Alsughayer, Ahmad

BACKGROUND: Patients with IBD are at increased risk for developing colorectal cancer. However, overall survival and disease-free survival for rectal cancer alone in patients with IBD has not been reported. OBJECTIVE: This study aimed to determine overall survival and disease-free survival for patients with rectal cancer in IBD versus non-IBD cohorts. DESIGN: This is a retrospective cohort study. SETTING: This study was conducted at an IBD referral center. PATIENTS: All consecutive adult patients with IBD diagnosed with rectal cancer and at least 1 year of postsurgery follow-up were included and matched in a 1:2 fashion (age, sex, preoperative stage) with patients with rectal cancer who did not have IBD. MAIN OUTCOMES MEASURES: Five-year overall survival and disease-free survival, 30-day postoperative complication, readmission, reoperation, and mortality rates were measured. METHODS: Survival rates were calculated using Kaplan-Meier estimates. The association of risk factors and long-term outcomes was assessed using Cox proportion hazard models. RESULTS: A total of 107 study patients with IBD who had rectal cancer were matched to 215 control patients; preoperative stages were as follows: 31% with stage I, 19% with stage II, 40% with stage III, and 10% with stage IV. Differences were observed (IBD vs non-IBD) in neoadjuvant chemotherapy (33.6% vs 52.6%, p = 0.001) and preoperative radiotherapy (35.5% vs 53.5%, p = 0.003). Postoperative complication rates were similar. On surgical pathology, patients with IBD had more lymphovascular invasion (12.9% vs 5.6%, p = 0.04) and positive circumferential resection margins (5.4% vs 0.9%, p = 0.03). On multivariable analysis, the diagnosis of IBD did not significantly impact long-term mortality (HR, 0.91; 95% CI, 0.53–1.57; p = 0.73) or disease-free survival (HR, 1.36; 95% CI, 0.84–2.21; p = 0.22). LIMITATIONS: This study was limited by its retrospective design and the use of single-center data. CONCLUSIONS: Patients have rectal cancer with IBD and without IBD have similar long-term and disease-free survival, despite lower rates of neoadjuvant treatment and higher margin positivity in patients with IBD. See Video Abstract at http://links.lww.com/DCR/B271. ¿LA ENFERMEDAD INFLAMATORIA INTESTINAL ACARREA PEORES RESULTADOS EN PACIENTES CON CÁNCER RECTAL? UN ANÁLISIS DE CASOS-COINCIDENTES ANTECEDENTES: Los pacientes con enfermedad inflamatoria intestinal (EII) tienen un mayor riesgo de desarrollar cáncer colorrectal. Sin embargo, no se ha informado la supervivencia general y la supervivencia libre de enfermedad para el cáncer rectal solo en pacientes con EII. OBJETIVO: Determinar la supervivencia general y la supervivencia libre de enfermedad para pacientes con cáncer rectal en cohortes con EII versus sin EII. DISEÑO: Estudio de cohorte retrospectivo. MARCO: Centro de referencia para enfermedad inflamatoria intestinal. PACIENTES: todos los pacientes adultos con EII diagnosticados con cáncer rectal, consecutives, y al menos un año de seguimiento postoperatorio se incluyeron y se emparejaron de manera 1: 2 (edad, sexo, etapa preoperatoria) con pacientes con cáncer rectal sin EII. MEDIDAS DE RESULTADO PRINCIPALES: Se midieron la supervivencia general a cinco años y la supervivencia libre de enfermedad, complicaciones postoperatorias a los 30 días, reingreso, reoperación y tasas de mortalidad. MÉTODOS: Las tasas de supervivencia se calcularon utilizando estimaciones de Kaplan-Meier. La asociación de factores de riesgo y resultados a largo plazo se evaluó mediante modelos de riesgo de proporción de Cox. RESULTADOS: Un total de 107 pacientes con EII y cáncer rectal se compararon con 215 pacientes de control; las etapas preoperatorias fueron las siguientes: 31% de Etapa I, 19% de Etapa II, 40% de Etapa III y 10% de Etapa IV. Se observaron diferencias (EII versus no EII) en