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Treatment of ulcerative colitis refractory to steroid therapy by oral microemulsion cyclosporine (Neoral).

International audienceBACKGROUND: Intravenous cyclosporine is active in 60% to 80% of patients with ulcerative colitis (UC) who failed to respond to intravenous corticosteroids. Several studies have suggested that cyclosporine in microemulsion form (Neoral) has some efficacy in this setting, but the optimal dose, blood level, time to response, and remission need to be better defined. The aim of this study was to evaluate the response to Neoral and its toxicity in active corticosteroid-refractory UC. METHODS: Between March 2002 and August 2005, 20 courses of Neoral [initial dose, 2.3 mg/kg (range, 1.8 to 2.8 mg/kg) every 12 hours] were prescribed in 19 consecutive patients for a UC attack that did not respond to intravenous methylprednisolone. All patients received prophylaxis against Pneumocystis carinii. RESULTS: Response was obtained in 17 of 20 attacks (85%) after 3.5 days (range, 1 to 7). Remission was obtained in 15 of 20 attacks (75%) after 13 days (range, 2 to 30 days). Four responders relapsed and underwent colectomy 21 to 900 days after the start of Neoral. Overall, 14 of 19 patients (74%) were colectomy free after a median follow-up of 8 months (range, 1 to 41 months). Cyclosporine blood levels were measured at fasting (C0) and 2 hours after Neoral administration (C2) in a subgroup of 10 responders. The results were 103 ng/mL (range, 32 to 240 ng/mL) for C0 and 761 ng/mL (183 to 1390 ng/mL) for C2. One severe bedridden patient with neonatal encephalopathy died. Main side effects observed were mild transient renal impairment (n = 2), hypertension (n = 1), cytomegalovirus infection (n = 2), and esophageal candidiasis (n = 1). CONCLUSIONS: In active corticosteroid-refractory UC, Neoral seems to have the same efficacy and toxicity as the intravenous form. Trough target cyclosporine blood levels should not exceed 100 ng/mL for C0 and 700 ng/mL for C2

Incidence and survival of gastric non-Hodgkin's lymphoma: a population-based study from the Association of the French Cancer Registries (FRANCIM).

BACKGROUND: Most epidemiological studies on gastric lymphomas (GL) were carried out before changes in therapy were introduced. The aim of the study was to measure the incidence of GL and to estimate survival. MATERIAL AND METHODS: Data were provided by the Association of the French Cancer Registries database. Age-standardized incidence rates were calculated for 786 incident cases diagnosed between 1978 and 2002. Crude and relative survival were calculated for 361 cases diagnosed between 1989 and 1997. Effects specific to sex, age at diagnosis, year of diagnosis, and grade of malignancy were estimated in multivariate analysis. RESULTS: Incidence was stable during the study period. However, high-grade GL frequency increased whereas low-grade and not otherwise specified (NOS) GL frequencies were respectively stable and decreased. At 5 years, relative survival was 63% in men and 60% in women. Patients aged 75 or older had a five-year relative survival of 33%. Age at diagnosis was the only significant prognostic factor in multivariate analysis. Time trend improvement in prognosis was observed. DISCUSSION: Results in elderly patients show that therapeutic regimens should be specifically designed and assessed for them. The prognosis improvement trend is probably related to the implementation of changes in management of patients and has to be confirmed by more recent data

High Prevalence of Anal Canal High-Risk Human Papillomavirus Infection in Patients With Crohn's Disease

International audienceThe increasing incidence of anal canal carcinomas requires better knowledge on anal human papillomavirus (HPV) infection. We aimed to assess anal canal HPV infection prevalence and risk factors among patients seen at a gastroenterology department in France

Sequential FOLFIRI.3 + Gemcitabine Improves Health-Related Quality of Life Deterioration-Free Survival of Patients with Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial

<div><p>Background</p><p>A randomized multicenter phase II trial was conducted to assess the sequential treatment strategy using FOLFIRI.3 and gemcitabine alternately (Arm 2) compared to gemcitabine alone (Arm 1) in patients with metastatic non pre-treated pancreatic adenocarcinoma. The primary endpoint was the progression-free survival (PFS) rate at 6 months. It concludes that the sequential treatment strategy appears to be feasible and effective with a PFS rate of 43.5% in Arm 2 at 6 months (26.1% in Arm 1). This paper reports the results of the longitudinal analysis of the health-related quality of life (HRQoL) as a secondary endpoint of this study.</p><p>Methods</p><p>HRQoL was evaluated using the EORTC QLQ-C30 at baseline and every two months until the end of the study or death. HRQoL deterioration-free survival (QFS) was defined as the time from randomization to a first significant deterioration as compared to the baseline score with no further significant improvement, or death. A propensity score was estimated comparing characteristics of partial and complete responders. Analyses were repeated with inverse probability weighting method using the propensity score. Multivariate Cox regression analyses were performed to identify independent factors influencing QFS.</p><p>Results</p><p>98 patients were included between 2007 and 2011. Adjusting on the propensity score, patients of Arm 2 presented a longer QFS of Global Health Status (Hazard Ratio: 0.52 [0.31-0.85]), emotional functioning (0.35 [0.21–0.59]) and pain (0.50 [0.31 – 0.81]) than those of Arm 1.</p><p>Conclusion</p><p>Patients of Arm 2 presented a better HRQoL with a longer QFS than those of Arm 1. Moreover, the propensity score method allows to take into account the missing data depending on patients’ characteristics.</p><p>Trial registration information</p><p>Eudract N° <a href="https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005703-34/FR" target="_blank">2006-005703-34</a>. (Name of the Trial: FIRGEM).</p></div

Kaplan-Meier survival curves of the HRQoL deterioration-free survival by treatment arm for the raw and the weighted analysis.

<p>Arm 1: gemcitabine alone, Arm 2: gemcitabine + FOLFIRI.3.</p

Proportion of complete, partial and non responders for HRQoL assessment in each treatment arm.

<p>Proportion of complete, partial and non responders for HRQoL assessment in each treatment arm.</p