ABSTRACT
Background: Soon after the Italian Medicine Agency (AIFA) authorized the first mRNA COVID-19 vaccine, BNT162b2 (ComirnatyR), the Italian Ministry of Health launched a national vaccination campaign. Giving the high risk of mortality from COVID-19, cancer patients were considered a priority group. However, data about BNT162b2 safety in this population are still lacking and the impact on patients' psychological state and social life was not studied. Herein we describe the adverse events (AE) related to the vaccine and the subjective experience of cancer patients treated and vaccinated at San Luigi Gonzaga University Hospital. Materials and methods: All cancer patients who accepted to participate in our campaign were vaccinated with BNT162b2 and included in the descriptive analysis. Patients who tested positive for COVID-19 after January 1st, 2021 were not recruited. An anonymous questionnaire about AE and psycho-social impact of the vaccination was administered to the study population 21 days after the first dose. The short-term AE reported after the second dose were investigated via a telephone questionnaire. Results: A total of 997 patients were included in the study, of whom 618 were affected by advanced cancer. At the time of the vaccination, 223 patients were receiving chemotherapy and/or immunotherapy. 49 patients have been infected and recovered from COVID-19. AE were reported in 37.3% cases after the first dose and in 48.5% cases after the second dose. The most common AE were muscle pain (26.7% and 27.4%, after the first and second dose respectively) and fatigue (10.4% and 16.8%). No severe AE had been reported. Before receiving the vaccine, 18% patients felt fearful and/or insecure about the vaccination, while 76.4% felt hopeful and/or enthusiast. After the first dose, 57.5% patients changed their feelings positively and 79.5% patients stated to feel much more confident in their social life. Patients' opinion about the vaccination was mainly influenced by the specialist/family doctor (38.7%) and by mass-media (25.8%), and the information they were given was considered adequate by 86% patients. Conclusions: Our data support the short-term safety of BNT162b2 in cancer patients, regardless of the disease staging and the concurrent treatment. Before the vaccination, most of our patients consulted the specialist or the family doctor receiving adequate information and being reassured. Moreover, the vaccination showed a positive psychological and social impact.
ABSTRACT
Background: Since Sars-Cov2 infection (COVID-19) has rapidly spread around the world, Italy has quickly become one of the most affected countries. Patients (pts) with thoracic malignancies had the highest frequency of severe complications. Healthcare systems introduced strict infection control measures to ensure optimal cancer care. This study aimed to investigate the efficacy of pre-procedure screening for COVID-19 and whether infection influenced the opportunity of patients to receive timely diagnosis and therapy. Material (patients) and methods: We retrospectively collected data of oncological procedures of pts with confirmed or suspected thoracic malignancies, treated at Oncology Dept or coming from Emergency Dept of San Luigi Gonzaga Hospital between Jun 2020 and Mar 2021 (from the end of the 1st wave until the middle of the 3rd one). Outpatients were evaluated by a nasopharyngeal swab (NPS) performed 24/48 hours before procedures. Inpatients were tested by NPS before and after hospitalization according to a predetermined schedule. 125 pts were included in this analysis. Median age was 72 years;males were 64%. ECOG Performance Status was 0-1 in 90% of pts. Histological types were: NSCLC (86.4%), SCLC (7.2%), mesothelioma (5.6%), amartochondroma (0.8%). Stages IV were 80%. 135 procedures were performed: 102 were diagnostic (75 lung biopsies, 21 bronchoscopies, 1 lumbar puncture, 2 thoracoscopies, 1 thoracentesis, 1 gastroscopy and 1 thoracic surgery), 25 palliative and 8 therapeutic. 89 and 46 procedures were performed in outpatients and inpatients, respectively. Of the 132 NPS performed, 8 were found to be positive. Positive pts were infected during the 2nd wave (from Nov 2020 to Jan 2021). One patient was infected during hospitalization, the other ones in community. Most of pts were asymptomatic, only 2 had mild symptoms. 6 procedures (4.4%) were postponed (5 diagnostic, 1 palliative), an explorative bronchoscopy was canceled and a diagnostic biopsy was performed even though the patient tested positive. The median time to resolution of the infection was 17 days (range 11-36). The median delay of the procedures was 36 days (range 14-55). 4 patients started systemic treatment in a median time of 40.5 days (range 21-57). Conclusions: Our analysis pointed out that Sars-Cov2 infection led to the postponement of a small but not negligible number of diagnostic and therapeutic procedures and that a structured screening for COVID19 is critical for the best management of scheduled procedures during pandemic.