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: At the end of 2019, a novel viral pneumonia, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was described in China. Since then, Italy has soon become one of the most affected countries. In this challenging situation, the oncological community was called to protect cancer patients (pts), especially those affected by lung cancer, considered one of the most vulnerable population due to older age, multiple comorbidities and type of infection. This study aimed to investigate the clinical management of NSCLC pts, in order to provide a reliable picture of real-word practice during the COVID-19 outbreak. Materials and Methods: A 29-questions survey focusing on the clinical management and therapeutic indications for NSCLC pts during COVID-19 pandemic was sent to 95 medical/thoracic oncologists across different Italian regions. Results: From April 12th to May 2nd, 79 responses were received, with an overall response rate of 83%. The majority (77.3%) of oncologists declared a significant change in the outpatient management of NSCLC pts. The number of consultations in case of suspected NSCLC decreased in about half of cases (46.8%), with a major reduction when considering the number of pts coming from the emergency department for a first oncological evaluation (60% of cases). The total number of pts with any stage, newly diagnosed NSCLC, within the observational period, was reported to be lower than the pre-pandemic era by the 56% of oncologists. For pts candidates to adjuvant chemotherapy and concurrent chemoradiation, the therapeutic indications followed guidelines in 62% and 72% of cases, respectively. As regards the metastatic disease, the majority of oncologists confirmed their clinical indication to first-line treatment. The collected data revealed major changes in the second line therapeutic options, most related to timing and schedules of administration. Lung cancer pts' accrual in clinical trials dramatically has fallen for 79% of oncologists and follow-up consultations were mostly managed by telemedicine. Conclusions: This survey showed that Italian oncologists are determined to follow the available guidelines for the clinical management of NSCLC pts during this emergency time, while more complicate is to deal with clinical trials. In this tough landscape, telemedicine provides a valid support to facilitate patient-healthcare interactions.