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Article ; Online: Concept design and simulation study on a "phantom" anvil for circular stapler.

Rulli, Francesco / Kartheuser, Alex / Amirhassankhani, Sasan / Mourad, Michel / Stefani, Mario / de Ferrá Aureli, Andrés / Sileri, Pierpaolo / Valentini, Pier Paolo

Surgical laparoscopy, endoscopy & percutaneous techniques

2015 Volume 25, Issue 2, Page(s) e72–5

Abstract: Introduction: Complications and challenges arising from the intraoperative double-stapling technique are seldom reported in colorectal surgery literature. Partial or full-thickness rectal injuries can occur during the introduction and the advancement of ...

Abstract	Introduction: Complications and challenges arising from the intraoperative double-stapling technique are seldom reported in colorectal surgery literature. Partial or full-thickness rectal injuries can occur during the introduction and the advancement of the circular stapler along the upper rectum. The aim of this study is to address some of these issues by designing and optimizing a "phantom" anvil manufactured to overcome difficulties throughout the rectal introduction and advancement of the circular stapler for the treatment of benign and malignant colon disease. Methods: The design of the "phantom" anvil has been performed using computer-aided modeling techniques, finite element investigations, and 2 essential keynotes in mind. The first one is the internal shape of the anvil, which is used for the connection to the gun. The second is the shape of the cap, which makes possible the insertion of the gun through the rectum. The "phantom" anvil has 2 functional requirements, which have been taken into account. The design has been optimized to avoid colorectal injuries, neoplastic dissemination (ie, mechanical seeding) and to reduce the fecal contamination. Results: Numerical simulations show that a right combination of both top and bottom fillet radii of the shape of the anvil can reduce the stress for the considered anatomic configuration of >90%. Both the fillet radii at the top and the bottom of the device influence the local stress of the colon rectum. Conclusions: A dismountable device, which is used only for the insertion and advancement of the stapler, allows a dedicated design of its shape, keeping the remainder of the stapler unmodified. Computer-aided simulations are useful to perform numerical investigations to optimize the design of this auxiliary part for both the safety of the patient and the ease of the stapler advancement through the rectum.
MeSH term(s)	Anastomosis, Surgical/methods ; Colon/surgery ; Colonic Diseases/surgery ; Colorectal Surgery/methods ; Computer Simulation ; Equipment Design ; Humans ; Surgical Staplers/standards ; Suture Techniques/instrumentation
Keywords	covid19
Language	English
Publishing date	2015-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	1475108-2
ISSN	1534-4908 ; 1530-4515 ; 1051-7200
ISSN (online)	1534-4908
ISSN	1530-4515 ; 1051-7200
DOI	10.1097/SLE.0000000000000113
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Zs.A 3200: Show issues

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Article ; Online: Analysis of Cell Subsets in Donor Lymphocyte Infusions from HLA Identical Sibling Donors after Allogeneic Hematopoietic Cell Transplant.

Ortí, Guillermo / Palacio-Garcia, Carles / García-Cadenas, Irene / Sánchez-Ortega, Isabel / Jimenez, María José / Azqueta, Carmen / Villacampa, Guillermo / Ferrà, Christelle / Parody, Rocio / Martino, Rodrigo / Bosch, Francesc / Querol, Sergi / Valcárcel, David

Transplantation and cellular therapy

2020 Volume 27, Issue 1, Page(s) 53.e1–53.e8

Abstract: Donor lymphocytes infusions (DLIs) are a major therapeutic approach to treat relapse and mixed chimerism after allogeneic hematopoietic cell transplant (alloHCT). The impact of the composition regarding different cell subsets in the development of graft- ... ...

