Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study

Alessio Cortellini; Sebastiano Buti; Daniele Santini; Fabiana Perrone; Raffaele Giusti; Marcello Tiseo; Melissa Bersanelli; Maria Michiara; Antonino Grassadonia; Davide Brocco; Nicola Tinari; Michele De Tursi; Federica Zoratto; Enzo Veltri; Riccardo Marconcini; Francesco Malorgio; Carlo Garufi; Marco Russano; Cecilia Anesi; Tea Zeppola; Marco Filetti; Paolo Marchetti; Andrea Botticelli; Gian Carlo Antonini Cappellini; Federica De Galitiis; Maria Giuseppa Vitale; Roberto Sabbatini; Sergio Bracarda; Rossana Berardi; Silvia Rinaldi; Marianna Tudini; Rosa Rita Silva; Annagrazia Pireddu; Francesco Atzori; Rita Chiari; Biagio Ricciuti; Daniela Iacono; Maria Rita Migliorino; Antonio Rossi; Giampiero Porzio; Katia Cannita; Valeria Ciciarelli; Maria Concetta Fargnoli; Paolo Antonio Ascierto; Corrado Ficorella

doi:10.1634/theoncologist.2018-0618

Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study

Alessio Cortellini, Sebastiano Buti, Daniele Santini, Fabiana Perrone, Raffaele Giusti, Marcello Tiseo, Melissa Bersanelli, Maria Michiara, Antonino Grassadonia, Davide Brocco, Nicola Tinari, Michele De Tursi, Federica Zoratto, Enzo Veltri, Riccardo Marconcini, Francesco Malorgio, Carlo Garufi, Marco Russano, Cecilia Anesi, Tea ZeppolaMarco Filetti, Paolo Marchetti, Andrea Botticelli, Gian Carlo Antonini Cappellini, Federica De Galitiis, Maria Giuseppa Vitale, Roberto Sabbatini, Sergio Bracarda, Rossana Berardi, Silvia Rinaldi, Marianna Tudini, Rosa Rita Silva, Annagrazia Pireddu, Francesco Atzori, Rita Chiari, Biagio Ricciuti, Daniela Iacono, Maria Rita Migliorino, Antonio Rossi, Giampiero Porzio, Katia Cannita, Valeria Ciciarelli, Maria Concetta Fargnoli, Paolo Antonio Ascierto, Corrado Ficorella

Istituto Dermopatico dell'Immacolata , IDI

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

Abstract

BACKGROUND: Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors.MATERIALS AND METHODS: Consecutive patients with advanced cancer, treated with anti-programmed death-1 (PD-1) agents, were evaluated according to the presence of pre-existing AIDs. The incidence of immune-related adverse events (irAEs) and clinical outcomes were compared among subgroups.RESULTS: A total of 751 patients were enrolled; median age was 69 years. Primary tumors were as follows: non-small cell lung cancer, 492 (65.5%); melanoma, 159 (21.2%); kidney cancer, 94 (12.5%); and others, 6 (0.8%). Male/female ratio was 499/252. Eighty-five patients (11.3%) had pre-existing AIDs, further differentiated in clinically active (17.6%) and inactive (82.4%). Among patients with pre-existing AIDs, incidence of irAEs of any grade was significantly higher when compared with patients without AIDs (65.9% vs. 39.9%). At multivariate analysis, both inactive (p = .0005) and active pre-existing AIDs (p = .0162), female sex (p = .0004), and Eastern Cooperative Oncology Group Performance Status

Original language	English
Pages (from-to)	e327-e337
Journal	Oncologist
Volume	24
Issue number	6
DOIs	https://doi.org/10.1634/theoncologist.2018-0618
Publication status	Published - Jun 2019

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Cortellini, A., Buti, S., Santini, D., Perrone, F., Giusti, R., Tiseo, M., Bersanelli, M., Michiara, M., Grassadonia, A., Brocco, D., Tinari, N., De Tursi, M., Zoratto, F., Veltri, E., Marconcini, R., Malorgio, F., Garufi, C., Russano, M., Anesi, C., ... Ficorella, C. (2019). Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study. Oncologist, 24(6), e327-e337. https://doi.org/10.1634/theoncologist.2018-0618

