Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study.

BACKGROUND: Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce.We compare the efficacy and safety of ADA biosimilars SB5, ABP501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. METHODS: A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. RESULTS: A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. CONCLUSIONS: Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.

We treated 533 IBD patients with adalimumab (ADA) biosimilars SB5, APB501, GP2017, and MSB11022. No differences between these 4 ADA biosimilars were found for reaching remission in naive patients, maintaining remission for nonmedical switching, clinical response, steroid-free remission, surgery rate, mucosal healing, or safety.

Comparison of performances of infliximab biosimilars CT-P13 versus SB2 in the treatment of inflammatory bowel diseases: a real-life multicenter, observational study in Italy.

BACKGROUND: To compare the performances of Infliximab (IFX) biosimilar CT-P13 and SB2 in the treatment of Inflammatory Bowel Diseases (IBD) outpatients in Italy. RESEARCH DESIGN AND METHODS: Three hundred and eighty IBD outpatients were retrospectively evaluated. The primary endpoint was to compare the two IFX biosimilars in terms of reaching and maintenance of remission at any timepoint. RESULTS: 197 patients with Ulcerative Colitis (UC) and 183 patients with Crohn's Disease (CD) treated with CT-P13 or SB2 and having a median (IQR) follow-up of 12 (6-36) months were compared: 230 (60.5%) were naïve to anti-TNFα, 20 (5.26%) were switched from IFX originator or from IFX CT-P13 to IFX SB2. Clinical remission was achieved in 133 (67.5%) UC patients and in 164 (89.6%) CD patients (p < 0.000), with no differences between CT-P13 and SB2 in the rate of remission in UC (p = 0.667) and CD (p = 0.286). Clinical response, steroid-free remission, rate of surgery, mucosal healing (MH) in UC, switching from IFX originator or from other biosimilar, and safety were similar. Higher MH rate was obtained in CD patients treated with CT-P13 (p = 0.004). CONCLUSION: This first comparative study found that both IFX biosimilars CT-P13 and SB2 are effective and safe in managing IBD outpatients.

Long-term real-life efficacy and safety of infliximab and adalimumab in the treatment of inflammatory bowel diseases outpatients.

BACKGROUND: Infliximab and adalimumab are widely used for the treatment of Crohn's disease and ulcerative colitis. AIM: To compare the long-term efficacy and safety of infliximab and adalimumab in a large cohort of Crohn's disease and ulcerative colitis patients reflecting real-life clinical practice. METHODS: Seven hundred twelve patients were retrospectively reviewed, 410 with Crohn's disease (268 treated with adalimumab and 142 with infliximab; median follow-up 60 months, range, 36-72) and 302 with ulcerative colitis (118 treated with adalimumab and 184 with infliximab; median follow-up 48 months, range, 36-84). RESULTS: In Crohn's disease, clinical remission was maintained in 75.0% of adalimumab vs. in 72.5% of infliximab patients (P = 0.699); mucosal healing and steroid-free remission were maintained in 49.5% of adalimumab vs. 63.9% of infliximab patients (P = 0.077) and in 77.7% of adalimumab vs. 77.3% in infliximab group (P = 0.957), respectively. In ulcerative colitis, clinical remission was maintained in 50.0% of adalimumab vs. 65.8% of infliximab patients (P < 0.000); mucosal healing and steroid-free remission were maintained in 80.6% of adalimumab vs. 77.0% of infliximab patients (P = 0.494) and in 90.2% of adalimumab vs. 87.5% of infliximab patients (P = 0.662), respectively. At the multivariate analysis, ileocolonic location and simple endoscopic score for Crohn's disease >10 were predictors of failure in Crohn's disease; treatment with adalimumab, BMI ≥30 and Mayo score >10 were predictors of failure in ulcerative colitis. infliximab was more likely to cause adverse events than adalimumab (16.6 vs. 6.2%, P < 0.000). CONCLUSION: Both adalimumab and infliximab are effective in long-term outpatients management of inflammatory bowel diseases. Adalimumab had a lower rate of adverse events.

Complicated diverticulitis mimicking colonic carcinoma: combined approach with endoscopy and budesonide.

