Real-world patient-reported and clinical outcomes of BNT162b2 mRNA COVID-19 vaccine in patients with cancer.
Authors: Ishwaria Mohan Subbiah, Loretta A. Williams, Angela Peek, Sanjay Shete, Bruno Palma Granwehr, David D'Achiardi, Anastasia Turin, Elizabeth A. Garcia, Janice Finder, Roy Chemaly, Kimberly Beltran, Kenna Rael Shaw, Meagan Whisenant, Scott Eric Woodman, Vinod Ravi, Hussein Abdul-Hassan Tawbi, Vivek Subbiah, Caroline Chung, Phillip Andrew Futreal, David A Jaffray
Journal: Journal of Clinical Oncology (2021)

6510 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- &amp; post-vaccine are aggregated via Syntropy platform: Palantir Foundry. Primary outcome is incidence of PRO symptoms bw dose 1 &amp; 2 across AYA 15-39y, mid-age 40-64y &amp; 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 &gt; 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 &amp; 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 &lt; 0.05). Pts w prior ICIs had higher severity of itch, rash (p &lt; 0.05) from baseline after both dose 1 &amp; 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 &lt; 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 &amp; 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.