Immunogenicity and Safety of COVID-19 Vaccine BNT162b2 for Patients with Solid Cancer: A Large Cohort Prospective Study from a Single Institution.

Autor:	Di Noia V; Medical Oncology 1 Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy. vincenzo.dinoia@ifo.gov.it., Pimpinelli F; Microbiology and Virology Unit, Dermatological Clinical Department, IRCCS San Gallicano Institute, Rome, Italy., Renna D; Medical Oncology 1 Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Barberi V; Department of Clinical and Molecular Medicine, Universita' La Sapienza di Roma, Rome, Italy., Maccallini MT; Department of Clinical and Molecular Medicine, Universita' La Sapienza di Roma, Rome, Italy., Gariazzo L; Department of Clinical and Molecular Medicine, Universita' La Sapienza di Roma, Rome, Italy., Pontone M; Microbiology and Virology Unit, Dermatological Clinical Department, IRCCS San Gallicano Institute, Rome, Italy., Monti A; Radiology and Diagnostic Imaging Department, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Campo F; Otolaryngology Head and Neck Surgery Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Taraborelli E; Medical Oncology 1 Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Di Santo M; Medical Oncology 1 Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Petrone F; Medical Oncology 1 Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Mandoj C; Department of Clinical Pathology and Cancer Biobank, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Ferraresi V; Sarcomas and Rare Tumors Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Ferretti G; Medical Oncology 1 Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Carlini P; Medical Oncology 1 Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Di Bella O; Medical Direction, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Conti L; Department of Clinical Pathology and Cancer Biobank, IRCCS Regina Elena National Cancer Institute, Rome, Italy., La Malfa AM; Pharmacy Unit, Medical Direction, IRCCS Regina Elena National Cancer Institute and San Gallicano Institute, Rome, Italy., Pellini R; Otolaryngology Head and Neck Surgery Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Bracco D; Medical Direction, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Giannarelli D; Biostatistic Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Morrone A; Scientific Direction, IRCCS San Gallicano Institute, Rome, Italy., Cognetti F; Medical Oncology 1 Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.; Department of Clinical and Molecular Medicine, Universita' La Sapienza di Roma, Rome, Italy.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Dec 15; Vol. 27 (24), pp. 6815-6823. Date of Electronic Publication: 2021 Sep 28.
DOI:	10.1158/1078-0432.CCR-21-2439
Abstrakt:	Purpose: We assessed the immunogenicity and safety of the BNT162b2 vaccine in a large cohort of patients with cancer (CP). Experimental Design: From March 1, 2021 to March 20, 2021, this prospective cohort study included 816 CP afferent to our institution and eligible for the vaccination. A cohort of 274 health care workers (HCW) was used as age- and sex-matched control group. BNT162b2 was administered as a two-dose regimen given 21 days apart. Blood samples to analyze anti-Spike (S) IgG antibodies (Ab) were collected prevaccination [timepoint (TP) 0], and at 3 weeks (TP1) and 7 weeks (TP2) after the first dose. Results: Patients characteristics: median age 62 (range, 21-97); breast/lung cancer/others (31/21/48%); active treatment/follow-up (90/10%). In the whole CP cohort, the serologic response rate (RR) and the titre of anti-S IgG significantly increased across the TPs; at TP2, the responders (IgG >15 AU/mL) were 94.2%. Active chemotherapy and chronic use of steroids were independent predictors of lower RR. Adverse events (AE) after the booster predicted higher likelihood of response (OR, 4.04; 95% confidence interval, 1.63-9.99; P = 0.003). Comparing the matched cohorts, the responders were significantly lower in CP than in HCW at TP1 (61.2% vs. 93.2%) and TP2 (93.3% vs. 100%), while the geometric mean concentration of IgG did not significantly differ at TP2 being significantly lower in CP (23.3) than in HCW (52.1) at TP1. BNT162b2 was well tolerated in CP; severe-grade AEs were 3.5% and 1.3% after the first and second doses, respectively. Conclusions: BNT162b2 assures serologic immunization without clinically significant toxicity in CP. The second dose is needed to reach a satisfactory humoral response. (©2021 American Association for Cancer Research.)
Databáze:	MEDLINE
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