Nivolumab and brain metastases in patients with advanced non-squamous non-small cell lung cancer

L. Crinò, G. Bronte, P. Bidoli, P. Cravero, E. Minenza, E. Cortesi, M.C. Garassino, C. Proto, F. Cappuzzo, F. Grossi, G. Tonini, M.G. Sarobba, G. Pinotti, G. Numico, R. Samaritani, L. Ciuffreda, A. Frassoldati, M. Bregni, A. Santo, F. PiantedosiA. Illiano, F. De Marinis, S. Tamberi, D. Giannarelli, A. Delmonte

Research output: Contribution to journalArticlepeer-review


Objectives: Brain metastases are common among patients with non-squamous non-small-cell lung cancer (NSCLC) and result in a poor prognosis. Consequently, such patients are often excluded from clinical trials. In Italy an expanded access program (EAP) was used to evaluate nivolumab efficacy and safety in this subpopulation outside a clinical trial. Materials and methods: In this EAP, nivolumab was available for patients with non-squamous NSCLC in progression after at least one systemic treatment for stage IIIB/IV disease. Nivolumab 3 mg/kg was administered intravenously every 2 weeks. Patients with brain metastases could be included if they were asymptomatic, neurologically stable and either off corticosteroids or on a stable or decreasing dose of ≤10 mg/day prednisone. Results: 409 out of 1588 patients included had asymptomatic or controlled brain metastases. A median of 7 doses (range 1–45) were delivered. Median follow-up was 6.1 months (range 0.1–21.9). The disease control rate was 39%: 4 patients had a complete response, 64 a partial response and 96 showed stable disease. At baseline, 118 patients were on corticosteroids and 74 were undergoing concomitant radiotherapy. The median overall survival in this subpopulation was 8.6 months (95% CI: 6.4–10.8). 337 discontinued treatment for various reasons, 23 (7%) of whom due to adverse events, in line with that observed in the overall population and in previous studies. Conclusions: Our results confirm that nivolumab is active in non-squamous NSCLC patients with brain metastases, despite their poor prognosis. Its safety profile is also concordant with results in the EAP overall population and in patients with other malignancies. © 2018 Elsevier B.V.
Original languageEnglish
Pages (from-to)35-40
Number of pages6
JournalLung Cancer
Publication statusPublished - 2019


  • Brain metastasis
  • Immune checkpoint inhibitors
  • Nivolumab
  • Non-small cell lung cancer
  • Non-squamous
  • aminotransferase
  • amylase
  • nivolumab
  • prednisone
  • triacylglycerol lipase
  • immunological antineoplastic agent
  • adult
  • advanced cancer
  • aged
  • anemia
  • anorexia
  • Article
  • asthenia
  • asymptomatic disease
  • brain metastasis
  • brain radiation
  • cancer growth
  • cancer patient
  • cancer radiotherapy
  • cancer staging
  • clinical study
  • cohort analysis
  • compassionate use
  • controlled study
  • corticosteroid therapy
  • diarrhea
  • disease control
  • drug dose reduction
  • drug efficacy
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  • dyspnea
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  • female
  • fever
  • follow up
  • human
  • hyperthyroidism
  • hypothyroidism
  • Italy
  • loss of appetite
  • major clinical study
  • male
  • nausea
  • non small cell lung cancer
  • overall survival
  • pain
  • pneumonia
  • population research
  • priority journal
  • side effect
  • treatment response
  • very elderly
  • vomiting
  • brain tumor
  • disease exacerbation
  • immunotherapy
  • lung tumor
  • middle aged
  • mortality
  • pathology
  • procedures
  • survival analysis
  • treatment outcome
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents, Immunological
  • Brain Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Disease Progression
  • Female
  • Humans
  • Immunotherapy
  • Lung Neoplasms
  • Male
  • Middle Aged
  • Survival Analysis
  • Treatment Outcome


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