key: cord-0948793-0gbcg74o
authors: Forster, M.; Würstlein, R.; König, A.; Beyer, S.; Degenhardt, T.; Burges, A.; Trillsch, F.; Mahner, S.; Harbeck, N.; Chelariu-Raicu, A.
title: 1592P Willingness to vaccinate and side effects of COVID-19 vaccination in patients with breast cancer and gynecological malignancies
date: 2021-09-30
journal: Annals of Oncology
DOI: 10.1016/j.annonc.2021.08.1585
sha: 188f1c1fb097717e779e31aa857eee9b8df3829f
doc_id: 948793
cord_uid: 0gbcg74o

Background: Cancer patients are at increased risk of developing severe COVID-19 disease. Possible side effects of systemic therapy and the lack of clinical data on safety and efficacy of COVID-19 vaccination in cancer patients cause uncertainty regarding the vaccination. Here, we evaluated attitude towards and effects of COVID-19 vaccination in patients with breast or gynecological cancer. The aim was to improve counseling of our patients in clinical routine. Methods: Since March 15th 2021, patients who received one of the approved COVID-19 vaccines were routinely interviewed about immediate (0-2 days) and late side effects (within two weeks after vaccination). Clinical parameters such as current therapy, time interval between therapy administration and vaccination, and changes in the therapy schedule due to the vaccination were documented. Furthermore, the willingness of non-vaccinated patients to be vaccinated was assessed. The collected data were anonymously analyzed as a part of routine quality assurance. Results: By May 10th 2021, 111 out of 217 (51.1%) interviewed patients had received at least one shot of COVID-19 vaccine and 21 patients both shots. More than half of the vaccinated patients were >55y (60.2%;mean: 60.7y, range 30-92y);69% with UICC/ FIGO stage III/IV cancer. 74.6% received Conmirnaty (BioNTech/ Pfizer), 18.9% Vaxzevria (AstraZeneca) and 6.5% Covid-19 Vaccine Moderna. After the first shot, 33.3% of the patients described no side effects, 49.1% reported a local reaction (swelling or pain), 23.4% flu-like symptoms, 10.8% headache and 3.6% nausea. 11 patients had symptoms that lasted longer than two days. In 11 cases, COVID-19 vaccination had an impact on delivery of the systemic therapy (n=10 postponements of therapy and n=1 dose reduction). 61.3% of the non-vaccinated patients (in total n=118) were already registered to get vaccinated;32.8% chose to postpone vaccination for personal reasons;5% refused vaccination. Conclusions: Breast and gynecological cancer patients appear to tolerate COVID-19 vaccination well under systemic therapy and only in few cases the vaccination interfered with the treatment schedule. Updated results will be presented at the ESMO Congress. Legal entity responsible for the study: LMU University Hospital. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

1 akFond, Moscow, Russian Federation; 2 Hematology, National Research Center for Hematology, Moscow, Russian Federation; 3 Hematology, Regional Clinical Hospital #2, Vladivostok, Russian Federation; 4 Bone Marrow Transplant, S.P. Botkin City Clinical Hospital, Moscow, Russian Federation; 5 Hematology, Republican Clinical Hospital #4, Saransk, Russian Federation; 6 Hematology, Regional Clinical Hospital, Yaroslavl, Russian Federation; 7 Research Institute, Pavlov University, Saint-Petersburg, Russian Federation; 8 Hematology, S.P. Botkin City Clinical Hospital, Moscow, Russian Federation; 9 Hematology, N.A. Semashko Republican Clinical Hospital, Ulan-Ude, Russian Federation; 10 Myeloproliferation, National Research Center for Hematology, Moscow, Russian Federation; 11 Hematology, Regional Clinical Hospital, Ekaterinburg, Russian Federation; 12 Hematology, City Clinical Hospital n.a. V.V. Veresaev Moscow Department of Healthcare, Moscow, Russian Federation; 13 Hematology, N.A. Semashko Regional Clinical Hospital, Nizhniy Novgorod, Russian Federation; 14 Biostatistics, National Research Center for Hematology, Moscow, Russian Federation 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.

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. 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. Methods: Since March 15 th 2021, patients who received one of the approved COVID-19 vaccines were routinely interviewed about immediate (0-2 days) and late side effects (within two weeks after vaccination). Clinical parameters such as current therapy, time interval between therapy administration and vaccination, and changes in the therapy schedule due to the vaccination were documented. Furthermore, the willingness of non-vaccinated patients to be vaccinated was assessed. The collected data were anonymously analyzed as a part of routine quality assurance. 

7%) and genitourinary (7%). 59% of the pts received chemotherapy,14.2% immunotherapy and 32.8% had radiotherapy over the past 12 months prior to receive the Covid 19 vaccination, which consisted of mRNA vaccines in 82.2% (Pfizer 46.2%, Moderna 36%). 4.9% of the pts refused vaccination. 82.3% of the pts had none (39.3%) or mild (43%) side-effects (S/E) and only 2.4% reported severe S/E. Most S/E lasted 1-3 days (89.4%) consisting mainly of sore arm (42.5%), headache (23.3%), fatigue (21.1%), and temperature (18.5%). Swollen lymph-nodes and allergic reactions were only reported in 0.7% (each). 49% of the pts were vaccinated while actively engaged on treatment, and in 96% there was no delay, interruption, or stoppage of the anticancer therapy. Conclusions: This is the first large report on Real word data voluntarily obtained from 1069 Belong.life users undergoing anticancer treatment with 90% of them receiving a Covid 19 vaccination. The large majority of pts had none or mild S/E (82.3%), and those were short lived (1-3 days in 89.4%) while only in 2% it was graded as severe

Consultant: MSD; Financial Interests, Personal, Advisory Role, Consultant: AstraZeneca. N. Moisa: Financial Interests, Personal, Full or part-time Employment: BelongTail. A. Litvin: Financial Interests, Personal, Full or part-time Employment: BelongTail. E. Malki: Financial Interests, Personal, Full or part-time Employment: BelongTail; Financial Interests, Personal, Full or part-time Employment: Belong.life. D.A. Vorobiof: Financial Interests, Personal, Full or part-time Employment: BelongTail; Financial Interests, Personal, Full or part-time Employment: Belong

1595P Acceptance of COVID-19 vaccination among cancer patients in an Irish cancer centre

Hospitalised cancer patients have a three times higher risk of death (14%) from COVID-19 than the general public. Vaccination provides an unprecedented opportunity to decrease morbidity & mortality, however, there is a limited data regarding cancer patients' attitudes towards COVID-19 vaccination. Methods: An anonymised questionnaire was completed by volunteering cancer patients attending the ambulatory care unit of a large tertiary cancer centre

Most (78%) had a good performance status (PS ¼ 0-1) & lung was the most frequent (28%) cancer type. Eight (6%) had previous COVID-19 infection. Among respondents, 128 (90%) intended on getting vaccinated, 12 (8%) were unsure & three (2%) would refuse. Those intent on vaccination were less concerned with side effects

Almost 20% (n¼28) reported that they were more likely to receive the flu vaccine due to the pandemic. Twelve (8%) identified attending their GP as a barrier, with 97% (n¼135) willing to attend hospital for vaccination. While this service is free, 69% (n¼99) were willing to pay