ABSTRACT
Background: COVID-19 disease is more severe in unvaccinated cancer patients compared with the general population. There is limited data regarding clinical efficacy of vaccination in these patients. Method(s): SerOzNET (ACTRN12621001004853) is a prospective observational cohort study of adults and children with cancer receiving COVID-19 vaccination. The primary endpoint is serological response. An important secondary endpoint is outcome of COVID-19 infection after vaccination. We report self- and clinician reported COVID-19 infections. Result(s): Of 395 adults (20 years +), 74 (19%) reported COVID-19 infection over mean duration on study of 259 days. 71 (97%) had received 2 vaccine doses, 51 (69%) received 3+ doses. 21 (28%) had antiviral treatment. 62 (84%) had symptoms, 7 (9%) required hospitalisation, 0 required ICU admission or died due to COVID-19. Of 113 children/adolescents (5-19 years), 31 (27%) reported COVID-19 infection over mean duration on study of 215 days. 28 (90%) had received 2 vaccination doses, and 12 (39%) received 3+ doses. 23 (74%) had symptoms, 8 (25%) required hospitalisation, 2 (6%) had antiviral therapy, 0 required ICU admission or died due to COVID-19. Pediatric pts with COVID-19 infection had increased risk of hospitalisation compared with adults (p=0.03). Hematological cancer pts had non-significant but numerically higher rates of hospitalisation (Table). [Formula presented] Conclusion(s): Pts with cancer are likely to be exposed to COVID-19, with infection rates similar to the wider population. Vaccination appears to protect against ICU admission in cancer patients. However, 9% of adults and 25% of children with cancer required hospitalisation for COVID-19, demonstrating increased severity of symptoms compared to the general population. Higher rates of infection and hospitalisation in pediatric pts may be partly attributable to the lower proportion of children who had received a 3rd vaccination dose at the time of infection. Clinical trial identification: ACTRN12621001004853. Legal entity responsible for the study: Monash Health. Funding(s): Cancer Australia (Australian Federal Government) Victorian Cancer Agency (Victorian State Government, Australia) Leukaemia Foundation (Foundation, Australia). Disclosure: All authors have declared no conflicts of interest. Copyright © 2022
ABSTRACT
Background: There is limited published data regarding safety and toxicity of Sars-CoV-2 vaccination in patients with cancer. This may contribute to vaccine hesitancy amongst some members of this vulnerable cohort (Nguyen 2022). Methods: SerOzNET (ACTRN12621001004853) is a large prospective cohort study of adults and children with cancer undergoing Sars-CoV-2 vaccination. Participants undertake surveys by text message link sent to their mobile phone, or on an iPad provided in clinic. A validated hesitancy survey is undertaken at enrolment (Oxford COVID-19 Vaccine Confidence and Complacency Scale), and prior to the 3rd vaccine dose. For children, a parental survey is also collected. Quality of life is assessed with serial EORTC QLQ-C30 (adults) or PedsQL (children, self- and parentreport) at baseline and serially throughout the study. Patient- reported vaccine toxicity is assessed by patient-reported CTCAE items for common vaccine related AEs and patient-reported impact of vaccination on cancer treatment (delays, hospitalisations). Medically ascertained vaccine toxicity is assessed by study investigators one month after the 3rd vaccination dose. Results: Five hundred and four participants have been enrolled (403 adults (80%) and 101 children (20%)). Hesitancy: At baseline, 351 adults (88%) and 56 children (55%) responded. The adult cohort was predominantly female (67.2%) with an average age of 53.8 years. Preliminary analysis showed similar levels of vaccination concerns between baseline (mean score = 18.4, SD = 5.1) and follow-up pre-3rd dose (mean score = 17.9, SD = 5.7) in adults. We will present results regarding whether self-reported COVID-19 vaccine toxicity after the first dose was related to change in hesitancy scores at follow-up, which may have implications for COVID-19 vaccine booster willingness. Patient toxicity surveys have been returned post dose 1 for 445/497 (91%), post dose 2 for 417/457 (91%) and post dose 3 for 280/334 (84%). Incidence of any AEs was high (77-100% depending on age and dose), however the incidence of severe AEs (patient reported) was low (0-10% depending on age and dose). Interruptions to cancer treatment after vaccination were uncommon (2-12%). Pain at the injection site was the most commonly reported AE for all ages and doses. Hospital admissions (any reason) were reported post dose 1 in 4/15 children aged 5-12, but were uncommon in older adolescents and adults. The most common systemic adverse effect was rigors in children 5-12, while adolescents and adults reported fatigue most frequently. Quality of life analysis is ongoing and will be presented at the meeting. Conclusions: It is feasible to collect detailed toxicity and quality of life data in a large cohort of cancer patients receiving COVID-19 vaccinations. Data to date are reassuring that severe adverse events and interruptions to cancer therapy are uncommon.