Complicated diverticulitis is an uncommon endoscopic finding. We report an unusual case of complicated diverticulitis in a 53-year-old man suffering from chronic constipation, abdominal pain and a recent episode of subocclusion. He underwent to colonoscopy that showed left-sided diverticulosis and a 3 cm irregular mass in the sigmoid. During biopsy sampling due to the suspect of colonic carcinoma, pus and bleeding came out from the lesion. After lavage, a large diverticulum with visible vessel at the bottom was found, which was clipped with stopping bleeding. After a short course of in-hospital treatment, at discharging the patient was treated with budesonide MMX9 mg/day for 8 weeks. At that time, colonoscopy did not show sign of diverticular inflammation, and inflammatory indexes were normal. This case demonstrates that the use of a topical steroid, combined with an endoscopic approach, may easily resolve an unusual endoscopic complication in patients suffering from complicated diverticular disease.

Reduction of Serum Concentrations and Synergy between Retinol, ß-Carotene, and Zinc According to Cancer Staging and Different Treatment Modalities Prior to Radiation Therapy in Women with Breast Cancer.

The procedures used for breast cancer treatment are able to increase the level of oxidative stress and cause depletion of antioxidants. OBJECTIVES: To investigate the relationship between serum concentrations of retinol, ß-carotene, and zinc, according to breast cancer staging, considering different treatment modalities prior to radiation therapy and the synergistic action between these micronutrients. METHODS: This is a cross-sectional observational study comprising a cohort of patients with breast cancer which was carried out prior to radiation therapy. Patients were divided into 3 groups: G1 comprised women who had undergone breast-conserving surgery, G2 comprised those who had undergone chemotherapy, and G3 those who had undergone breast-conserving surgery and chemotherapy. Serum concentrations of retinol, ß-carotene, and zinc were quantified. Breast cancer staging was based on the TNM (Tumor, Node, Metastasis) classification of malignant tumors, a type of staging tool for different cancers. RESULTS: A total of 230 patients were assessed. A decrease of the serum concentrations of the micronutrients assessed as the staging level of the disease increased was observed. Surgery alone had a greater negative impact on serum concentrations of retinol. Considering the treatments prior to radiotherapy, patients undergoing surgery alone and chemotherapy associated with surgery had higher percentages of deficiency of ß-carotene and retinol. There was a positive correlation between the concentrations of zinc, retinol, and ß-carotene, showing a synergy between these micronutrients. CONCLUSION: A significant reduction in the serum concentrations of the assessed micronutrients was observed, according to the increase in breast cancer staging. The synergy between the micronutrients must be considered in order to maximize the benefits and minimize the adverse effects of irradiation to normal cells.

Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers.

BACKGROUND: The purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers. METHODS: Consecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety. RESULTS: One hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission. CONCLUSION: This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naïve patients and those switching from IFX originator.

Vedolizumab is effective and safe in real-life treatment of inflammatory bowel diseases outpatients: A multicenter, observational study in primary inflammatory bowel disease centers.

BACKGROUND: Italian data currently available in managing ulcerative colitis (UC) and Crohn's disease (CD) patients with vedolizumab (VDZ) are coming just from secondary and tertiary centers. The present study aimed to assess the real-life efficacy and safety of VDZ to achieve remission in inflammatory bowel diseases (IBD) outpatients in primary gastroenterology centers. METHODS: Clinical activity was scored according to the Mayo score in UC and to the Harvey-Bradshaw Index (HBI) in CD. The primary endpoints were the achievement of clinical remission and safety. Secondary endpoints were clinical response to treatment, achievement of mucosal healing (MH), and steroid discontinuation. RESULTS: One hundred and thirty-six pts. were enrolled (91 UC and 45 CD pts). During an 18-month median follow-up, clinical remission was present in 63 (46.3%) pts.: in particular, it occurred in 48 (52.7%) patients in UC group and in 15 (33.3%) patients in CD group (p = 0.003). more in UC group. Fecal calprotectin ≥400 µg/g and presence of comorbidities were factors significantly related to the failure of remission in UC and CD, respectively. Ten (7.3%) cases of adverse events were recorded (2 required suspension of treatment). Clinical response was present in 105 (72.2%) pts.: 71 (78.0%) in UC and 34 (75.5%) in CD group. MH occurred in 47 (62.7%) UC and in 9 (50.0%) CD patients. Steroids discontinuation occurred in 92 (67.6%) pts.; 61 (67.0%) UC and 31 (68.9%) CD pts. CONCLUSION: VDZ is effective and safe in IBD outpatients, especially in UC patients.

