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1.
Artículo en Inglés | MEDLINE | ID: mdl-38600714

RESUMEN

The aim of the study was to examine the relationships between unfounded COVID-19 beliefs and distress and powerlessness, specifically, whether distress and powerlessness are causes or consequences of unfounded COVID-19 beliefs represented by conspiracy beliefs and pseudoscientific beliefs regarding treatment and measures. Unfounded beliefs were assessed using the COVID-19 Unfounded Beliefs Scale; distress was measured with the Symptom Checklist-10, and powerlessness was measured with four items measuring the feeling of losing control. Data collection took place during three phases of the pandemic in Slovakia (October 2021, N = 1838; July 2022, N = 1,420; April 2023, N = 925). Results suggest that individuals with stronger unfounded beliefs about COVID-19 reported greater powerlessness longitudinally, and individuals with stronger COVID-19 unfounded beliefs treatment and measures reported greater distress longitudinally (notably, beliefs about COVID-19 measures in the first wave were associated with distress in the second wave, and beliefs about COVID-19 treatment in the second wave were associated with distress in the third wave). The present findings corroborate an existential threat model of conspiracy theories that says the relationship between unfounded beliefs and indicators of well-being is bidirectional, so interventions should be focused both on eliminating the unfounded beliefs and strengthening well-being.

2.
Br J Soc Psychol ; 2024 Jan 25.
Artículo en Inglés | MEDLINE | ID: mdl-38270221

RESUMEN

The paper reports the results of registered conceptual replications of the indirect effect of institutional trust in the relationship between precarity and the endorsement of conspiracy beliefs (CB). The original study of Adam-Troian et al. (2023; British Journal of Social Psychology, 62(S1), 136-159) indicated that subjective appraisals of economic hardship are associated with lower trust in governments and institutions, which in turn is associated with stronger endorsement of CB. Our Studies 1 to 3 report a series of replications using Slovak panel data. Study 4 reports a replication of the mediation model using data from the European Social Survey Round 10 collected in 17 countries. To provide a quantitative synthesis of these and previous results, we conducted mini meta-analysis (N = 50,340). Although the strength of the observed relationships differed across the studies to some degree, the original patterns of relations remained robust, supporting the original model. The study corroborates the view that to curb the spread of CB, it is necessary to address structural issues, such as growing financial insecurity, socioeconomic inequalities, and the deficit of institutional trust. Finally, we discuss the role of cultural and political settings in conditioning the mechanisms through which precarity enhances the endorsement of CB.

3.
BMC Psychol ; 11(1): 79, 2023 Mar 24.
Artículo en Inglés | MEDLINE | ID: mdl-36964636

RESUMEN

BACKGROUND: The present study explored moderators of the relation between environmental concerns and pro-environmental behaviour that could help close the green gap. METHODS: A sample of 500 individuals (250 women) participated in the study. Apart from socio-demographic characteristics, participants answered questions about their environmental concerns and pro-environmental behaviour, collectivism and individualism, time orientation and emotional responses to climate change. RESULTS: Our results corroborate the view that collectivism, future orientation and prosocial tendencies may form a single component of outward orientation, while individualism and immediate orientation form self-centred orientation. Generally, outwardly oriented individuals and those less self-centred reported more pro-environmental behaviour. However, strongly self-centred individuals, even when reporting elevated helplessness, showed increased involvement in pro-environmental behaviour once their concerns were high. CONCLUSIONS: The study contributes to the literature by pointing out that both outward and self-centred orientations have the potential to insulate individuals against the negative effect helplessness may have on pro-environmental behaviour. This could inform strategies that would both prompt individuals already concerned to act and arouse more concern among those who are not yet preoccupied with climate change.


