If you don't remember your password, you can reset it by entering your email address and clicking the Reset Password button. You will then receive an email that contains a secure link for resetting your password
If the address matches a valid account an email will be sent to __email__ with instructions for resetting your password
The first report on coronavirus disease 2019 (COVID-19) vaccine refusal by patients with solid cancer in Italy: Early data from a single-institute survey
Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, Rome, ItalyDipartimento di Medicina Clinica e Molecolare, Università La Sapienza di Roma, Rome, Italy
High mortality rate related to coronavirus disease 2019 (COVID-19) was observed in patients with cancer.
•
Cancer patients have high priority for COVID-19 vaccination for their vulnerability.
•
A refusal rate of 11.2% was found in our large cohort of eligible cancer patients.
•
Adequate information and clear regulatory decisions are required to promote vaccination.
Abstract
Introduction
Patients with cancer have an increased risk of complications from coronavirus disease 2019 (COVID-19) infection, including death, and thus, they were considered as high-priority subjects for COVID-19 vaccination. We report on the compliance with the COVID-19 vaccine of patients affected by solid tumours.
Materials and methods
Patients with cancer afferent to Medical Oncology 1 Unit of Regina Elena National Cancer Institute in Rome were considered eligible for vaccination if they were receiving systemic immunosuppressive antitumor treatment or received it in the last 6 months or having an uncontrolled advanced disease. The Pfizer BNT162b2 vaccine was proposed to all candidates via phone or during a scheduled visit. The reasons for refusal were collected by administrating a 6-item multiple-choice questionnaire.
Results
From 1st March to 20th March 2021, of 914 eligible patients, 102 refused vaccination (11.2%, 95% confidence interval [CI] 9.1–13.2). The most frequent (>10%) reasons reported were concerns about vaccine-related adverse events (48.1%), negative interaction with concomitant antitumor therapy (26.7%), and the fear of allergic reaction (10.7%). The refusal rate (RR) after 15th March (date of AstraZeneca-AZD1222 suspension) was more than doubled compared with the RR observed before (19.7% versus 8.6%, odds ratio [OR] 2.60, 95% CI 1.69–3.99; P < 0.0001). ECOG-PS 2 was associated with higher RR compared with ECOG-PS 0-1 (OR 2.94, 95% CI 1.04–8.34; P = 0.04). No statistically significant differences in RR according to other clinical characteristics were found.
Conclusions
Our experience represents the first worldwide report on the adherence of patients with cancer to COVID-19 vaccination and underlines how regulatory decisions and media news spreading could influence the success of the campaign.
Patients with cancer have an increased risk of complications from coronavirus disease 2019 (COVID-19) infection, including a mortality rate of 30% if hospitalised [
]. In Italy, the Ministry of Health and FOCE confederation of oncologists/cardiologists/haematologists work together to offer COVID-19 vaccine with high priority to frail patients affected by these diseases. The troubled authorisation iter of COVID-19 vaccines, such as occurred for AstraZeneca AZD1222, which was even suspended temporarily during 15th March to 19th March 2021 [
], and the great attention reserved by media to vaccine safety information, may influence adherence to vaccination. We report on the compliance of patients affected by cancer with COVID-19 vaccine based on a large population from a single institutional experience.
2. Materials and Methods
Accordingly to the government's plan, patients affected by solid tumour and afferent to Medical Oncology 1 Unit of Regina Elena National Cancer Institute in Rome were considered eligible for vaccination if they were receiving systemic immunosuppressive/myelosuppressive antitumor treatment or received it in the last 6 months or having an uncontrolled advanced disease. Pfizer BNT162b2 vaccine with a fixed schedule was proposed to all candidates by phone contact or during a scheduled visit. After receiving adequate information from the physicians on the benefits/risks ratio, patients who refused vaccination answer anonymously a 6-item multiple-choice questionnaire (Supplementary material) to collect the specific reasons for withdrawal. The survey was conducted according to the rules of the local ethics committee.
3. Results
From 1 st March to 20th March 2021, we proposed Pfizer BNT162b2 to 914 patients with cancer. Females were 61%, and the median age was 62 (range 21–97) years. Breast cancer (31.2%), lung cancer (19.7%), and melanoma (14.7%) were the most frequent (>10%) tumour subtypes. Most patients were on active treatment or received it within the last 6 months (96%), and 4% were under surveillance with progressive disease. Of 914 eligible patients, 102 refused vaccination (11.2%, 95% confidence interval [CI] 9.1–13.2). The most frequent (>10%) reasons reported were concerns about vaccine-related adverse events, negative interaction with concomitant antitumor therapy, and the fear of allergic reaction, recorded in 48.1%, 26.7%, and 10.7% of answers, respectively (Fig. 1A). The refusal rate (RR) after 15th March (date of AstraZeneca AZD1222 suspension) was more than doubled compared with the RR observed before (19.7% versus 8.6%, OR 2.60, 95% CI 1.69–3.99; P < 0.0001; Fig. 1B). ECOG-PS 2 was associated with higher RR compared with ECOG-PS 0-1(OR 2.94, 95% CI 1.04–8.34; P = 0.04). No statistically significant differences in RR according to other clinical characteristics were found (Table 1).
Fig. 1(A) Reasons reported by patients with cancer who refused COVID-19 vaccination in the questionnaire ∗.Others are self-reported reasons by patients (data not shown). (B) Refusal rate of COVID-19 vaccination in patients with cancer observed between 1st March and 14th March, 15th March and 20th March, and 1st March and 20th March. COVID-19, coronavirus disease 2019. No, number; Pts, Patients
To our knowledge, our experience represents the first worldwide report on the withdrawal rate of COVID-19 vaccination in patients with cancer.
