Efficacy of bendamustine and rituximab as first salvage treatment in chronic lymphocytic leukemia and indirect comparison with ibrutinib: a GIMEMA, ERIC and UK CLL FORUM study.

We performed an observational study on the efficacy of ben-damustine and rituximab (BR) as first salvage regimen in chronic lymphocytic leukemia (CLL). In an intention-to-treat analysis including 237 patients, the median progression-free survival (PFS) was 25 months. The presence of del(17p), unmutated IGHV and advanced stage were associated with a shorter PFS at multivariate analysis. The median time-to-next treatment was 31.3 months. Front-line treatment with a chemoimmunotherapy regimen was the only predictive factor for a shorter time to next treatment at multivariate analysis. The median overall survival (OS) was 74.5 months. Advanced disease stage (i.e. Rai stage III-IV or Binet stage C) and resistant disease were the only parameters significantly associated with a shorter OS. Grade 3-5 infections were recorded in 6.3% of patients. A matched-adjusted indirect comparison with ibrutinib given second-line within Named Patient Programs in the United Kingdom and in Italy was carried out with OS as objective end point. When restricting the analysis to patients with intact 17p who had received chemoimmunotherapy in first line, there was no difference in OS between patients treated with ibrutinib (63% alive at 36 months) and patients treated with BR (74.4% alive at 36 months). BR is an efficacious first salvage regimen in CLL in a real-life population, including the elderly and unfit patients. BR and ibrutinib may be equally effective in terms of OS when used as first salvage treatment in patients without 17p deletion.

Clinical impact of a 6-week preoperative very low calorie diet on body weight and liver size in morbidly obese patients.

BACKGROUND: Laparoscopic Roux-en-Y gastric bypass (LRYGB) may be a technically challenging surgical technique when features such as thick abdominal wall and increased liver volume are present. Very low calorie diets in the form of liquid meal replacements given 6 weeks prior to surgery have proven to decrease liver volume. The aim of our study was to assess the effect of a 6-week preoperative low calorie/regular diet on liver volume and body weight in morbidly obese patients. METHODS: A pilot study was carried out in 20 morbidly obese patients with an 800-kcal diet for 6 weeks. They were followed weekly to ensure proper compliance. CT scan was used for determining liver volume every 2 weeks in order to assess the impact of the diet. Baseline values were taken as controls for every patient as tied measures. Statistical analysis was suitable to variable scaling and performed using SPSS v. 20.0. Parametric and non-parametric test for tied measures were done. Any p value lesser than 0.05 or 5% was considered as statistically significant. RESULTS: Twenty patients adhered to the diet intervention for 6 weeks prior to LRYGB. Median ± SD age was 34.5 ± 11.5 years and 17 were female (85%). Heart rate and blood pressure did not vary across the study. Initial median ± SD BMI was 46.02 ± 5.29 kg/m2 (range 38.7-54.8). Repeated and tied measurements across the 6 weeks of treatment within individuals resulted statistically significant for reducing BMI (p < 0.0001). CT scan assessed liver volume initially as a control and in weeks 2, 4 and 6. Parametric and non-parametric assessment for multiple measurements also showed statistical significance among these values (p < 0.0001). Diet tolerability was additionally evaluated with a questionnaire showing more than 80% of acceptability with discrete rates of nausea (15%) and diarrhoea (15%). CONCLUSIONS: Based on our results, we demonstrated that a very low calorie diet with home ingredients is capable for effectively reducing body weight and liver size in morbidly obese patients. This relatively short intervention (4 to 6 weeks) was accomplished in all our patients with a high frequency of compliance and a low rate of secondary effects.