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BACKGROUND: The efficacy of preoperative oral antibiotics alone compared with mechanical and oral antibiotic bowel preparation in minimally invasive surgery is still a matter of debate. OBJECTIVE: This study aimed to assess the trend of surgical site infection rates in parallel to the utilization of bowel preparation modality over time for minimally invasive colorectal surgeries in the United States. DESIGN: This study is a retrospective analysis. SETTINGS: The American College of Surgeons National Surgical Quality Improvement Program database was the source of data for this study. PATIENTS: Adult patients who underwent elective colorectal surgery and reported bowel preparation modality were included. MAIN OUTCOME MEASURES: The primary outcomes measured were the trends and the comparison of surgical site infection rates for mutually exclusive groups according to the underlying disease (colorectal cancer, IBD, and diverticular disease) who underwent bowel preparation using oral antibiotics or combined mechanical and oral antibiotic bowel preparation. Patients who underwent rectal surgery were analyzed separately. RESULTS: A total of 30,939 patients were included. Of them, 12,417 (40%) had rectal resections. Over the 7-year study period, mechanical and oral antibiotic bowel preparation utilization increased from 29.3% in 2012 to 64.0% in 2018; p < 0.0001 at the expense of no preparation and mechanical bowel preparation alone. Similarly, oral antibiotics utilization increased from 2.3% in 2012 to 5.5% in 2018; p < 0.0001. For patients with colon cancer, patients who had oral antibiotics alone had higher superficial surgical site infection rates than patients who had combined mechanical and oral antibiotic bowel preparation (1.9% vs 1.1%; p = 0.043). Superficial, deep, and organ space surgical site infection rates were similar for all other comparative colon surgery groups (cancer, IBD, and diverticular disease). Patients with rectal cancer who had oral antibiotics had higher rates of deep surgical site infection (0.9% vs 0.1%; p = 0.004). However, superficial, deep, and organ space surgical site infection rates were similar for all other comparative rectal surgery groups. LIMITATIONS: This study was limited by the retrospective nature of the analysis. CONCLUSION: This study revealed widespread adoption of mechanical and oral antibiotic bowel preparation and increased adoption of oral antibiotics over the study period. Surgical site infection rates are similar from a clinical relevance standpoint among most comparative groups, questioning the systematic preoperative addition of mechanical bowel preparation to oral antibiotics alone in all patients for minimally invasive colorectal surgery. See Video Abstract at http://links.lww.com/DCR/B828. PREPARACIÓN INTESTINAL CON ANTIBIÓTICOS ORALES SIN PREPARACIÓN MECÁNICA EN CIRUGÍAS COLORRECTALES MÍNIMAMENTE INVASIVAS: PRÁCTICA ACTUAL Y PERSPECTIVAS FUTURAS ANTECEDENTES: La eficacia de los antibióticos orales preoperatorios solos en comparación con la preparación intestinal mecánica mas antibióticos orales en la cirugía mínimamente invasiva es un tema de debate que todavía esta en curso. OBJETIVO: Este estudio tuvo como objetivo evaluar la tendencia de las tasas de infección del sitio quirúrgico en relacion a la utilización de la modalidad de preparación intestinal a lo largo del tiempo en cirugías colorrectales mínimamente invasivas en los Estados Unidos. DISEÑO: Análisis retrospectivo. ENTORNO CLINICO: Base de datos del Programa Nacional de Mejoramiento de la Calidad Quirúrgica del Colegio Estadounidense de Cirujanos. PACIENTES: Pacientes adultos sometidos a cirugía colorrectal electiva y reportados con modalidad de preparación intestinal. PRINCIPALES MEDIDAS DE VALORACIÓN: Tendencias y comparacion de las tasas de infección del sitio quirúrgico para grupos mutuamente excluyentes según la enfermedad subyacente (cáncer colorrectal, enfermedad inflamatoria intestinal y enfermedad diverticular) que se sometieron a preparación intestinal usando antibióticos orales exclusivamente o preparación intestinal mecánica combinada con antibióticos orales. Los pacientes que se sometieron a