Abstract	Donor lymphocytes infusions (DLIs) are a major therapeutic approach to treat relapse and mixed chimerism after allogeneic hematopoietic cell transplant (alloHCT). The impact of the composition regarding different cell subsets in the development of graft-versus-host disease (GVHD) is not fully understood. We performed a cell subsets analysis of 56 DLIs from fully HLA-compatible identical matched sibling donors (MSDs) in 36 alloHCT patients and studied its association with GVHD. A median of one DLI was infused per patient. Fourteen patients (38%) developed GVHD. The cell composition analysis of the first DLI (DLI1) showed that a high dose of B cells (P = .03) and CD27
MeSH term(s)	Chimerism ; Graft vs Host Disease ; Hematopoietic Stem Cell Transplantation ; Humans ; Siblings ; T-Lymphocytes, Regulatory
Language	English
Publishing date	2020-09-26
Document type	Journal Article
ZDB-ID	3062231-1
ISSN	2666-6367
ISSN (online)	2666-6367
DOI	10.1016/j.bbmt.2020.09.024
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Article ; Online: Clinical outcome and prognostic factors of patients with Richter syndrome: real-world study of the Spanish Chronic Lymphocytic Leukemia Study Group (GELLC).

Abrisqueta, Pau / Delgado, Julio / Alcoceba, Miguel / Oliveira, Ana Carla / Loscertales, Javier / Hernández-Rivas, Jose A / Ferrà, Christelle / Cordoba, Raul / Yáñez, Lucrecia / Medina, Angeles / Motlló, Cristina / Iacoboni, Gloria / Villacampa, Guillermo / González, Marcos / Bosch, Francesc

British journal of haematology

2020 Volume 190, Issue 6, Page(s) 854–863

Abstract: Richter syndrome (RS) is an uncommon evolution of chronic lymphocytic leukaemia (CLL) with a dismal prognosis. Clinical-biological features predicting outcome and best therapeutic approach for these patients remain to be established. In this study, 128 ... ...

Abstract	Richter syndrome (RS) is an uncommon evolution of chronic lymphocytic leukaemia (CLL) with a dismal prognosis. Clinical-biological features predicting outcome and best therapeutic approach for these patients remain to be established. In this study, 128 patients with RS, including 112 diffuse large B-cell lymphoma (DLBCL)-type RS, 15 Hodgkin lymphoma (HL)-type RS, and one plasmablastic lymphoma, were identified in 11 centres of the Spanish CLL Study Group (GELLC). The median overall survival (OS) was 5·9 months for DLBCL-type RS and 30·8 months for HL-type RS. Eastern Cooperative Oncology Group Performance Status, haemoglobin level, platelet count, serum lactate dehydrogenase and β2-microglobulin levels, tumour protein p53 (TP53) abnormalities in the CLL clone concomitant to RS, number of prior therapies, and clonal relationship between CLL and RS, were associated with OS in patients with DLBCL-type RS. A platelet count of <100 × 10
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Disease-Free Survival ; Female ; Follow-Up Studies ; Hodgkin Disease/blood ; Hodgkin Disease/genetics ; Hodgkin Disease/mortality ; Hodgkin Disease/therapy ; Humans ; Leukemia, Lymphocytic, Chronic, B-Cell/blood ; Leukemia, Lymphocytic, Chronic, B-Cell/genetics ; Leukemia, Lymphocytic, Chronic, B-Cell/mortality ; Leukemia, Lymphocytic, Chronic, B-Cell/therapy ; Lymphoma, Large B-Cell, Diffuse/blood ; Lymphoma, Large B-Cell, Diffuse/genetics ; Lymphoma, Large B-Cell, Diffuse/mortality ; Lymphoma, Large B-Cell, Diffuse/therapy ; Male ; Middle Aged ; Retrospective Studies ; Spain ; Survival Rate ; Syndrome
Language	English
Publishing date	2020-06-09
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	80077-6
ISSN	1365-2141 ; 0007-1048
ISSN (online)	1365-2141
ISSN	0007-1048
DOI	10.1111/bjh.16748
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Article: COVID-19 Vaccination Improved Psychological Distress (Anxiety and Depression Scores) in Chronic Kidney Disease Patients: A Prospective Study.