Effectiveness and safety of adalimumab to treat outpatient ulcerative colitis: A real-life multicenter, observational study in primary inflammatory bowel disease centers.

Adalimumab (ADA) was approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments in 2014, but no data from real life are currently available. The aim of the present study was to assess the real-life efficacy and safety of ADA in managing UC outpatients in some Italian primary inflammatory bowel disease (IBD) centers after approval of ADA reimbursement.Consecutive UC outpatients with at least 3-month follow-up were retrospectively evaluated. The primary end point was the induction and maintenance of remission in UC, defined as Mayo score ≤2.One hundred seven patients were included. At 3-month follow-up, obtained in 102 (95.3%) patients, 56 (54.9%) patients achieved a clinical remission. At univariate analysis, both Mayo partial score >7 and Mayo subscore for endoscopy = 3 at entry showed to be significantly associated with the lack of remission induction.During a median (95% confidence interval [CI]) follow-up of 18 (12-24) months, 56.6% of patients were under clinical remission; clinical response was achieved in 89.2% of cases. Mucosal healing was achieved in 66 (76.7%) patients, and colectomy occurred in 3 (2.8%) patients. Both C-reactive protein and fecal calprotectin values significantly decreased during follow-up. Steroids discontinuation occurred in 67 (66.7%) patients, and ADA dose escalation was adopted in 9 (16.1%) patients under remission. No factor was significantly related to the maintenance of clinical remission.This first Italian experience found ADA safe and effective to induce and maintain remission in real-life UC outpatients.

USE OF 125IODINE SEEDS (ROLLIS) FOR INTRA-OPERATIVE LOCALIZATION OF NONPALPABLE BREAST LESIONS: ANALYSIS OF THE IMPLANT OF 338 SEEDS IN 284 PATIENTS / Uso de sementes de iodo-125 (ROLLIS) para localização intraoperatória de lesões impalpáveis da mama: análise do implante de 338 sementes em 284 pacientes

Objective: To analyze the feasibility, efficacy and results of the use of 125Iodine seeds for intra-operative localization of nonpalpable breast lesions. Method: Retrospective review of 284 patients, referred by various breast specialist surgeons, with radiologically detected but clinically nonpalpable microcalcifications or nodules, submitted to pre-operatory 125Iodine seed implant, between July 2012 and September 2016. A total of 338 seeds were implanted in ordinary radiologic departments, supported by ultrasonography or mammography exams, chosen according to the morphologic aspect of the lesion. Radioguided surgical procedure took place on the same day or few days after the implant of the seeds, with the help of a radiation detector called Gamaprobe, which directs the surgeons towards the radioactive seeds and to the lesion to be resected. Results: All implants were performed as outpatient procedures, with patients immediately returning to their daily activities. No complications such as pain, bleeding, infeccion and haematoma were recorded. Pathologists had no difficulty in preparing the surgical specimens for histopathologic analysis. Surgical safety margins were considered adequate in all pathologic reports, with no need for re-operations. The healing process was not jeopardized by radiation, and the surgeons were pleased with the improvement on intraoperative lesions localizations and shortening on operatory time. Cosmetic results were well accepted by the patients. Conclusion: The 125Iodine seed implant is an effective alternative method for intraoperative localization of radiologically detectable and clinically nonpalpable breast lesions.

