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.

Crino, L., Bronte, G., Bidoli, P., Cravero, P., Minenza, E., Cortesi, E., et al. (2019). Nivolumab and brain metastases in patients with advanced non-squamous non-small cell lung cancer. LUNG CANCER, 129, 35-40 [10.1016/j.lungcan.2018.12.025].

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

Bidoli P.;
2019

Abstract

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.
Articolo in rivista - Articolo scientifico
Brain metastasis
Immune checkpoint inhibitors
Nivolumab
Non-small cell lung cancer
Non-squamous
Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Immunological
Brain Neoplasms
Carcinoma, Non-Small-Cell Lung
Disease Progression
Female
Humans
Immunotherapy
Italy
Lung Neoplasms
Male
Middle Aged
Nivolumab
Survival Analysis
Treatment Outcome
English
2019
129
35
40
none
Crino, L., Bronte, G., Bidoli, P., Cravero, P., Minenza, E., Cortesi, E., et al. (2019). Nivolumab and brain metastases in patients with advanced non-squamous non-small cell lung cancer. LUNG CANCER, 129, 35-40 [10.1016/j.lungcan.2018.12.025].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/281346
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