Institute Jules Bordet ULB

Brussels, Belgium

Institute Jules Bordet ULB

Brussels, Belgium

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Socie G.,Service dHematologie Greffe | Socie G.,University Paris Diderot | Socie G.,French Institute of Health and Medical Research | Vigouroux S.,Service dHematologie Clinique et Therapie Cellulaire | And 13 more authors.
Blood | Year: 2017

Treatment of steroid-resistant acute graft-versus-host disease (GVHD) remains an unmet clinical need. Inolimomab, a monoclonal antibody to CD25, has shown encouraging results in phase 2 trials. This phase 3 randomized, open-label, multicenter trial compared inolimomab vs usual care in adult patients with steroid-refractory acute GVHD. Patients were randomly selected to receive treatment with inolimomab or usual care (the control group was treated with antithymocyte globulin [ATG]). The primary objective was to evaluate overall survival at 1 year without changing baseline allocated therapy. A total of 100 patients were randomly placed: 49 patients in the inolimomab arm and 51 patients in the ATG arm. The primary criteria were reached by 14 patients (28.5%) in the inolimomab and 11 patients (21.5%) in the ATG arms, with a hazard ratio of 0.874 (P = .28). With a minimum follow-up of 1 year, 26 (53%) and 31 (60%) patients died in the inolimomab and ATG arms, respectively. Adverse events were similar in the 2 arms, with fewer viral infections in the inolimomab arm compared with the ATG arm. The primary end point of this randomized phase 3 trial was not achieved. The lack of a statistically significant effect confirms the need for development of more effective treatments for acute GVHD. This trial is registered to https://www.clinicaltrialsregister.eu/ctr-search/search as EUDRACT 2007-005009-24. © 2017 by The American Society of Hematology.


Czuczman M.S.,Roswell Park Cancer Institute | Kahanic S.,Siouxland Hematology Oncology Associates | Forero A.,University of Alabama at Birmingham | Davis G.,Teva Branded Pharmaceutical Products R&D Inc. | And 6 more authors.
Annals of Hematology | Year: 2015

The efficacy/tolerability of bendamustine, a unique alkylator, plus ofatumumab, a human anti-CD20 monoclonal antibody, was evaluated for previously untreated indolent B cell non-Hodgkin’s lymphoma (NHL). The study investigated whether the overall response rate (ORR) for bendamustine-ofatumumab was similar to historical bendamustine-rituximab ORRs (≥90 %). In this multicenter, open-label, single-arm, phase II study, patients received six planned 28-day cycles of bendamustine (90 mg/m2 on days 1 and 2 of each cycle) and ofatumumab (300 mg on day 1, 1000 mg on day 8 of cycle 1, and on day 1 of subsequent cycles). The primary outcome was ORR. Secondary objectives included safety and tolerability. Exploratory evaluations included percentage of patients with positive baseline [18F]fluorodeoxyglucose positron emission tomography (FDG-PET) scans who converted to negative postbaseline and quality of life (QOL) scores. The treated/safety analysis population received ≥1 dose of either therapy. The bendamustine-ofatumumab ORR was 90 % (95 % confidence interval, 77.8–96.6) in 49 treated patients (67 % complete response, 22 % partial response). No patients had progressive disease. Bendamustine-ofatumumab was acceptably tolerated. All 49 patients had ≥1 adverse event, the most common being nausea (61 %), fatigue (55 %), and infusion-related reactions (45 %, all but 1 occurring during cycle 1). The proportion of patients whose FDG-PET scans converted to negative postbaseline was 88 %. Changes in QOL scores were minor. In patients with treatment-naive, indolent B cell NHL, bendamustine-ofatumumab exhibited a high degree of activity (90 % ORR), comparable with historical bendamustine-rituximab ORRs (≥90 %), and was adequately tolerated (ClinicalTrials.gov identifier: NCT01108341). © 2015, Springer-Verlag Berlin Heidelberg.


