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.

Adjuvant or neoadjuvant chemotherapy in minimal N2 stage IIIA nonsmall cell lung cancer.

PURPOSE OF REVIEW: In the last decade, numerous randomized trials have evaluated the benefit of (neo-)adjuvant chemotherapy in nonsmall cell lung cancer. This article will review the recent data on perioperative chemotherapy in stage III A-N2 nonsmall cell lung cancer and future research opportunities are presented. RECENT FINDINGS: Four retrospective series, two phase 2 and four phase 3 trials in the neoadjuvant setting and one retrospective series, two phase 2 trials and two phase 3 trials in the adjuvant setting are retrieved and discussed. SUMMARY: The available evidence does not allow to change the current recommendation regarding the management of patients presenting with biopsy-proven clinical stage IIIA-N2 nonsmall cell lung cancer: their preferred treatment is chemoradiotherapy. Surgery with neoadjuvant or adjuvant chemotherapy is not proven superior to radiotherapy. The patient occasionally presenting with unforeseen pN2 despite adequate preoperative mediastinal staging should be offered adjuvant cisplatin-based chemotherapy and possibly postoperative radiotherapy.