Cortellini, A, Buti, S, Santini, D, Perrone, F, Giusti, R, Tiseo, M, Bersanelli, M, Michiara, M, Grassadonia, A, Brocco, D, Tinari, N, De Tursi, M, Zoratto, F, Veltri, E, Marconcini, R, Malorgio, F, Garufi, C, Russano, M, Anesi, C, Zeppola, T, Filetti, M, Marchetti, P, Botticelli, A, Antonini Cappellini, GC, De Galitiis, F, Vitale, MG, Sabbatini, R, Bracarda, S, Berardi, R, Rinaldi, S, Tudini, M, Silva, RR, Pireddu, A, Atzori, F, Chiari, R, Ricciuti, B, Iacono, D, Migliorino, MR, Rossi, A, Porzio, G, Cannita, K, Ciciarelli, V, Fargnoli, MC, Ascierto, PA & Ficorella, C 2019, 'Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study', Oncologist, vol. 24, no. 6, pp. e327-e337. https://doi.org/10.1634/theoncologist.2018-0618

@article{674d3df395a0415e91dc622453986512,

title = "Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study",

abstract = "BACKGROUND: Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors.MATERIALS AND METHODS: Consecutive patients with advanced cancer, treated with anti-programmed death-1 (PD-1) agents, were evaluated according to the presence of pre-existing AIDs. The incidence of immune-related adverse events (irAEs) and clinical outcomes were compared among subgroups.RESULTS: A total of 751 patients were enrolled; median age was 69 years. Primary tumors were as follows: non-small cell lung cancer, 492 (65.5%); melanoma, 159 (21.2%); kidney cancer, 94 (12.5%); and others, 6 (0.8%). Male/female ratio was 499/252. Eighty-five patients (11.3%) had pre-existing AIDs, further differentiated in clinically active (17.6%) and inactive (82.4%). Among patients with pre-existing AIDs, incidence of irAEs of any grade was significantly higher when compared with patients without AIDs (65.9% vs. 39.9%). At multivariate analysis, both inactive (p = .0005) and active pre-existing AIDs (p = .0162), female sex (p = .0004), and Eastern Cooperative Oncology Group Performance Status ",

author = "Alessio Cortellini and Sebastiano Buti and Daniele Santini and Fabiana Perrone and Raffaele Giusti and Marcello Tiseo and Melissa Bersanelli and Maria Michiara and Antonino Grassadonia and Davide Brocco and Nicola Tinari and {De Tursi}, Michele and Federica Zoratto and Enzo Veltri and Riccardo Marconcini and Francesco Malorgio and Carlo Garufi and Marco Russano and Cecilia Anesi and Tea Zeppola and Marco Filetti and Paolo Marchetti and Andrea Botticelli and {Antonini Cappellini}, {Gian Carlo} and {De Galitiis}, Federica and Vitale, {Maria Giuseppa} and Roberto Sabbatini and Sergio Bracarda and Rossana Berardi and Silvia Rinaldi and Marianna Tudini and Silva, {Rosa Rita} and Annagrazia Pireddu and Francesco Atzori and Rita Chiari and Biagio Ricciuti and Daniela Iacono and Migliorino, {Maria Rita} and Antonio Rossi and Giampiero Porzio and Katia Cannita and Valeria Ciciarelli and Fargnoli, {Maria Concetta} and Ascierto, {Paolo Antonio} and Corrado Ficorella",