PubMed | Red Cross, Caritas Internationalis, Médecins Sans Frontières, Global Health Borders Refugee and Onshore Services and 47 more.
Type: Journal Article | Journal: The European respiratory journal | Year: 2015

This paper describes an action framework for countries with low tuberculosis (TB) incidence (<100 TB cases per million population) that are striving for TB elimination. The framework sets out priority interventions required for these countries to progress first towards pre-elimination (<10 cases per million) and eventually the elimination of TB as a public health problem (less than one case per million). TB epidemiology in most low-incidence countries is characterised by a low rate of transmission in the general population, occasional outbreaks, a majority of TB cases generated from progression of latent TB infection (LTBI) rather than local transmission, concentration to certain vulnerable and hard-to-reach risk groups, and challenges posed by cross-border migration. Common health system challenges are that political commitment, funding, clinical expertise and general awareness of TB diminishes as TB incidence falls. The framework presents a tailored response to these challenges, grouped into eight priority action areas: 1) ensure political commitment, funding and stewardship for planning and essential services; 2) address the most vulnerable and hard-to-reach groups; 3) address special needs of migrants and cross-border issues; 4) undertake screening for active TB and LTBI in TB contacts and selected high-risk groups, and provide appropriate treatment; 5) optimise the prevention and care of drug-resistant TB; 6) ensure continued surveillance, programme monitoring and evaluation and case-based data management; 7) invest in research and new tools; and 8) support global TB prevention, care and control. The overall approach needs to be multisectorial, focusing on equitable access to high-quality diagnosis and care, and on addressing the social determinants of TB. Because of increasing globalisation and population mobility, the response needs to have both national and global dimensions.


Lonnroth K.,World Health Organization | Migliori G.B.,Collaborating Center for Tuberculosis and Lung Diseases | Abubakar I.,Public Health England | D'Ambrosio L.,Collaborating Center for Tuberculosis and Lung Diseases | And 70 more authors.
European Respiratory Journal | Year: 2015

This paper describes an action framework for countries with low tuberculosis (TB) incidence (<100 TB cases per million population) that are striving for TB elimination. The framework sets out priority interventions required for these countries to progress first towards "pre-elimination" (<10 cases per million) and eventually the elimination of TB as a public health problem (less than one case per million). TB epidemiology in most low-incidence countries is characterised by a low rate of transmission in the general population, occasional outbreaks, a majority of TB cases generated from progression of latent TB infection (LTBI) rather than local transmission, concentration to certain vulnerable and hard-to-reach risk groups, and challenges posed by cross-border migration. Common health system challenges are that political commitment, funding, clinical expertise and general awareness of TB diminishes as TB incidence falls. The framework presents a tailored response to these challenges, grouped into eight priority action areas: 1) ensure political commitment, funding and stewardship for planning and essential services; 2) address the most vulnerable and hard-to-reach groups; 3) address special needs of migrants and cross-border issues; 4) undertake screening for active TB and LTBI in TB contacts and selected high-risk groups, and provide appropriate treatment; 5) optimise the prevention and care of drug-resistant TB; 6) ensure continued surveillance, programme monitoring and evaluation and case-based data management; 7) invest in research and new tools; and 8) support global TB prevention, care and control. The overall approach needs to be multisectorial, focusing on equitable access to high-quality diagnosis and care, and on addressing the social determinants of TB. Because of increasing globalisation and population mobility, the response needs to have both national and global dimensions. ©ERS 2015.


PubMed | Institute Paoli Calmettes, Institute Jules Bordet ULB, EUSA Pharma, Jazz Pharmaceuticals and 9 more.
Type: | Journal: Blood | Year: 2016

Treatment of steroid resistant (SR) aGVHD remains an unmet clinical need. Inolimomab, a monoclonal antibody to CD25, has shown encouraging results in phase II trials. This phase III randomized, open-label, multicenter compared Inolimomab vs. usual care in adult patients with steroid-refractory aGvHD. Patients were randomized to treatment with Inolimomab or usual care [control group were all treated with Anti Thymocyte Globulin (ATG)]. The primary objective was to evaluate overall survival at 1 year without changing baseline allocated therapy. A total of 100 patients were randomized; 49 patients in the Inolimomab arm and 51 patients in the ATG arm. The primary criteria was reached by 14 patients (28.5%) in Inolimomab and 11 patients (21.5%) in the ATG arm, with a hazard ratio of 0,874 (P=0.28). With a minimum follow-up of 1 year, 26 (53%) and 31 (60%) patients died in the Inolimomab and ATG arms, respectively. Adverse events were similar in the two arms, with fewer viral infections in the Inolimomab arm compared to the ATG arm. The primary endpoint of this randomized phase III trial was not achieved. The lack of a statistically significant effect confirms the need for development of more effective treatments for acute GvHD. This trial is registered to https://www.clinicaltrialsregister.eu/ctr-search/search as EUDRACT 2007-005009-24.


