An efficacy that reaches 94% but with two doses in 21 days. This is the ‘formula’ that manages to protect cancer patients who receive the anti-Covid vaccine. This is certified by the largest study in the world on the immunological response and on the safety of the mRNA vaccine in people affected by cancer, which is Italian and was conducted at the Regina Elena-Sapienza University of Rome. The research was published in the American Association for Cancer Research (AACR) official journal Clinical Cancer Research.
Cancer patients enrolled
The study enrolled 816 patients with different types of solid malignancies, in particular breast cancer (31%), lung cancer (21%) and melanoma (15%), on active treatment or undergoing treatment within 6 months prior to vaccination. Covid. “All patients received both doses of the vaccine 21 days apart – he explains Francesco Cognetti, Professor of Medical Oncology Sapienza University of Rome and Director of Medical Oncology Regina Elena of Rome. “The serological response rate and the positive immunoglobulin (IgG) titer were measured at three different times: before vaccination, at 3 and 7 weeks after the first injection”.
The antibody response
The comparison group with healthy people was represented by 274 health workers, who underwent full-cycle anti-Covid immunization. “The antibody response rate – continues Cognetti – has significantly increased in cancer patients from 59.8% at 21 days from the first dose to 94.2% after 7 weeks. On the other hand, healthy operators showed a response rate of 93.7% already 21 days after the first dose, reaching 100% at 7 weeks “. All vaccinated cancer patients were followed up with frequent molecular swabs. Overall, only 5 cases (0.6%) of asymptomatic Covid infections were recorded. “This confirms the very high value of vaccination in this very fragile patient population,” adds the oncologist.
Vaccine, cortisone and neutralizing antibodies
In the study, the antibody response was lower in people treated with chemotherapy and with prolonged use of steroids, precisely because of the immunosuppressive effects of these treatments. It is the first time that the negative impact of glucorticoids (cortisone), a class of steroid hormones, on the efficacy of the anti Covid mRNA vaccine, so far only shown in people with chronic inflammatory diseases, has been highlighted. This is why, according to oncologists, the unnecessary use of steroids should be avoided. The study also revealed the low added value of neutralizing antibodies, even particularly expensive, whose tests can be avoided in cancer patients.
How long does immunity last
How long does immunoreactivity last over time? “Preliminary data currently being published – concludes Cognetti – show a significant decrease in the antibody rate in cancer patients under active treatment 6 months after the first dose, a much more significant decrease than in the other subjects and a forecast of zeroing of antibodies in these patients at about 9 months compared to 16 months in healthy people. These data, therefore, are of undoubted usefulness in the selection of temporal priorities for the administration of the third dose in cancer patients “.
The example of Lazio
Lazio was the first region in Italy to vaccinate cancer patients last March. “The results of this study – he says Alessio D’Amato, Lazio Region Health Councilor and Social-Health Integration – validate our decision. In Lazio there was an unprecedented effort thanks to the teamwork conducted by health workers and institutions. Our Region has distinguished itself for efficiency precisely towards the most fragile and we started first also with the administration of the third dose of the anti Covid vaccine for this population “.
The fragility of cancer patients
People with cancer are at high risk of serious consequences and death if infected with the virus. However, until now there was very limited scientific evidence on the immunogenicity and safety of the vaccine in this population, as it was excluded from the phase 3 studies that led to the approval of the serum. The research already published to date has considered only a few dozen cancer patients. “This is a fundamental study that shows how vaccination induces an immune response in a high percentage of patients with solid neoplasms” – he explains Gianni Rezza, Director General of Prevention, Ministry of Health. It will now be extremely important to evaluate the long-term effect of vaccination ”.
The importance of the timing of administration
The study clearly shows the fundamental value of the second dose in people affected by cancer and very frail, who must receive it within 21 days of the first, under penalty of the potential risk of contagion. Foce (Federation of Oncologists, Cardiologists, Hematologists) had already reported the potential dangerous consequences of the delay of the second dose of vaccine for cancer patients undergoing active treatment, in which the timing of the two administrations had to be strictly respected.
Sample size and serological assessments
In addition to being the study with the largest case history in the world on the efficacy of the anti Covid vaccine in cancer patients undergoing active treatment, it is also the first to be carried out with serology assessments at three different times: before vaccination, after the first inoculation. and then to the second. An Israeli and an American research on much smaller case series considered the results only in two moments: before vaccination and at the end of the full course, thus not analyzing the results after the first dose. “The study presented today reaffirms the high profile of Italian medical research in the international scenario and shines the spotlight on a range of fragile patients that must be better protected”, underlines the Rector Antonella Polimeni. “I am particularly proud of Sapienza’s contribution in combating the pandemic, which is founded on the indissoluble link between assistance, research and teaching. A model that has produced virtuous cases and concrete results “.
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