cirugía rectal se analizaron por separado. RESULTADOS: Se incluyeron un total de 30.939 pacientes. De ellos, 12.417 (40%) se sometieron a resecciones rectales. Durante el período de estudio de siete años, la preparación mecánica del intestino y la utilización de antibióticos orales aumentó del 29,3% en 2012 al 64,0% en 2018; p < 0,0001 sobre la no preparación y de la preparación intestinal mecánica exclusivamente. De manera similar, la utilización de antibióticos orales ha aumentado del 2,3% en 2012 al 5,5% en 2018; p < 0,0001. Para los pacientes con cáncer de colon, los pacientes que recibieron antibióticos orales solos tuvieron mayores tasas de infección superficial del sitio quirúrgico en comparación con los pacientes que recibieron una preparación intestinal mecánica combinada con antibióticos orales (1,9% frente a 1,1%; p = 0,043). Las tasas de infección superficial, profundo del sitio quirúrgico y de los compartimientos intraabdominales fueron similares para todos los demás grupos de cirugía de colon (cáncer, enfermedad inflamatoria intestinal y enfermedad diverticular). Los pacientes con cáncer de recto que recibieron antibióticos orales tuvieron tasas más altas de infección profunda del sitio quirúrgico (0,9% frente a 0,1%; p = 0,004). Sin embargo, las tasas de infección del sitio quirúrgico superficial, profundo y de los compartimientos intraabdominales fueron similares comparativamente para todos los demás grupos de cirugía rectal. LIMITACIONES: Carácter retrospectivo del análisis. CONCLUSIONES: Este estudio reveló la adopción generalizada de preparación intestinal mecánica y antibióticos orales y una mayor aceptación de antibióticos orales durante el período de estudio. Las tasas de infección del sitio quirúrgico parecen ser similares desde un punto de vista de relevancia clínica entre la mayoría de los grupos comparados, lo que cuestiona la adición preoperatoria sistemática de preparación intestinal mecánica a antibióticos orales solos en todos los pacientes para cirugía colorrectal mínimamente invasiva. Consulte Video Resumen en http://links.lww.com/DCR/B828. (Traducción— Dr. Ingrid Melo)

BACKGROUNDCognitive‐behavioral stress management interventions are associated with improved psychological well‐being for cancer survivors. The availability of, access to, and outreach of these in‐person interventions are limited, however. The current study, therefore, evaluated the efficacy of StressProffen, a digital application (app)–based stress management intervention for cancer survivors, in a 12‐month randomized controlled trial.METHODSCancer survivors 1 year or less after their treatment (N = 172) were randomized to the StressProffen intervention (n = 84) or a usual‐care control group (n = 88). The intervention was delivered in a simple blended care model: 1) 1 in‐person introduction session, 2) 10 app‐based cognitive‐behavioral stress management modules, and 3) 2 follow‐up phone calls. Stress (Perceived Stress Scale), anxiety and depression (Hospital Anxiety and Depression Scale), self‐regulatory fatigue (Self‐Regulatory Fatigue 18), and health‐related quality of life (HRQOL; RAND‐36) were examined at the baseline and at 6 and 12 months. Generalized linear models for repeated measures were fitted to compare effects over time.RESULTSParticipants were mainly female (82%), had a mean age of 52 years (standard deviation, 11.3 years; range, 20‐78 years), and had a variety of cancer types (mostly breast cancer [48%]). Over the 12‐month study time, the intervention group reported significantly decreased stress (P < .001), depression (P = .003), and self‐regulatory fatigue (P = .002) as well as improved HRQOL (for 6 of 8 domains, P ≤ .015) in comparison with controls. The largest favored effects for the intervention group were observed at 6 months: stress (estimated mean difference [MD], –5.1; P < .001), anxiety (MD, –1.4; P = .015), depression (MD, –2.1; P < .001), self‐regulatory fatigue (MD, –4.9; P < .001), and HRQOL (7 of 8 domains; P ≤ .037).CONCLUSIONSDigital stress management interventions such as StressProffen have the potential to extend the outreach of psychological interventions and provide easily available and effective psychosocial support for cancer survivors.