Asunto(s)
Emociones , Conducta Social , Humanos , Femenino , Individualidad
4.
Data Brief ; 47: 108980, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-36818582

RESUMEN

The dataset comprises responses provided by 500 individuals (250 women) recruited by an external agency to be representative of the Slovak population concerning age and gender. Participants gave written consent to participate in the study by confirming that they are over 18 and have read all the information about the study before agreeing to participate in an online survey hosted on Qualtrics. Along with socio-demographic characteristics and vaccination hesitancy and refusal, the dataset contains variables that could explain variation in dependant variables: horizontal-vertical individualism-collectivism, consideration of future consequences, prosocial motivations, helplessness, and the sense of threat caused by vaccination but also the COVID-19 pandemic and the climate change. In the original paper, the authors performed correlational analysis and hierarchical regressions investigating antecedents of vaccination hesitancy and refusal. The data inform interventions aimed at boosting vaccination rates, particularly amongst highly sceptical societies such as Slovakia. Apart from investigating the relations between various forms of prosocial behaviour such as vaccination intentions and attitudes, helping behaviour during the pandemic, and pro-environmental behaviour, the dataset offers an opportunity to delve deeper into the drivers of various forms of socially beneficial behaviour. Ultimately, the data could help corroborate the existence of two new constructs of outward orientation (comprising future orientation, collectivism and prosocial motivations) and self-centred orientation (immediate orientation and individualism) that could be useful in explaining individual differences in prosocial intentions and behaviour.

5.
Curr Psychol ; : 1-15, 2023 Jan 26.
Artículo en Inglés | MEDLINE | ID: mdl-36718393

RESUMEN

Scientific reasoning and trust in science are two facets of science understanding. This paper examines the contribution of science understanding, over and above analytic thinking, to the endorsement of conspiracy and pseudoscientific beliefs about COVID-19 and behavioral intentions to engage in the recommended preventive behavior. We examined the direct and indirect effects of science understanding on normative health behavior in a representative sample of the Slovak population (N = 1024). The results showed more support for the indirect pathway: individuals with a better understanding of science generally had fewer epistemically suspect beliefs and as a consequence tended to behave more in line with the evidence-based guidelines and get vaccinated. Neither scientific reasoning nor trust in science directly predicted non-compliance with preventive measures, but analytic thinking correlated positively with non-compliance with preventive measures. The strongest predictor of epistemically suspect beliefs was trust in science, which also directly predicted the intention to get vaccinated against COVID-19. Therefore, reasoning about which experts or sources to believe (second-order scientific reasoning) has become more important than directly evaluating the original evidence (first-order scientific reasoning). Supplementary information: The online version contains supplementary material available at 10.1007/s12144-023-04284-y.

6.
Acta Psychol (Amst) ; 227: 103606, 2022 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35524994

RESUMEN

The study investigated antecedents of attitudes towards vaccines against COVID-19 and vaccination behaviour, and sought to identify areas where interventions aimed at increasing vaccination rates would be most effective. A sample of 500 Slovaks (250 women) responded to questions concerning their socio-demographic and personality characteristics, collectivism and individualism, consciousness of future consequences, and emotional responses to both vaccination and the pandemic. The study indicates that helplessness related to the vaccine efficacy evaluation and fear of its potential risks are the strongest antecedents of vaccination behaviour and anti-vaccination attitudes. Jointly with the fear of the COVID-19, they explained over 26% and 33% of variance in behaviour and attitudes, respectively. The results indicate that the efficiency of appeals to solidarity may be limited when fear and helplessness are widespread as they seem to strongly outweigh individuals' outward motivations to get vaccinated.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Actitud , COVID-19/prevención & control , Miedo/psicología , Femenino , Humanos , SARS-CoV-2 , Justicia Social , Vacunación/psicología
7.
Vnitr Lek ; 68(E-1): 22-26, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35459402

RESUMEN

The goal of this case report is to describe the young childhood cancer survivor who was treated for nonHodgkin lymphoma with chemotherapy containing anthracycline doxorubicin and who developed symptoms of serious cardiovascular damage 27 years after diagnosis of cancer. The patient is in longterm complete remission of the lymphoma. He started guideline medical therapies for chronic heart failure and had a cardioverter defibrillator implanted for primary prevention of sudden cardiac death. He is currently a candidate for heart transplantation.


