Screening uptake of colonoscopy versus fecal immunochemical testing in first-degree relatives of patients with non-syndromic colorectal cancer: A multicenter, open-label, parallel-group, randomized trial (ParCoFit study).

BACKGROUND: Colonoscopy screening is underused by first-degree relatives (FDRs) of patients with non-syndromic colorectal cancer (CRC) with screening completion rates below 50%. Studies conducted in FDR referred for screening suggest that fecal immunochemical testing (FIT) was not inferior to colonoscopy in terms of diagnostic yield and tumor staging, but screening uptake of FIT has not yet been tested in this population. In this study, we investigated whether the uptake of FIT screening is superior to the uptake of colonoscopy screening in the familial-risk population, with an equivalent effect on CRC detection. METHODS AND FINDINGS: This open-label, parallel-group, randomized trial was conducted in 12 Spanish centers between February 2016 and December 2021. Eligible individuals included asymptomatic FDR of index cases <60 years, siblings or ≥2 FDR with CRC. The primary outcome was to compare screening uptake between colonoscopy and FIT. The secondary outcome was to determine the efficacy of each strategy to detect advanced colorectal neoplasia (adenoma or serrated polyps ≥10 mm, polyps with tubulovillous architecture, high-grade dysplasia, and/or CRC). Screening-naïve FDR were randomized (1:1) to one-time colonoscopy versus annual FIT during 3 consecutive years followed by a work-up colonoscopy in the case of a positive test. Randomization was performed before signing the informed consent using computer-generated allocation algorithm based on stratified block randomization. Multivariable regression analysis was performed by intention-to-screen. On December 31, 2019, when 81% of the estimated sample size was reached, the trial was terminated prematurely after an interim analysis for futility. Study outcomes were further analyzed through 2-year follow-up. The main limitation of this study was the impossibility of collecting information on eligible individuals who declined to participate. A total of 1,790 FDR of 460 index cases were evaluated for inclusion, of whom 870 were assigned to undergo one-time colonoscopy (n = 431) or FIT (n = 439). Of them, 383 (44.0%) attended the appointment and signed the informed consent: 147/431 (34.1%) FDR received colonoscopy-based screening and 158/439 (35.9%) underwent FIT-based screening (odds ratio [OR] 1.08; 95% confidence intervals [CI] [0.82, 1.44], p = 0.564). The detection rate of advanced colorectal neoplasia was significantly higher in the colonoscopy group than in the FIT group (OR 3.64, 95% CI [1.55, 8.53], p = 0.003). Study outcomes did not change throughout follow-up. CONCLUSIONS: In this study, compared to colonoscopy, FIT screening did not improve screening uptake by individuals at high risk of CRC, resulting in less detection of advanced colorectal neoplasia. Further studies are needed to assess how screening uptake could be improved in this high-risk group, including by inclusion in population-based screening programs. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT02567045).

Stent as bridge to surgery decreases postoperative complications without worsening oncological outcomes: retrospective unicentric cohort study and stent placement protocol.

BACKGROUND: Even if the use of stent as bridge to surgery (BTS) for obstructive colon cancer was described long ago, there is still much controversy on their use. Patient recovery before surgery and colonic desobstruction are just some of the reasons to defend this management that can be found in several available articles. METHODS: This is a single-center, retrospective cohort study, including patients with obstructive colon cancer treated between 2010 and 2020. The primary aim of this study is to compare medium-term oncological outcomes (overall survival, disease-free survival) between stent as BTS and ES groups. The secondary aims are to compare perioperative results (in terms of approach, morbidity and mortality, and rate of anastomosis/stomas) between both groups and, within the BTS group, analyze whether there are any factors that may influence oncological outcomes. RESULTS: A total of 251 patients were included. Patients belonging to the BTS cohort presented a higher rate of laparoscopic approach, required less intensive care management, less reintervention, and less permanent stoma rate, when comparing with patients who underwent urgent surgery (US). There were not significant differences in terms of disease-free survival and overall survival between the two groups. Lymphovascular invasion negatively affected oncological results but was not related with stent placement. CONCLUSION: The stent as a bridge to surgery is a good alternative to urgent surgery, which leads to a decrease in postoperative morbidity and mortality without significantly worsening oncological outcomes.

Switching between reference adalimumab and biosimilars in chronic immune-mediated inflammatory diseases: A systematic literature review.

AIMS: Adalimumab is a biological therapy used to treat different chronic inflammatory diseases. At present, there is an increasing number of adalimumab biosimilars. To assume the acceptability of interchangeability between reference adalimumab and biosimilars, there should be evidence about efficacy and safety of this switching. Regulation of this practice falls under the authority of individual European Union Member States. The aim of this study is to systematically review the evidence on the efficacy, safety and immunogenicity of switching between reference adalimumab and biosimilars in different chronic immune-mediated inflammatory diseases. METHODS: Studies presenting data about switching between reference adalimumab and biosimilars were identified by sensitive search strategies in Medline and EMBASE from 1 January 2004 to 30 June 2021. RESULTS: A total of 471 references were obtained and 21 finally included in the analysis (total number of patients switching: 2802). Eight different adalimumab biosimilars were tested after receiving reference adalimumab. Eight articles included rheumatoid arthritis (RA), one miscellaneous rheumatic disease, six psoriasis (PSO) and six inflammatory bowel disease (IBD) patients. Overall, the efficacy results in the switching groups were comparable to those obtained in the arms of continuous biosimilar and continuous reference adalimumab. There were no significant differences in treatment emergent adverse events, anti-drug or neutralising antibodies among the three groups. CONCLUSIONS: Switching between reference adalimumab and biosimilars has no impact on efficacy, safety and immunogenicity in patients with RA, PSO and IBD. This finding was consistent for the different adalimumab biosimilars analysed. These conclusions could probably be extended to other rheumatic diseases such as psoriatic arthritis and ankylosing spondylitis.

[Telematic consultations by nursing staff for patients with inflammatory bowel disease: evaluation of its capacity for resolving problems and its costs]. / Consulta telemática realizada por Enfermería en pacientes con enfermedad inflamatoria intestinal: valoración de su capacidad resolutiva y costes.

INTRODUCTION: The management of patients with inflammatory bowel disease (IBD) is associated with a significant use of healthcare resources. In 2009, a digestive diseases nursing consultation, with availability of health telematic media was created in our hospital (CHUVI). The important activity performed in this area encouraged us to quantify the cost savings for the care health system. AIMS: 1) To evaluate the results of the implementation of a telematic IBD consultation. 2) To assess the capacity for resolving problems by nurses. 3) To estimate the potential cost savings of telematic nursing consultation in IBD. MATERIAL AND METHOD: We collected data on telematic activity from 2009 to 2011. The estimated cost saving was calculated by applying the fees for health services published by our National Health Service (SERGAS) for care in new outbreaks of IBD activity. Data were analyzed with SPSS 15.0 RESULTS: There was a significant linear increase on the resolution of telephone demands by nurses (P=.03) and an important decrease of demands needing medical advice (P<.0001). Focusing on IBD outbreak claims (n=452), only 65 patients (14.38%) required medical attention in emergency services, and 33 (7.3%) were hospitalized. Altogether we calculated an average cost saving since 2009 to 2011 of 73,603€. CONCLUSIONS: We found a gradual increase in resolving telematic care demands by nurses. Telematic consultation can lead to significant cost savings, which justify the implementation of a digestive diseases nurse consultation.