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Pembrolizumab for advanced melanoma: experience from the Spanish Expanded Access Program
González-Cao, M; Arance, A; Piulats, JM; Marquez-Rodas, I; Manzano, JL; Berrocal, A; Crespo, G; Rodriguez, D; Perez-Ruiz, E; Berciano, M; Soria, A; Castano, AG; Espinosa, E; Montagut, C; Alonso, L; Puertolas, T; Aguado, C; Royo, MA; Blanco, R; Rodríguez, JF; Muñoz, E; Mut, P; Barron, F; Martin-Algarra, S.
Affiliation
  • González-Cao, M; University Hospital. Barcelona. Spain
  • Arance, A; Hospital Clinic I Provincial. Barcelona. Spain
  • Piulats, JM; Catalan Institute of Oncology. Barcelona. Spain
  • Marquez-Rodas, I; Gregorio Marañón Institute of Health Research. Madrid. Spain
  • Manzano, JL; Germans Trias I Pujol University Hospital. Barcelona. Spain
  • Berrocal, A; General University Hospital. Valencia. Spain
  • Crespo, G; Burgos University Hospital. Burgos. Spain
  • Rodriguez, D; Insular University Hospital of Gran CanariaCanary. Islands. Spain
  • Perez-Ruiz, E; Costa del Sol Hospital. Marbella. Spain
  • Berciano, M; Regional University Hospital of Malaga. Malaga. Spain
  • Soria, A; Ramony Cajal Hospital. Madrid. Spain
  • Castano, AG; Marqués de Valdecilla University Hospital. Santander. Spain
  • Espinosa, E; La Paz University Hospital. Madrid. Spain
  • Montagut, C; Del Mar University Hospital. Barcelona. Spain
  • Alonso, L; Virgen de la Victoria Hospital. Malaga. Spain
  • Puertolas, T; Miguel Servet University Hospital. Zaragoza. Spain
  • Aguado, C; San Carlos Hospital. Madrid. Spain
  • Royo, MA; Dr. Peset Hospital. Valencia. Spain
  • Blanco, R; Consorci Sanitari de Terrassa. Barcelona. Spain
  • Rodríguez, JF; Clara Campal Hospital. Madrid. Spain
  • Muñoz, E; Valld’Hebron University Hospital. Barcelona. Spain
  • Mut, P; Son Llatzer University Hospital. Mallorca. Spain
  • Barron, F; National Cancer Institute. Mexico City. México
  • Martin-Algarra, S; Navarra University Clinic. Pamplona. Spain
Clin. transl. oncol. (Print) ; 19(6): 761-768, jun. 2017. tab, graf
Article in English | IBECS | ID: ibc-162834
Responsible library: ES1.1
Localization: BNCS
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 (AU)
RESUMEN
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Collection: National databases / Spain Health context: SDG3 - Health and Well-Being / SDG3 - Target 3.4 Reduce premature mortality due to noncommunicable diseases Health problem: Target 3.4: Reduce premature mortality due to noncommunicable diseases / Melanoma Database: IBECS Main subject: Health Promotion / Melanoma / Neoplasm Metastasis / Neoplasm Staging Type of study: Observational study / Prognostic study Limits: Adult / Aged / Female / Humans / Male Language: English Journal: Clin. transl. oncol. (Print) Year: 2017 Document type: Article Institution/Affiliation country: Burgos University Hospital/Spain / Catalan Institute of Oncology/Spain / Clara Campal Hospital/Spain / Consorci Sanitari de Terrassa/Spain / Costa del Sol Hospital/Spain / Del Mar University Hospital/Spain / Dr. Peset Hospital/Spain / General University Hospital/Spain / Germans Trias I Pujol University Hospital/Spain / Gregorio Marañón Institute of Health Research/Spain
Search on Google
Collection: National databases / Spain Health context: SDG3 - Health and Well-Being / SDG3 - Target 3.4 Reduce premature mortality due to noncommunicable diseases Health problem: Target 3.4: Reduce premature mortality due to noncommunicable diseases / Melanoma Database: IBECS Main subject: Health Promotion / Melanoma / Neoplasm Metastasis / Neoplasm Staging Type of study: Observational study / Prognostic study Limits: Adult / Aged / Female / Humans / Male Language: English Journal: Clin. transl. oncol. (Print) Year: 2017 Document type: Article Institution/Affiliation country: Burgos University Hospital/Spain / Catalan Institute of Oncology/Spain / Clara Campal Hospital/Spain / Consorci Sanitari de Terrassa/Spain / Costa del Sol Hospital/Spain / Del Mar University Hospital/Spain / Dr. Peset Hospital/Spain / General University Hospital/Spain / Germans Trias I Pujol University Hospital/Spain / Gregorio Marañón Institute of Health Research/Spain
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