Kurt G Tournoy1, Michiel Thomeer2, Paul Germonpré3, Sofie Derijcke4, Rebecca De Pauw5, Daniëlla Galdermans6, Karl Govaert7, Elke Govaerts8, Rob Schildermans9, Isabelle Declercq10, Nele De Brucker11, Karin Pat12, Rika Van Herreweghe13, Luc Van Zandweghe14, Luc Vanmaele15, Valerie Van Damme16, Heidi Marien17, Sofie De Craene18, Isabelle Fabry19, Patrick Alexander20, Piet Vercauter21, Ingel Demedts22. 1. Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium; Faculty of Medicine and Life Sciences, Ghent University, Ghent, Belgium. Electronic address: kurt.tournoy@olvz-aalst.be. 2. Ziekenhuis Oost Limburg, Limburg and Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium. 3. AZ Maria Middelares Gent, Belgium. 4. AZ Groeninge Kortrijk, Belgium. 5. AZ Sint-Jan Brugge-Oostende AV Campus Brugge, Belgium. 6. ZNA Middelheim - Stuyvenberg - Sint-Erasmus Antwerpen, Belgium. 7. KLINA Brasschaat, Belgium. 8. AZ Sint-Lucas Gent, Belgium. 9. AZ Sint-Lucas Brugge, Belgium. 10. Jan Yperman Ziekenhuis Ieper, Belgium. 11. Imelda Ziekenhuis Bonheiden, Belgium. 12. Jessa Ziekenhuis Hasselt, Belgium. 13. Algemeen Stedelijk Ziekenhuis Aalst, Belgium. 14. AZ Sint Blasius Dendermonde, Belgium. 15. AZ Zeno Knokke-Blankenberge, Belgium. 16. Sint-Andries Ziekenhuis Tielt, Belgium. 17. AZ Sint-Rembert Ziekenhius Torhout, Belgium. 18. AZ West Veurne, Belgium. 19. AZ Sint-Jan Brugge-Oostende AV Campus Oostende, Belgium. 20. AZ Glorieux, Ronse, Belgium. 21. Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium. 22. AZ Delta Roeselare, Belgium.
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, 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.
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 NSCLCpatients 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.
Authors: Laurie E Steffen McLouth; Thomas W Lycan; Beverly J Levine; Jennifer Gabbard; Jimmy Ruiz; Michael Farris; Stefan C Grant; Nicholas M Pajewski; Kathryn E Weaver; W Jeffrey Petty Journal: Clin Lung Cancer Date: 2019-11-29 Impact factor: 4.785
Authors: Alexander Liede; Rohini K Hernandez; Sally W Wade; Ronghai Bo; Nathan C Nussbaum; Elizabeth Ahern; William C Dougall; Mark J Smyth Journal: Oncoimmunology Date: 2018-09-05 Impact factor: 8.110
Authors: R A Juergens; C Mariano; J Jolivet; N Finn; J Rothenstein; M N Reaume; A Faghih; C Labbé; S Owen; F A Shepherd; J Villeneuve; F Romeyer; F Pettersson; C Butts Journal: Curr Oncol Date: 2018-12-01 Impact factor: 3.677