Objetivo: Avaliar a exequibilidade e a eficácia do método de implante de sementes de 125Iodo (ROLLIS) para localização intraoperatória de lesões impalpáveis da mama. Método: Trata-se de um estudo retrospectivo, incluindo 284 pacientes com nódulos ou microcalcificações mamárias, visíveis na mamografia e/ou ultrassonografia, porém, clinicamente impalpáveis, submetidas a implantes de sementes de 125Iodo, de julho de 2012 a setembro de 2016, sendo implantado um total de 338  sementes. As  pacientes foram encaminhadas por diversos mastologistas que executaram cirurgias radioguiadas com auxílio de detector de radiação denominado Gamaprobe, realizadas no mesmo dia do implante ou vários dias após, seguindo a agenda do centro cirúrgico, da equipe médica e a conveniência da paciente. Resultados: Os implantes foram realizados em regime ambulatorial, com imediato retorno das pacientes às atividades cotidianas, não sendo registrada qualquer complicação como dor, hemorragia, infecção ou hematoma. Os patologistas não constataram prejuízo no processamento do espécimen cirúrgico. O processo cicatricial se efetuou normalmente, obtendo-se plena satisfação por parte dos cirurgiões, que referiram maior facilidade na localização intraoperatória das lesões e diminuição no tempo operatório. O resultado cosmético também foi beneficiado, sendo bem aceito pelas pacientes. As margens cirúrgicas foram consideradas adequadas em todos os casos, graças à avaliação feita pelo patologista e às ampliações executadas no momento da cirurgia, dispensando re-excisões. Conclusão: O implante de sementes de 125Iodo (ROLLIS) é uma técnica segura e eficaz para localização intraoperatória de lesões radiologicamente visíveis, porém clinicamente impalpáveis, da mama.

How to Differentiate Segmental Colitis Associated With Diverticulosis and Inflammatory Bowel Diseases.

The segmental colitis associated with diverticulosis," better known by its acronym "SCAD," is a chronic inflammatory process localized in the colonic area presenting diverticulosis, and therefore mainly in the sigmoid colon. By definition, both the rectum and the right colon are spared from any inflammation both endoscopically and from a histologic point of view. Recent data have hypothesized that SCAD may be an independent clinical entity within the inflammatory bowel disease set of diseases. Compared with inflammatory bowel disease, SCAD seems to have a more benign outcome, with low rate of complications.

Predictive value of the Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification on the outcome of diverticular disease of the colon: An international study.

BACKGROUND: Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification has been recently developed for patients suffering from diverticulosis and diverticular disease. AIMS: We assessed retrospectively the predictive value of DICA in patients for whom endoscopic data and clinical follow-up were available. METHODS: For each patient, we recorded: age, severity of DICA, presence of abdominal pain, C-reactive protein and faecal calprotectin test (if available) at the time of diagnosis; months of follow-up; therapy taken during the follow-up to maintain remission (if any); occurrence/recurrence of diverticulitis; need of surgery. RESULTS: We enrolled 1651 patients (793 M, 858 F, mean age 66.6 ± 11.1 years): 939 (56.9%) patients were classified as DICA 1, 501 (30.3%) patients as DICA 2 and 211 (12.8%) patients as DICA 3. The median follow-up was 24 (9-38) months. Acute diverticulitis (AD) occurred/recurred in 263 (15.9%) patients; surgery was necessary in 57 (21.7%) cases. DICA was the only factor significantly associated to the occurrence/recurrence of diverticulitis and surgery either at univariate (χ(2 )= 405.029; p < 0.0001) or multivariate analysis (hazard ratio = 4.319, 95% confidence interval (CI) 3.639-5.126; p < 0.0001). Only in DICA 2 patients was therapy effective for prevention of AD occurrence/recurrence with a hazard ratio (95% CI) of 0.598 (0.391-0.914) (p = 0.006, log rank test). Mesalazine-based therapies reduced the risk of AD occurrence/recurrence and needs of surgery with a hazard ratio (95% CI) of 0.2103 (0.122-0.364) and 0.459 (0.258-0.818), respectively. CONCLUSIONS: DICA classification is a valid parameter to predict the risk of diverticulitis occurrence/recurrence in patients suffering from diverticular disease of the colon.

Histological inflammation in ulcerative colitis in deep remission under treatment with infliximab.

BACKGROUND AND OBJECTIVE: There are few data on how histological signs of inflammation develop under treatment with infliximab (IFX). We investigated the patterns of histological features of inflammation in patients with UC in sustained clinical and endoscopic remission under IFX. METHODS: We performed a retrospective study on 47 patients with UC in clinical and endoscopic remission and undergoing surveillance colonoscopy with biopsies while receiving maintenance therapy with IFX. Each colonic segment was evaluated based on the Mayo endoscopic subscore and the Geboes histology score (range 0-5.4). RESULTS: Globally, 6110 biopsy specimens were collected from 235 colonoscopies. At the beginning of the follow-up, histological features of inflammation were found in 48.9% of patients receiving maintenance IFX therapy; 25.9% of them had at least moderate inflammation based on histology scores. At the end of the follow-up, when patients were still under endoscopic and clinical remission, 40.4% of patients had at least one biopsy specimen with evidence of any histological inflammation during the follow-up, and 19.1% had biopsy specimens that met the Geboes criteria for histological inflammation and architectural alteration. In none of the different disease locations (pancolitis, left-sided colitis, distal colitis) histological inflammation improved significantly during the follow-up. CONCLUSIONS: Patients in clinical and endoscopic remission from UC under IFX still frequently have histological features of inflammation.

