key: cord-0938434-3urvbwm9
authors: Zemel, M.; Kian, W.; Kestenbaum, E. H.; Alguayn, W.; Levitas, D.; Sharb, A. A.; Shalata, W.; Rouvinov, K.; Nesher, L.; Yakobson, A.
title: 1589P Safety of the BNT162b2 mRNA COVID-19 vaccine in oncologic patients undergoing numerous cancer treatment options
date: 2021-09-30
journal: Annals of Oncology
DOI: 10.1016/j.annonc.2021.08.1582
sha: 797c2cdc3dbca8b8c3c7b6290dc1bfe18b293a24
doc_id: 938434
cord_uid: 3urvbwm9

Background: The COVID-19 pandemic, caused by the SARS-CoV2 virus, has infected millions worldwide with cancer patients demonstrating a higher prevalence for severe disease and poorer outcomes. Recently, the BNT162b2 mRNA COVID-19 vaccine was released as the primary means to combat COVID-19. The currently reported incidence of local and systemic side effects was 27% in the general public. The safety of the BNT162b2 mRNA COVID-19 vaccine has not been studied in patients with an active cancer diagnosis who are either ongoing or plan to undergo oncologic therapy. Methods: This retrospective single center study reviewed the charts of 210 patients with active cancer diagnoses that received both doses of the BNT162b2 mRNA COVID-19 vaccine. The development of side effects from the vaccine, hospitalizations or exacerbations from various oncologic treatment were documented. Type of oncologic treatment (immunotherapy, chemotherapy, hormonal, biologic, radiation or mixed) was documented to identify if side effects were related to treatment type. The time at which the vaccine was administered in relation to treatment onset (on long term therapy, within one month of therapy or prior to therapy) was also documented to identify any relationships. Results: 65 (31%) participants experienced side effects from the BNT162b2 mRNA COVID-19 vaccine, however most were mild to moderate. Treatment protocol was not linked to the development of vaccine related side effects (p =.202), nor was immunotherapy, specifically, (p =.942). The timing of vaccine administered in relation to treatment onset was also not related to vaccine related side effects (p =.653). 6 (2.9%) participants were hospitalized and 4 (2%) died. Conclusions: The incidence of side effects in cancer patients is similar to what has been reported for the general public (31% vs 27%). Therefore, we believe that the BNT162b2 mRNA COVID-19 vaccine is safe in oncologic patients undergoing numerous cancer treatments. Legal entity responsible for the study: A. Yakobson. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

Conclusions: In our study, cancer pts were more susceptible to SARS-CoV-2 infection. The cumulative incidence of COVID-19 was higher in active vs. inactive cancer subjects. However, cancer is a heterogeneous group of diseases and pts with different tumor types had differing susceptibility to COVID-19 phenotypes. COVID-19 fatality rates for subgroups will be reported at the meeting.

Legal entity responsible for the study: University Hospital of Parma. Background: Little is known about natural anti-SARS-CoV-2 antibody seroprevalence post COVID-19 and safety of vaccines in COVID-19 survivors with cancer.

Methods: Among 2795 consecutive patients (pts) with COVID-19 and cancer registered to OnCovid between 01/2020 and 02/2021, we examined natural seroprevalence of anti-SARS-CoV-2 Antibodies (SC2Ab, IgM or IgG) in pts tested post-infection. We analysed prevalence and safety of SARS-Cov-2 vaccine administration in pts who underwent clinical re-assessment at participating institutions.

: Out of 350 pts tested for SC2Ab, 318 (90.9%) had a positive SC2Ab titre postconvalescence. Neither baseline features (sex, age, comorbidities, smoking history, tumour stage/status, anticancer-therapy and primary tumour) nor COVID-19-specific features (complications, hospitalization, sequelae) were significantly associated SC2Ab status. Receipt of COVID-19 specific therapy was higher among SC2Ab+ pts (62.6% vs 40.6%, p¼0.0156). Out of 593 pts with known vaccination status, 178 (30%) had received 1 dose, whilst 38 pts (6.4%) received 2 doses of mRNA based (70.2%) or viral vector vaccine (17.4%). Vaccinated pts were more likely aged 65 years (59% vs 48.3%, p¼0.0172), with loco-regional tumour stage (56% vs 40.8%, p¼0.0014), on anti-cancer therapy at COVID-19 (49.1% vs 38.2%, p¼0.0168) and history of prior hospitalisation due to COVID-19 (61.8% vs 48.3%, p¼0.0029). Vaccine-related adverse events were reported for 18/56 evaluable pts (32.1%) and included injection site reactions (50%), fever (44.4%), arthralgias (33.3%), fatigue (33.3%) and allergy (5.5%). No long-term vaccine-related morbidity was reported.

