title: The safety of nivolumab for the treatment of advanced non-small cell lung cancer.
abstract: Immune checkpoint blockaders (ICBs) act by unbalancing the immune system, thus favoring the development of an immune-mediated antitumor effect. ICBs targeting the programmed cell death receptor-1 (PD-1) have recently been investigated in a number of advanced tumors, including non-small cell lung cancer (NSCLC). Nivolumab, a fully human IgG4 kappa directed against PD-1, has been the first ICB to be approved for second-line treatment of advanced NSCLC. Areas covered: In this review we focus on the clinical development of nivolumab for the treatment of advanced NSCLC, with an emphasis on its safety profile. In addition, we summarize the most common types of immune-related adverse events (irAEs) associated with nivolumab, mainly due to organ inflammation secondary to autoimmunity. Expert opinion: Nivolumab is the preferred treatment option for platinum-pretreated advanced NSCLC, having convincingly shown higher efficacy compared with standard docetaxel chemotherapy in phase III trials. The same trials showed far less incidence of either any grade and severe treatment-related AEs with nivolumab compared with chemotherapy. IrAEs associated with nivolumab are rarely severe in intensity, and often resolve with prompt management. Future studies will explore nivolumab in combination strategies with either platinum-based chemotherapy or other ICBs in treatment-naïve advanced NSCLC patients.
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Metro
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Biagio
authors.initials: B
authors.lastname: Ricciuti
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Brambilla
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Baglivo
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Soli
authors.affiliation: b Medical Oncology , Santa Maria Hospital, Azienda Ospedaliera di Terni , Terni , Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Minenza
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Giulia Costanza
authors.initials: GC
authors.lastname: Leonardi
authors.affiliation: c Pharmacy Unit , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: D'arpino
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Colabrese
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Tazza
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Zicari
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Minotti
authors.affiliation: a Medical Oncology , Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia , Perugia , Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Chiari
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D000077594:Nivolumab; D061026:Programmed Cell Death 1 Receptor / Q000276:immunology
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D061026:Programmed Cell Death 1 Receptor; D000077594:Nivolumab
keywords: Immune checkpoint blockade; immune-related adverse events; nivolumab; non-small cell lung cancer; safety