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Safety of extended interval dosing immune checkpoint inhibitors: a multicenter cohort study.
Cantini, Luca; Paoloni, Francesco; Pecci, Federica; Spagnolo, Francesco; Genova, Carlo; Tanda, Enrica Teresa; Aerts, Sophie; Rebuzzi, Sara Elena; Fornarini, Giuseppe; Zoratto, Federica; Fancelli, Sara; Lupi, Alessio; Della Corte, Carminia Maria; Parisi, Alessandro; Bennati, Chiara; Ortega, Cinzia; Atzori, Francesco; Piovano, Pier Luigi; Orciuolo, Corrado; De Tursi, Michele; Ghidini, Michele; Botticelli, Andrea; Scagnoli, Simone; Belluomini, Lorenzo; Leporati, Rita; Veccia, Antonello; Di Giacomo, Anna Maria; Festino, Lucia; Cortinovis, Diego; Acquati, Mirko; Filetti, Marco; Giusti, Raffaele; Tucci, Marco; Sergi, Maria Chiara; Garutti, Mattia; Puglisi, Fabio; Manglaviti, Sara; Citarella, Fabrizio; Santoni, Matteo; Rijavec, Erika; Lo Russo, Giuseppe; Santini, Daniele; Addeo, Alfredo; Antonuzzo, Lorenzo; Indini, Alice; Rocchi, Marco Bruno Luigi; Cortellini, Alessio; Grossi, Francesco; Ascierto, Paolo Antonio; Aerts, Joachim G J V.
Afiliación
  • Cantini L; Clinical Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy.
  • Paoloni F; Department of Pulmonary Medicine, Erasmus MC Cancer Institute, University Medical Center, Rotterdam, the Netherlands.
  • Pecci F; Labcorp Drug Development Inc, Princeton, NJ, USA.
  • Spagnolo F; Clinical Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy.
  • Genova C; Clinical Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy.
  • Tanda ET; Medical Oncology Unit 2, Istituto di ricovero e cura a carattere scientific (IRCCS) Ospedale Policlinico San Martino, Genova, Italy.
  • Aerts S; Academic Medical Oncology Unit, Istituto di ricovero e cura a carattere scientific (IRCCS) Ospedale Policlinico San Martino, Genoa, Italy.
  • Rebuzzi SE; Department of Internal Medicine and Medical Specialties, School of Medicine, University of Genoa, Italy.
  • Fornarini G; Medical Oncology Unit 2, Istituto di ricovero e cura a carattere scientific (IRCCS) Ospedale Policlinico San Martino, Genova, Italy.
  • Zoratto F; Department of Pulmonary Medicine, Erasmus MC Cancer Institute, University Medical Center, Rotterdam, the Netherlands.
  • Fancelli S; Department of Internal Medicine and Medical Specialties, School of Medicine, University of Genoa, Italy.
  • Lupi A; Medical Oncology Unit, Ospedale San Paolo, Savona, Italy.
  • Della Corte CM; Medical Oncology Unit 1, Istituto di ricovero e cura a carattere scientific (IRCCS) Ospedale Policlinico San Martino, Genoa, Italy.
  • Parisi A; UOC Oncologia, Ospedale Santa Maria Goretti, Latina, Italy.
  • Bennati C; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
  • Ortega C; Clinical Oncology Unit, Careggi University Hospital, Florence, Italy.
  • Atzori F; Clinical Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy.
  • Piovano PL; Department of Precision Medicine, University of Campania, Italy.
  • Orciuolo C; Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
  • De Tursi M; S Maria delle Croci Hospital, AUSL della Romagna, Ravenna, Italy.
  • Ghidini M; Oncology, Asl Cn2, Ospedale Michele e Pietro Ferrero, Verduno, Italy.
  • Botticelli A; Medical Oncology Unit, University Hospital and University of Cagliari, Cagliari, Italy.
  • Scagnoli S; Oncology Unit, Azienda Ospedaliera "SS. Antonio e Biagio e C. Arrigo", Alessandria, Italy.
  • Belluomini L; Istituto di ricovero e cura a carattere scientific (IRCCS), National Cancer Institute Regina Elena, Rome, Italy.
  • Leporati R; Department of Innovative Technologies in Medicine and Dentistry, University G. D'Annunzio, Chieti-Pescara, Italy.
  • Veccia A; Oncology Unit, Fondazione Istituto di ricovero e cura a carattere scientific (IRCCS) Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.
  • Di Giacomo AM; Medical Oncology Unit A, Policlinico Umberto I, Radiological, Oncological, Pathological Sciences Department, Sapienza University of Rome, Italy.
  • Festino L; Medical Oncology Unit B, Policlinico Umberto I, Rome, Italy.
  • Cortinovis D; Section of Oncology, Department of Medicine, University of Verona School of Medicine and Verona University Hospital Trust, Verona, Italy.