We report high seroprevalence (>90%) of SC2Ab in convalescent cancer pts who survived COVID-19 irrespective of baseline demographics, oncological characteristics and COVID-19 severity. COVID-19 vaccines appear to be safe in cancer pts with history of prior infection.

Legal entity responsible for the study: Imperial College London. released as the primary means to combat COVID-19. The currently reported incidence of local and systemic side effects was 27% in the general public. The safety of the BNT162b2 mRNA COVID-19 vaccine has not been studied in patients with an active cancer diagnosis who are either ongoing or plan to undergo oncologic therapy.

Methods: This retrospective single center study reviewed the charts of 210 patients with active cancer diagnoses that received both doses of the BNT162b2 mRNA COVID-19 vaccine. The development of side effects from the vaccine, hospitalizations or exacerbations from various oncologic treatment were documented. Type of oncologic treatment (immunotherapy, chemotherapy, hormonal, biologic, radiation or mixed) was documented to identify if side effects were related to treatment type. The time at which the vaccine was administered in relation to treatment onset (on long term therapy, within one month of therapy or prior to therapy) was also documented to identify any relationships.

Results: 65 (31%) participants experienced side effects from the BNT162b2 mRNA COVID-19 vaccine, however most were mild to moderate. Treatment protocol was not linked to the development of vaccine related side effects (p ¼ .202), nor was immunotherapy, specifically, (p ¼ .942). The timing of vaccine administered in relation to treatment onset was also not related to vaccine related side effects (p ¼ .653). 6 (2.9%) participants were hospitalized and 4 (2%) died.

Conclusions: The incidence of side effects in cancer patients is similar to what has been reported for the general public (31% vs 27%). Therefore, we believe that the BNT162b2 mRNA COVID-19 vaccine is safe in oncologic patients undergoing numerous cancer treatments.

Legal entity responsible for the study: A. Yakobson.

Funding: Has not received any funding. Background: Since SARS-CoV-2 infection heavily affects vulnerable populations including those with immune suppression, it is of special value to study clinical course, treatment outcomes, and immunity in patients (pts) with hematological (hem) malignancies.

Methods: CHRONOS19 is an ongoing observational study in adult pts (18 years) with hem diseases (malignant or non-malignant) and COVID-19 in Russia. This webbased registry collected de-identified data from 15 centers all over the country at 30, 90, and 180 days after lab-confirmed or suspected (based on CT and/or clinical symptoms) COVID-19 diagnosis. The primary endpoint was 30-day all-cause mortality.

Results: As of data cut-off on April 14, 2021, 626 pts were enrolled in the study; 562 were eligible for primary endpoint assessment, n (%): M/F 271 (48%) / 291 (52%), median age 56 years, malignant disease in 516 (92%) pts, among them induction phase / relapse or refractory / remission / NA in 180 (35%) / 120 (23%) / 187 (36%) / 29 (6%) pts. Thirty-day all-cause mortality in pts with hem malignancies was 19%; 83% of deaths were due to COVID-19 complications. No increase of hem disease relapse rate after COVID-19 was observed at Day 90 or Day 180, although 180-day data was still not mature at the time of analysis. IgG to SARS-CoV-2 was detected in 84% of pts with hem malignancies (167/199). The highest rate of detected antibody immunity was found in pts with chronic myeloproliferative neoplasms (100%; 13/13), HL (100%; 12/12), and multiple myeloma (97%; 34/35), the lowest e in pts with CLL (62%; 8/13) and NHL (60%; 6/10 and 56%; 10/18 for low-grade and high-grade lymphoma, respectively). igG detection rate in CD20+ lymphoma (60%) was significantly lower than in HL or T-cell lymphoma (p¼0.004). Pts with ECOG 0-2 throughout the disease had a high rate of antibody immunity (90%; 104/116) vs. those with ECOG 3-4 at the time of COVID-19 diagnosis (77.5%; 31/40) or with worsening of ECOG to 3-4 during the disease (78%; 36/ 46). Five cases of SARS-CoV-2 re-infection were described.

Conclusions: Pts with hem malignancies and COVID-19 have higher mortality than the general population. Low post-disease antibody immunity to SARS-CoV-2 and cases of re-infection may justify vaccination of these pts and warrant further research.

Clinical trial identification: NCT04422470.

Legal entity responsible for the study: National Research Center for Hematology.

Funding: Has not received any funding. 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 vaccinerelated AEs will be collected, as well as, serological results, tumor and treatmentrelated data, and survival.

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 ModernaÒ vaccine on behalf of the Hospital Vaccination Program. AES to 1 st 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

Bristol-Myers Squibb, MSD, Novartis, Roche, Takeda; Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim

Financial Interests, Personal, Advisory Board: AstraZeneca Boehringer Ingelheim Roche BMS. All other authors have declared no conflicts of interest

1592P Willingness to vaccinate and side effects of COVID-19 vaccination in patients with breast cancer and gynecological malignancies