Garcia-Llana, Helena / Panizo, Nayara / Gandía, Lorena / Orti, Marisa / Giménez-Civera, Elena / Forquet, Claudia / D'Marco, Luis / Puchades, Maria Jesús / Sargsyan, Mari / Sanchís, Irina / Ribera, Carmen / Marco, Mª Inés / Ferrá, Cristela Moncho / Pérez-Baylach, Carmen María / Bonilla, Begoña / Moncho Francés, Francesc / Perez-Bernat, Elisa / Sancho, Asunción / Górriz, Jose Luis

Vaccines

2022 Volume 10, Issue 2

Abstract: The purpose of the study is to analyze the impact of vaccination against SARS-CoV-2 on anxiety and depression scores in patients with different modalities of chronic kidney disease. One hundred and seventeen renal patients (50 hemodialysis patients, 13 ... ...

Abstract	The purpose of the study is to analyze the impact of vaccination against SARS-CoV-2 on anxiety and depression scores in patients with different modalities of chronic kidney disease. One hundred and seventeen renal patients (50 hemodialysis patients, 13 peritoneal dialysis patients, 32 kidney transplants, and 22 advanced chronic kidney disease patients at pre-dialysis care) were evaluated for depression, anxiety, health-related quality of life (HRQOL), and perceived fears and resources with standardized (Hospital Anxiety and Depression Scale (HADS)) and self-reported questionnaires. The measure points were before vaccination and 15 days after vaccination. The main finding of the study was that there was a decrease in the global mean of normal scores for anxiety and depression symptoms in chronic kidney disease patients post-vaccination. We did not find statistically significant differences in depression or anxiety scores, nor any HRQOL differences between the treatment groups. The three main fears reported by the participants at baseline were those of adverse effects, not getting the vaccine, and lack of information. These findings highlight the potential interest of assessing psychological variables related to the impact of vaccination against SARS-CoV-2. New studies will be required to assess the impact of comprehensive vaccine coverage and its psychological impact.
Language	English
Publishing date	2022-02-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines10020299
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Article ; Online: Long-term outcomes in patients with relapsed/refractory acute myeloid leukemia and other high-risk myeloid malignancies after undergoing sequential conditioning regimen based on IDA-FLAG and high-dose melphalan.

Bone marrow transplantation

2022 Volume 57, Issue 8, Page(s) 1304–1312

Abstract: Allogeneic hematopoietic cell transplantation (alloHCT) remains the only curative option for relapsed/refractory acute myeloid leukemia and other high-risk myeloid malignancies. To improve alloHCT results in this setting, sequential regimens were ... ...

Abstract	Allogeneic hematopoietic cell transplantation (alloHCT) remains the only curative option for relapsed/refractory acute myeloid leukemia and other high-risk myeloid malignancies. To improve alloHCT results in this setting, sequential regimens were designed as a strategy to lower tumor burden and quickly induce the graft-versus-leukemia effect. We analyzed long-term outcomes of a sequential regimen based on IDA-FLAG and high-dose melphalan, as set forth by the CETLAM cooperative group. This protocol yielded a high complete response rate (89%) and a lower cumulative relapse incidence (30% at five years) compared to other regimens. Five-year non-relapse mortality, however, reached 45%, with grade 3-4 acute graft-versus-host disease being the most frequent adverse event (a 100-day incidence of 29%). Altogether, 5-year overall survival was 25% in this group of patients with otherwise dismal prognosis. Long-term survivors enjoyed a good quality of life after a median follow-up of 68 months.
MeSH term(s)	Disease-Free Survival ; Graft vs Host Disease/etiology ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Leukemia, Myeloid, Acute/complications ; Melphalan/therapeutic use ; Myeloproliferative Disorders ; Quality of Life ; Recurrence ; Retrospective Studies ; Transplantation Conditioning/methods
Chemical Substances	Melphalan (Q41OR9510P)
Language	English
Publishing date	2022-05-28
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632854-4
ISSN	1476-5365 ; 0268-3369 ; 0951-3078
ISSN (online)	1476-5365
ISSN	0268-3369 ; 0951-3078
DOI	10.1038/s41409-022-01703-9
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Zs.A 2168: Show issues

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Article ; Online: Scientific knowledge gaps on the biology of non-fish marine species across European Seas

Frontiers in Marine Science, Vol

2023 Volume 10

Abstract: Available information and potential data gaps for non-fish marine organisms (cnidarians, crustaceans, echinoderms, molluscs, sponges, mammals, reptiles, and seabirds) covered by the global database SeaLifeBase were reviewed for eight marine ecosystems ( ... ...

