Phase II Study of Sequential Infusion of Donor Lymphocyte Infusion and Cytokine-Induced Killer Cells for Patients Relapsed after Allogeneic Hematopoietic Stem Cell Transplantation.

Seventy-four patients who relapsed after allogeneic stem cell transplantation were enrolled in a phase IIA study and treated with the sequential infusion of donor lymphocyte infusion (DLI) followed by cytokine-induced killer (CIK) cells. Seventy-three patients were available for the intention to treat analysis. At least 1 infusion of CIK cells was given to 59 patients, whereas 43 patients received the complete cell therapy planned (58%). Overall, 12 patients (16%) developed acute graft-versus-host disease (aGVHD) of grades I to II in 7 cases and grades III to IV in 5). In 8 of 12 cases, aGVHD developed during DLI treatment, leading to interruption of the cellular program in 3 patients, whereas in the remaining 5 cases aGVHD was controlled by steroids treatment, thus allowing the subsequent planned administration of CIK cells. Chronic GVHD (cGVHD) was observed in 11 patients (15%). A complete response was observed in 19 (26%), partial response in 3 (4%), stable disease in 8 (11%), early death in 2 (3%), and disease progression in 41 (56%). At 1 and 3 years, rates of progression-free survival were 31% and 29%, whereas rates of overall survival were 51% and 40%, respectively. By multivariate analysis, the type of relapse, the presence of cGVHD, and a short (<6 months) time from allogeneic hematopoietic stem cell transplantation to relapse were the significant predictors of survival. In conclusion, a low incidence of GVHD is observed after the sequential administration of DLI and CIK cells, and disease control can be achieved mostly after a cytogenetic or molecular relapse.

Technical performance of colonoscopy: the key role of sedation/analgesia and other quality indicators.

BACKGROUND: It is essential to identify the factors in clinical practice that influence the technical performance of colonoscopy as a basis for quality improvement programs. AIMS: To assess the factors linked to two key indicators of colonoscopy performance, i.e., cecal intubation and polyp diagnosis. DESIGN AND SETTING: Consecutives colonoscopies performed over a 2-wk period in 278 unselected practice sites throughout Italy were prospectively evaluated. A multivariate model was developed to identify determinants of the performance indicators of colonoscopy. RESULTS: In total, 12,835 patients (mean age 60.5 yr, standard deviation [SD] 15.1, 53% men) were studied. Sedation and/or analgesia was administered in 55.3% of procedures: 28.8% of patients received intravenous (IV) benzodiazepines, 15.4% received benzodiazepines in combination with narcotics, 3.1% received propofol, and 7.5% received other sedation regimens. Overall, cecal intubation was achieved in 80.7% of procedures, and the polyp detection rate was 27.3%. Multivariate analysis showed that the strongest predictors of cecal intubation were the quality of bowel preparation (inadequate vs excellent: odds ratio [OR] 0.013, 95% confidence interval [CI] 0.009-0.018; fair vs excellent: OR 0.246, 95% CI 0.209-0.290; and good vs excellent: OR 0.586, 95% CI 0.514-0.667) and the use of sedation (IV benzodiazepines vs no sedation: OR 1.460, 95% CI 1.282-1.663; IV benzodiazepines and narcotics vs no sedation: OR 2.128, 95% CI 1.776-2.565; and propofol vs no sedation: OR 2.355, 95% CI 1.590-3.488). The colonoscopy setting (workload and organizational complexity of the center) and the endoscopist colonoscopy volume were other factors independently correlated with completion of the procedure. Detection of polyps partially depended on the quality of bowel cleansing (inadequate vs excellent: OR 0.511, 95% CI 0.404-0.647) and use of sedation (OR 1.172, 95% CI 1.074-1.286). CONCLUSION: In usual clinical practice, the use of sedation/analgesia, the colon-cleansing quality, the endoscopist experience, and some features related to the colonscopy setting decisively influence the quality of colonoscopy. These factors indicate the targets of future corrective measures to boost the quality of this examination.