Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment

Tania Buttiron Webber; Nicoletta Provinciali; Marco Musso; Martina Ugolini; Monica Boitano; Matteo Clavarezza; Mauro D'Amico; Carlotta Defferrari; Alberto Gozza; Irene Maria Briata; Monica Magnani; Fortuna Paciolla; Nadia Menghini; Emanuela Marcenaro; Raffaele De Palma; Nicoletta Sacchi; Leonello Innocenti; Giacomo Siri; Oriana D'Ecclesiis; Isabella Cevasco; Sara Gandini; Andrea DeCensi

doi:10.1016/j.ejca.2021.09.030

Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment

Tania Buttiron Webber, Nicoletta Provinciali, Marco Musso, Martina Ugolini, Monica Boitano, Matteo Clavarezza, Mauro D'Amico, Carlotta Defferrari, Alberto Gozza, Irene Maria Briata, Monica Magnani, Fortuna Paciolla, Nadia Menghini, Emanuela Marcenaro, Raffaele De Palma, Nicoletta Sacchi, Leonello Innocenti, Giacomo Siri, Oriana D'Ecclesiis, Isabella CevascoSara Gandini, Andrea DeCensi

Research output: Contribution to journal › Article › peer-review

Abstract

PURPOSE: Initial findings in patients with cancer suggest a lower seroconversion to SARS-CoV-2 vaccination possibly related to myelo-immunosuppressive therapies. We conducted a prospective study to assess factors predicting poor seroconversion and adverse events following immunisation (AEFI) to the BNT162b2 vaccine in patients on active treatment.

PATIENTS AND METHODS: Cancer patients, candidates to two doses of BNT162b2 SARS-CoV-2 vaccination, were enrolled. Patients on active surveillance served as controls. The primary endpoint was poor seroconversion (anti S1/S2 IgG < 25 AU/mL) after 21 days from the second dose.

RESULTS: Between March and July 2021, 320 subjects were recruited, and 291 were assessable. The lack of seroconversion at 21 days from the second dose was 1.6% (95% CI, 0.4-8.7) on active surveillance, 13.9% (8.2-21.6) on chemotherapy, 11.4% (5.1-21.3) on hormone therapy, 21.7% (7.5-43.7) on targeted therapy and 4.8% (0.12-23.8) on immune-checkpoint-inhibitors (ICI). Compared to controls, the risk of no IgG response was greater for chemotherapy (p = 0.033), targeted therapy (0.005) and hormonotherapy (p = 0.051). Lymphocyte count < 1 × 109/L (p = 0.04) and older age (p = 0.03) also significantly predicted poor seroconversion. Overall, 43 patients (14.8%) complained of AEFI, mostly of mild grade. Risk of AEFI was greater in females (p = 0.001) and younger patients (p = 0.009).

CONCLUSION: Chemotherapy, targeted therapy, hormone therapy, lymphocyte count < 1 × 109/L, and increasing age predict poor seroconversion after two doses of BNT162b2 in up to 20% of patients, indicating the need for a third dose and long-term serological testing in non-responders. AEFI occur much more frequently in women and younger subjects who may benefit from preventive medications. CLINICALTRIALS.

GOV IDENTIFIER: NCT04932863.

Original language	English
Pages (from-to)	105-112
Number of pages	8
Journal	Eur. J. Cancer
Volume	159
DOIs	https://doi.org/10.1016/j.ejca.2021.09.030
Publication status	E-pub ahead of print - Oct 11 2021

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Buttiron Webber, T., Provinciali, N., Musso, M., Ugolini, M., Boitano, M., Clavarezza, M., D'Amico, M., Defferrari, C., Gozza, A., Briata, I. M., Magnani, M., Paciolla, F., Menghini, N., Marcenaro, E., De Palma, R., Sacchi, N., Innocenti, L., Siri, G., D'Ecclesiis, O., ... DeCensi, A. (2021). Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment. Eur. J. Cancer, 159, 105-112. https://doi.org/10.1016/j.ejca.2021.09.030

