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

(2018) LUNG CANCER. 115. p.49-55
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Abstract
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, Eastem 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.
Keywords
Non-small cell lung cancer, Nivolumab, Immunotherapy, Metastatic lung cancer, IMMUNE CHECKPOINT INHIBITORS, UPDATE

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MLA
Tournoy, Kurt, et al. “Does Nivolumab for Progressed Metastatic Lung Cancer Fulfill Its Promises? : An Efficacy and Safety Analysis in 20 General Hospitals.” LUNG CANCER, vol. 115, 2018, pp. 49–55.
APA
Tournoy, K., Thomeer, M., Germonpré, P., Derijcke, S., De Pauw, R., Galdermans, D., … Demedts, I. (2018). Does nivolumab for progressed metastatic lung cancer fulfill its promises? : an efficacy and safety analysis in 20 general hospitals. LUNG CANCER, 115, 49–55.
Chicago author-date
Tournoy, Kurt, Michiel Thomeer, Paul Germonpré, Sofie Derijcke, Rebecca De Pauw, Daniëlla Galdermans, Karl Govaert, et al. 2018. “Does Nivolumab for Progressed Metastatic Lung Cancer Fulfill Its Promises? : An Efficacy and Safety Analysis in 20 General Hospitals.” LUNG CANCER 115: 49–55.
Chicago author-date (all authors)
Tournoy, Kurt, Michiel Thomeer, Paul Germonpré, Sofie Derijcke, Rebecca De Pauw, Daniëlla Galdermans, Karl Govaert, Elke Govaerts, Rob Schildermans, Isabelle Declercq, Nele De Brucker, Karin Pat, Rika Van Herreweghe, Luc Van Zandweghe, Luc Vanmaele, Valerie Van Damme, Heidi Marien, Sofie De Craene, Isabelle Fabry, Patrick Alexander, Piet Vercauter, and Ingel Demedts. 2018. “Does Nivolumab for Progressed Metastatic Lung Cancer Fulfill Its Promises? : An Efficacy and Safety Analysis in 20 General Hospitals.” LUNG CANCER 115: 49–55.
Vancouver
1.
Tournoy K, Thomeer M, Germonpré P, Derijcke S, De Pauw R, Galdermans D, et al. Does nivolumab for progressed metastatic lung cancer fulfill its promises? : an efficacy and safety analysis in 20 general hospitals. LUNG CANCER. 2018;115:49–55.
IEEE
[1]
K. Tournoy et al., “Does nivolumab for progressed metastatic lung cancer fulfill its promises? : an efficacy and safety analysis in 20 general hospitals,” LUNG CANCER, vol. 115, pp. 49–55, 2018.
@article{8622075,
  abstract     = {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, Eastem 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.},
  author       = {Tournoy, Kurt and Thomeer, Michiel and Germonpré, Paul and Derijcke, Sofie and De Pauw, Rebecca and Galdermans, Daniëlla and Govaert, Karl and Govaerts, Elke and Schildermans, Rob and Declercq, Isabelle and De Brucker, Nele and Pat, Karin and Van Herreweghe, Rika and Van Zandweghe, Luc and Vanmaele, Luc and Van Damme, Valerie and Marien, Heidi and De Craene, Sofie and Fabry, Isabelle and Alexander, Patrick and Vercauter, Piet and Demedts, Ingel},
  issn         = {0169-5002},
  journal      = {LUNG CANCER},
  keywords     = {Non-small cell lung cancer,Nivolumab,Immunotherapy,Metastatic lung cancer,IMMUNE CHECKPOINT INHIBITORS,UPDATE},
  language     = {eng},
  pages        = {49--55},
  title        = {Does nivolumab for progressed metastatic lung cancer fulfill its promises? : an efficacy and safety analysis in 20 general hospitals},
  url          = {http://dx.doi.org/10.1016/j.lungcan.2017.11.008},
  volume       = {115},
  year         = {2018},
}

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