos. CONCLUSIONES/DISCUSIÓN: Esta encuesta Delphi establece descriptores de consenso internacional para las variables intraoperatorias que se han utilizado para producir un protocolo operatorio sinóptico. Esto ayudará a establecer protocolos operativos definidos para mejorar la comunicación clínica, las medidas de calidad y la investigación clínica. (Traducción—Dr. Felipe Bellolio)