Buttiron Webber, T, Provinciali, N, Musso, M, Ugolini, M, Boitano, M, Clavarezza, M, D'Amico, M, Defferrari, C, Gozza, A, Briata, IM, Magnani, M, Paciolla, F, Menghini, N, Marcenaro, E, De Palma, R, Sacchi, N, Innocenti, L, Siri, G, D'Ecclesiis, O, Cevasco, I, Gandini, S & DeCensi, A 2021, 'Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment', Eur. J. Cancer, vol. 159, pp. 105-112. https://doi.org/10.1016/j.ejca.2021.09.030

@article{02e5cf74a7804daca49e096ce38d79d1,

title = "Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment",

abstract = "PURPOSE: Initial findings in patients with cancer suggest a lower seroconversion to SARS-CoV-2 vaccination possibly related to myelo-immunosuppressive therapies. We conducted a prospective study to assess factors predicting poor seroconversion and adverse events following immunisation (AEFI) to the BNT162b2 vaccine in patients on active treatment.PATIENTS AND METHODS: Cancer patients, candidates to two doses of BNT162b2 SARS-CoV-2 vaccination, were enrolled. Patients on active surveillance served as controls. The primary endpoint was poor seroconversion (anti S1/S2 IgG < 25 AU/mL) after 21 days from the second dose.RESULTS: Between March and July 2021, 320 subjects were recruited, and 291 were assessable. The lack of seroconversion at 21 days from the second dose was 1.6% (95% CI, 0.4-8.7) on active surveillance, 13.9% (8.2-21.6) on chemotherapy, 11.4% (5.1-21.3) on hormone therapy, 21.7% (7.5-43.7) on targeted therapy and 4.8% (0.12-23.8) on immune-checkpoint-inhibitors (ICI). Compared to controls, the risk of no IgG response was greater for chemotherapy (p = 0.033), targeted therapy (0.005) and hormonotherapy (p = 0.051). Lymphocyte count < 1 × 109/L (p = 0.04) and older age (p = 0.03) also significantly predicted poor seroconversion. Overall, 43 patients (14.8%) complained of AEFI, mostly of mild grade. Risk of AEFI was greater in females (p = 0.001) and younger patients (p = 0.009).CONCLUSION: Chemotherapy, targeted therapy, hormone therapy, lymphocyte count < 1 × 109/L, and increasing age predict poor seroconversion after two doses of BNT162b2 in up to 20% of patients, indicating the need for a third dose and long-term serological testing in non-responders. AEFI occur much more frequently in women and younger subjects who may benefit from preventive medications. CLINICALTRIALS.GOV IDENTIFIER: NCT04932863.",

author = "{Buttiron Webber}, Tania and Nicoletta Provinciali and Marco Musso and Martina Ugolini and Monica Boitano and Matteo Clavarezza and Mauro D'Amico and Carlotta Defferrari and Alberto Gozza and Briata, {Irene Maria} and Monica Magnani and Fortuna Paciolla and Nadia Menghini and Emanuela Marcenaro and {De Palma}, Raffaele and Nicoletta Sacchi and Leonello Innocenti and Giacomo Siri and Oriana D'Ecclesiis and Isabella Cevasco and Sara Gandini and Andrea DeCensi",