quimioterapia neoadyuvante (33.6% frente a 52.6%, p = 0.001) y radioterapia preoperatoria (35.5% frente a 53.5%, p = 0.003). Las tasas de complicaciones postoperatorias fueron similares. En la patología quirúrgica, los pacientes con EII tuvieron más invasión linfovascular (12.9% frente a 5.6%, p = 0.04) y márgenes de resección circunferencial positivos (5.4% frente a 0.9%, p = 0.03). En el análisis multivariable, el diagnóstico de EII no tuvo un impacto significativo en la mortalidad a largo plazo (HR 0.91; IC del 95%: 0.53-1.57, p = 0.73) o la supervivencia libre de enfermedad (HR 1.36; IC del 95%: 0.84-2.21, p = 0.22) LIMITACIONES: Diseño retrospectivo, centro único de datos. CONCLUSIONES: Los pacientes con EII y sin EII con cáncer rectal tienen una supervivencia similar a largo plazo y libre de enfermedad, a pesar de las tasas más bajas de tratamiento sneoadyuvante y un mayor margen positivo en pacientes con EII. Consulte Video Resumen en http://links.lww.com/DCR/B271.

BACKGROUND: There is no study to date examining the safety of initiating or restarting biologic therapy after major abdominal surgery for Crohn’s disease. OBJECTIVE: The purpose of this study was to determine differences in the rates of 90-day superficial surgical site infections, intra-abdominal sepsis, and overall postoperative infectious complications among patients who were initiated on or restarted a biologic within 90 days postoperatively compared with those who were not. DESIGN: This was a retrospective cohort study. SETTINGS: The study was conducted at an IBD referral center. PATIENTS: Adult patients with Crohn’s disease who received a biologic therapy within 90 days of a major abdominal operation between May 20, 2014, and December 31, 2018, were included. MAIN OUTCOMES MEASURES: Ninety-day superficial surgical site infection, intra-abdominal sepsis, and overall postoperative infectious complications were measured. RESULTS: A total of 680 patients with Crohn’s disease were included: 351 were initiated on biologic therapy within 90 days after surgery and 329 were not. Patients exposed to biologic therapy postoperatively were younger (p < 0.001), had a lower BMI (p = 0.0014), were less often diabetic (p = 0.0011), and were more often exposed preoperatively to biologics (p < 0.0001) and immunomodulators (p < 0.0001) but not corticosteroids (p = 0.8399). Of those exposed postoperatively, nearly all (93.7%) had been on a biologics preoperatively, and most resumed the same biologic (68.0%). The median time to starting biologic therapy postoperatively was 31 days (range, 7–89 d). Postoperative biologic exposure was not associated with an increased risk of superficial surgical site infection (HR = 1.02 (95% CI, 0.95–1.09) per week; p = 0.59), intra-abdominal sepsis (HR = 1.07 (95% CI, 0.99–1.16); p = 0.73), or overall postoperative infectious complications (HR = 1.02 (95% CI, 0.98–1.07); p = 0.338); the overall rates of each at 90 days was 13%, 8%, and 28%. LIMITATIONS: The study was limited by its retrospective design and single-center data. CONCLUSIONS: Postoperative initiation or resumption of biologic therapy did not increase 90-day rates of superficial surgical site infection, intra-abdominal sepsis, or total infectious complications after major abdominal surgery for Crohn’s disease. See Video Abstract at http://links.lww.com/DCR/B207. ¿SON SEGUROS LOS FÁRMACOS BIOLÓGICOS EN EL POSTOPERATORIO INMEDIATO? UNA EVALUACIÓN DE UN SOLO CENTRO DE PACIENTES QUIRÚRGICOS CONSECUTIVOS CON ENFERMEDAD DE CROHN ANTECEDENTES: No hay ningún estudio hasta la fecha que examine la seguridad de iniciar o reiniciar la terapia biológica después de una cirugía abdominal mayor en enfermedad de Crohn. OBJETIVO: Determinar las diferencias en las tasas a 90 días de infecciones del sitio quirúrgico superficial, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales entre los