ABSTRACT
Background: With the approval of the vaccines against SARS-CoV-2, oncologic scientific societies have recommended cancer p to be prioritized for vaccination. Since cancer p have not participated in vaccine development studies, these recommendations arise some questions regarding their efficacy, safety and impact on survival. The aim of this prospective study is to evaluate the immune response to the SARS-CoV-2 vaccine in LC p. Secondary objectives include vaccine-related adverse events (AE), cancer treatment AE after vaccination, impact of the vaccine on survival, immune response, toxicity and survival outcomes in p>75 y, (re)infection after vaccination, complications and mortality. Methods: LCp who receive the vaccine against SARS-COV-2 are candidates to participate in this study. A pre-vaccination IgG determination will be performed to identify p with previous infection, but asymptomatic course. After vaccination, IgG will be repeated at 3, 6 and 12 months. Information on short and long term vaccine-related AEs will be collected, as well as, serological results, tumor and treatment-related data, and survival. Results: From March, 31 to April 15, 2021,106p have participated in the study. 58.5% were male, median age was 66 y (46- 83), 90.6% were Non-Small Cell LC, 83% has stage IV at diagnosis, Systemic therapy included EGFR/ALK/ROS1/RET/MET TKI (22.6%), immunotherapy (IT) (39.6%), chemotherapy (CT) (19.4%) and CTIT (14.1%). 4p were not receiving active therapy. 94.3% received Moderna® vaccine on behalf of the Hospital Vaccination Program. AES to 1st dose (1D) included local pain (16%), swelling (0.9%), fever (2.8%) and myalgia (0.9%). 5p had prior known COVID infection. No vaccine-related AE were reported in this group. 6p were admitted after vaccination due to cancer-related symptoms. No deaths were reported. Definitive data on baseline and 3-m serological data, as well as complete 1D and 2D related-AE and potential interactions with cancer therapy will be presented later. Conclusions: 1D of SARS-COV-2 vaccine appears to be safe irrespective of systemic therapy in our cohort of LCp. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: M. Saigí: Financial Interests, Institutional, Funding: Merck;Financial Interests, Personal, Other: BMS;Financial Interests, Personal, Other: Pfizer. E. Carcereny Costa: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, MSD, Novartis, Roche, Takeda;Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, MSD, Novartis, Pfizer, Roche, Takeda, Amgen;Financial Interests, Personal, Other: Bristol-Myers Squibb, Pfizer, Roche, Takeda. M. Domenech: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS. A. Estival: Financial Interests, Personal, Other: Lilly, Pharmamar, Bayer, MSD, BMS, Roche. Honoraria: Roche, MSD, AstraZeneca, Pharmamar. M. Romeo Marín: Non-Financial Interests, Personal, Advisory Board: MSD, GSK;Non-Financial Interests, Personal, Other: AZ. M.T. Moran Bueno: Financial Interests, Personal, Advisory Board: AstraZeneca Boehringer Ingelheim Roche BMS. All other authors have declared no conflicts of interest.
ABSTRACT
Background: Coronavirus disease 2019 (COVID19) is diagnosed by detecting the virus by reverse transcription polymerase chain reaction (RT-PCR). The majority of p go on to develop antibodies (Ab) against viral proteins. However, it is not known how long these antibodies last nor whether cancer treatments could affect the duration of immune response. The prognosis and greater or lesser vulnerability of the oncological population are also unknown. Methods: This prospective, longitudinal, multicenter serological study in the setting of SARS-CoV-2 was carried out in 50 Spanish hospitals. Eligibility criteria was a diagnosis of any thoracic cancer. The first determinations were performed between April 21, 2020 and June 3, 2020, either for p in follow up or in active treatment. Between September 10, 2020, and November 20, 2020, the second antibody (Ab) determination was performed in all previously seropositive p. Clinical and treatment data were collected, as was their clinical situation at study end. Study objectives were to prospectively determine seroprevalence in unselected lung cancer p during the first wave of the pandemic;the natural history of these p;the persistence of immunity more than 4 months after first determination;protection or lack thereof against reinfection after this period, and the nature of such protection;and the influence of treatments on maintenance or loss of immunity. Results: Of 1,500 p studied, 128 were seropositive, representing an overall prevalence of 8.5% seropositivity [95% confidence interval [CI], 7.2%, 10.1%]. Seventy-five percent were in active cancer treatment. COVID-19 infection was suspected in 47.7% [95% CI, 38.8%, 56.6%]. A second determination was performed on average 4.5 months later [IQR: 4;5] and obtained for 104 of the initially seropositive p (81%). A second determination could not be obtained in 24 p, the majority due to death caused by disease progression (73%). In the second determination, IgG was not detected in 30.8% (32/104) of p. The severity of the infection, the need for hospitalization (p: 0.032) and the presence of symptoms at diagnosis (p: 0.02), including fever (p: 0.005) and nasal congestion (p: 0.005), were associated with persistence of immunity in the second determination. No variables or treatments received were associated with Ab loss. At time of last follow-up among those p for whom a second determination was performed, 89% (93 p) had completely recovered from the virus, with no lasting after effects. Only 1 of the 128 (0.78%) seropositive p had died from COVID-19. Conclusions: The prevalence of infection in lung cancer p is similar to that of the general population. Immunity against SARS-CoV-2 does not appear to be compromised by treatment, persisting beyond 4 months. Neither do mortality rates appear to be particularly high in this unselected population.