ABSTRACT
Introduction: The CHOICE study was primarily designed to capture CLL patients' (pts) preferences towards different treatment attributes through a Discrete Choice Experiment (DCE) in Italy. This study was carried out in the period Feb-Jul 2020, during the 1st wave of COVID19 pandemic, and provides an insight of the pts' perception. about treatments available in CLL (1-2). Methods: This cross-sectional multicenter observational study enrolled, WATCH&WAIT (W&W) or TREATED CLL pts (~50% each, controlled at site level). Exclusion criteria were inability to take oral drugs, cognitive disorders that could impair questionnaire's comprehension and concomitant therapy for other malignancies. Pts were asked to fill in aDCE Questionnaire, composed of 9/10 blocks (for W&W/TREATED respectively) each composed of 8 comparisons between 2 profiles with the following attributes: treatment and relevant duration, PFS, risk of infection, risk of organ damage, risk of diarrhea (levels specified in Figure 1). Each pt was centrally assigned to 1 block of 8 comparisons. Pts could ask questionnaire explanations to the medical staff, but they were asked to self-complete it. Results: 401 pts from16 centers were enrolled in the study,199 W&W and 198 TREATED pts completed the questionnaire and were considered evaluable. Main pts' characteristics are shown in Table 1. Of the 198 TREATED pts, 73.7% were ON-treatment (30.8% 1st-line, 69.2% further lines) while 26.3% were OFF-treatment. W&W pts rated as the most attribute of treatment important the 'Possibility of infections' (relative importance, RI=36.2%), followed by 'Treatment and Relevant duration' (RI=28.0%) and 'PFS' (RI=16.9%). (Figure1A). When stratifying pts by geography, W&W pts from the North regions (more impacted during the 1st wave) rated as most important the 'Treatment and Relevant duration' (RI=40.3%) followed by the 'Possibility of infection' (RI=27.2%). Pts from the Center-South regions rated as most important the 'Possibility of infection' (RI=43.4%) followed by the 'Possible occurrence of Organ damage' (RI=21.6%). TREATED pts gave more importance to the 'Treatment and relevant duration' (RI =33.3%) followed by the 'Possibility of infections' (RI =28.8%) (Figure1B) with no difference between patients from the north and center-south areas. Conclusions: Unlike other DCE studies available in the current literature (1-2), the results of the CHOICE study may have been influenced by the pandemic. While the essential attribute in pre-pandemic DCE studies was the PFS, the most important attribute in DCE studies conducted during the first pandemic wave was represented by the infection concerns. Hospital access constraints, the necessity for personal protective equipment, and social distance may have influenced patient responses. (Table Presented).
ABSTRACT
Introduction: All the available CLL therapies differ for relevant aspects as duration of response, mode of administration, treatment duration and adverse events: the CHOICE study was designed to investigate CLL patients' Quality of Life (QoL) and preferences towards different treatment attributes through a Discrete Choice Experiment (DCE) in Italy. Due to the timeline of the study, started in Feb2020, the collected data offer an insight of patients' perception and attitude during the 1 st wave of the COVID-19 pandemic, as opposed to other DCE results available in CLL (1-2). Methods: This cross-sectional multi-center observational study enrolled patients (pts) with CLL, WATCH&WAIT (W&W) or already TREATED (around 50% each, controlled at site level), who signed the informed consent for study participation. Exclusion criteria were inability to take oral drugs, cognitive disorders that could impair questionnaire's comprehension and concomitant therapy for other malignancies. Pts were asked to fill in 3 QoL questionnaires: EQ-5D-5L, EORTC