pacientes en que se inició o reinició un biológico dentro de los 90 días después de la operación en comparación con aquellos que no lo recibieron. DISEÑO: Estudio de cohorte retrospectivo. ESCENARIO: Centro de referencia de enfermedad inflamatoria intestinal. PACIENTES: Pacientes adultos con enfermedad de Crohn que recibieron una terapia biológica dentro de los 90 días de una operación abdominal mayor entre el 20 de mayo de 2014 y el 31 de diciembre de 2018. PRINCIPALES MEDIDAS DE RESULTADO: Infección superficial del sitio quirúrgico, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales a 90 días. RESULTADOS: Se incluyeron un total de 680 pacientes con enfermedad de Crohn: 351 se iniciaron en terapia biológica dentro de los 90 días posteriores a la cirugía y 329 no. Los pacientes expuestos a terapia biológica después de la operación eran más jóvenes (p <0.001), tenían un índice de masa corporal más bajo (p = 0.0014), eran con menos frecuencia diabéticos (p = 0.0011) y estaban expuestos con mayor frecuencia preoperatoriamente a fármacos biológicos (p <0.0001) e inmunomoduladores (p <0.0001) pero no a corticosteroides (p = 0.8399). De los expuestos postoperatoriamente, casi todos (93.7%) habían estado en terapia biológica en el preoperatorio, y la mayoría reanudó la misma terapia biológica (68%). La mediana de tiempo para comenzar la terapia biológica después de la operación fue de 31 días (rango, 7-89 días). La exposición biológica postoperatoria no se asoció con un mayor riesgo de infección superficial del sitio quirúrgico (HR 1.02 (0.95-1.09) por semana, p = 0.59), sepsis intraabdominal. (HR: 1.07 (0.99-1.16), p = 0.73), o complicaciones infecciosas postoperatorias generales (HR: 1.02, intervalo de confianza del 95% 0.98-1.07, p = 0.338); las tasas generales de cada uno a los 90 días fue del 13%, 8% y 28%. LIMITACIONES: Diseño retrospectivo, y datos de un centro único. CONCLUSIONES: El inicio o la reanudación en el postoperatorio de la terapia biológica no aumentaron las tasas a 90 días de infección superficial de sitio quirúrgico, sepsis intraabdominal o complicaciones infecciosas totales después de una cirugía abdominal mayor por enfermedad de Crohn. Consulte el Video Resumen en http://links.lww.com/DCR/B207. (Traducción—Dr Jorge Silva Velazco)

Abstract Introduction The impact of ustekinumab on adverse postoperative outcomes in Crohn’s disease (CD) remains largely unknown. We determined the difference in 90-day postoperative complication rates among CD patients exposed to ustekinumab within 12 weeks prior to an abdominal operation as compared to patients not exposed to biologic therapy. Methods A retrospective chart review of all adults with CD who underwent an abdominal operation between October 1, 2017 and December 31, 2018 at a single tertiary medical center was performed. Data collection included patient demographics, concurrent immunosuppression, serum laboratory values, operative values, and 90-day outcomes including superficial surgical site infection (sSSI), intra-abdominal sepsis, overall infectious complications, readmission, and reoperation rates. The primary outcome was the 90-day rate of intra-abdominal sepsis. Results Fifty-seven CD patients received ustekinumab and 277 received no biologic therapy in the 12 weeks prior to major abdominal surgery. Ustekinumab-exposed patients were younger, less likely to have diabetes mellitus or active tobacco exposure, were more often obese, and more often taking a concurrent immunomodulator. Ustekinumab remained an independent predictor of intra-abdominal sepsis on multivariable logistic regression. Immunomodulator exposure was associated with significantly increased rates of sSSI and overall complication rates. Conclusions Ustekinumab is associated with increased rates of 90-day postoperative intra-abdominal sepsis following a major abdominal operation for CD.