note = "Copyright {\textcopyright} 2021. Published by Elsevier Ltd.",

year = "2021",

month = oct,

day = "11",

doi = "10.1016/j.ejca.2021.09.030",

language = "English",

volume = "159",

pages = "105--112",

journal = "Eur. J. Cancer",

issn = "0959-8049",

publisher = "Elsevier Ltd",

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TY - JOUR

T1 - Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment

AU - Buttiron Webber, Tania

AU - Provinciali, Nicoletta

AU - Musso, Marco

AU - Ugolini, Martina

AU - Boitano, Monica

AU - Clavarezza, Matteo

AU - D'Amico, Mauro

AU - Defferrari, Carlotta

AU - Gozza, Alberto

AU - Briata, Irene Maria

AU - Magnani, Monica

AU - Paciolla, Fortuna

AU - Menghini, Nadia

AU - Marcenaro, Emanuela

AU - De Palma, Raffaele

AU - Sacchi, Nicoletta

AU - Innocenti, Leonello

AU - Siri, Giacomo

AU - D'Ecclesiis, Oriana

AU - Cevasco, Isabella

AU - Gandini, Sara

AU - DeCensi, Andrea

PY - 2021/10/11

Y1 - 2021/10/11

N2 - PURPOSE: Initial findings in patients with cancer suggest a lower seroconversion to SARS-CoV-2 vaccination possibly related to myelo-immunosuppressive therapies. We conducted a prospective study to assess factors predicting poor seroconversion and adverse events following immunisation (AEFI) to the BNT162b2 vaccine in patients on active treatment.PATIENTS AND METHODS: Cancer patients, candidates to two doses of BNT162b2 SARS-CoV-2 vaccination, were enrolled. Patients on active surveillance served as controls. The primary endpoint was poor seroconversion (anti S1/S2 IgG < 25 AU/mL) after 21 days from the second dose.RESULTS: Between March and July 2021, 320 subjects were recruited, and 291 were assessable. The lack of seroconversion at 21 days from the second dose was 1.6% (95% CI, 0.4-8.7) on active surveillance, 13.9% (8.2-21.6) on chemotherapy, 11.4% (5.1-21.3) on hormone therapy, 21.7% (7.5-43.7) on targeted therapy and 4.8% (0.12-23.8) on immune-checkpoint-inhibitors (ICI). Compared to controls, the risk of no IgG response was greater for chemotherapy (p = 0.033), targeted therapy (0.005) and hormonotherapy (p = 0.051). Lymphocyte count < 1 × 109/L (p = 0.04) and older age (p = 0.03) also significantly predicted poor seroconversion. Overall, 43 patients (14.8%) complained of AEFI, mostly of mild grade. Risk of AEFI was greater in females (p = 0.001) and younger patients (p = 0.009).CONCLUSION: Chemotherapy, targeted therapy, hormone therapy, lymphocyte count < 1 × 109/L, and increasing age predict poor seroconversion after two doses of BNT162b2 in up to 20% of patients, indicating the need for a third dose and long-term serological testing in non-responders. AEFI occur much more frequently in women and younger subjects who may benefit from preventive medications. CLINICALTRIALS.GOV IDENTIFIER: NCT04932863.

AB - PURPOSE: Initial findings in patients with cancer suggest a lower seroconversion to SARS-CoV-2 vaccination possibly related to myelo-immunosuppressive therapies. We conducted a prospective study to assess factors predicting poor seroconversion and adverse events following immunisation (AEFI) to the BNT162b2 vaccine in patients on active treatment.PATIENTS AND METHODS: Cancer patients, candidates to two doses of BNT162b2 SARS-CoV-2 vaccination, were enrolled. Patients on active surveillance served as controls. The primary endpoint was poor seroconversion (anti S1/S2 IgG < 25 AU/mL) after 21 days from the second dose.RESULTS: Between March and July 2021, 320 subjects were recruited, and 291 were assessable. The lack of seroconversion at 21 days from the second dose was 1.6% (95% CI, 0.4-8.7) on active surveillance, 13.9% (8.2-21.6) on chemotherapy, 11.4% (5.1-21.3) on hormone therapy, 21.7% (7.5-43.7) on targeted therapy and 4.8% (0.12-23.8) on immune-checkpoint-inhibitors (ICI). Compared to controls, the risk of no IgG response was greater for chemotherapy (p = 0.033), targeted therapy (0.005) and hormonotherapy (p = 0.051). Lymphocyte count < 1 × 109/L (p = 0.04) and older age (p = 0.03) also significantly predicted poor seroconversion. Overall, 43 patients (14.8%) complained of AEFI, mostly of mild grade. Risk of AEFI was greater in females (p = 0.001) and younger patients (p = 0.009).CONCLUSION: Chemotherapy, targeted therapy, hormone therapy, lymphocyte count < 1 × 109/L, and increasing age predict poor seroconversion after two doses of BNT162b2 in up to 20% of patients, indicating the need for a third dose and long-term serological testing in non-responders. AEFI occur much more frequently in women and younger subjects who may benefit from preventive medications. CLINICALTRIALS.GOV IDENTIFIER: NCT04932863.

U2 - 10.1016/j.ejca.2021.09.030

DO - 10.1016/j.ejca.2021.09.030

M3 - Article

C2 - 34742157

VL - 159

SP - 105

EP - 112

JO - Eur. J. Cancer

JF - Eur. J. Cancer

SN - 0959-8049

ER -

Predictors of poor seroconversion and adverse events to SARS-CoV-2 mRNA BNT162b2 vaccine in cancer patients on active treatment

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