Abstract	Available information and potential data gaps for non-fish marine organisms (cnidarians, crustaceans, echinoderms, molluscs, sponges, mammals, reptiles, and seabirds) covered by the global database SeaLifeBase were reviewed for eight marine ecosystems (Adriatic Sea, Aegean Sea, Baltic Sea, Bay of Biscay/Celtic Sea/Iberian Coast, Black Sea, North Sea, western Mediterranean Sea, Levantine Sea) across European Seas. The review of the SeaLifeBase dataset, which is based on published literature, analyzed information coverage for eight biological characteristics (diet, fecundity, maturity, length-weight relationships, spawning, growth, lifespan, and natural mortality). These characteristics are required for the development of ecosystem and ecological models to evaluate the status of marine resources and related fisheries. Our analyses revealed that information regarding these biological characteristics in the literature was far from complete across all studied areas. The level of available information was nonetheless reasonably good for sea turtles and moderate for marine mammals in some areas (Baltic Sea, Bay of Biscay/Celtic Sea/Iberian Coast, Black Sea, North Sea and western Mediterranean Sea). Further, seven of the areas have well-studied species in terms of information coverage for biological characteristics of some commercial species whereas threatened species are generally not well studied. Across areas, the most well-studied species are the cephalopod common cuttlefish (Sepia officinalis) and the crustacean Norway lobster (Nephrops norvegicus). Overall, the information gap is narrowest for length-weight relationships followed by growth and maturity, and widest for fecundity and natural mortality. Based on these insights, we provide recommendations to prioritize species with insufficient or missing biological data that are common across the studied marine ecosystems and to address data deficiencies.
Keywords	data gaps ; marine biodiversity ; marine mammals ; seabirds ; marine reptiles ; marine invertebrates ; Science ; Q ; General. Including nature conservation ; geographical distribution ; QH1-199.5
Subject code	333
Language	English
Publishing date	2023-10-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
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Article ; Online: Scientific knowledge gaps on the biology of non-fish marine species across European Seas

2023

Abstract	Available information and potential data gaps for non-fish marine organisms (cnidarians, crustaceans, echinoderms, molluscs, sponges, mammals, reptiles, and seabirds) covered by the global database SeaLifeBase were reviewed for eight marine ecosystems (Adriatic Sea, Aegean Sea, Baltic Sea, Bay of Biscay/Celtic Sea/Iberian Coast, Black Sea, North Sea, western Mediterranean Sea, Levantine Sea) across European Seas. The review of the SeaLifeBase dataset, which is based on published literature, analyzed information coverage for eight biological characteristics (diet, fecundity, maturity, length-weight relationships, spawning, growth, lifespan, and natural mortality). These characteristics are required for the development of ecosystem and ecological models to evaluate the status of marine resources and related fisheries. Our analyses revealed that information regarding these biological characteristics in the literature was far from complete across all studied areas. The level of available information was nonetheless reasonably good for sea turtles and moderate for marine mammals in some areas (Baltic Sea, Bay of Biscay/Celtic Sea/Iberian Coast, Black Sea, North Sea and western Mediterranean Sea). Further, seven of the areas have well-studied species in terms of information coverage for biological characteristics of some commercial species whereas threatened species are generally not well studied. Across areas, the most well-studied species are the cephalopod common cuttlefish (Sepia officinalis) and the crustacean Norway lobster (Nephrops norvegicus). Overall, the information gap is narrowest for length-weight relationships followed by growth and maturity, and widest for fecundity and natural mortality. Based on these insights, we provide recommendations to prioritize species with insufficient or missing biological data that are common across the studied marine ecosystems and to address data deficiencies.
Subject code	333
Language	English
Publisher	Frontiers
Publishing country	de
Document type	Article ; Online
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Article ; Online: COVID-19 Vaccination Improved Psychological Distress (Anxiety and Depression Scores) in Chronic Kidney Disease Patients

