Real-world patient-reported and clinical outcomes of BNT162b2 mRNA COVID-19 vaccine in patients with cancer

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.