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2.
Leukemia and Lymphoma ; 62(SUPPL 1):S23-S24, 2021.
Article in English | EMBASE | ID: covidwho-1747042

ABSTRACT

Ibrutinib is the only once-daily Bruton's tyrosine kinase (BTK) inhibitor with significant survival benefit vs. chemo- and/or immunotherapy in multiple phase 3 studies of patients (pts) with chronic lymphocytic leukemia (CLL). It has profoundly changed the treatment landscape of CLL with the longest follow-up. However, seven years (yrs) after ibrutinib was approved in Italy by regulatory agencies for CLL treatment, available data on the patterns of care of such pts in the setting of clinical practice is limited. Herein we present the first interim analysis (IA) of EVIdeNCE (ClinicalTrials.gov Identifier: NCT03720561), a multicenter, observational clinical study designed to describe the current management of pts receiving ibrutinib in a real-world setting in Italy in terms of retention rate: the study's primary end point. Methods EVIDENCE 312 treatment-naïve (TN) 38% and relapsed/refractory (R/R) 62% pts with CLL according to the iwCLL diagnosis criteria observed at 39 Italian hematological institutions in the period between November 2018 and October 2019. Inclusion criteria were treatment with ibrutinib according to the European Summary of Product Characteristics as per routine clinical practice started within the previous 3 months. The purpose of this IA is to provide demographics and disease characteristics at baseline and a preliminary evaluation of ibrutinib retention rate after one year of follow-up, along with its safety profile. The median age of pts at the time of ibrutinib initiation was 71.0 yrs (range 41.0-89.0), with 60% ≥70 yrs, 63.2% male, and 90% with Eastern Cooperative Oncology Group (ECOG) performance 0-1. Baseline Rai stage 0-I, II, and III-IV accounted for 18.3, 29.7, and 52.1% pts, respectively. Patients in stage IV were observed in 40% of the R/R and 27% in the TN subgroup. Considering 120 pts with known mutational status, del(17p) and/or TP53 mutation were present in 50.0% of pts (TN =52.1%, R/R = 48.6%), while IGHV was unmutated in 35.0% (TN =33.3% and R/R = 36.15) and mutated in 15.0% (TN =14.6%, R/R = 15.3%). At baseline, 62.9% of pts had comorbidities and 30.6% presented with a history of cardiovascular diseases (CVDs). A CIRS score ≥6 was observed in 28.5% of pts. The median time from CLL diagnosis to the start of ibrutinib was 5.1 yrs (TN 1.75 yrs vs. R/R 7.27 yrs). At least 1 treatment-emergent adverse event (TEAE) of any grade was experienced by 70.7% of pts. Frequencies were as follows: infections (30.8%;COVID-19 infections 3.2%), arthralgia (10.8%), neutropenia (9.3%), fatigue (8.4%), diarrhea (7.7%), atrial fibrillation (7.4%;grade 3-4, 4.2%), fever (7.1%), rash (6.4%), anemia (6.1%), and hypertension (4.2%). Mild bleeding TEAEs were reported in 16.1% of pts with no major bleeding event. TEAEs were more frequent in the elderly (≥65 yrs) while no significant differences in the rate of TEAEs were recorded in TN and R/R pts (69.7 vs. 71.4%, respectively). Serious TEAEs were reported in 21.9% of pts. Overall in intention to treat (ITT), 32 deaths (10%) were observed (TN =8, R/R = 24). The most common causes of death were infections (3.5%) and progressive disease (PD) (1.9%). Permanent discontinuation was observed in 56 (18%) of the pts (TN =17.2%, R/R = 18.7%) and it mostly occurred within the first 6 months. The main causes of discontinuation were toxicity (6.1%), PD (3.8%), and death (3.5%). Temporary interruptions (≤3 months without therapy and/or dose modifications) during the whole observation period occurred in 30.3% (TN =35.3%, R/R = 27.2%) and 37.7% (TN =37.5%, R/R = 37.8%) of pts, respectively, mainly determined by toxicity and clinical judgment. Finally, in this first IA after 17.3 months (range 1.1-27.0) median follow-up, the ibrutinib retention rate (calculated as the ratio between the number of patients who retained ibrutinib treatment over the total number of patients at risk) at 1-year was 81.9% [95% confidence interval (CI), 77.2-86.1%] with no difference between TN 83.2% (95% CI, 75.2-89.4%) and R/R 81.2% pts (95% CI, 74.9-86.4%). EVIDENCE is the first realw rld study of ibrutinib use in CLL clinical practice in Italy. Ibrutinib retention rate at one-year suggests a better knowledge and expertise of hematologists in the management of ibrutinib-related toxicities that may result in an improved long-term outcome of pts with CLL.