Abstract Background:Chronic pain conditions entail significant personal and societal burdens and improved outreach of evidence-based pain self-management programs are needed. Digital cognitive-behavioral self-management interventions have shown promise. However, evidence is still scarce and several challenges with such interventions for chronic pain exist. Exploring patients' experiences and engagement with digital interventions may be an essential step towards developing meaningful digital self-management interventions for those living with chronic pain. Objectives:This study aimed to gain insight into the experiences of people with chronic pain when engaging with EPIO, an application (app)-based cognitive-behavioral pain self-management intervention program.Methods: Participants (N=50) living with chronic pain received access to the EPIO intervention for 3 months. During this time, all participants received a follow-up phone call at 2-3 weeks, and a subsample (n=15) also participated in individual semi-structured interviews after 3 months. A qualitative design was used and thematic analysis was employed aiming to capture participants’ experiences when engaging with the EPIO intervention program. Results:Findings identifying program-related experiences and engagement were organized into three main topics, each with three sub-themes: (1) Engaging with EPIO; motivation to learn, fostering joy and enthusiasm, and helpful reminders and personalization, (2) Coping with pain in everyday life; awareness, practice and using EPIO, and (3) The value of engaging with the EPIO program; EPIO – a friend, making peace with the presence of pain, and fostering communication and social support. Conclusions: The current study explored participants’ experiences and engagement with EPIO, a digital self-management intervention program for people living with chronic pain. Findings highlighted identifying valued aspects related to motivation for engagement, incorporating content in support of daily coping, and encouraging a sense of acceptance and relatedness as vital components for facilitating program engagement.Trial Registration: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104

Abstract Background: A recent study from the Acute Leukemia Working Party of EBMT demonstrated that outcomes of allogeneic hematopoietic cell transplantation (allo-HCT) for adults with acute lymphoblastic leukemia (ALL) have improved significantly over time and that total body irradiation (TBI) should be considered as the preferable type of myeloablative conditioning (MAC). This study, however, did not compare outcomes of allo-HCT in patients with CNS involvement (CNS-pos) vs. those without CNS disease (CNS-neg). Study population: Here, we evaluate post allo-HCT outcomes of 547 patients (CNS-pos at initial presentation=96, CNS-neg=451) who underwent the procedure in first complete remission (CR1) between 2009 and 2019 at an EBMT participating transplant center. The distribution of ALL subtypes were as follows: CNS-pos (Ph-neg B ALL=28%, Ph-pos B ALL=27%, and T-cell ALL=45%) and for CNS-neg (Ph-neg B ALL=21%, Ph-pos B ALL=44%, and T-cell ALL=35%), p=0.01. The primary endpoint was leukemia-free survival (LFS). Results: The median follow up was not statistically different between the CNS-pos (78.7 months) and the CNS-neg group (67.2 months), p=0.58. Patients in the CNS-pos group were younger (median age 31.3 vs. 39.7 years, p=0.004), received the procedure more recently (median year 2012 vs. 2010, p=0.003), were less likely to have a Karnofsky score of equal or higher than 90 (70.8% vs. 81.9%, p=0.017), or to have received peripheral blood stem cells (PBSC) (61.5% vs. 72.7%, p=0.028). The groups did not differ in regards to donor source (URD, 50% vs. 56.5%, p=0.24) or the intensity of the preparative regimen (MAC, 82.3% vs. 85.6%, p=0.41). In multivariate analysis, CNS-pos were associated with higher cumulative incidence of relapse (HR=1.58 (95%CI=1.06-2.35), P=0.025) and a trend for an inferior leukemia-free survival (LFS) (HR=1.38 (95%CI=0.99-1.92), p=0.057), but did not adversely impact overall survival (OS) (HR=1.28 (95%CI=0.89-1.85), p=0.18). A subgroup multivariate analysis limited to patients with CNS-pos showed that prescribing a TBI MAC regimen (vs. others) results in a lower cumulative incidence of relapse (HR=0.35 (95%CI=0.15-0.79), p=0.012) and better LFS (HR=0.43 (95%CI=0.22-0.83), p=0.01) and OS (HR=0.44 (95%CI=0.21-0.92), p=0.03). Use of PBSC (vs. BM) was also independently associated with better OS (HR=0.53 (95%CI=0.29-0.99), p=0.046). Conclusion: Notwithstanding the inherent limitations of registry data, particularly ascertaining the absence of CNS involvement in the CNS-neg group, our results show CNS involvement as an independent risk factor for relapse following allo-HCT. Our data support, nonetheless, the choice of a TBI-based MAC regimen in this group of patients but stresses the need for close monitoring of relapse after allo-HCT. Disclosures Labopin: Jazz Pharmaceuticals: Honoraria. Bazarbachi: Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Hikma: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Astra Zeneca: Membership on an entity's Board of Directors or advisory committees. Mielke: Immunicum: Other: Data safety monitoring board; DNA Prime SA: Speakers Bureau; Gilead/KITE: Other: Travel support, Expert panel ; Miltenyi: Other: Data safety monitoring board; Novartis: Speakers Bureau; Celgene/BMS: Speakers Bureau. Socie: Alexion: Research Funding. Huynh: Jazz Pharmaceuticals: Honoraria. Yakoub-Agha: Jazz Pharmaceuticals: Honoraria. Giebel: Janssen: Honoraria, Speakers Bureau; Pfizer: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau; Amgen: Consultancy, Honoraria, Speakers Bureau. Peric: Therakos, Servier, MSD, Astellas, Novartis, Abbvie, Pfizer: Honoraria. Mohty: Sanofi: Honoraria, Research Funding; Pfizer: Honoraria; Novartis: Honoraria; Takeda: Honoraria; Jazz: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Gilead: Honoraria; Celgene: Honoraria, Research Funding; Bristol Myers Squibb: Honoraria; Astellas: Honoraria; Amgen: Honoraria; Adaptive Biotechnologies: Honoraria.