Helena Garcia-Llana / Nayara Panizo / Lorena Gandía / Marisa Orti / Elena Giménez-Civera / Claudia Forquet / Luis D’Marco / Maria Jesús Puchades / Mari Sargsyan / Irina Sanchís / Carmen Ribera / Mª Inés Marco / Cristela Moncho Ferrá / Carmen María Pérez-Baylach / Begoña Bonilla / Francesc Moncho Francés / Elisa Perez-Bernat / Asunción Sancho / Jose Luis Górriz

Vaccines, Vol 10, Iss 299, p

A Prospective Study

2022 Volume 299

Abstract	The purpose of the study is to analyze the impact of vaccination against SARS-CoV-2 on anxiety and depression scores in patients with different modalities of chronic kidney disease. One hundred and seventeen renal patients (50 hemodialysis patients, 13 peritoneal dialysis patients, 32 kidney transplants, and 22 advanced chronic kidney disease patients at pre-dialysis care) were evaluated for depression, anxiety, health-related quality of life (HRQOL), and perceived fears and resources with standardized (Hospital Anxiety and Depression Scale (HADS)) and self-reported questionnaires. The measure points were before vaccination and 15 days after vaccination. The main finding of the study was that there was a decrease in the global mean of normal scores for anxiety and depression symptoms in chronic kidney disease patients post-vaccination. We did not find statistically significant differences in depression or anxiety scores, nor any HRQOL differences between the treatment groups. The three main fears reported by the participants at baseline were those of adverse effects, not getting the vaccine, and lack of information. These findings highlight the potential interest of assessing psychological variables related to the impact of vaccination against SARS-CoV-2. New studies will be required to assess the impact of comprehensive vaccine coverage and its psychological impact.
Keywords	COVID-19 ; vaccination ; psychological distress ; chronic kidney disease ; Medicine ; R
Subject code	150
Language	English
Publishing date	2022-02-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
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Article ; Online: Acute GVHD prophylaxis plus ATLG after myeloablative allogeneic haemopoietic peripheral blood stem-cell transplantation from HLA-identical siblings in patients with acute myeloid leukaemia in remission: final results of quality of life and long-term outcome analysis of a phase 3 randomised study.

Bonifazi, Francesca / Solano, Carlos / Wolschke, Christine / Sessa, Mariarosaria / Patriarca, Francesca / Zallio, Francesco / Nagler, Arnon / Selleri, Carmine / Risitano, Antonio Maria / Messina, Giuseppe / Bethge, Wolfgang / Herrera, Pilar / Sureda, Anna / Carella, Angelo Michele / Cimminiello, Michele / Guidi, Stefano / Finke, Jürgen / Sorasio, Roberto / Ferra, Christelle /

Sierra, Jorge / Russo, Domenico / Benedetti, Edoardo / Milone, Giuseppe / Benedetti, Fabio / Heinzelmann, Marion / Pastore, Domenico / Jurado, Manuel / Terruzzi, Elisabetta / Narni, Franco / Völp, Andreas / Ayuk, Francis / Ruutu, Tapani / Kröger, Nicolaus

The Lancet. Haematology

2019 Volume 6, Issue 2, Page(s) e89–e99

Abstract: Background: We previously showed that human anti-T-lymphocyte globulin (ATLG) plus ciclosporin and methotrexate given to patients with acute leukaemia in remission, having allogeneic haemopoietic stem-cell transplantation with peripheral blood stem ... ...