3.
Blood ; 138:4684, 2021.
Article in English | EMBASE | ID: covidwho-1582352

ABSTRACT

Introduction Ibrutinib is the only once-daily Bruton's tyrosine kinase (BTK) inhibitor with significant survival benefit vs chemo- and /or immunotherapy in multiple phase 3 studies of patients (pts) with chronic lymphocytic leukemia (CLL). It has profoundly changed the treatment landscape of CLL with the longest follow-up. However, seven years (yrs) after ibrutinib was approved in Italy by regulatory agencies for CLL treatment, available data on the patterns of care of such pts in the setting of clinical practice is limited. Herein we present the first interim analysis (IA) of EVIdeNCE (ClinicalTrials.gov Identifier: NCT03720561), a multicenter, observational clinical study designed to describe the current management of pts receiving ibrutinib in real-world setting in Italy in terms of retention rate: the study's primary end point. Methods EVIDENCE 312 treatment-naïve (TN) 38% and relapsed/refractory (R/R) 62% pts with CLL according to the iwCLL diagnosis criteria observed at 39 Italian hematological institutions in the period between November 2018 and October 2019. Inclusion criteria were treatment with ibrutinib according to the European Summary of Product Characteristics as per routine clinical practice started within the previous 3 months. The purpose of this IA is to provide demographics and disease characteristics at baseline and a preliminary evaluation of ibrutinib retention rate after one year of follow-up, along with its safety profile. Results The median age of pts at the time of ibrutinib initiation was 71.0 yrs (range 41.0-89.0), with 60% ≥70 yrs, 63.2% male, and 90% with Eastern Cooperative Oncology Group (ECOG) performance 0-1. Baseline Rai stage 0-I, II, and III-IV accounted for 18.3%, 29.7% and 52.1% pts, respectively. Patients in stage IV were observed in 40% of the R/R and 27% in TN subgroup. Considering 120 pts with known mutational status, del(17p) and/or TP53 mutation were present in 50.0% of pts (TN=52.1%, R/R=48.6%), while IGHV was unmutated in 35.0% (TN=33.3% and R/R=36.15) and mutated in 15.0% (TN=14.6%, R/R=15.3%). At baseline, 62.9% of pts had comorbidities and 30.6% presented with a history of cardiovascular diseases (CVDs). A CIRS score ≥6 was observed in 28.5% of pts. The median time from CLL diagnosis to the start of ibrutinib was 5.1 yrs (TN 1.75 yrs vs R/R 7.27 yrs). At least 1 treatment-emergent adverse event (TEAE) of any grade was experienced by 70.7% of pts. Frequencies were as follows: infections (30.8%;COVID-19 infections 3.2%), arthralgia (10.8%), neutropenia (9.3%), fatigue (8.4%), diarrhea (7.7%), atrial fibrillation (7.4%;grade 3-4, 4.2%), fever (7.1%), rash (6.4%), anemia (6.1%) and hypertension (4.2%). Mild bleeding TEAEs were reported in 16.1% of pts with no major bleeding