note = "{\textcopyright} AlphaMed Press 2019.",

year = "2019",

month = jun,

doi = "10.1634/theoncologist.2018-0618",

language = "English",

volume = "24",

pages = "e327--e337",

journal = "Oncologist",

issn = "1083-7159",

publisher = "Wiley Blackwell",

number = "6",

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TY - JOUR

T1 - Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy

T2 - A Real-World Transverse Study

AU - Cortellini, Alessio

AU - Buti, Sebastiano

AU - Santini, Daniele

AU - Perrone, Fabiana

AU - Giusti, Raffaele

AU - Tiseo, Marcello

AU - Bersanelli, Melissa

AU - Michiara, Maria

AU - Grassadonia, Antonino

AU - Brocco, Davide

AU - Tinari, Nicola

AU - De Tursi, Michele

AU - Zoratto, Federica

AU - Veltri, Enzo

AU - Marconcini, Riccardo

AU - Malorgio, Francesco

AU - Garufi, Carlo

AU - Russano, Marco

AU - Anesi, Cecilia

AU - Zeppola, Tea

AU - Filetti, Marco

AU - Marchetti, Paolo

AU - Botticelli, Andrea

AU - Antonini Cappellini, Gian Carlo

AU - De Galitiis, Federica

AU - Vitale, Maria Giuseppa

AU - Sabbatini, Roberto

AU - Bracarda, Sergio

AU - Berardi, Rossana

AU - Rinaldi, Silvia

AU - Tudini, Marianna

AU - Silva, Rosa Rita

AU - Pireddu, Annagrazia

AU - Atzori, Francesco

AU - Chiari, Rita

AU - Ricciuti, Biagio

AU - Iacono, Daniela

AU - Migliorino, Maria Rita

AU - Rossi, Antonio

AU - Porzio, Giampiero

AU - Cannita, Katia

AU - Ciciarelli, Valeria

AU - Fargnoli, Maria Concetta

AU - Ascierto, Paolo Antonio

AU - Ficorella, Corrado

PY - 2019/6

Y1 - 2019/6

N2 - BACKGROUND: Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors.MATERIALS AND METHODS: Consecutive patients with advanced cancer, treated with anti-programmed death-1 (PD-1) agents, were evaluated according to the presence of pre-existing AIDs. The incidence of immune-related adverse events (irAEs) and clinical outcomes were compared among subgroups.RESULTS: A total of 751 patients were enrolled; median age was 69 years. Primary tumors were as follows: non-small cell lung cancer, 492 (65.5%); melanoma, 159 (21.2%); kidney cancer, 94 (12.5%); and others, 6 (0.8%). Male/female ratio was 499/252. Eighty-five patients (11.3%) had pre-existing AIDs, further differentiated in clinically active (17.6%) and inactive (82.4%). Among patients with pre-existing AIDs, incidence of irAEs of any grade was significantly higher when compared with patients without AIDs (65.9% vs. 39.9%). At multivariate analysis, both inactive (p = .0005) and active pre-existing AIDs (p = .0162), female sex (p = .0004), and Eastern Cooperative Oncology Group Performance Status

AB - BACKGROUND: Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors.MATERIALS AND METHODS: Consecutive patients with advanced cancer, treated with anti-programmed death-1 (PD-1) agents, were evaluated according to the presence of pre-existing AIDs. The incidence of immune-related adverse events (irAEs) and clinical outcomes were compared among subgroups.RESULTS: A total of 751 patients were enrolled; median age was 69 years. Primary tumors were as follows: non-small cell lung cancer, 492 (65.5%); melanoma, 159 (21.2%); kidney cancer, 94 (12.5%); and others, 6 (0.8%). Male/female ratio was 499/252. Eighty-five patients (11.3%) had pre-existing AIDs, further differentiated in clinically active (17.6%) and inactive (82.4%). Among patients with pre-existing AIDs, incidence of irAEs of any grade was significantly higher when compared with patients without AIDs (65.9% vs. 39.9%). At multivariate analysis, both inactive (p = .0005) and active pre-existing AIDs (p = .0162), female sex (p = .0004), and Eastern Cooperative Oncology Group Performance Status

U2 - 10.1634/theoncologist.2018-0618

DO - 10.1634/theoncologist.2018-0618

M3 - Article

VL - 24

SP - e327-e337

JO - Oncologist

JF - Oncologist

SN - 1083-7159

IS - 6

ER -

Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study

Abstract

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