Abstract	Background: We previously showed that human anti-T-lymphocyte globulin (ATLG) plus ciclosporin and methotrexate given to patients with acute leukaemia in remission, having allogeneic haemopoietic stem-cell transplantation with peripheral blood stem cells from an HLA-identical sibling donor after myeloablative conditioning, significantly reduced 2-year chronic graft-versus-host disease (cGVHD) incidence and severity, without increasing disease relapse and infections, and improves cGVHD-free and relapse-free survival (cGRFS). The aim of an extended follow-up study was the assessment of long-term outcomes, which are, in this context, scarcely reported in the literature. We report unpublished data on quality of life (QoL) from the original study and the results of a follow-up extension. Methods: In the original open-label study, patients with acute myeloid and lymphoblastic leukaemia in first or subsequent remission, having sibling HLA-identical allogeneic peripheral blood stem-cell transplantation, were randomly assigned (1:1) to receive ATLG plus standard GVHD prophylaxis with ciclosporin and short-term methotrexate (ATLG group) or standard GVHD prophylaxis without ATLG (non-ATLG group). Conditioning regimens were cyclophosphamide 120 mg/kg with either total body irradiation (12 Gy) or busulfan (12·8 mg/kg intravenously or 16 mg/kg orally), with or without etoposide (30-60 mg/kg). Randomisation was stratified according to centre and disease risk. The primary endpoint was cumulative incidence of cGVHD at 2 years. The primary and secondary endpoints, excluding QoL, have been published. QoL, assessed using European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-HDC29 questionnaires, was an unpublished secondary endpoint, which we now report here. A follow-up extension was then done, with the primary endpoint cumulative incidence of cGVHD. Enrolment has been completed for both studies. The original trial (number, NCT00678275) and follow-up extension (number, NCT03042676) are registered at ClinicalTrials.gov. Findings: In the original study, from Dec 14, 2006, to Feb 2, 2012, 161 patients were enrolled and 155 were randomly assigned to either the ATLG group (n=83) or to the non-ATLG group (n=72). In the follow-up study, which started on Feb 7, 2017, and was completed on June 30, 2017, 61 patients were included in the ATLG group and 53 were included in the non-ATLG group. Global health status showed a more favourable time course in the ATLG group compared with the non-ATLG group (p=0·02; treatment by visit interaction). ATLG was descriptively superior to non-ATLG at 24 months for physical function (points estimate -14·8 [95% CI -26·4 to -3·1]; p=0·014) and social function (-19·1 [-38·0 to -0·2]; p=0·047), gastrointestinal side-effects (8·8 [2·5-15·1]; p=0·008) and effect on family (13·5 [1·2-25·8]; p=0·032). Extended follow-up (median 5·9 years [IQR 1·7-7·9]) confirmed a lower 5-year cGVHD incidence (30·0% [95% CI 21·4-41·9] vs 69·1% [59·1-80·1]; analysis for entire follow-up, p<0·001), no increase in relapses (35·4% [26·4-47·5] vs 22·5% [14·6-34·7]; p=0·09), improved cGRFS (34·3% [24·2-44·5] vs 13·9% [7·1-22·9]; p=0·005), and fewer patients still in immunosuppression (9·6% vs 28·3%; p=0·017) in the ATLG group compared with the non-ATLG group. 5-year overall survival, relapse-free survival, and non-relapse mortality did not differ significantly between groups. Interpretation: The addition of ATLG to standard GVHD prophylaxis improves the probability of surviving without disease relapse and cGVHD after myeloablative peripheral blood stem-cell transplantation from an HLA-identical sibling donor for patients with acute leukaemia in remission. Further additional benefits are better QoL and shorter immunosuppressive treatment compared with standard GVHD prophylaxis without ATLG. Therefore, in this setting, ATLG plus standard GVHD prophylaxis should be preferred over the standard GVHD prophylaxis alone. Funding: Neovii Biotech.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antilymphocyte Serum/immunology ; Disease-Free Survival ; Female ; Graft vs Host Disease/etiology ; Graft vs Host Disease/prevention & control ; HLA Antigens/metabolism ; Hematopoietic Stem Cell Transplantation/adverse effects ; Humans ; Leukemia, Myeloid, Acute/immunology ; Leukemia, Myeloid, Acute/metabolism ; Leukemia, Myeloid, Acute/therapy ; Male ; Middle Aged ; Quality of Life ; Siblings ; Young Adult
Chemical Substances	Antilymphocyte Serum ; HLA Antigens
Language	English
Publishing date	2019-01-29
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ISSN	2352-3026
ISSN (online)	2352-3026
DOI	10.1016/S2352-3026(18)30214-X
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Article ; Online: Safety of obinutuzumab alone or combined with chemotherapy for previously untreated or relapsed/refractory chronic lymphocytic leukemia in the phase IIIb GREEN study.