event. TEAEs were more frequent in the elderly (≥65 yrs) while no significant differences in the rate of TEAEs were recorded in TN and R/R pts (69.7% vs 71.4%, respectively). Serious TEAEs were reported in 21.9% of pts. Overall in intention to treat (ITT), 32 deaths (10%) were observed (TN=8, R/R=24). The most common causes of death were infections (3.5%) and progressive disease (PD) (1.9%). Permanent discontinuation was observed in 56 (18%) of the pts (TN=17.2%, R/R=18.7%) and it mostly occurred within the first 6 months. Main causes of discontinuation were toxicity (6.1%), PD (3.8%) or death (3.5%). Temporary interruptions (≤ 3 months without therapy and/or dose modifications) during the whole observation period occurred in 30.3% (TN=35.3%, R/R=27.2%) and 37.7% (TN=37.5%, R/R=37.8%) of pts, respectively, mainly determined by toxicity and clinical judgment. Finally, in this first IA after 17.3 months (range 1.1 - 27.0) median follow-up, the ibrutinib retention rate (calculated as the ratio between the number of patients who retained ibrutinib treatment over the total number of patients at risk) at 1-year was 81.9% [95% confidence interval (CI), 77.2% - 86.1%] with no difference between TN 83.2% (95% CI, 75.2% - 89.4%) and R/R 81.2% pts (95% CI, 74.9% - 86.4%). Conclusions EVIDENCE is the irst real-world study of ibrutinib use in CLL clinical practice in Italy. Ibrutinib retention rate at one-year suggests a better knowledge and expertise of hematologists in the management of ibrutinib-related toxicities that may result in an improved long-term outcome of pts with CLL. Disclosures: Molica: Janssen: Consultancy, Honoraria;Abbvie: Consultancy, Honoraria;Astrazeneca: Honoraria. Scarfo: Astra Zeneca: Honoraria;Abbvie: Honoraria;Janssen: Honoraria, Other: Travel grants. Murru: Abbvie: Consultancy, Honoraria, Other: travel and accommodation;Janssen: Consultancy, Honoraria. Sportoletti: AstraZeneca: Consultancy, Honoraria;Janssen: Consultancy, Honoraria;AbbVie: Consultancy, Honoraria. Frigeri: Celgene: Consultancy, Speakers Bureau;Abbvie: Speakers Bureau;Janssen: Consultancy, Speakers Bureau;Amgen: Speakers Bureau. Sanna: Janssen: Consultancy;Abbvie: Consultancy;Astra Zeneca: Consultancy. Coscia: Janssen: Honoraria, Other, Research Funding;AbbVie: Honoraria, Other;AstraZeneca: Honoraria;Gilead: Honoraria. Reda: Abbvie: Consultancy;Astra Zeneca: Consultancy;Beigene: Consultancy;Janssen: Consultancy. Tafuri: Novartis: Research Funding;Roche: Research Funding;Celgene: Research Funding. Grugnetti: Janssen: Current Employment. Magarotto: Janssen: Current Employment. Mauro: Tskeda: Consultancy, Honoraria;Gilead: Consultancy, Honoraria;Janssen: Consultancy, Honoraria, Speakers Bureau;Abbvie: Consultancy, Honoraria, Speakers Bureau;Roche: Consultancy, Honoraria;Astra Zeneca: Consultancy, Honoraria, Speakers Bureau.