Asunto(s)
Desfibriladores Implantables , Insuficiencia Cardíaca , Neoplasias , Arritmias Cardíacas/complicaciones , Arritmias Cardíacas/terapia , Niño , Muerte Súbita Cardíaca/etiología , Muerte Súbita Cardíaca/prevención & control , Desfibriladores Implantables/efectos adversos , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/terapia , Humanos , Masculino , Neoplasias/complicaciones , Sobrevivientes , Adulto Joven
8.
Curr Psychol ; : 1-12, 2022 Mar 19.
Artículo en Inglés | MEDLINE | ID: mdl-35340689

RESUMEN

The present study investigated the relationship between outward orientation and COVID-related prosocial behavior, including adherence to containment measures, caring for others and providing support, limiting one's social life and responsible purchasing behavior. A sample of 500 Slovaks (250 women) aged between 18 and 86 (M = 44.32, SD = 15.66) participated in the study and responded to questions concerning their sociodemographic and personality characteristics, collectivism and individualism, the consciousness of future consequences and emotional responses to the pandemic. The results show that apart from the perceived threat of COVID-19, vertical collectivism is among the strongest antecedents of COVID-related prosocial behavior. Specifically, feelings of threat, vertical collectivism, conscientiousness, agreeableness, liberalism, and education predicted more prosocial behavior during the pandemic. Consequently, the study indicates that while excessive fear may have adverse effects on individuals' well-being, appealing to and cultivating collectivistic sentiments could contribute not only to containing the pandemic but also to making others' lives more bearable while it lasts.

9.
J Health Psychol ; 27(3): 534-547, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-33016131

RESUMEN

We examined whether scientific reasoning is associated with health-related beliefs and behaviors over and above general analytic thinking ability in the general public (N = 783, aged 18-84). Health-related beliefs included: anti-vaccination attitudes, COVID-19 conspiracy beliefs, and generic health-related epistemically suspect beliefs. Scientific reasoning correlated with generic pseudoscientific and health-related conspiracy beliefs and COVID-19 conspiracy beliefs. Crucially, scientific reasoning was a stronger independent predictor of unfounded beliefs (including anti-vaccination attitudes) than general analytic thinking was; however, it had a more modest role in health-related behaviors.


Asunto(s)
Actitud Frente a la Salud , COVID-19 , Conductas Relacionadas con la Salud , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Movimiento Anti-Vacunación , Humanos , Persona de Mediana Edad , Pandemias , SARS-CoV-2 , Adulto Joven
10.
Thromb Res ; 207: 126-130, 2021 Oct 04.
Artículo en Inglés | MEDLINE | ID: mdl-34624672

RESUMEN

BACKGROUND: Cases of ChAdOx1 nCoV-19 (AstraZeneca) vaccinated patients with thrombocytopenia, elevated D-dimer, and elevated platelet factor 4 (PF4) antibody levels with- and without thrombosis have been reported. No recommendations regarding the duration of anticoagulation have been made, because data on the long-term course beyond the first weeks is lacking. OBJECTIVE: To report on the treatment, medical course, and longitudinal follow-up of laboratory parameters in patients with vaccine-induced prothrombotic immune thrombocytopenia (VIPIT). PATIENTS: We followed VIPIT patients with- (n = 3) and without (n = 3) venous thromboembolism fulfilling the aforementioned laboratory criteria. RESULTS: Elevated D-dimer (median: 35.10 µg/ml, range: 17.80-52.70), thrombocytopenia (42 G/l, 20-101), and strong positivity in the platelet factor 4 (PF4)/heparin-enzyme-immunoassay (2.42 optical density [OD], 2.06-3.13; reference range < 0.50) were present in all patients after vaccination (10 days, 7-17). Routine laboratory parameters rapidly improved upon initiation of treatment (comprising therapeutic non-heparin anticoagulation in all patients and high dose immunoglobulins ± corticosteroids in 5 patients). PF4 antibody levels slowly decreased over several weeks. Patients were discharged in good physical health (8 days, 5-13). VIPIT did not recur during follow-up (12 weeks, 8-17). Five of 6 patients fully recovered (in 2 patients thrombosis had resolved, in 1 patient exertional dyspnea persisted). CONCLUSIONS: Remissions without sequelae can be achieved upon rapid initiation of treatment in patients with VIPIT. Platelet factor 4 antibody levels slowly decreased over several weeks but VIPIT did not recur in any of our patients. Continuation of anticoagulation in VIPIT patients at least until PF4 antibody negativity is reached seems reasonable.

