Effects of a pressure-ulcer audit and feedback regional programme at 1 and 2 years in nursing homes: A prospective longitudinal study

Pressure ulcer is a frequent complication in patients hospitalized in nursing homes and has a serious impact on quality of life and overall health. Moreover, ulcer treatment is highly expensive. Several studies have shown that pressure ulcer prevention is cost-effective. Audit and feedback programmes can help improve professional practices in pressure ulcer prevention and thus reduce their occurrence. The aim of this study was to analyze, with a prospective longitudinal study, the effectiveness of an audit and feedback programme at 1- and 2-year follow-up for reducing pressure ulcer prevalence and enhancing adherence to preventive practices in nursing homes

A phase I/II feasibility vaccine study by autologous leukemic apoptotic corpse-pulsed dendritic cells for elderly AML patients

International audienceThis was a phase I/II study testing the feasibility of a vaccine by autologous leukemic apoptotic corpse-pulsed dendritic cells (DC) in elderly acute myeloid leukemia (AML) patients in first or second complete remission. Pulsed DC were administered at doses of 9 × 106 subcutaneously (1 mL) and 1 × 106 intra-dermally (0.1 mL). Five doses of vaccine were planned on days +1 + 7 + 14 + 21 and +35. Five DC-vaccines were produced and injected for all five patients included in the study. No severe adverse event was documented. Larger Phase 2 studies are now required to precise the role of DC-vaccines with leukemic apoptotic bodies in older as well as younger AML populations

Are adverse drug reaction patterns different between romiplostim and eltrombopag? 2009-2013 French PharmacoVigilance assessment.

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Liquid formulation of ifosfamide increased risk of encephalopathy: A case-control study in a pediatric population

International audienceBACKGROUND:Several clusters of encephalopathy occurred after the market change from Holoxan® (ifosfamide lyophilized powder) to Ifosfamide EG® (liquid formulation) and justified a formal survey in 2015. In June 2016, the regulatory authority decided to apply a precautionary measure in reducing the shelf life of Ifosfamide EG® at 7 months. One-year study from spontaneous reports lead to suspect a potential residual risk. Due to the many limitations associated with spontaneous notifications, we performed a multicentric observational study, aiming to better explore this pharmacovigilance signal.METHODS:We performed a case-control study in pediatric oncology Departments of 25 university hospitals between July 1st, 2016 and July 1st, 2018. All children (<18 y.o.) receiving liquid formulation or lyophilized powder formulation during the study period were included. Patients with at least one occurrence of encephalopathy were considered as cases. Logistic regression model was used to estimate the odds ratio of encephalopathy between exposure groups.RESULTS:During the study period, 52 cases and 495 controls were included. A residual over-risk of encephalopathy was associated with ifosfamide 7-month shelf-life liquid formulation compared to lyophilized powder (adjusted OR 1.91, 95% CI: 1.03-3.53).CONCLUSIONS:Observed difference does not seem to be related to the pathology treated, the doses used, the co-medications, a meningeal localization and/or an irradiation of the central nervous system. This study confirms data from spontaneous reports that led to the precautionary measure for the liquid formulation. Even if the risk of encephalopathy seems reduced, our study suggests the persistence of a residual risk of encephalopathy associated with liquid formulation compared to the lyophilized powder

Diagnosis and prognosis are comforted by integrated assessment of next-generation sequencing in chronic myeloid malignancies. A real-life study

International audienceNext generation sequencing (NGS) investigates for somatic mutations. The utility of incorporating routine sequencing to guide diagnosis and therapeutic decisions remains challenging. We report an observational multicentric study that aimed to assess the impact of somatic mutations testing by NGS in a real-life setting of chronic myeloid malignancies (CMM). A total of 177 patients were enrolled, partitioned in two overlapping groups. In group A (N=94), the indication was to search for clonal hematopoiesis (CH), in a context of suspected myelodysplastic syndrome or myeloproliferative neoplasia. In group B (N=95), the theranostic impact of somatic mutations was studied. A panel of 34 genes was applied on DNA extracted from blood or bone marrow samples. Within group A, the detection of CH comforted the diagnosis of CMM for 31 patients while absence of CH ruled out the suspected diagnosis in 47 patients. Within group B, NGS identified prognostic somatic mutations in 32 patients, with a therapeutic impact in 18 cases. The use of NGS in daily practice was found here to be useful for an integrated final diagnosis in 83% of the patients through the presence or absence of somatic mutations. Moreover, exploration for somatic mutations had a prognostic impact that led to treatment modification in 19% of the cases. This study outlines the fact that adequate prescription of these new investigations may have a significant positive medico-economic impact by allowing appropriate management of the patients

Prognostic value of high-sensitivity measurable residual disease assessment after front-line chemoimmunotherapy in chronic lymphocytic leukemia

International audienceMeasurable residual disease (MRD) status is widely adopted in clinical trials in patients with chronic lymphocytic leukemia (CLL). Findings from FILO group trials (CLL2007FMP, CLL2007SA, CLL2010FMP) enabled investigation of the prognostic value of high-sensitivity (0.7 × 10-5) MRD assessment using flow cytometry, in blood (N = 401) and bone marrow (N = 339), after fludarabine, cyclophosphamide, and rituximab (FCR)-based chemoimmunotherapy in a homogeneous population with long follow-up (median 49.5 months). Addition of low-level positive MRD < 0.01% to MRD ≥ 0.01% increased the proportion of cases with positive MRD in blood by 39% and in bone marrow by 27%. Compared to low-level positive MRD < 0.01%, undetectable MRD was associated with significantly longer progression-free survival (PFS) when using blood (72.2 versus 42.7 months; hazard ratio 0.40, p = 0.0003), but not when using bone marrow. Upon further stratification, positive blood MRD at any level, compared to undetectable blood MRD, was associated with shorter PFS irrespective of clinical complete or partial remission, and a lower 5-year PFS rate irrespective of IGHV-mutated or -unmutated status (all p < 0.05). In conclusion, high-sensitivity (0.0007%) MRD assessment in blood yielded additional prognostic information beyond the current standard sensitivity (0.01%). Our approach provides a model for future determination of the optimal MRD investigative strategy for any regimen