  • Acquati M; Medical Oncology, Fondazione Istituto di ricovero e cura a carattere scientific (IRCCS) Istituto Nazionale dei Tumori, Milano, Italy.
  • Filetti M; Medical Oncology, Santa Chiara Hospital, Largo Medaglie d'Oro 1, Trento, Italy.
  • Giusti R; Center for Immuno-Oncology, University of Siena, University Hospital of Siena, Siena, Italy.
  • Tucci M; Melanoma Unit, Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori Istituto di ricovero e cura a carattere scientific (IRCCS) Fondazione "G. Pascale", Naples, Italy.
  • Sergi MC; SC Oncologia Medica ASST H S Gerardo, Monza, Italy.
  • Garutti M; SC Oncologia Medica ASST H S Gerardo, Monza, Italy.
  • Puglisi F; Phase 1 Unit, Fondazione Policlinico Universitario Agostino Gemelli, Istituto di ricovero e cura a carattere scientific (IRCCS), Rome, Italy.
  • Manglaviti S; Medical Oncology Unit, Sant'Andrea Hospital of Rome, Italy.
  • Citarella F; Medical Oncology Unit, Department of Interdisciplinary Medicine, University of Bari Aldo Moro, Italy.
  • Santoni M; Medical Oncology Unit, Department of Interdisciplinary Medicine, University of Bari Aldo Moro, Italy.
  • Rijavec E; CRO Aviano, National Cancer Institute, Istituto di ricovero e cura a carattere scientific (IRCCS), Aviano, Italy.
  • Lo Russo G; CRO Aviano, National Cancer Institute, Istituto di ricovero e cura a carattere scientific (IRCCS), Aviano, Italy.
  • Santini D; Department of Medicine (DAME), University of Udine, Udine, Italy.
  • Addeo A; Thoracic Unit, Medical Oncology Department 1, Fondazione Istituto di ricovero e cura a carattere scientific (IRCCS) Istituto Nazionale dei Tumori di Milano, Italy.
  • Antonuzzo L; Department of Medical Oncology, Campus Bio-Medico University, Rome, Italy.
  • Indini A; Oncology Unit, Macerata Hospital, Macerata, Italy.
  • Rocchi MBL; Medical Oncology Unit, Ospedale di Circolo e Fondazione Macchi, asst Settelaghi, Varese, Italy.
  • Cortellini A; Thoracic Unit, Medical Oncology Department 1, Fondazione Istituto di ricovero e cura a carattere scientific (IRCCS) Istituto Nazionale dei Tumori di Milano, Italy.
  • Grossi F; UOC Oncologia Medica Territoriale, Sapienza Università, Polo Pontino, Rome, Italy.
  • Ascierto PA; Oncology Department, University Hospital Geneva, Geneva, Switzerland.
  • Aerts JGJV; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
J Natl Cancer Inst ; 115(7): 796-804, 2023 07 06.
Article en En | MEDLINE | ID: mdl-37042716
BACKGROUND: Real-life spectrum and survival implications of immune-related adverse events (irAEs) in patients treated with extended interval dosing (ED) immune checkpoint inhibitors (ICIs) are unknown. METHODS: Characteristics of 812 consecutive solid cancer patients who received at least 1 cycle of ED monotherapy (pembrolizumab 400 mg Q6W or nivolumab 480 mg Q4W) after switching from canonical interval dosing (CD; pembrolizumab 200 mg Q3W or nivolumab 240 mg Q2W) or treated upfront with ED were retrieved. The primary objective was to compare irAEs patterns within the same population (before and after switch to ED). irAEs spectrum in patients treated upfront with ED and association between irAEs and overall survival were also described. RESULTS: A total of 550 (68%) patients started ICIs with CD and switched to ED. During CD, 225 (41%) patients developed any grade and 17 (3%) G3 or G4 irAEs; after switching to ED, any grade and G3 or G4 irAEs were experienced by 155 (36%) and 20 (5%) patients. Switching to ED was associated with a lower probability of any grade irAEs (adjusted odds ratio [aOR] = 0.83, 95% confidence interval [CI] = 0.64 to 0.99; P = .047), whereas no difference for G3 or G4 events was noted (aOR = 1.55, 95% CI = 0.81 to 2.94; P = .18). Among patients who started upfront with ED (n = 232, 32%), 107 (41%) developed any grade and 14 (5%) G3 or G4 irAEs during ED. Patients with irAEs during ED had improved overall survival (adjusted hazard ratio [aHR] = 0.53, 95% CI = 0.34 to 0.82; P = .004 after switching; aHR = 0.57, 95% CI = 0.35 to 0.93; P = .025 upfront). CONCLUSIONS: Switching ICI treatment from CD and ED did not increase the incidence of irAEs and represents a safe option also outside clinical trials.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antineoplásicos Inmunológicos / Neoplasias Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: J Natl Cancer Inst Año: 2023 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antineoplásicos Inmunológicos / Neoplasias Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: J Natl Cancer Inst Año: 2023 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Estados Unidos