QLQ-C30, QLQ CLL-16, described elsewhere. DCE Questionnaire was composed of 9/10 blocks (for W&W/TREATED, respectively) each composed of 8 comparisons between 2 profiles with the following attributes: “Treatment and relevant duration”, “PFS”, “Possibility of infections”, “Possible occurrence of organ damage”, “Possible occurrence of diarrhea”, with levels specified in Fig1. Each patient (pt) was centrally assigned to 1 block of 8 comparisons. Each pt could ask questionnaire explanations to the medical staff but self-completed it on an App specifically developed for the study. Results: 401 pts were enrolled in Italy across 16 centers (Feb-Jul 2020),199 W&W and 198 TREATED pts completed the DCE questionnaire and were included in the evaluable population. Main pts' characteristics are shown in Table 1. 73.7% of TREATED pts were ON-treatment (30.8% in 1st-line, 69.2% in further lines) and 26.3% were OFF-treatment. DCE results showed that W&W pts rated as most important the ‘Possibility of infections’ (relative importance, RI=36.2%), followed by ‘Treatment and Relevant duration’ (RI=28.0%), ‘PFS’ (RI=16.9%), while ‘Possible occurrence of organ damage’ (RI=12.5%) and ‘Possible occurrence of Diarrhea’ (RI=6.4%) had lower impact on the preference (Fig 1A). DCE in TREATED pts showed that they gave more importance to ‘Treatment and relevant duration’ (RI =33.3%) followed by ‘Possibility of infections’ (RI =28.8%). The RI of the other attributes was lower: ‘Possible occurrence of organ damage’ (RI =19.4%), ‘PFS’ (RI =9.8%), ‘Possible occurrence of diarrhea’ (RI =8.7%, Fig 1B). A sub-analysis stratifying pts from Northern regions (more impacted during the 1 st wave of the pandemic) and Center-Southern regions showed that in W&W pts from North Regions the attribute with a higher impact is ‘Treatment and Relevant duration’ (RI=40.3%) followed by ‘Possibility of infection’ (RI=27.2%), while in W&W pts from Central-Southern area, the attribute with a higher impact is ‘Possibility of infection’ (RI=43.4%) followed by ‘Possible occurrence of Organ damage’ (RI=21.6%). In TREATED pts no difference between the 2 groups has been shown and the results are consistent with the total population. Conclusions: CHOICE study was planned to understand CLL patients' preferences towards different treatment attributes, but the results have been impacted by the concurrent COVID-19 pandemic. In contrast to previously published DCEs (1-2), where PFS was the most important attribute, in the CHOICE study pts put much more emphasis on their concerns about possible infections: this could be due to the influence of the 1 st Covid-19 pandemic wave, with the relevant feeling of uncertainty, also due to the great attention that media has dedicated to the issue of infection in general, especially for vulnerable individuals such as CLL pts. The limitation in hospital access during the 1 st wave and the overall need of personal protection (masks usage) and s cial distancing might have influenced patients' responses too. The “infodemic” and the uncertainty had probably such a strong effect on patient's feelings, that PFS was no longer the most important attribute being substituted by the fear of hospitals access and infections. We thereby suggest that the pandemic had a great impact not only on the conduct of the study but also on patients' perception of their disease, if not properly reassured. [Formula presented] Disclosures: Molica: Astrazeneca: Honoraria;Abbvie: Consultancy, Honoraria;Janssen: Consultancy, Honoraria. Laurenti: AbbVie: Consultancy, Honoraria, Research Funding;Gilead: Honoraria;Roche: Honoraria, Research Funding;Janssen: Consultancy, Honoraria;AstraZeneca: Consultancy, Honoraria;BeiGene: Honoraria. Ghia: Gilead: Consultancy, Research Funding;Celgene/Juno/BMS: Consultancy, Honoraria;BeiGene: Consultancy, Honoraria;ArQule/MSD: Consultancy, Honoraria;AstraZeneca: