Clinical and Translational Oncology

, Volume 19, Issue 6, pp 761–768

Pembrolizumab for advanced melanoma: experience from the Spanish Expanded Access Program

  • M. González-Cao
  • A. Arance
  • J. M. Piulats
  • I. Marquez-Rodas
  • J. L. Manzano
  • A. Berrocal
  • G. Crespo
  • D. Rodriguez
  • E. Perez-Ruiz
  • M. Berciano
  • A. Soria
  • A. G. Castano
  • E. Espinosa
  • C. Montagut
  • L. Alonso
  • T. Puertolas
  • C. Aguado
  • M. A. Royo
  • R. Blanco
  • J. F. Rodríguez
  • E. Muñoz
  • P. Mut
  • F. Barron
  • S. Martin-Algarra
  • Spanish Melanoma Group
Research Article

DOI: 10.1007/s12094-016-1602-1

Cite this article as:
González-Cao, M., Arance, A., Piulats, J.M. et al. Clin Transl Oncol (2017) 19: 761. doi:10.1007/s12094-016-1602-1

Abstract

Background

The programmed death (PD-1) inhibitor pembrolizumab has been recently approved for the treatment of advanced melanoma. We evaluated the clinical activity of pembrolizumab in melanoma patients treated under the Spanish Expanded Access Program.

Methods

Advanced melanoma patients who failed to previous treatment lines were treated with pembrolizumab 2 mg/kg every three weeks. Patients with brain metastases were not excluded if they were asymptomatic. Data were retrospectively collected from 21 centers in the Spanish Melanoma Group.

Results

Sixty-seven advanced melanoma patients were analyzed. Most patients were stage M1c (73.1%), had high LDH levels (55.2%) and had ECOG PS 1 or higher (59.7%). For cutaneous melanoma patients, median overall survival was 14.0 months; the 18-month overall survival rate was 47.1%. Overall response rate was 27%, including three patients with complete responses (6.5%). Median response duration was not reached, with 83.3% of responses ongoing (3.5 m+ to 20.4 m+). From ten patients included with brain metastases, four (40%) had an objective response, two (20%) of them achieved a complete response. Significant prognostic factors for overall survival were LDH level, ECOG PS and objective response. There were no serious adverse events.

Conclusion

Although this was a heavily pretreated cohort, pembrolizumab activity at the approved dose and schedule was confirmed in the clinical setting with long-term responders, also including patients with brain metastases.

Keywords

Expanded access program Melanoma Pembrolizumab Survival CNS metastases 

Supplementary material

12094_2016_1602_MOESM1_ESM.docx (13 kb)
Supplementary material 1 (DOCX 12 kb)

Copyright information

© Federación de Sociedades Españolas de Oncología (FESEO) 2016

Authors and Affiliations

  • M. González-Cao
    • 1
  • A. Arance
    • 2
  • J. M. Piulats
    • 3
  • I. Marquez-Rodas
    • 4
  • J. L. Manzano
    • 5
  • A. Berrocal
    • 6
  • G. Crespo
    • 7
  • D. Rodriguez
    • 8
  • E. Perez-Ruiz
    • 9
  • M. Berciano
    • 10
  • A. Soria
    • 11
  • A. G. Castano
    • 12
  • E. Espinosa
    • 13
  • C. Montagut
    • 14
  • L. Alonso
    • 15
  • T. Puertolas
    • 16
  • C. Aguado
    • 17
  • M. A. Royo
    • 18
  • R. Blanco
    • 19
  • J. F. Rodríguez
    • 20
  • E. Muñoz
    • 21
  • P. Mut
    • 22
  • F. Barron
    • 23
  • S. Martin-Algarra
    • 24
  • Spanish Melanoma Group
  1. 1.Translational Cancer Research Unit, Dr. Rosell Oncology InstituteQuiron Dexeus University HospitalBarcelonaSpain
  2. 2.Hospital Clinic I ProvincialBarcelonaSpain
  3. 3.Catalan Institute of OncologyBarcelonaSpain
  4. 4.Gregorio Marañón Institute of Health ResearchMadridSpain
  5. 5.Germans Trias I Pujol University HospitalBarcelonaSpain
  6. 6.General University HospitalValenciaSpain
  7. 7.Burgos University HospitalBurgosSpain
  8. 8.Insular University Hospital of Gran CanariaCanary IslandsSpain
  9. 9.Costa del Sol HospitalMarbellaSpain
  10. 10.Regional University Hospital of MalagaMalagaSpain
  11. 11.Ramony Cajal HospitalMadridSpain
  12. 12.Marqués de Valdecilla University HospitalSantanderSpain
  13. 13.La Paz University HospitalMadridSpain
  14. 14.Del Mar University HospitalBarcelonaSpain
  15. 15.Virgen de la Victoria HospitalMalagaSpain
  16. 16.Miguel Servet University HospitalZaragozaSpain
  17. 17.San Carlos HospitalMadridSpain
  18. 18.Dr. Peset HospitalValenciaSpain
  19. 19.Consorci Sanitari de TerrassaBarcelonaSpain
  20. 20.Clara Campal HospitalMadridSpain
  21. 21.Valld’Hebron University HospitalBarcelonaSpain
  22. 22.Son Llatzer University HospitalMallorcaSpain
  23. 23.National Cancer InstituteMexico CityMexico
  24. 24.Navarra University ClinicPamplonaSpain

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