Leblond, Véronique / Aktan, Melih / Ferra Coll, Christelle M / Dartigeas, Caroline / Kisro, Jens / Montillo, Marco / Raposo, João / Merot, Jean-Louis / Robson, Susan / Gresko, Ekaterina / Bosch, Francesc / Stilgenbauer, Stephan / Foà, Robin

Haematologica

2018 Volume 103, Issue 11, Page(s) 1889–1898

Abstract: The safety of obinutuzumab, alone or with chemotherapy, was studied in a non-randomized, open-label, non-comparative, phase IIIb study (GREEN) in previously untreated or relapsed/refractory chronic lymphocytic leukemia. Patients received obinutuzumab ... ...

Abstract	The safety of obinutuzumab, alone or with chemotherapy, was studied in a non-randomized, open-label, non-comparative, phase IIIb study (GREEN) in previously untreated or relapsed/refractory chronic lymphocytic leukemia. Patients received obinutuzumab 1000 mg alone or with chemotherapy (investigator's choice of fludarabine-cyclophosphamide for fit patients, chlorambucil for unfit patients, or bendamustine for any patient) on days 1, 8 and 15 of cycle 1, and day 1 of cycles 2-6 (28-day cycles), with the cycle 1/day 1 dose administered over two days. The primary end point was safety/tolerability. Between October 2013 and March 2016, 972 patients were enrolled and 971 treated (126 with obinutuzumab monotherapy, 193 with obinutuzumab-fludarabine-cyclophosphamide, 114 with obinutuzumab-chlorambucil, and 538 with obinutuzumab-bendamustine). Grade ≥3 adverse events occurred in 80.3% of patients, and included neutropenia (49.9%), thrombocytopenia (16.4%), anemia (9.6%), and pneumonia (9.0%); rates were similar in first-line and relapsed/refractory patients, and in first-line fit and unfit patients. Using expanded definitions, infusion-related reactions were observed in 65.4% of patients (grade ≥3, 19.9%; mainly seen during the first obinutuzumab infusion), tumor lysis syndrome in 6.4% [clinical and laboratory; highest incidence with obinutuzumab-bendamustine (9.3%)], and infections in 53.7% (grade ≥3, 20.1%). Serious and fatal adverse events were seen in 53.1% and 7.3% of patients, respectively. In first-line patients, overall response rates at three months post treatment exceeded 80% for all obinutuzumab-chemotherapy combinations. In the largest trial of obinutuzumab to date, toxicities were generally manageable in this broad patient population. Safety data were consistent with previous reports, and response rates were high. (
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bendamustine Hydrochloride/administration & dosage ; Bendamustine Hydrochloride/adverse effects ; Chlorambucil/administration & dosage ; Chlorambucil/adverse effects ; Cyclophosphamide/administration & dosage ; Cyclophosphamide/adverse effects ; Female ; Humans ; Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy ; Leukemia, Lymphocytic, Chronic, B-Cell/pathology ; Male ; Middle Aged ; Vidarabine/administration & dosage ; Vidarabine/adverse effects ; Vidarabine/analogs & derivatives
Chemical Substances	Antibodies, Monoclonal, Humanized ; Chlorambucil (18D0SL7309) ; Cyclophosphamide (8N3DW7272P) ; Bendamustine Hydrochloride (981Y8SX18M) ; Vidarabine (FA2DM6879K) ; obinutuzumab (O43472U9X8) ; fludarabine (P2K93U8740)
Language	English
Publishing date	2018-07-05
Publishing country	Italy
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2017.186387
Database	MEDical Literature Analysis and Retrieval System OnLINE

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