11.
Clin Lymphoma Myeloma Leuk ; 21(10): e782-e791, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-34275773

RESUMEN

INTRODUCTION: The results of treatment of acute lymphoblastic leukemia (ALL) from the low population countries are missing in the literature. PATIENTS AND METHODS: We retrospectively examined biological characteristics and survival of 90 patients with ALL. RESULTS: At median follow-up 17 months, 52 men and 38 women were eligible for the analysis with median age 43 years (18-74). As for the risk stratification, 25.6% of patients were in standard risk, 46.7% in high risk and 27.8% in very high-risk group. Complete remission achieved 88.9% of patients. We observed 5.6% of induction deaths and 4.5% of resistant disease. 47.8% of the patients underwent allogeneic stem cell transplantation (alloSCT), 59% in the young adults (YA; < 40 years) and 40% in adult group (≥ 40 years). We noticed 32.6% relapses overall with median survival of relapsed patients 3.9 months. YA patients had longer survival than adults: 3-year overall survival (OS) 65.0% vs 30.2%; (HR = 0.36; 95% CI 0.2-0.64; P = .001) and event free survival (EFS) 51.5% vs 21.9%; (HR = 0.45; 95% CI 0.26-0.78; P = .005). There was significant difference in 3-year EFS between risk groups in YA patients 90.9%, 48.0%, 11.4%; (P = .001). OS after alloSCT individually for the YA was 62.6% and for adults 39.1%, hazard ratio (HR) = 0.49 (95% CI 0.20-1.21); (P = .095). We observed 14% early deaths, 25.6% late deaths and 3 relapses (7%) after allogeneic stem cell transplantation. CONCLUSIONS: Our data proved that even in a low population country similar result can be achieved as in larger ones while using well designed adapted protocols from leukemic study groups.


Asunto(s)
Leucemia-Linfoma Linfoblástico de Células Precursoras/epidemiología , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Eslovaquia , Adulto Joven
12.
Front Psychol ; 12: 719330, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34248810

RESUMEN

[This corrects the article DOI: 10.3389/fpsyg.2020.584424.].

13.
Appl Cogn Psychol ; 35(3): 720-729, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33821088

RESUMEN

Societal crises and stressful events are associated with an upsurge of conspiracy beliefs that may help people to tackle feelings of lack of control. In our study (N = 783), we examined whether people with higher feelings of anxiety and lack of control early in the COVID-19 pandemic endorse more conspiracy theories. Our results show that a higher perception of risk of COVID-19 and lower trust in institutions' response to the pandemic were related to feelings of anxiety and lack of control. Feeling the lack of control, but not anxiety, independently predicted COVID-19 conspiracy theory endorsement. Importantly, COVID-19 conspiracy beliefs were strongly correlated with generic conspiracy and pseudoscientific beliefs, which were likewise associated with the feeling of lack of control and lower trust in institutions. The results highlight that considering people's emotional responses to the COVID-19 pandemic is crucial for our understanding of the spread of conspiracy and pseudoscientific beliefs.