Consultancy, Honoraria, Research Funding;Acerta/AstraZeneca: Consultancy, Honoraria, Research Funding;AbbVie: Consultancy, Honoraria, Research Funding;Janssen: Consultancy, Honoraria, Research Funding;Roche: Consultancy, Honoraria;Sunesis: Research Funding. Coscia: Gilead: Honoraria;Janssen: Honoraria, Other, Research Funding;AstraZeneca: Honoraria;AbbVie: Honoraria, Other. Cuneo: AstraZeneca: Consultancy, Speakers Bureau;Janssen: Consultancy, Speakers Bureau;Gilead: Consultancy, Speakers Bureau;AbbVie: Consultancy, Speakers Bureau. Gaidano: Beigene: Honoraria;Janssen: Honoraria, Speakers Bureau;AstraZeneca: Honoraria;AbbVie: Honoraria, Speakers Bureau;Incyte: Honoraria. Mauro: Takeda: Consultancy, Speakers Bureau;Gilead: Consultancy, Research Funding, Speakers Bureau;Roche: Consultancy, Speakers Bureau;Janssen: Consultancy, Speakers Bureau;AstraZeneca: Consultancy, Speakers Bureau;AbbVie: Consultancy, Speakers Bureau. Pane: AbbVie;Amgen;Novartis: Other: Travel, accommodation, expenses;AbbVie;Amgen;Novartis, GSK, Incyte: Speakers Bureau;Novartis Pharma SAS;: Research Funding;AbbVie;Amgen;Novartis, GSK, Incyte: Consultancy. Gualberti: AbbVie: Current Employment. Iannella: AbbVie: Current Employment. Finsinger: AbbVie: Current Employment. Caira: AbbVie: Current Employment. Sportoletti: AstraZeneca: Consultancy, Honoraria;Janssen: Consultancy, Honoraria;AbbVie: Consultancy, Honoraria.
ABSTRACT
Background: From March to May of the current year, the Department of onco-hematology of “Guglielmo da Saliceto” hospital of Piacenza vaccinated 108 haematological patients with a m-RNA vaccine, either Pfizer- BionNTech or Moderna. The aim of this study is to investigate the efficacy and safety of COVID-19 vaccine Materials and methods: This is an observational study. We analyzed the humoral immune response by antibody titer (IgG) at baseline (T0) and 4-6 weeks after the first dose of vaccine (T1). We evaluated whether age, sex, hematologic disease, previous bone marrow transplant, past COVID-19 infection and antitumor treatments interfere with the development of the humoral immune response evaluated with an anti-SARS-CoV-2 IgG ChemiLuminescent ImmunoAssay (LIAISON SARS-CoV2 S1/S2 IgGDIASORIN Inc.) measured in AU/ml. An antibody level 315 AU/ml was considered relevant. Results: From the 108 patients enrolled, 87 patients with median age of 65 years (IQR 58-71) have T1 IgG determination available of which 51 patients (58,62%) seroconverted, with IgG median value of 254 AU/ml (IQR 98,1-385 AU/ml), whereas 36 patients (41,38%) did not, with IgG median value of 3.8 AU/ml (IQR 3.8-4,5 AU/ml). Being on active anticancer treatment at the time of vaccination (p 0,03), especially on anti-CD20 monoclonal therapy (p 0.001), showed a statistically significant effect on seroconversion in univariate analysis, while age over 60 years and sex (male vs female) are near to be significant (respectively p 0.05 and p 0.06). Hematologic disease and previous bone marrow transplant (without differentiate between allo-HSCT and auto-HSCT) seem not to influence the immune response. In multivariate analysis, only anti-CD20 monoclonal therapy deeply reduces the probability of seroconversion (99,97%, p 0.003). The latter does not seem to be influenced by age, sex and active therapy (including all the remaining immunomodulant or immunosuppressor treatments). None of the patients had adverse reactions to vaccine, neither allergic nor immunological. Conclusions: More than half of the patients seroconverted. Active antitumor therapy, especially anti-CD20 monoclonal antibody, seems to have a negative effect on seroconversion. We are actually testing the cell-mediated immune response to prove the efficacy of COVID vaccination also in those immunocompromised subjects who did not seroconverted. The m-RNA vaccines seem to be safe in patients with immune deficiency.