Effectiveness of adalimumab for ambulatory ulcerative colitis patients after failure of infliximab treatment: a first "real-life" experience in primary gastroenterology centers in Italy.

BACKGROUND: Adalimumab (ADA) is the key treatment for ulcerative colitis (UC) unresponsive or intolerant to standard treatments. Our aim was to assess the efficacy and safety of ADA in treating ambulatory UC patients in primary gastroenterology centers. METHODS: Fifteen patients (6 male, median age 29.9 years, range 22.8-39.9 years) were enrolled. All were previously treated with infliximab (IFX). Clinical activity and endoscopic severity were scored according to the Crohn's disease activity index (CDAI) score and Mayo subscore for endoscopy, respectively. Patients were clinically assessed at weeks 4, 8, and thereafter at weeks 16, 24, 32, 40, 48, and 54. Colonoscopy was performed before starting treatment, at weeks 24 and 54. The co-primary endpoints were clinical remission at 24 and 54 weeks. The secondary endpoints included: 1) sustained clinical remission; 2) steroid-sparing effect; 3) mucosal healing; 4) need for colectomy. Induction dose of ADA was 160 mg at week 0, and then 80 mg at week 2, while ADA maintenance treatment was 40 mg every two weeks. RESULTS: Clinical remission was obtained in 11 (73.3%) and 15 (100%) patients at weeks 24 and 54 respectively. Ten patients (66.7%) were able to discontinue steroids and were under corticosteroid-free remission at week 54. No patients underwent to colectomy. Eight patients (53.33%) at week 24 and 9 patients (60%) at week 54 achieved complete mucosal healing (Mayo endoscopic score 0). Side effects were reported in 2 of 15 patients (13.3%); none of those patients stopped treatment. CONCLUSION: ADA seems to be effective and safe in UC outpatients affected by UC, and previously treated with IFX.

Managing ambulatory ulcerative colitis patients with infliximab: a long term follow-up study in primary gastroenterology centers.

BACKGROUND: Infliximab (IFX) is the key treatment for ulcerative colitis (UC) unresponsive to standard treatments. The aim of the present study was to assess the efficacy and safety of IFX in treating ambulatory UC patients in primary gastroenterology centers. METHODS: One hundred and eighteen patients (65 M, 63 F, median age 34 years, range 19-71 years), affected by UC, were treated with IFX. Clinical efficacy, safety, mucosal healing (MH), and histological healing (HH) were assessed at a scheduled follow-up of 42 months. RESULTS: Percentage of patients with clinical remission persistence at 42-month follow-up was 70.4%. Colectomy occurred in only 3 patients (2.7%). At 42-month follow-up percentage of patients with MH was 44.6%, and percentage of patients with HH was 24.3%. HH at 6-month follow-up occurred in 13 out of 34 patients (38.2%) with C-reactive protein (CRP) <3 and in 8 out of 76 patients (10.5%) with CRP ≥ 3 (p=0.002). Side effects were reported in 16 patients (13.6%): infusion reactions occurred in 7 patients, other severe side-effects occurred in 3 patients, and opportunistic infections occurred in 3 patients (2.5%). Finally, 3 cancers (2.5%) occurred during the follow-up period (1 breast, 1 kidney and 1 rectal cancer). Both univariate and multivariate analyses showed Hb <11.5 g/dL and HH at 6-month follow-up to be significantly associated with treatment failure during follow-up. CONCLUSIONS: IFX seems to be effective and safe in long-term treatment of outpatients affected by UC.

