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Erschienen in: International Journal of Clinical Pharmacy 1/2019

22.12.2018 | Research Article

A multicentre observational study of the effectiveness, safety and economic impact of nivolumab on non-small-cell lung cancer in real clinical practice

verfasst von: Macarena Merino Almazán, Juan Manuel Duarte Pérez, Juan Francisco Marín Pozo, Ana Laura Ortega Granados, Begoña Muros De Fuentes, Paz Quesada Sanz, Ana Isabel Gago Sánchez, Patricia Rodríguez Gómez, José Miguel Jurado García, Fátima Artime Rodríguez-Hermida, María José Martínez Bautista, Antonio Rueda Ramos, Beatriz Mora Rodríguez, María Carmen Martínez Díaz, Pablo Nieto Guindo, Margarita Garrido Siles, Rosa Villatoro Roldán, José Carlos Roldán Morales, Silvia María Artacho Criado, Úrsula Baños Roldán, Ángel Inoriza Rueda, María Teresa Garrido Martínez

Erschienen in: International Journal of Clinical Pharmacy | Ausgabe 1/2019

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Abstract

Background Immunotherapy has become a standard treatment for lung cancer; however, the high cost makes it necessary to assess health outcomes. Objective The aim of this study was to evaluate the effectiveness, safety and economic cost of nivolumab in real-world clinical practice. Setting Fifteen regional and academic hospitals from Spain participated in this study. Methods This study was a retrospective, multicentre and observational study involving patients who experienced progression after first-line therapy for non-small-cell lung cancer and were treated with nivolumab between January 2016 and July 2017. Effectiveness and safety were evaluated by the oncologist, and the data from the electronic clinical records of the patients were collected by the research team. Economic cost was calculated using the cost of acquiring nivolumab for the public health system. Main outcome measures Effectiveness variables were overall survival (OS) and progression-free survival (PFS). The safety variable was the incidence of adverse events (AEs), and the cost per life-year gained (LYG) was the economic variable. Results A total of 221 patients were enrolled (83.7% men). The mean age was 64.5 years, and 84.6% of the patients had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0–1. Squamous tumours accounted for 59.7% of the total, and 78.7% of the patients presented a time since platinum therapy (TPT) > 6 months. The mean nivolumab dose was 216 mg (SD 211), and the treatment duration was 7.0 months (95% CI 5.8–8.1). The median PFS was 5.3 months (95% CI 3.2–7.3), and OS was 9.7 months (95% CI 7.6–11.8). The median PFS and OS values were statistically significantly superior for patients with an ECOG score of 0–1 and for patients with a TPT > 6 months. The median OS was also statistically significantly superior for patients with non-squamous histology. Regarding safety, 71% of the patients presented AEs of any grade, and in 18.6%, the nivolumab treatment had to be delayed or discontinued. The cost of nivolumab per patient was €19,910.00 (SD 19,369), and the cost per LYG was €110,026.00 (€77,557.00–€231,171.00). Conclusions This study confirms that the efficacy and safety of nivolumab treatment in a real population are comparable to the results obtained in clinical trials. A greater clinical benefit of nivolumab therapy was observed in patients with an ECOG score of 0–1, a TPT > 6 months or non-squamous histology. Despite the benefit observed, the cost per LYG is above the threshold of efficiency established by public health institutes.
Literatur
1.
Zurück zum Zitat Stewart BW, Wild CP. World cancer report 2014. International Agency for Research on Cancer, Lyon. 2014. ISBN: 978-92-832-0443-5. Stewart BW, Wild CP. World cancer report 2014. International Agency for Research on Cancer, Lyon. 2014. ISBN: 978-92-832-0443-5.
2.
Zurück zum Zitat Escuín JS. Lung cancer in Spain. Current epidemiology, survival and treatment. Arch Bronconeumol. 2009;45:341–8.PubMed Escuín JS. Lung cancer in Spain. Current epidemiology, survival and treatment. Arch Bronconeumol. 2009;45:341–8.PubMed