PubMed | University Hospitals Leuven, ZNA Stuivenberg, Vrije Universiteit Brussel, Beernem and 5 more.
Type: Published Erratum | Journal: Journal of geriatric oncology | Year: 2016

The authors regret: A calculation error was corrected in Table 3. As mentioned under the table, the percentage of patients under Baseline was calculated from the total no. of patients with geriatric recommendations data (n = 932 pts). This was mistakenly calculated from the number of patients with available GA data (n = 979). Percentages have been recalculated. The corrected table is reproduced here (Table 3). We emphasize that these percentages are not mentioned in the text of the paper nor do they change any of the conclusions. The authors would like to apologize for any inconvenience caused.


PubMed | University Hospitals Leuven, ZNA Stuivenberg, Vrije Universiteit Brussel, Beernem and 5 more.
Type: Journal Article | Journal: Journal of geriatric oncology | Year: 2015

The main objective of this study was to describe geriatric recommendations based on a geriatric assessment (GA) and to evaluate the implementation of these recommendations.A two-step approach of screening followed by a GA was implemented in nine hospitals in Belgium. Patients 70 years were included at diagnosis or at disease progression/relapse. Concrete geriatric recommendations were systematically documented and reported to the treating physicians and consisted of referrals to professional health care workers. Patient charts were reviewed after one month to verify which geriatric recommendations have been performed.From August 2011 to July 2012, 1550 patients were included for analysis. The median age was 77 (range: 70-97) and 57.0% were female. A solid tumour was diagnosed in 91.4% and a haematological malignancy in 8.6%. Geriatric screening with the G8 identified 63.6% of the patients for GA (n=986). A median of two geriatric recommendations (range: 1-6) were given for 76.2% (95%CI: 73.4-78.8) of the evaluable patients (n=710). A median of one geriatric recommendation (range: 1-5) was performed in 52.1% (95%CI: 48.4-55.8) of the evaluable patients (n=689). In general, 460 or 35.3% (95%CI: 32.8-38.0) of all the geriatric recommendations were performed. Geriatric recommendations most frequently consisted of referrals to the dietician (60.4%), social worker (40.3%), and psychologist (28.9%).This implementation study provides insight into GA-based recommendations/interventions in daily oncology practice. Geriatric recommendations were given in about three-fourths of patients. About one-third of all geriatric recommendations were performed in approximately half of these patients.


Baitar A.,ZNA Middelheim | Kenis C.,University Hospitals Leuven | Moor R.,Cliniques Universitaires Saint Luc | Decoster L.,Vrije Universiteit Brussel | And 11 more authors.
Journal of Geriatric Oncology | Year: 2015

Purpose: The main objective of this study was to describe geriatric recommendations based on a geriatric assessment (GA) and to evaluate the implementation of these recommendations. Patients and Methods: A two-step approach of screening followed by a GA was implemented in nine hospitals in Belgium. Patients ≥. 70. years were included at diagnosis or at disease progression/relapse. Concrete geriatric recommendations were systematically documented and reported to the treating physicians and consisted of referrals to professional health care workers. Patient charts were reviewed after one month to verify which geriatric recommendations have been performed. Results: From August 2011 to July 2012, 1550 patients were included for analysis. The median age was 77 (range: 70-97) and 57.0% were female. A solid tumour was diagnosed in 91.4% and a haematological malignancy in 8.6%. Geriatric screening with the G8 identified 63.6% of the patients for GA (n. = 986). A median of two geriatric recommendations (range: 1-6) were given for 76.2% (95%CI: 73.4-78.8) of the evaluable patients (n. = 710). A median of one geriatric recommendation (range: 1-5) was performed in 52.1% (95%CI: 48.4-55.8) of the evaluable patients (n. = 689). In general, 460 or 35.3% (95%CI: 32.8-38.0) of all the geriatric recommendations were performed. Geriatric recommendations most frequently consisted of referrals to the dietician (60.4%), social worker (40.3%), and psychologist (28.9%). Conclusion: This implementation study provides insight into GA-based recommendations/interventions in daily oncology practice. Geriatric recommendations were given in about three-fourths of patients. About one-third of all geriatric recommendations were performed in approximately half of these patients. © 2015 Elsevier Inc.

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