Relationship between two year PSA nadir and biochemical recurrence in prostate cancer patients treated with iodine-125 brachytherapy / A relação entre PSA nadir de dois anos e recidiva bioquímica no tratamento do câncer de próstata com braquiterapia de semente de iodo-125

Objective To evaluate the relationship between two year PSA nadir (PSAn) after brachytherapy and biochemical recurrence rates in prostate cancer patients. Materials and Methods In the period from January 1998 to August 2007, 120 patients were treated with iodine-125 brachytherapy alone. The results analysis was based on the definition of biochemical recurrence according to the Phoenix Consensus. Results Biochemical control was observed in 86 patients (71.7%), and biochemical recurrence, in 34 (28.3%). Mean PSAn was 0.53 ng/ml. The mean follow-up was 98 months. The patients were divided into two groups: group 1, with two year PSAn < 0.5 ng/ml after brachytherapy (74 patients; 61.7%), and group 2, with two year PSAn ≥ 0.5 ng/ml after brachytherapy (46 patients; 38.3%). Group 1 presented biochemical recurrence in 15 patients (20.3%), and group 2, in 19 patients (43.2%) (p < 0.02). The analysis of biochemical disease-free survival at seven years, stratified by the two groups, showed values of 80% and 64% (p < 0.02), respectively. Conclusion Levels of two year PSAn ≥ 0.5 ng/ml after brachytherapy are strongly correlated with a poor prognosis. This fact may help to identify patients at risk for disease recurrence. .

Objetivo Avaliar os valores de PSA nadir (PSAn) dois anos após braquiterapia e sua relação com a taxa de recidiva bioquímica. Materiais e Métodos Cento e vinte pacientes foram tratados no período de janeiro de 1998 a agosto de 2007. Todos os pacientes foram submetidos a braquiterapia isolada. Os resultados foram analisados com base na definição de recidiva bioquímica do Consenso Phoenix. Resultados Oitenta e seis pacientes (71,7%) tiveram controle bioquímico e 34 (28,3%) apresentaram recidiva bioquímica. O PSAn médio foi 0,53 ng/ml. O seguimento médio foi 98 meses. Os pacientes foram divididos em dois grupos: grupo 1, com PSAn < 0,5 ng/ml dois anos após a braquiterapia (74 pacientes; 61,7%), e grupo 2, com PSAn ≥ 0,5 ng/ml dois anos após a braquiterapia (46 pacientes; 38, 3%). O grupo 1 teve recidiva bioquímica em 15 pacientes (20,3%) e o grupo 2 em 19 pacientes (43,2%) (p < 0,02). A análise da sobrevida livre de doença bioquímica de sete anos, estratificada pelos dois grupos, apresentou valores de 80% e 64% (p < 0,02), respectivamente. Conclusão Os níveis de PSAn ≥ 0,5 ng/ml dois anos após a braquiterapia estão fortemente correlacionados com mau prognóstico. Este fato pode ajudar a identificar pacientes com risco de recidiva da doença. .

Effectiveness and safety of infliximab and adalimumab for ambulatory Crohn's disease patients in primary gastroenterology centres.

BACKGROUND: Infliximab (IFX) and adalimumab (ADA) are the key treatments for Crohn's Disease (CD), unresponsive to standard treatments. Our aim was to compare the efficacy and safety of IFX and ADA in treating CD in clinical practice. METHODS: One hundred and twenty-six patients (61 M, 65 F, mean age 36.2 years, range 19-67 years), affected by CD, were treated with infliximab (IFX, 59 patients) or adalimumab (ADA, 66 patients). Clinical efficacy, mucosal healing (MH), histological healing (HH), and safety were assessed. MH was defined complicated if healing of ulcers occurred with deformation of bowel profile and/or complete colonoscopy was impossible because of scars. RESULTS: Patients were followed-up for 36 months. No difference was found between IFX and ADA in maintaining long-term clinical remission, MH and HH. Complicated MH was present in 17 (28.8%) patients in IFX group and in 7 (10.6%) patients in ADA group (p=0.012). In 9 (15.2%) patients in IFX group and 2 (3.0%) patients in ADA group colonoscopy was incomplete without cecal intubation or terminal ileum exploration (p=0.024). Side effects were similar in both groups. CONCLUSIONS: Both IFX and ADA seem to be effective and safe in long-term outpatient treatment of CD in clinical practice.

The relationship between serum vitamin A and breast cancer staging before and after radiotherapy.