14.
Br J Haematol ; 193(2): 325-338, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33605445

RESUMEN

The manageable toxicity profile of obinutuzumab (GA101; G) alone or with chemotherapy in first-line (1L; fit and non-fit) and relapsed/refractory (R/R) patients with chronic lymphocytic leukaemia (CLL) was established in the primary analysis of the Phase IIIb GREEN trial (Clinicaltrials.gov: NCT01905943). The final analysis (cut-off, 31 January 2019) is reported here. Patients received G (1000 mg) alone (G-mono; fit and non-fit patients) or with chemotherapy [fludarabine and cyclophosphamide (FC; fit patients); chlorambucil (non-fit patients); bendamustine (any patient)]. Study endpoints were safety (primary) and efficacy (secondary). Subgroup analyses were performed on prognostic biomarkers in 1L CLL. Overall, 630 patients received 1L and 341 received R/R CLL treatment. At the final analysis, no new safety signals were observed [Grade ≥ 3 adverse events (AEs): 1L 82·7%, R/R 84·5%; serious AEs: 1L 58·1%, R/R 62·5%]. Neutropenia (1L 50·5%, R/R 53·4%) and thrombocytopenia (1L 14·6%, R/R 19·1%) were the most common Grade 3-5 AEs. G-mono-, G-bendamustine and G-FC-treated patients with unmutated immunoglobulin heavy chain trended towards shorter progression-free survival. Achievement of minimal residual disease negativity was greatest in 1L patients treated with G-FC. In this final analysis of the GREEN trial, the safety profile of G was consistent with current risk management strategies. Biomarker analyses supported efficacy in the specific subgroups.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Antineoplásicos Inmunológicos/uso terapéutico , Cadenas Pesadas de Inmunoglobulina/efectos de los fármacos , Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/efectos adversos , Antineoplásicos Inmunológicos/administración & dosificación , Antineoplásicos Inmunológicos/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Clorhidrato de Bendamustina/administración & dosificación , Clorhidrato de Bendamustina/efectos adversos , Clorhidrato de Bendamustina/uso terapéutico , Biomarcadores Farmacológicos , Clorambucilo/administración & dosificación , Clorambucilo/efectos adversos , Clorambucilo/uso terapéutico , Ciclofosfamida/administración & dosificación , Ciclofosfamida/efectos adversos , Ciclofosfamida/uso terapéutico , Femenino , Humanos , Cadenas Pesadas de Inmunoglobulina/genética , Masculino , Persona de Mediana Edad , Neoplasia Residual/epidemiología , Neutropenia/inducido químicamente , Neutropenia/epidemiología , Ensayos Clínicos Controlados no Aleatorios como Asunto , Supervivencia sin Progresión , Recurrencia , Seguridad , Trombocitopenia/inducido químicamente , Trombocitopenia/epidemiología , Resultado del Tratamiento , Vidarabina/administración & dosificación , Vidarabina/efectos adversos , Vidarabina/análogos & derivados , Vidarabina/uso terapéutico
15.
Front Psychol ; 12: 726076, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-35095634

RESUMEN

One of the appeals of conspiracy theories in times of crises is that they provide someone to blame for what has happened. Thereby, they increase distrust, negative feelings, and hostility toward implicated actors, whether those are powerful social outgroups or one's own government representatives. Two studies reported here examine associations of COVID-19 conspiracy theories with prejudice, support for violence, and other and negative social outcomes. In Study 1 (N = 501), the endorsement of the more specific conspiracy theories about the alleged role of China was associated with more prejudiced views of Chinese and Italian people. In Study 2 (N = 1024), lowered trust in government regulations and increased hostility associated with the COVID-19 and generic conspiracy beliefs were correlated with justification of and willingness to engage in non-compliance with regulations, violent attacks on 5G masts, and anti-government protests. Across both of the studies, higher exposure to news about COVID-19 was associated with lower endorsement of conspiracy theories, but also with increased feelings of anxiety and lack of control, which in turn were correlated with higher COVID-19 conspiracy beliefs endorsement. We highlight the potential social problems which are associated with the wide-spread endorsement of COVID-19 conspiracy theories.

16.
Front Psychol ; 11: 584424, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33178085

RESUMEN

Belief in astrology remains strong even today, and one of the explanations why some people endorse paranormal explanations is the individual differences in analytical thinking. Therefore, the main aim of this paper was to determine the effects of priming an analytical or intuitive thinking style on the credulity of participants. In two experiments (N = 965), analytic thinking was induced and the source of fake profile (astrological reading vs. psychological testing) was manipulated and participants' prior paranormal beliefs, anomalous explanation, cognitive reflection, and depression were measured. Although analytic thinking was proved to be hard to induce experimentally, the results showed that analytic thinking predicts credulity and belief in the paranormal was linked with experiencing more anomalous experiences and more paranormal explanations. The more people were able to think analytically, the less credulous they were as reflected in the lower acceptance of fake profile as accurate.