ABSTRACT
Background: COVID-19 infection has poor outcomes for patients (pts) with cancer. Understanding vaccine response as a correlate of protection from severe infection is essential to advise pts regarding protective behaviours and optimal vaccine schedule. This Australian cohort is unique due to low rates of COVID-19 exposure at study entry (July-November 2021). and use of a 3 dose schedule. Pts initially received 2 doses of either BNT162b2 (Pf) at a 3 week interval, or ChadOx1-S (AZ) at a 6 week interval, all then received a 3rd dose, either mRNA-1273 (Mod) or Pf after 2-4 months, and finally a 4th dose at an interval of a further 3 months, for a subset. Methods: SerOzNET (ACTRN12621001004853) has enrolled pts with solid and haematological (haem) cancers prior to initial vaccination. Serial blood samples were processed for serum, PBMC and PMN at timepoints: 0, then 3-4 weeks post dose 1 then 2 then 3 then 4 (where administered). We report here neutralizing antibodies (nAb) against wild type (wt) and delta and omicron variants of concern (VOC);quantitative S-protein IgG antibody (Abbott);Tcell correlates measured by levels of interferon-g (IFN g), tumour necrosis factor-a, interleukins (IL-) 2/ 4/5/13;and epigenetic profiling of T cells. Results: The cohort consists of 401 pts with median age 58 (range 18-85);59% female;128 (32%) haem cancers. 377 (94%) are on current or recent (< 12 months) systemic therapy: 162 (43%) chemotherapy, 62 (16%) immunotherapy, 40 (10%) combined chemo/immunotherapy, 113 (29%) hormonal or targeted therapy. 42 (10%) received anti-CD20 therapy < 12 months, 6 (1.4%) had allogeneic stem cell transplant. NAb levels against wt are available for 256 pts post dose 1, 245 pts post dose 2 and 159 pts post dose 3 (will be updated). Response rates post dose were respectively 27%, 77% and 88%. Pts with haem cancer were less likely to respond to vaccination at any time compared to pts with solid cancer (p < 0.001, chi-squared test). After 3 doses, 3.8% of pts with solid cancer and 27.8% with haem cancer lacked NAb. NAb results to VOC delta are available for 92 pts post dose 2: 25/92 (27%) were negative, compared with a non-response rate to wt of 15% at same time in same pts. IFN-γ-Spike response was detectable in 18/31 (58%) and 24/30 (80%) pts post dose 1 and 2 respectively. 101 pts to date have received a 4th dose;data will be available at the meeting, as will epigenetic profiles and detailed clinicopathological correlations. Conclusions: This interim analysis shows that a significant proportion of pts with haem cancers (27.8%) lack protective Sars-CoV-2 antibodies following 3 vaccinations, whereas only 3.8% of solid cancer pts lack detectable response. Results from other B and T cell parameters may also be important in identifying pts less well protected by vaccination. Follow up is ongoing, response rate post 4th dose will be presented at the meeting.
ABSTRACT
Background: Potential moral hazards from COVID-19 for patient-facing oncology staff include rationalizing treatment, but prior research into staff distress has not included ancillary/administrative staff or compared geographic settings. We sought to document measures of distress and perceived preparedness from diverse oncology staff during the COVID-19 pandemic response, and correlate these with unfolding events. Methods:We utilized a mixed-methods approach comprising weekly diarising of executive communications and eventsby investigators, and prospective self-administered online surveys-by staff. Survey domains included perceived institutional preparedness, personal wellbeing, and perceived stress using a distress thermometer (0-10, no-extreme distress). Responses were Likert-scaled or free-text. Quantitative responses were aggregated by role/site and analysed using R. These were correlated with emergent qualitative themes using the Framework Method. The study was conducted at a metropolitan and a regional hospital in Queensland, Australia. Results: 12 surveys across 18 weeks commencing April 3, 2020 (encompassing 1st lockdown, lockdown easing, and 2nd lockdown) had 993 individual responses. 40% respondents were located regionally. Role categories included: nursing (50%), allied health (18%), medical (16%), administrative (15%), ancillary (e.g. cleaner, food service) (1%). Emergent themes were: Strategies for protectionat work and home. Up to 27% respondents reported being able to attend to critical personal needs only sometimes or less, although patients were perceived to be well supported most/all of the time (>90% responses). Navigating rules and keeping up-high levels of perceived institutional preparedness in >75% responders coexisted alongside fluctuating levels of self-reported distress, from median 5 (IQR 3-7) at 1st lockdown outset to 1 (IQR 1-4) after lockdown restriction easing. Tempered optimism-pride in one's place was reported both as reflecting healthcare worker identity and as Australians in the context of low local infection rates. No significant differences in distress or preparedness perceptions were evident comparing geographic sites. Framing the new normal-although respondents longitudinally reported increasing familiarity with pandemic directives, distress levels increased concurrently with the announcement of 2nd lockdown. Conclusions: In the context of low local COVID-19 infection rates, oncology staff regardless of role and geographic setting reported high perceptions of institutional preparedness. Distress levels increased concurrently with lockdown phases and reports of distress and psychosocial workload fatigue were made by various workers including administrative and ancillary. These should be considered frontline staff for the purpose of workplace psychosocial support in pandemic responses.