A cross-sectional survey conducted on French patients with cancer before the starting of the vaccination campaign reported the unwillingness to get vaccinated in 16.6% of subjects [
]. The rate observed was higher than that reported in our study, which was otherwise based on effective withdrawals. Furthermore, in the French study, more than half of the patients were under surveillance or receiving hormone therapy in contrast with our study population mostly including patients on active treatment.
The overall RR of 11.2% observed in our study could be considered relevant if compared with that reported by the press for Italian health operators (ranges from 1% to 3.5%), even if this estimate seems to be in contrast with the peak of 11–15% reported by some regional authorities, such as in Lombardy and Puglia [
Interestingly, the RR had more than doubled after the ban of AZD1222-vaccine, demonstrating how decisions by the regulatory agencies and the news spreading by media could influence the willingness of the patient to get vaccinated. This increase of RR appears much higher than that (of 5 percentage points) reported by a pool conducted on a random sample from Italian people in the same period [
]. It is conceivable that patients with cancer could be more negatively influenced by information about vaccine safety because concerns related to their frailty were more elevated. In fact, the RR was also significantly higher in patients with poorer clinical conditions (ECOG-PS 2), although they represent a small subset of the study population.
Our survey study is affected by some limitations, such as the potential risk of underestimation due to untraceable patients, whose number was however limited, and the single institutional design. However, the large sample size permits a reliable estimate of the adherence of patients although external validation could be warranted for confirmation.
Given the vulnerability of patients with cancer for severe complications and mortality related to COVID-19, the dramatic drop of adherence to vaccination observed would translate into an unacceptably high cost in otherwise preventable deaths. Health care authorities have been called to action to overcome hesitancy on vaccination in the oncological and general population by promoting adequate education and psychological interventions [
]. To pursue a successful vaccination campaign, with the appropriate consideration for frail patients, we also suggest more clarity in the decisions by the regulatory agencies and more caution in the news spreading of potential safety alarm, whose release too often occurred before a valid scientific revision. Drug safety and information transparency should be guaranteed to avoid the diffusion of threatening uncertainty in public opinion.
Funding
No funding to declare.
Conflict of interest statement
V.D.N. received speaker’s fee by AstraZeneca, MSD, BMS, Istituto Gentili, Boehringer Ingelheim. V.D.N. received grant consultancies by AstraZeneca, MSD, BMS, Boehringer Ingelheim and travel fee from MSD and Boehringer Ingelheim. V.D.N. received institutional research grants from Roche. F.C. was a member of advisory board of GSK, Roche, AstraZeneca, and Eli-Lilly. F.C. received speaker’s fee by GSK, Roche, AstraZeneca, Eli-Lilly, Novartis, Amgen, Pfizer, MSD, BMS, Astellas, and Eli-Lilly. All remaining authors have declared no conflicts of interest.
Acknowledgements
The authors thank medical oncologists, residents, nurses, hospital pharmacists, and data managers (all affiliated with Medical Oncology of Regina Elena National Cancer Institute, Rome, Italy) for their commitment to the COVID-19 vaccination campaign for patients with cancer. The authors thank the patients afferent to our Unit and their families.
Appendix A. Supplementary data
The following is the Supplementary data to this article:
Patients with active cancer may have a higher risk of severe complications to COVID-19 due to their disease, to cancer treatment, age and comorbidities [1]. They have been excluded from the pivotal clinical trials for COVID19 vaccines despite included in the priority category for COVID19 vulnerability [1]. Few data are available on efficacy and safety profiles of vaccines against SARS-CoV-2 in patients with cancer, resulting in imprecise predictive health models [2,3]. Recently the first analysis has been reported on the efficacy of SARS-CoV-2 vaccine in the context of a prospective study enrolling patients and health care workers who received the RNA-based SARS-CoV-2 BNT162b2 vaccine ‘BNT162b2’, with and without the second booster dose at 3 weeks [4].
We read with interest the study reported by Di Noia et al. [1] in the August issue of European Journal of Cancer about adherence to SARS-COV-2 vaccine, entitled ‘The first report on coronavirus disease 2019 (COVID-19) vaccine refusal by patients with solid cancer in Italy: early data from a single-institute survey’.
We appreciate the interest of our colleagues in our recent article entitled “The first report on COVID-19 vaccine refusal by patients with cancer in Italy: early data from a single-institute survey” in which we originally provided a snapshot of the adherence to the vaccination campaign of patients affected by solid cancer and afferent to our institution [1]. During a period of three weeks from 1st to 20th March 2021, we found a refusal rate among patients with cancer of 11.2%, which significantly increased from 8.6 to 19.7%, after the temporary suspension of the AstraZeneca AZD1222 vaccine.
In a recently published article in the European Journal of Cancer, Di Noia et al. [1] documented a vaccine refusal rate towards COVID-19 immunisation of 11% in patients with solid tumours after being informed by their treating physicians of the benefits and potential risks of receiving a COVID-19 vaccine. Several studies worldwide have documented varying rates of vaccine hesitancy among oncological patients that can be as high as 59% [2–8]. The increased risk of infection and COVID-19 associated morbidity and mortality in cancer patients, as well as the emergence of new SARS-CoV-2 variants that keep imposing a tremendous strain on health care services worldwide, makes the high hesitancy rate towards COVID-19 immunisation a matter of great concern.
00310-5&id=gr1.jpg){kind=link}