Does nivolumab for progressed metastatic lung cancer fulfill its promises? An efficacy and safety analysis in 20 general hospitals.

OBJECTIVES: In patients with refractory or recurrent non-small-cell lung cancer (NSCLC) after first line chemotherapy, phase III trials showed superiority of nivolumab, an IgG4 programmed death-1 immune-checkpoint-inhibitor antibody, over docetaxel. We evaluated case mix, effectiveness and safety of nivolumab upon implementation in general practice. MATERIALS AND METHODS: In 20 general hospitals, all consecutive NSCLC patients treated with nivolumab within the medical need program (inclusion period 12 months) in Flanders - Belgium were evaluated. RESULTS: There were 267 patients, Eastern Cooperative Oncology Group (ECOG) score was 2 in 24% and 0-1 in 76%. In 48%, two or more systemic regimens were given before nivolumab. The median overall survival was 7.8 months (95% confidence interval (CI) 6.3-9.3). At one year, the overall survival rate was 36.5±0.34%. Median progression-free survival was 3.7 months (95% CI 2.9-4.5). An objective response was obtained in 23.2%. ECOG score 2 and presence of liver metastasis strongly correlated with worse survival (p<0.00001). Treatment related adverse events grade 3 or 4 were reported in 21%, colitis (4%) and pneumonitis (7%) were most frequent. CONCLUSION: Upon implementation of nivolumab therapy in general hospitals, the case mix was characterized by a more heavily pretreated population with a substantial fraction of patients with ECOG score 2. The median overall survival is slightly inferior to what was published in the randomized phase III trials. An ECOG score 2 and the presence of liver metastasis correlated strongly with a worse survival. We report a high prevalence of serious adverse events.

EBUS-TBNA in the workup of a mediastinal mass.

Guided by endobronchial ultrasound (EBUS), mediastinal lymph nodes can be reached in a safe, minimally invasive manner, allowing fine needle aspiration for cytologic diagnosis with a high sensitivity and specificity. In describing the following clinical case, we demonstrate the use of EBUS-transbronchial needle aspiration (TBNA) in the workup of a paratracheal mass in a young female patient. Immunocytochemical analysis revealed it to be a peripheral nerve sheath tumor. EBUS-TBNA complemented computerized tomography, fluoro-deoxy-glucose positron emission tomography, and magnetic resonance imaging in establishing the diagnosis of this infrequently encountered mediastinal neoplasm. Fluoro-deoxy-glucose positron emission tomography has a potential to discriminate between high-grade sarcoma and benign soft tissue tumors, but it remains unreliable to differentiate benign schwannoma from low-grade sarcomas such as malignant peripheral nerve sheath tumor. When properly prepared, cell blocks obtained from TBNA of a paratracheal mass offer the possibility of cytologic examination and immunocytochemical staining, confirming the diagnosis of mediastinal neurogenic tumors.