ABSTRACT
Background: The severe, acute respiratory syndrome, coronavirus 2 (SARS-CoV-2), leading to coronavirus-19 (COVID-19), was detected for the first time in Wuhan, China in December 2019. In general, governments and health authorities have taken precautions during the COVID-19 pandemic to reduce viral spread and protect vulnerable citizens. Patients with multiple myeloma (MM) have an increased risk of being infected with COVID-19 and developing a fatal course due to the MM-related immunodeficiency (Glenthøj, A et al. PMID: 32939853). To some extent, the COVID-19 pandemic has changed standard of care towards extended use of oral regimens and limiting hospital visits (Terpos E et al.PMID: 32444866). We aimed to investigate the quality of life (QoL) of Danish patients with MM during the COVID-19 pandemic. We hypothesized that patients living alone and those under the age of 65 years, as a consequence of the pandemic, would experience impaired QoL due to social isolation and fear of infection with SARS-CoV-2. Methods: The Danish prospective, nation-wide, observational survey “Quality of life in Danish patients with multiple myeloma” (QoL-MM) (Nielsen LK et al. PMID: 30656677) framed our study. In QoL-MM, survey data are obtained at enrolment and subsequently at 12 follow-up time points over a two-year period. The following PRO questionnaires are used;the cancer-generic instrument of European Organisation for Research and Treatment of Cancer Quality of life (EORTC) QLQ-C30 (EORTC QLQ-C30), the Multiple Myeloma module QLQ-MY20 (EORTC QLQ-MY20), the Chemotherapy-Induced Peripheral Neuropathy module (EORTC QLQ-CIPN20) and the Short-form health survey version 2 (SF12v2). In the present study, a subpopulation of the QoL-MM cohort was constructed, based on the response time of the questionnaires. QoL was compared using patient-reported outcome (PRO) data obtained before and during the COVID-19 pandemic at group level. In a Danish context, first wave was defined as April to June 2020 and the second wave as November 2020 to January 2021. The QoL data were analyzed using mixed effects linear regression, with a year-period-interaction. Pre-COVID versus COVID mean domain score difference was considered evident, if the difference was both statistically significant (p-value <0.05) and clinically relevant, using minimal important difference (MID) defined as 0.3 standard deviation of the mean score. Results: The study included 616 patients (63% newly diagnosed and 37% relapsed) with a mean age of 68.2 years (standard deviation, 9.2);40% were females;76% were married/cohabiting, and 24% single. Questionnaire completion rates during the investigated periods were between 96% and 97%. In total, 1,685 completed sets of questionnaires were included in the analyses. The patients reported no statistically significant and clinically relevant difference in QoL during the first and second waves of the COVID-19 pandemic, compared to one year earlier, see table 1. When analyzing the subpopulations, we found that patients below 65 years reported improved physical health summaries (p-value 0.016), decreased fatigue (p-value < 0.001), less insomnia (p-value 0.002) and improved role functioning (p-value <0.001) during the first wave, reaching both statistical significance and the threshold of MID. The group of patients living alone reported improved role functioning during the first wave, reaching both statistical significance (p-value <0.001) and the threshold of MID. These findings were not evident during the second wave, see table 1. Conclusion: As a group, Danish patients with MM did not report impaired QoL during the COVID-19 pandemic. In contrary, we observed improvements in some domains in patients below 65 years. Our observations indicate that the patients with MM have felt cared for and in good hands during the first and second waves of the COVID-19 pandemic. However, part of the reason for our finding of no negative impact on QoL by the pandemic could be that the questionnaires used were not developed to capture the impact of the pandemi on QoL. Importantly, our results suggest that QoL data collected in clinical trials during the pandemic allow interpretation without adjusting for the impact of the pandemic. [Formula presented] Disclosures: Redder: Janssen-Ciliag: Research Funding. Frederiksen: Alexion: Research Funding;Gilead: Research Funding;Abbvie: Research Funding;Janssen Pharmaceuticals: Research Funding;Novartis: Research Funding. https://www.qualitymetric.com/health-surveys/the-sf-12v2-pro-health-survey/
ABSTRACT
