Nivolumab and brain metastases in patients with advanced non-squamous non-small cell lung cancer
| Autor: | Francovito Piantedosi, Antonio Santo, Claudia Proto, Antonio Frassoldati, Angelo Delmonte, Filippo de Marinis, Libero Ciuffreda, Enrico Cortesi, Paolo Bidoli, Graziella Pinotti, Marco Bregni, Riccardo Samaritani, Federico Cappuzzo, Lucio Crinò, Alfonso Illiano, Paola Cravero, Elisa Minenza, Giuseppe Tonini, Diana Giannarelli, Gianmauro Numico, Stefano Tamberi, Maria Giuseppina Sarobba, Francesco Grossi, Marina Chiara Garassino, Giuseppe Bronte |
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| Přispěvatelé: | Crino, L, Bronte, G, Bidoli, P, Cravero, P, Minenza, E, Cortesi, E, Garassino, M, Proto, C, Cappuzzo, F, Grossi, F, Tonini, G, Sarobba, M, Pinotti, G, Numico, G, Samaritani, R, Ciuffreda, L, Frassoldati, A, Bregni, M, Santo, A, Piantedosi, F, Illiano, A, De Marinis, F, Tamberi, S, Giannarelli, D, Delmonte, A |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Oncology Male Cancer Research Lung Neoplasms 0302 clinical medicine Antineoplastic Agents Immunological Non-small cell lung cancer Carcinoma Non-Small-Cell Lung Aged 80 and over education.field_of_study Brain Neoplasms Brain metastasis Immune checkpoint inhibitors Nivolumab Non-squamous Middle Aged Treatment Outcome Italy 030220 oncology & carcinogenesis Disease Progression Female Immunotherapy medicine.symptom Pulmonary and Respiratory Medicine Adult medicine.medical_specialty Population Socio-culturale Asymptomatic 03 medical and health sciences Internal medicine medicine Humans Lung cancer education Cancer staging Aged brain metastasis immune checkpoint inhibitors nivolumab non-small cell lung cancer non-squamous business.industry medicine.disease Survival Analysis 030104 developmental biology Expanded access Concomitant business |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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