ABSTRACT
Background: Most COVID-19 (C19) vaccine trials excluded patients with active cancer. Here, we report our real-world patient-reported and clinical outcomes of BNT162b2 mRNA C19 vaccine in patients with cancer. Methods: Our institutional Data-Driven Determinants for COVID-19 Oncology Discovery Effort (D3CODE) follows a longitudinal observational cohort of pts w cancer getting C19 vaccine. Pts complete a validated PRO tool, MD Anderson Symptom Inventory (MDASI, 13 core, 6 interference plus 17 items of symptoms from prior vaccine trials) pre-dose 1, then daily x 6d, then weekly, then on day of dose 2, then daily x 6d, then weekly x 3w. Demographics, cancer variables, prior immune checkpoint inhibitors (ICI), C19 status pre- & post-vaccine are aggregated via Syntropy platform: Palantir Foundry. Primary outcome is incidence of PRO symptoms bw dose 1 & 2 across AYA 15-39y, mid-age 40-64y & senior 65y+ cohorts. Secondary outcomes include PRO symptom incidence post-dose 2, post-vaccine change in cancer symptoms, post-vaccine symptom severity based on prior ICI, and confirmed C19 > 7 days post-dose 2. First planned 8-wk interim analysis is reported here. Results: 6388 pts w cancer (4973 w mets) received a BNT162b2 vaccine dose (4811 both doses, 1577 received one & await dose 2). Overall, median age 64y (range 16-95y);382 AYAs, 2927 mid-age, 3079 seniors (65-70y n = 1158, 70-79y n = 1521, 80-89y n = 378, 90y+ n = 22). 4099 (64%) are White, 823 (13%) AA, 791 (12%) Hispanic, 441 (7%) Asians. Primary cancers: breast (1397), GU (821), heme (775), thoracic/HN (745), and CRC (385). Prior to dose 1, 1862 had no prior systemic tx while 4526 pts did including 3243 who had only non-IO tx (chemo, targeted tx), 1,283 had immunotherapy including 857 who had ICIs prior to dose 1. Patient-reported symptoms after C19 Vaccine: Of 6388 pts, 4714 (74% response rate, median age 67y, range 16-95y) completed 16485 PRO surveys. After 2 doses, seniors reported lower mean scores vs mid-age or AYAs on 22 of 36 symptoms including injection site pain, palpitations, itch, rash, malaise, fevers/chills, arthralgia, myalgia, headache, pain, fatigue, nausea, disturbed sleep, distress (p < 0.05). Pts w prior ICIs had higher severity of itch, rash (p < 0.05) from baseline after both dose 1 & 2 vs pts without systemic tx. Post dose 1, pts with prior ICI had higher increase in fatigue, malaise, itch, rash, myalgia, anorexia from their baseline vs pts without systemic tx (p < 0.05). C19 Outcomes: Of 6388 pts, 616 had a C19 test at any time post-dose 1: 23 (0.36%) tested positive of whom 20 (0.3%) were between dose 1 & 2;two (0.031%) were within 7 days post-dose 2, and one patient (0.016%) tested positive 16 days after dose 2, requiring admission. Conclusions: This real-world observational cohort demonstrates post-vaccine symptom burden and outcomes in patients with cancer. Second interim analysis is planned at 16 weeks.
ABSTRACT
Background: The symptom burden experienced by patients with cancer who contract the COVID-19 (C19) infection remains to be fully understood. To accurately assess this symptom burden, we developed a valid, reliable patient-reported outcome (PRO) measure of C19 symptoms combined with a known measure of cancer symptom burden. Methods: Within the institutional initiative on COVID-19 and cancer named Data- Driven Determinants for COVID-19 Oncology Discovery Effort (D3CODE), patients with cancer and PCR-positive C19 tests were invited to participate in this longitudinal study after providing consent. Pts completed the EQ-5D-5L and the 13 symptom severity and 6 interference items of the core MD Anderson Symptom Inventory (MDASI) plus 14 COVID-specific symptom items generated from literature and expert review. Items were measured on a 0-10 scale, 0 = none to 10 = worst imaginable symptom or interference. Demographic and disease information was collected. Psychometric procedures determined validity and reliability of the MDASI-COVID. Results: 600 pts enrolled, mean age 56.5y (range 20 to 91y). 59% female, 80% white. 78% solid tumors, 19% heme cancers. 12.5% required hospitalization for C19. Median number of days between positive C19 test and PRO completion was 17 days. Mean overall health rating on EQ-5D-5L was 78.3 (SD 19.6), best being 100. Highest mean (M) severity symptoms on the MDASI-COVID were fatigue (M 3.45, SD 2.17), drowsiness (M 2.50, SD 2.89), sleep disturbance (M 2.44, SD 2.99), malaise (M 2.37, SD 3.05), and distress (M 2.27, SD 2.90). Most severe (≥ 7) symptoms) reported were fatigue (21.3% of pts), change in taste (14.8%), change in smell (14.4%), malaise (14.3%), sleep disturbance (14.3%), and drowsiness (14%). Internal consistency (Cronbach α) of the 27 symptom items was 0.957, of the 6 interference items was 0.937. Mean severity of the 27 symptom items was significantly correlated with overall EQ-5D-5L health rating (correlation = -0.45, P < 0.0005), demonstrating concurrent validity. Mean symptom severity and interference showed known-group validity between patients who required C19 hospitalization (symptom M 2.32, SD 2.09;interference M 3.29, SD 3.02) and those who did not (symptom M 1.69, SD 1.85;interference M 2.20, SD 2.64) (symptom P 0.007;interference P 0.004). Conclusions: We have validated a novel PRO, the MDASI-COVID, to quantify the combined symptom burden in patients with cancer and COVID-19. This measure allows longitudinal evaluation of COVID-19 on cancer symptom burden and provide clinicians with an accurate tool for ongoing symptom assessment and management. Longitudinal analysis on long-term symptoms related to COVID-19 and cancer are ongoing.