17.
Cancer Med ; 8(4): 1401-1405, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30888118

RESUMEN

No data are available regarding obesity and outcome in Chronic Lymphocytic Leukemia (CLL). We analyzed 263 patients from the AGMT CLL-8a Mabtenance trial for the impact of obesity. The trial included patients after rituximab-containing induction treatment in first or second line that had achieved at least a PR. A randomization to rituximab maintenance treatment (375 mg/m2 q3 months for 2 years) vs observation was performed. In this cohort 22% of the patients (58/263) were classified as obese. The baseline response to induction treatment was inferior in obese patients with a lower CR rate (43.1% vs 60.5% in obese vs non-obese, P = 0.018) and with a lower rate of patients achieving MRD negativity after chemoimmunotherapy induction treatment (19.6% vs 35.8%, P = 0.02). The PFS outcome of obese patients was significantly worse in the observation group of the trial (24 vs 39 months median PFS, P = 0.03). However, in the rituximab maintenance group the outcome for obese vs non-obese was not different (P = 0.4). In summary, obesity was overall associated with a worse outcome of chemoimmunotherapy induction. However, rituximab maintenance treatment seems to be able to overcome this negative effect.


Asunto(s)
Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico , Obesidad/complicaciones , Rituximab/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Leucemia Linfocítica Crónica de Células B/mortalidad , Quimioterapia de Mantención , Masculino , Persona de Mediana Edad , Obesidad/mortalidad , Pronóstico , Rituximab/uso terapéutico , Análisis de Supervivencia , Resultado del Tratamiento
18.
Int J Hematol ; 108(5): 550-553, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-29931624

RESUMEN

Myeloid sarcoma is a rare presentation of acute leukemia as a solid tumor at various extramedullary sites. It may present concurrently, before or after the onset of systemic bone marrow leukemia. Unusual clinical localization may lead to misdiagnosis, or delayed diagnosis and treatment. We describe the first case, to our knowledge, of de novo myeloid sarcoma of the breast confirmed as acute promyelocytic leukemia. Immunohistochemical analysis, flow cytometry, fluorescent in situ hybridization analysis and molecular analysis using RQ-PCR of tissue samples should be routine in determining the correct diagnosis in this setting.


Asunto(s)
Neoplasias de la Mama/diagnóstico , Leucemia Promielocítica Aguda/diagnóstico , Sarcoma Mieloide/diagnóstico , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Biopsia , Médula Ósea/patología , Neoplasias de la Mama/genética , Neoplasias de la Mama/metabolismo , Diagnóstico Diferencial , Femenino , Citometría de Flujo , Humanos , Inmunohistoquímica , Hibridación Fluorescente in Situ , Leucemia Promielocítica Aguda/genética , Leucemia Promielocítica Aguda/metabolismo , Imagen por Resonancia Magnética , Mamografía , Sarcoma Mieloide/genética , Sarcoma Mieloide/metabolismo , Resultado del Tratamiento
19.
Leukemia ; 32(8): 1778-1786, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29749403

RESUMEN

GREEN (NCT01905943) is a non-randomized, open-label phase IIIb study investigating obinutuzumab alone or plus chemotherapy in chronic lymphocytic leukemia (CLL). We report a preplanned subgroup analysis of 158 previously untreated CLL patients receiving obinutuzumab-bendamustine (G-B). Patients received six 28-day cycles (C) of G-B: obinutuzumab day (D)1/D2 of C1 (25 mg D1/975 mg D2), 1000 mg D8 and D15 of C1, and D1 of C2-6; and bendamustine 70/90 mg/m2 D1 and D2 of C1-6. The primary endpoint was safety/tolerability. Grade ≥3 adverse events (AEs) occurred in 82.3% of patients, including neutropenia (49.4%), thrombocytopenia (12.0%) and febrile neutropenia (10.8%). Serious AEs included neutropenia (12.7%), febrile neutropenia (9.5%) and pneumonia (7.6%). Rates of grade ≥3 infections and infusion-related reactions were 20.3% and 17.1%, respectively. Due to tumor lysis syndrome (TLS; 8.2%), including two associated fatalities (one in another study cohort), additional risk-minimization measures were implemented. Overall response rate was 81.0%. After 32.8 months' median observation time, 2-year progression-free survival was 81.8%. Minimal residual disease was undetectable in 59.5% (94/158) and 27.8% (44/158) of patients for blood and bone marrow, respectively. Frontline G-B appears to have manageable toxicity with clinical activity in CLL. Careful TLS risk assessment, pretreatment and monitoring is required.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Resistencia a Antineoplásicos/efectos de los fármacos , Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Neoplasia Residual/tratamiento farmacológico , Terapia Recuperativa , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/administración & dosificación , Clorhidrato de Bendamustina/administración & dosificación , Femenino , Estudios de Seguimiento , Humanos , Leucemia Linfocítica Crónica de Células B/patología , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/patología , Neoplasia Residual/patología , Pronóstico , Inducción de Remisión , Rituximab/administración & dosificación , Tasa de Supervivencia
20.
Lancet Haematol ; 3(7): e317-29, 2016 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-27374465