3.
Zurück zum Zitat Reck M, Popat S, Reinmuth N, Ruysscher DD, Kerr KM, Peters S. Metastatic non-small-cell lung cancer (NSCLC): ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(3):iii27–39.CrossRefPubMed Reck M, Popat S, Reinmuth N, Ruysscher DD, Kerr KM, Peters S. Metastatic non-small-cell lung cancer (NSCLC): ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(3):iii27–39.CrossRefPubMed
7.
Zurück zum Zitat Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WEE, Poddubskaya E, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015;373:123–35.CrossRefPubMedPubMedCentral Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WEE, Poddubskaya E, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015;373:123–35.CrossRefPubMedPubMedCentral
8.
Zurück zum Zitat Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373:1627–39.CrossRefPubMedPubMedCentral Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373:1627–39.CrossRefPubMedPubMedCentral
9.
Zurück zum Zitat Novello S, Barlesi F, Califano R, Cufer T, Ekman S, Levra MG, et al. Metastatic non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v1–27.CrossRefPubMed Novello S, Barlesi F, Califano R, Cufer T, Ekman S, Levra MG, et al. Metastatic non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v1–27.CrossRefPubMed
12.
Zurück zum Zitat Garde-Noguera J, Martin-Martorell P, De-Julián M, Pérez-Altozano J, Salvador-Coloma C, García-Sanchez J, et al. Predictive and prognostic clinical and pathological factors of nivolumab efficacy in non-small-cell lung cancer patients. Clin Trans Oncol. 2018;20:1072–9.CrossRef Garde-Noguera J, Martin-Martorell P, De-Julián M, Pérez-Altozano J, Salvador-Coloma C, García-Sanchez J, et al. Predictive and prognostic clinical and pathological factors of nivolumab efficacy in non-small-cell lung cancer patients. Clin Trans Oncol. 2018;20:1072–9.CrossRef
13.
Zurück zum Zitat Oya Y, Yoshida T, Kuroda H, Mikubo M, Kondo C, Shimizu J, et al. Predictive clinical parameters for the response of nivolumab in pretreated advanced non-small-cell lung cancer. Oncotarget. 2017;8:103117–28.CrossRefPubMedPubMedCentral Oya Y, Yoshida T, Kuroda H, Mikubo M, Kondo C, Shimizu J, et al. Predictive clinical parameters for the response of nivolumab in pretreated advanced non-small-cell lung cancer. Oncotarget. 2017;8:103117–28.CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat Fujimoto D, Yoshioka H, Kataoka Y, Morimoto T, Kim YH, Tomii K, et al. Efficacy and safety of nivolumab in previously treated patients with non-small cell lung cancer: a multicenter retrospective cohort study. Lung Cancer. 2018;119:14–20.CrossRefPubMed Fujimoto D, Yoshioka H, Kataoka Y, Morimoto T, Kim YH, Tomii K, et al. Efficacy and safety of nivolumab in previously treated patients with non-small cell lung cancer: a multicenter retrospective cohort study. Lung Cancer. 2018;119:14–20.CrossRefPubMed
Metadaten
Titel
A multicentre observational study of the effectiveness, safety and economic impact of nivolumab on non-small-cell lung cancer in real clinical practice
verfasst von
Macarena Merino Almazán
Juan Manuel Duarte Pérez
Juan Francisco Marín Pozo
Ana Laura Ortega Granados
Begoña Muros De Fuentes
Paz Quesada Sanz
Ana Isabel Gago Sánchez
Patricia Rodríguez Gómez
José Miguel Jurado García
Fátima Artime Rodríguez-Hermida
María José Martínez Bautista
Antonio Rueda Ramos
Beatriz Mora Rodríguez
María Carmen Martínez Díaz
Pablo Nieto Guindo
Margarita Garrido Siles
Rosa Villatoro Roldán
José Carlos Roldán Morales
Silvia María Artacho Criado
Úrsula Baños Roldán
Ángel Inoriza Rueda
María Teresa Garrido Martínez
Publikationsdatum
22.12.2018
Verlag
Springer International Publishing
Erschienen in
International Journal of Clinical Pharmacy / Ausgabe 1/2019
Print ISSN: 2210-7703
Elektronische ISSN: 2210-7711
DOI
https://doi.org/10.1007/s11096-018-0772-z

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