AbstractBackgroundRecent population-based female breast cancer and prostate cancer polygenic risk scores (PRS) have been developed. We assessed the associations of these PRS with breast and prostate cancer risks for male BRCA1 and BRCA2 pathogenic variant carriers.Methods483 BRCA1 and 1318 BRCA2 European ancestry male carriers were available from the Consortium of Investigators of Modifiers of BRCA1/2 (CIMBA). A 147-single nucleotide polymorphism (SNP) prostate cancer PRS (PRSPC) and a 313-SNP breast cancer PRS were evaluated. There were 3 versions of the breast cancer PRS, optimized to predict overall (PRSBC), estrogen receptor (ER)–negative (PRSER-), or ER-positive (PRSER+) breast cancer risk.ResultsPRSER+ yielded the strongest association with breast cancer risk. The odds ratios (ORs) per PRSER+ standard deviation estimates were 1.40 (95% confidence interval [CI] =1.07 to 1.83) for BRCA1 and 1.33 (95% CI = 1.16 to 1.52) for BRCA2 carriers. PRSPC was associated with prostate cancer risk for BRCA1 (OR = 1.73, 95% CI = 1.28 to 2.33) and BRCA2 (OR = 1.60, 95% CI = 1.34 to 1.91) carriers. The estimated breast cancer odds ratios were larger after adjusting for female relative breast cancer family history. By age 85 years, for BRCA2 carriers, the breast cancer risk varied from 7.7% to 18.4% and prostate cancer risk from 34.1% to 87.6% between the 5th and 95th percentiles of the PRS distributions.ConclusionsPopulation-based prostate and female breast cancer PRS are associated with a wide range of absolute breast and prostate cancer risks for male BRCA1 and BRCA2 carriers. These findings warrant further investigation aimed at providing personalized cancer risks for male carriers and informing clinical management.

AbstractUtility of adjuvant chemotherapy for stage II cancer remains a matter of debate. Clinical guidelines suggest adjuvant chemotherapy for stage II tumors with high‐risk features, in particular T4 tumors. However, limited consensus exists regarding the importance of other high‐risk features (lymphovascular or perineural invasion, microsatellite instability). Our study aimed to investigate the impact of adjuvant chemotherapy for stage IIA (T3N0) colon cancer patients. Patients who underwent colectomy for stage IIA colon adenocarcinoma (2010‐2015) were identified in the National Cancer Database (NCDB) and divided in two groups based on receipt of adjuvant chemotherapy vs observation. Inverse probability of treatment weighting (IPTW)‐adjusted Kaplan‐Meier and Cox proportional hazards regression analyses were performed to compare overall survival between the two groups. Subgroup analysis of patients with specific high‐risk features LVI, PNI and MSI was performed. Among 46 688 surgical patients with stage IIA colon adenocarcinoma 5937 (12.7%) received adjuvant chemotherapy, while 40 751 (87.3%) were observed. Five‐year IPTW‐adjusted survival was higher in the adjuvant chemotherapy group (79.7% [95% CI 79.1, 80.2]) compared to the observation group (70.3% [95% CI 69.7, 70.9]). Patients with high‐risk pathological features showed an estimated 5‐year survival benefit of 11.3% (78.2% [95% CI 77.4, 79.1] vs 66.9% [95% CI 65.9, 67.8]) when treated with adjuvant chemotherapy. This NCDB analysis revealed a survival benefit for patients with stage IIA colon adenocarcinoma and high‐risk features that were treated with adjuvant chemotherapy.