4.
International Journal of Stroke ; 16(2 SUPPL):189-190, 2021.
Article in English | EMBASE | ID: covidwho-1554576

ABSTRACT

Background and Aims: Early treatment greatly reduces the negative effects of stroke. The pandemic in the last period has dramatically affected stroke care around the world. Worldwide there was a reduction in hospitalizations, thrombolysis, mechanical thrombectomies. In Italy is was the same: reduction in hospitalizations for strokes, thrombolysis, while the number of mechanical thrombectomies remained unchanged. Sardinia an Italian island with about one and a half million inhabitants have 3 Stroke Units. The Stroke Unit of Sassari one of the three guarantees treatment for the whole of northern Sardinia, about 500,000 inhabitants. Methods: We analyzed hospitalizations, thrombolysis and mechanical thrombectomies in 2020, the year of the pandemic, and 2019, the previous year, at Sassari Stroke Unit Results: In our hospital, the number of hospitalizations for stroke in 2020 decreased compared to 2019 (535vs475) but unlike the rest of the world and Italy, the number of thrombolysis remained constant, the number of mechanical thrombectomies increased. In 2019, thrombolyses were 109 while in 2020, 111;thrombectomies in 2019 were 20, in 2020, 29. Conclusions: Many Stroke Units during the pandemic were converted into Covid structure. In Sassari throughout 2020, stroke patients had always a preferential code both in the case of suspected Covidrelated and unrelated pathology. Our Stroke unit remained unchanged as number of health workers. Probably due to this reason thrombolyses and mechanical thrombectomies has not suffered any deflections despite the pandemic. It is essential to maintain adequate care conditions for stroke patients even during the pandemic to reduce the risk of mortality and disability from stroke.

6.
Emerg Infect Dis ; 27(3): 749-758, 2021 03.
Article in English | MEDLINE | ID: covidwho-1054978

ABSTRACT

The Faroe Islands was one of the first countries in the Western Hemisphere to eliminate coronavirus disease (COVID-19). During the first epidemic wave in the country, 187 cases were reported between March 3 and April 22, 2020. Large-scale testing and thorough contact tracing were implemented early on, along with lockdown measures. Transmission chains were mapped through patient history and knowledge of contact with prior cases. The most common reported COVID-19 symptoms were fever, headache, and cough, but 11.2% of cases were asymptomatic. Among 187 cases, 8 patients were admitted to hospitals but none were admitted to intensive care units and no deaths occurred. Superspreading was evident during the epidemic because most secondary cases were attributed to just 3 infectors. Even with the high incidence rate in early March, the Faroe Islands successfully eliminated the first wave of COVID-19 through the early use of contact tracing, quarantine, social distancing, and large-scale testing.


Subject(s)
COVID-19/epidemiology , Contact Tracing , Physical Distancing , Quarantine , Adolescent , Adult , Aged , COVID-19/prevention & control , Child , Child, Preschool , Denmark/epidemiology , Epidemics , Female , Hospitalization , Humans , Incidence , Infant , Infant, Newborn , Male , Middle Aged , Young Adult
7.
Bulletin Epidemiologique Hebdomadaire ; 29:582-588, 2020.
Article in French | CAB Abstracts | ID: covidwho-958702

ABSTRACT

Introduction - In French Guiana, the French Red Cross (CRf), Doctors of the World (MdM) and the Permanence d'acces aux soins de sante (Pass) of Cayenne Hospital caring for precarious people during lockdowns, observed difficulty in access to food. So, they decided to conduct a survey to quantify food insecurity among their recipients. Materials and methods - This survey was based on face-to-face questionnaires proposed to any adults visiting the care center of CRf or MdM or Pass situated in Cayenne and its surroundings. The questionnaire measured the household food insecurity using 3 tools: food consumption score (FCS), Coping Strategies Index (rCSI) and Household Hunger Scale (HHS). Results - Two hundred and twenty-one households were included in the survey. The results demonstrated that two in five households had insufficient food consumption in the seven past days and over 80% of households suffered from hunger during the past month. To overcome the problem of food shortages, 36% of households adopted severe coping strategies likely to have negative long-term effects. For most of the households assessed, the weekly food budget had fallen during COVID-19 crisis and nearly half of households had 30 euros or less to feed the whole family. Discussion and conclusion - The survey conducted among people visiting the care centers near the precarious neighborhoods of Cayenne and its surroundings documented the real and alarming food insecurity of the households investigated. More studies would be needed to assess the impact of the COVID-19 crisis on household food and nutrition insecurity in French Guiana.

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