TY - JOUR T1 - Immune checkpoint inhibitor therapy and outcomes from SARS-CoV-2 infection in patients with cancer: a joint analysis of OnCovid and ESMO-CoCARE registries JF - Journal for ImmunoTherapy of Cancer JO - J Immunother Cancer DO - 10.1136/jitc-2022-005732 VL - 10 IS - 11 SP - e005732 AU - Alessio Cortellini AU - Gino M Dettorre AU - Urania Dafni AU - Juan Aguilar-Company AU - Luis Castelo-Branco AU - Matteo Lambertini AU - Spyridon Gennatas AU - Vasileios Angelis AU - Ailsa Sita-Lumsden AU - Jacobo Rogado AU - Paolo Pedrazzoli AU - David Viñal AU - Aleix Prat AU - Maura Rossi AU - Rossana Berardi AU - Teresa Alonso-Gordoa AU - Salvatore Grisanti AU - Georgia Dimopoulou AU - Paola Queirolo AU - Sylvain Pradervand AU - Alexia Bertuzzi AU - Mark Bower AU - Dirk Arnold AU - Ramon Salazar AU - Marco Tucci AU - Kevin J Harrington AU - Francesca Mazzoni AU - Uma Mukherjee AU - Zoi Tsourti AU - Olivier Michielin AU - Fanny Pommeret AU - Joan Brunet AU - Bruno Vincenzi AU - Giuseppe Tonini AU - Andrea Patriarca AU - Federica Biello AU - Marco Krengli AU - Josep Tabernero AU - George Pentheroudakis AU - Alessandra Gennari AU - Solange Peters AU - Emanuela Romano AU - David J Pinato Y1 - 2022/11/01 UR - http://jitc.bmj.com/content/10/11/e005732.abstract N2 - Background As management and prevention strategies against COVID-19 evolve, it is still uncertain whether prior exposure to immune checkpoint inhibitors (ICIs) affects COVID-19 severity in patients with cancer.Methods In a joint analysis of ICI recipients from OnCovid (NCT04393974) and European Society for Medical Oncology (ESMO) CoCARE registries, we assessed severity and mortality from SARS-CoV-2 in vaccinated and unvaccinated patients with cancer and explored whether prior immune-related adverse events (irAEs) influenced outcome from COVID-19.Findings The study population consisted of 240 patients diagnosed with COVID-19 between January 2020 and February 2022 exposed to ICI within 3 months prior to COVID-19 diagnosis, with a 30-day case fatality rate (CFR30) of 23.6% (95% CI 17.8 to 30.7%). Overall, 42 (17.5%) were fully vaccinated prior to COVID-19 and experienced decreased CFR30 (4.8% vs 28.1%, p=0.0009), hospitalization rate (27.5% vs 63.2%, p<0.0001), requirement of oxygen therapy (15.8% vs 41.5%, p=0.0030), COVID-19 complication rate (11.9% vs 34.6%, p=0.0040), with a reduced need for COVID-19-specific therapy (26.3% vs 57.9%, p=0.0004) compared with unvaccinated patients. Inverse probability of treatment weighting (IPTW)-fitted multivariable analysis, following a clustered-robust correction for the data source (OnCovid vs ESMO CoCARE), confirmed that vaccinated patients experienced a decreased risk of death at 30 days (adjusted OR, aOR 0.08, 95% CI 0.01 to 0.69).Overall, 38 patients (15.8%) experienced at least one irAE of any grade at any time prior to COVID-19, at a median time of 3.2 months (range 0.13–48.7) from COVID-19 diagnosis. IrAEs occurred independently of baseline characteristics except for primary tumor (p=0.0373) and were associated with a significantly decreased CFR30 (10.8% vs 26.0%, p=0.0462) additionally confirmed by the IPTW-fitted multivariable analysis (aOR 0.47, 95% CI 0.33 to 0.67). Patients who experienced irAEs also presented a higher median absolute lymphocyte count at COVID-19 (1.4 vs 0.8 109 cells/L, p=0.0098).Conclusion Anti-SARS-CoV-2 vaccination reduces morbidity and mortality from COVID-19 in ICI recipients. History of irAEs might identify patients with pre-existing protection from COVID-19, warranting further investigation of adaptive immune determinants of protection from SARS-CoV-2.Data are available on reasonable request. Individual, deidentified participant data and data dictionary may be made available at the request of investigators whose proposed use of the data has been approved by the OnCovid consortium and ESMO CoCARE steering committees following review of a methodologically sound research proposal. ER -