RESUMEN

BACKGROUND: In many patients with chronic lymphocytic leukaemia requiring treatment, induction therapy with rituximab plus chemotherapy improves outcomes compared with chemotherapy alone. In this study we aimed to investigate the potential of rituximab maintenance therapy to prolong disease control in patients who respond to rituximab-containing induction regimens. METHODS: In this randomised, international, multicentre, open-label, phase 3 clinical trial, we enrolled patients who had achieved a complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) to first-line or second-line rituximab-containing chemoimmunotherapy and randomly assigned them in a 1:1 ratio (central block randomisation in the electronic case report form system) to either intravenous rituximab 375 mg/m(2) every 3 months, or observation alone, for 2 years. Stratification was by country, line of treatment, type of chemotherapy added to the rituximab backbone, and degree of remission following induction. The primary endpoint was progression-free survival. Efficacy analysis was done in the intention-to-treat population. This is the final, event-triggered analysis. Final analysis was triggered by the occurrence of 92 events. This trial is registered with ClinicalTrials.gov, number NCT01118234. FINDINGS: Between April 1, 2010, and Dec 23, 2013, 134 patients were randomised to rituximab and 129 to observation alone. Median observation times were 33·4 months (IQR 25·7-42·8) for the rituximab group and 34·0 months (25·4-41·9) for the observation group. Progression-free survival was significantly longer in the rituximab maintenance group (47·0 months, IQR 28·5-incalculable) than with observation alone (35·5 months, 95% CI 25·7-46·3; hazard ratio [HR] 0·50, 95% CI 0·33-0·75, p=0·00077). The incidence of grade 3-4 haematological toxicities other than neutropenia was similar in the two treatment groups. Grade 3-4 neutropenia occurred in 28 (21%) patients in the rituximab group and 14 (11%) patients in the observation group. Apart from neutropenia, the most common grade 3-4 adverse events were upper (five vs one [1%] patient in the observation group) and lower (three [2%] vs one [1%]) respiratory tract infection, pneumonia (nine [7%] vs two [2%]), thrombopenia (four [3%] vs four [3%]), neoplasms (five [4%] vs four [3%]), and eye disorders (four [3%] vs two [2%]). The overall incidence of infections of all grades was higher among rituximab recipients (88 [66%] vs 65 [50%]). INTERPRETATION: Rituximab maintenance therapy prolongs progression-free survival in patients achieving at least a PR to induction with rituximab plus chemotherapy, and the treatment is well tolerated overall. Although it is associated with an increase in infections, there is no excess in infection mortality, suggesting that remission maintenance with rituximab is an effective and safe option in the management of chronic lymphocytic leukaemia in early treatment phases. FUNDING: Arbeitsgemeinschaft Medikamentöse Tumortherapie gemeinnützige GmbH (AGMT), Roche.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Inmunoterapia , Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico , Rituximab/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Clorhidrato de Bendamustina/administración & dosificación , Ciclofosfamida/administración & dosificación , Femenino , Humanos , Leucemia Linfocítica Crónica de Células B/patología , Leucemia Linfocítica Crónica de Células B/fisiopatología , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Inducción de Remisión , Tasa de Supervivencia , Vidarabina/administración & dosificación , Vidarabina/análogos & derivados
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