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 A. Ascierto,Corrado Ficorella +44 more
TLDR
The finding of a greater incidence of irAEs among female patients ranks among the "hot topics" in gender-related differences in immuno-oncology.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 <2 (p = .0030) were significantly related to a higher incidence of irAEs of any grade. No significant differences were observed regarding grade 3/4 irAEs and objective response rate among subgroups. Pre-existing AIDs were not significantly related with progression-free survival and overall survival. CONCLUSION This study quantifies the increased risk of developing irAEs in patients with pre-existing AIDs who had to be treated with anti-PD-1 immunotherapy. Nevertheless, the incidence of grade 3/4 irAEs is not significantly higher when compared with control population. The finding of a greater incidence of irAEs among female patients ranks among the "hot topics" in gender-related differences in immuno-oncology. IMPLICATIONS FOR PRACTICE Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors but are frequent in clinical practice. This study quantifies the increased risk of developing immune-related adverse events (irAEs) in patients with pre-existing AIDs who had to be treated with anti-programmed death-1 immunotherapy. Nevertheless, their toxicities are mild and the incidence of grade 3/4 irAEs is not significantly higher compared with those of controls. These results will help clinicians in everyday practice, improving their ability to offer a proper counselling to patients, in order to offer an immunotherapy treatment even to patients with pre-existing autoimmune disease.read more
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TL;DR: The association between baseline steroids administered for cancer-related indication, systemic antibiotics, PPIs and worse clinical outcomes with PD-1/PD-L1 checkpoint inhibitors is confirmed, which can be assumed to have immune-modulating detrimental effects.
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Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: review of the literature and personalized risk-based prevention strategy
J.B.A.G. Haanen,Marc S. Ernstoff,Yinghong Wang,Alexander M. Menzies,Igor Puzanov,Petros Grivas,J.M.G. Larkin,Solange Peters,John A. Thompson,Michel Obeid +9 more
TL;DR: This work challenges the exclusion from ICI therapy for patients with cancer and active ADs and proposes the implementation of an international registry to study such novel strategies in a prospective fashion.
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Jordi Remon,Francesco Passiglia,Myung-Ju Ahn,Fabrice Barlesi,Patrick M. Forde,Edward B. Garon,Scott N. Gettinger,Sarah B. Goldberg,Roy S. Herbst,Leora Horn,Kaoru Kubota,Shun Lu,Laura Mezquita,Luis Paz-Ares,Sanjay Popat,Sanjay Popat,Sanjay Popat,Kurt A. Schalper,Ferdinandos Skoulidis,Martin Reck,Alex A. Adjei,Giorgio V. Scagliotti +21 more
TL;DR: An international panel of experts in the field of thoracic malignancies discusses topics, evaluating currently available scientific evidence, and provides clinical recommendations, which may guide oncologists in their current practice, and elucidate future treatment strategies and research priorities.
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Real world data in the era of Immune Checkpoint Inhibitors (ICIs): Increasing evidence and future applications in lung cancer.
Giulia Pasello,Alberto Pavan,Ilaria Attili,Alberto Bortolami,Laura Bonanno,Jessica Menis,Pierfranco Conte,Valentina Guarneri +7 more
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