INTRODUCTION: Several adverse effects of radiotherapy have been associated with the process of increased oxidative stress in the organism. In this context, vitamin A noteworthy for its important role in combating oxidative stress, in addition to its chemoprotective effect. OBJECTIVE: To assess the serum levels of vitamin A (retinol and ß-carotene) and their relationship to breast cancer staging in patients before and after radiotherapy. METHODS: This is a prospective study of women with breast cancer who were evaluated from October 2011 to September 2012 before (T0) and after radiotherapy (T1-7 days). Serum retinol and ß-carotene levels were analyzed using High Performance Liquid Chromatography. The assignment of breast cancer stages was based on the classification of malignant tumors that has been proposed by the International Union Against Cancer. RESULTS: 230 patients (mean age 63.6 years, SD ± 9.38) were evaluated. There was a significant reduction in the serum retinol (45.1 ± 18.2 µg/dL at T0 to 27.1 ± 11.7 µg/dL at T1, p < 0.001) and ß-carotene (209.0 ± 153.6 µg/L at T0 to 47.7 ± 25.5 µg/L at T1, p < 0.001). There was also a significant difference in serum retinol (p < 0.001) and ß-carotene (p = 0.003) levels based on the disease stage. CONCLUSIONS: It is recommended the early establishment of adequation serum concentrations of retinol and beta-carotene, offering nutritional assistance for those patients with deficiencies, in order to minimize the harmful effects of radiation.

Relationship between two year PSA nadir and biochemical recurrence in prostate cancer patients treated with iodine-125 brachytherap.

OBJECTIVE: To evaluate the relationship between two year PSA nadir (PSAn) after brachytherapy and biochemical recurrence rates in prostate cancer patients. MATERIALS AND METHODS: In the period from January 1998 to August 2007, 120 patients were treated with iodine-125 brachytherapy alone. The results analysis was based on the definition of biochemical recurrence according to the Phoenix Consensus. RESULTS: Biochemical control was observed in 86 patients (71.7%), and biochemical recurrence, in 34 (28.3%). Mean PSAn was 0.53 ng/ml. The mean follow-up was 98 months. The patients were divided into two groups: group 1, with two year PSAn < 0.5 ng/ml after brachytherapy (74 patients; 61.7%), and group 2, with two year PSAn ≥ 0.5 ng/ml after brachytherapy (46 patients; 38.3%). Group 1 presented biochemical recurrence in 15 patients (20.3%), and group 2, in 19 patients (43.2%) (p < 0.02). The analysis of biochemical disease-free survival at seven years, stratified by the two groups, showed values of 80% and 64% (p < 0.02), respectively. CONCLUSION: Levels of two year PSAn ≥ 0.5 ng/ml after brachytherapy are strongly correlated with a poor prognosis. This fact may help to identify patients at risk for disease recurrence.

OBJETIVO: Avaliar os valores de PSA nadir (PSAn) dois anos após braquiterapia e sua relação com a taxa de recidiva bioquímica. MATERIAIS E MÉTODOS: Cento e vinte pacientes foram tratados no período de janeiro de 1998 a agosto de 2007. Todos os pacientes foram submetidos a braquiterapia isolada. Os resultados foram analisados com base na definição de recidiva bioquímica do Consenso Phoenix. RESULTADOS: Oitenta e seis pacientes (71,7%) tiveram controle bioquímico e 34 (28,3%) apresentaram recidiva bioquímica. O PSAn médio foi 0,53 ng/ml. O seguimento médio foi 98 meses. Os pacientes foram divididos em dois grupos: grupo 1, com PSAn < 0,5 ng/ml dois anos após a braquiterapia (74 pacientes; 61,7%), e grupo 2, com PSAn ≥ 0,5 ng/ml dois anos após a braquiterapia (46 pacientes; 38, 3%). O grupo 1 teve recidiva bioquímica em 15 pacientes (20,3%) e o grupo 2 em 19 pacientes (43,2%) (p < 0,02). A análise da sobrevida livre de doença bioquímica de sete anos, estratificada pelos dois grupos, apresentou valores de 80% e 64% (p < 0,02), respectivamente. CONCLUSÃO: Os níveis de PSAn ≥ 0,5 ng/ml dois anos após a braquiterapia estão fortemente correlacionados com mau prognóstico. Este fato pode ajudar a identificar pacientes com risco de recidiva da doença.