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Background: Cancer patients are at higher risk of developing severe COVID-19. However, safety and efficacy of COVID-19 vaccination in cancer patients undergoing treatment is unclear. Methods: In this interventional prospective multi-cohort study, priming and booster doses of the BNT162b2 COVID-19 vaccine were administered 21 days apart to solid tumor patients receiving chemotherapy, immunotherapy, targeted- or hormonal therapy, and patients with a hematologic malignancy receiving rituximab or after allogeneic hematopoietic stem cell transplantation. Primary endpoint was anti-SARS-CoV-2 receptor binding domain (RBD) antibody level at 28 days post-booster. Anti-RBD IgG titers above 200 IU/ml was used to define high-responders as it leads to a neutralization response required for 50% protection against symptomatic SARS-CoV-2 infection in 268 independent subjects. Secondary endpoints included self-reported adverse events (AEs), antibody response over time and number of breakthrough infections after vaccination. Findings: 28 days post-booster vaccination of 197 cancer patients, antibody response was lower in the hematological cohort (geometric mean titer (GMT) 17·61 IU/mL [95% CI 7·17-43·24]) and the chemotherapy cohort (GMT 234·05 IU/mL [95% 95%CI 122·10-448·66]) when compared to healthy individuals (n=40; GMT 1844·93 IU/mL [95% CI 1383·57-2460·14]), irrespective of timing of vaccination during chemotherapy cycles. Only 55% and 7% of patients receiving chemotherapy or rituximab could be categorized as high-responders at 28 days post-booster. During the study period, five subjects tested positive for SARS-CoV-2 infection, including three after full vaccination. Local and systemic AEs were mostly mild to moderate, with only 1-3% of patients experiencing severe AEs. Local, but not systemic, AEs occurred more frequently after booster than after priming dose. Interpretation: The BNT162b2 vaccine is well-tolerated in cancer patients under active treatment. However, the antibody response of immunized cancer patients was delayed and diminished, mainly in patients receiving chemotherapy or rituximab, resulting in breakthrough infections. Trial Registration: EudraCT number 2021-000300-38 Funding: The regulatory sponsor was the Antwerp University Hospital (EudraCT number 2021-000300-38). The trial was funded by the Belgian Government through Sciensano (COVID-19_SC004, COVID- 19_SC059, COVID-19_SC061). Declaration of Interest: MP declares to have an advisory role within Remedus, all other authors declare no competing interests. Ethical Approval: The study was approved by the local ethics committee and was executed in accordance with Good Clinical Practice and the Declaration of Helsinki (ICH GCP E6(R2)).

COVID-19 is an infectious pandemic disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus with varying presentations ranging from asymptomatic, sensation of a mild cold or influenza to severe bilateral pneumonia and death.1 Patients with cancer and COVID-19 are at a significantly higher likelihood of poor disease outcomes.2 3 In the absence of a vaccine or adequate treatment of COVID-19 current measures to minimise the infectious risk of SARS-CoV-2 in a cancer patient population are focused on physical distancing and protective measures. As it is clear that a hospital is a high-risk setting to contract COVID-19, one of the strategies we can use to treat patients with cancer as safe as possible is to reduce hospital visits to a strict minimum. We previously reported on AMTRA …

142 Background: The purpose of this non-randomized prospective cohort analysis was to implement and validate a tailored symptom management and intervention system, which integrates tailored education and advice for improving symptom self-management among cancer patients. We hypothesized that improved symptom self-management allows for early symptom control, better compliance, better dose intensity and reduce the necessity for extra visits / ER-visits. Methods: Patients initiating systemic therapy for malignant disease used a pre-programmed device in order to register compliance (in case of oral treatment), 12 clinical symptoms and 2 biometrics (weight and temperature). These real time data were collected onto a central platform, stratified according to different grades based on the PRO Common Terminology Criteria for Adverse Events (PRO-CTCAE ); and processed by an algorithm to render personalized advise when necessary. In case of severe (≥ Gr III) toxicity a dedicated nurse would intervene. Our primary outcome was symptom burden assessed via patient report tool. Secondary outcomes included relative dose intensity. Results: 168 Cancer patients were recruited from June 1st 2017 to December 31st 2017 across 4 sites, 76 men and 92 women. The median age 63 years (range 23-88 yr). 8275 Registrations were analyzed, pain was most frequently scored and loss of appetite was the most frequent gr III PROM. 108 patients scored toxicities (1413) requiring follow up or intervention by a dedicated nurse; resulting in 99 extra interventions: 34 extra consultations and 15 hospitalizations. Supportive treatment was adapted in 2, supportive advice given in 40 and in 12 instances no registration of the action was retrieved. Conclusions: The ambulatory follow up of patients with anti-cancer treatment appears feasible and reliable. Further effort to provide at home symptom management is warranted and requires both a logistic framework, as well as continuous education of motivated caregivers and patients. Evaluation on dose intensity and compliance of treatment will follow.

e18208 Background: Health Information Technology (HIT) is increasingly integrated in clinical cancer care. Simultaneous routine assessment of patient reported outcomes (PROs) reliably improve symptom management, patient-provider communication and ultimately survival. Methods: his pilot study is a single center experience with the development and validation of an I-PRO tool (AMOCT). After obtaining informed consent, outpatients, using oral anticancer treatment, recorded their medication intake and 17 PRO measures (PROM) using this I-PRO tool. The device allowed real time data collection via a central platform. The registered data were processed by an algorithm, which stratifies the data into different grades according to international standards of care (CTCAE v4.0). In response to registration of data, patients received either automated symptom management suggestions or were referred to their caregivers. Patient clinical and demographic information is collected from medical records and analyzed using descriptive statistics. Results: 63 Patients were included, 51% male, mean age 61.5 (range 28-83). 41% Of patients used capecitabine, 24% regorafenib, 16% TAS 102, 5% pazopanib and 5% sunitinib. Of the 1873 PROM-scores, 308 scores needed nurses’ attention, ultimately leading to dose reductions in 7 patients (12%). Most often due to weight loss, skin toxicity and asthenia. 41 Patients stopped registration: 51% because treatment ended, 27 % died, 10% dropped out, 5% progressed, 5% were lost to follow up and 2% never started. This tool was well adopted and demonstrated treatment compliance in > 85% patients. Conclusions: This study confirms the feasibility of the program, in an outpatient setting. This I-PRO tool provides a means to register compliance and toxicity of treatment. The compliance to the I-PRO tool will be confirmed, with further development of this program in a multicenter, randomized design. Evaluation of quality of life, PROM’s and further exploration of the relationship between optimal pharmacovigilance and improvement of patient’s outcome will ensue.