Advertisement

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

  • Macarena Merino Almazán
  • Juan Manuel Duarte Pérez
  • Juan Francisco Marín PozoEmail author
  • 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
Research Article
  • 92 Downloads

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.

Keywords

Immunotherapy Nivolumab Non-small-cell lung cancer Real-world data Spain 

Notes

Funding

No funding was received for this study.

Conflicts of interest

The authors declare that they have no conflicts of interest.

References

  1. 1.
    Stewart BW, Wild CP. World cancer report 2014. International Agency for Research on Cancer, Lyon. 2014. ISBN: 978-92-832-0443-5.Google Scholar
  2. 2.
    Escuín JS. Lung cancer in Spain. Current epidemiology, survival and treatment. Arch Bronconeumol. 2009;45:341–8.PubMedGoogle Scholar
  3. 3.
    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.CrossRefGoogle Scholar
  4. 4.
    NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-Small Cell Lung Cancer (ver.1.2019). National Comprehensive Cancer Network, Washington. 2018. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed 29 Oct 2018.
  5. 5.
    EMA/CHMP/215704/2016 Committee for Medicinal Products for Human Use (CHMP) Assessment report OPDIVO International non-proprietary name: nivolumab. European Medicines Agency. 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/003985/WC500209378.pdf. Accessed 29 Oct 2018.
  6. 6.
    OPDIVO, INN-nivolumab—Annex I. Summary of product characteristics. European Medicines Agency. 2018. https://www.ema.europa.eu/documents/product-information/opdivo-epar-product-information_en.pdf. Accessed 29 Oct 2018.
  7. 7.
    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.CrossRefGoogle Scholar
  8. 8.
    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.CrossRefGoogle Scholar
  9. 9.
    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.CrossRefGoogle Scholar
  10. 10.
    Hospital costs. Analytical Accounting. Statistical Portal of the SNS. Ministerio de Sanidad, Consumo y Bienestar Social. Servicios Sociales e Igualdad. 2018. http://www.mscbs.gob.es/estadEstudios/estadisticas/docs/CMBD/PESOS_COSTES_APR_GRD_V32_2016.xls. Accessed 29 Oct 2018.
  11. 11.
    Castañeda Macías I, Martínez-Brocal Ogayar I, Alegre del Rey EJ, Marín Gil R. Nivolumab for non-small cell lung cancer metastatic for squamous histology in pre-treated patients. Evaluation report for the pharmacotherapeutic guide of hospitals of Andalusia. Sociedad Española de Farmacia Hospitalaria. 2016. http://gruposdetrabajo.sefh.es/genesis/genesis/Documents/Nivolumab_CPNMescamoso_GFTHA_11_2016.doc. Accessed 29 Oct 2018.
  12. 12.
    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.CrossRefGoogle Scholar
  13. 13.
    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.CrossRefGoogle Scholar
  14. 14.
    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.CrossRefGoogle Scholar
  15. 15.
    Protocol for the therapeutic use of drugs in lung cancer. Oncology Clinical Permanent Committee. Comisión Central para la Optimización y Armonización Farmacoterapéutica. Servicio Andaluz de Salud. 2017. http://www.juntadeandalucia.es/servicioandaluzdesalud/library/plantillas/externa.asp?pag=/contenidos/gestioncalidad/gasistencial/farmacia/protocolo/Protoc_uso_terapeut_farmacos_cancer_pulmon.pdf. Accessed 29 Oct 2018.

Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  • Macarena Merino Almazán
    • 1
  • Juan Manuel Duarte Pérez
    • 2
  • Juan Francisco Marín Pozo
    • 3
    Email author return OK on get
  • Ana Laura Ortega Granados
    • 4
  • Begoña Muros De Fuentes
    • 5
  • Paz Quesada Sanz
    • 6
  • Ana Isabel Gago Sánchez
    • 7
  • Patricia Rodríguez Gómez
    • 8
  • José Miguel Jurado García
    • 9
  • Fátima Artime Rodríguez-Hermida
    • 10
  • María José Martínez Bautista
    • 11
  • Antonio Rueda Ramos
    • 12
  • Beatriz Mora Rodríguez
    • 13
  • María Carmen Martínez Díaz
    • 14
  • Pablo Nieto Guindo
    • 15
  • Margarita Garrido Siles
    • 16
  • Rosa Villatoro Roldán
    • 17
  • José Carlos Roldán Morales
    • 18
  • Silvia María Artacho Criado
    • 19
  • Úrsula Baños Roldán
    • 20
  • Ángel Inoriza Rueda
    • 21
  • María Teresa Garrido Martínez
    • 22
  1. 1.Hospital Pharmacy DepartmentComplejo Hospitalario de JaénJaénSpain
  2. 2.Pharmacology Department of Faculty of PharmacyUniversity of GranadaGranadaSpain
  3. 3.Hospital Pharmacy Department, Servicio Farmacia HospitalariaComplejo Hospitalario de JaénJaénSpain
  4. 4.Medical Oncology DepartmentComplejo Hospitalario de JaénJaénSpain
  5. 5.Hospital Pharmacy DepartmentHospital Clínico Virgen de la VictoriaMálagaSpain
  6. 6.Hospital Pharmacy DepartmentHospital Punta de EuropaAlgecirasSpain
  7. 7.Hospital Pharmacy DepartmentHospital Universitario Reina SofíaCórdobaSpain
  8. 8.Hospital Pharmacy DepartmentHospital Universitario San CecilioGranadaSpain
  9. 9.Medical Oncology DepartmentHospital Universitario San CecilioGranadaSpain
  10. 10.Hospital Pharmacy DepartmentHospital Virgen de las NievesGranadaSpain
  11. 11.Hospital Pharmacy DepartmentHospital Universitario Puerta del MarCádizSpain
  12. 12.Medical Oncology DepartmentHospital Universitario Puerta del MarCádizSpain
  13. 13.Hospital Pharmacy DepartmentHospital Regional Universitario MálagaMálagaSpain
  14. 14.Hospital Pharmacy DepartmentHospital Puerto RealPuerto RealSpain
  15. 15.Hospital Pharmacy DepartmentHospital TorrecárdenasAlmeríaSpain
  16. 16.Hospital Pharmacy DepartmentHospital Costa del SolMarbellaSpain
  17. 17.Medical Oncology DepartmentHospital Costa del SolMarbellaSpain
  18. 18.Hospital Pharmacy DepartmentHospital SAS de La LíneaLa LíneaSpain
  19. 19.Hospital Pharmacy DepartmentHospital ValmeSevilleSpain
  20. 20.Hospital Pharmacy DepartmentHospital Virgen MacarenaSevilleSpain
  21. 21.Medical Oncology DepartmentHospital Juan Ramón JiménezHuelvaSpain
  22. 22.Hospital Pharmacy DepartmentHospital Juan Ramón JiménezHuelvaSpain

Personalised recommendations