Background: In December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was detected for the first time in Wuhan, China, causing the coronavirus disease 2019 (COVID-19). Mortality rate in patients with multiple myeloma (MM) hospitalized due to COVID-19 has been reported to be 50% higher compared to non-cancer patients. The COVID-19 pandemic has resulted in adaption of myeloma care recommendations including key principles of limiting hospital visits by use of telemedicine communication and to use oral agents as much as possible and/or allowing treatment breaks. To mitigate the risk of COVID-19 spreading, extensive national lockdowns have been practiced and patients and caregivers have been encouraged to practice social distancing. Aims: The aim was to investigate the impact of the first and second wave of the COVID-19 pandemic on quality of life (QoL) in Danish patients with MM. Methods: The study was designed as a cross-sectional study comparing QoL in patients with MM using data obtained the year before the pandemic (pre-COVID) as a reference in comparison to the COVID period. In a Danish context, first wave was defined as April to June 2020 and the second wave as November 2020 to January 2021. The survey data originates from an ongoing cohort study, "Quality of life in Danish Multiple Myeloma patients" (QoL-MM), which is a Danish prospective, nationwide, observational survey, initiated in February 2017. Survey data are obtained at enrolment and subsequently at 12 follow-up time points over a two-year period including 24 QoL domains assessed by the European Organisation for Research and Treatment of Cancer Quality of life QLQC30, the Multiple Myeloma module QLQ-MY20, the Chemotherapy- Induced Peripheral Neuropathy module and the Short-form health survey version 2. The QoL data was analysed using mixed effects linear regression, with a year-period-interaction. Pre-COVID versus COVID mean domain score difference was considered evident, if the difference was both statistically significant (p-value <0.05) and clinical relevant using minimal important difference defined as 0.3 standard deviation of the mean score of all included 2019 answers. For data validation, the mean scores of the pre-COVID period were compared to the mean scores for 2018. Results: In the study, 616 patients was included (63% newly diagnosed and 37% relapsed) with a mean age of 68.2 years (standard deviation 9.2). Females represent 40% of the population. Seventy-six percent were married/ cohabiting, 24% single. The completion rates during the investigated periods were between 94% to 97%, and a total of 2,576 completed sets of questionnaires were included in the analyses. The Danish MM patients reported no statistical significant and clinical relevant difference in QoL during the first or second wave of the COVID-19 pandemic compared to one year earlier. Summary/Conclusion: Patients with MM infected by COVID-19 are in increased risk of dying and the pandemic has to some extent affected the usual clinical care program and caused restrictions in their everyday living. However, the pandemic does not seem to impact the patients′ reporting's of QoL. A limitation, however, may be that the questionnaires used are not validated to capture psychosocial health during a pandemic. Still, our results is important as it documents that QoL collected in clinical trials during the pandemic allow interpretation without adjusting for the impacts of the pandemic.
ABSTRACT
BACKGROUND: Cancer patients are vulnerable to infections, are older and often have comorbidities in comparison to the general population, which increases the risk for severe outcomes related to COVID-19 diagnosis. METHODS: This study is a prospective, nationwide study in patients with solid cancer and SARS-CoV-2 infection included between 10 March to 15 June 2020. Patient's baseline characteristics were collected. The study's primary outcome was overall survival within 30 days of verified SARS-CoV-2 infection. Secondary outcomes were hospital admission, admission to an ICU, and need for supplemental oxygen. RESULTS: A total of 112 patients with a cancer diagnosis and verified SARS-CoV-2 infection were identified. After one month of follow up, hospitalization was required for 54% (n = 61) and 21% of the patients had died and 14 of the 23 deceased cancer patients were ≥70 years. Most patients were classified with mild COVID-19 symptoms (66%, n = 74); however, 48% (n = 23) of the ≥70-year-olds patients were classified with severe or critical COVID-19 symptoms. Among the total study population, 61% (n = 68) had comorbidities and comorbidity were more frequently observed among the deceased (91%, n = 21) and older cancer patients (≥70 years, 81%, n = 39). CONCLUSIONS: Acknowledging the low sample size in this study, our work shows that age and comorbidities, but not recent cytotoxic therapy, are associated with adverse outcomes of SARS-CoV-2 infection for patients with solid cancer. Particularly, patients with progressive disease seem to be at greater risk of a fatal outcome from COVID-19.HighlightsAge, performance status, and comorbidities are strong predictors of adverse outcome in cancer patients with SARS-CoV-2 infection.Patients with progressive cancer disease seem to be at greater risk of a fatal outcome from COVID-19.Recent cytotoxic therapy, however, did not seem to be associated with increased risk for adverse outcomes of SARS-CoV-2 infection for patients with solid cancer.