Effectiveness and safety of pembrolizumab monotherapy in patients with locally advanced or metastatic non-small-cell lung cancer.

INTRODUCTION: Immunotherapy has become a standard treatment for lung cancer; the objective of this study was to evaluate the effectiveness, safety of pembrolizumab monotherapy in patients with advanced or metastatic non-small-cell lung cancer used in real-world clinical practice. MATERIAL AND METHODS: Retrospective observational study of every patient treated with pembrolizumab in our centre from January 2017 to June 2019. Outcomes collected: sex, age, Eastern Cooperative Oncology Group, programmed death receptor 1 level, previous metastatic line therapies, adverse events and smoking status. RESULTS: A total of 62 patients were reviewed. The median age was 62.34 ± 10.62 years, 48 (77.41%) were men and 91.93% of patients had Eastern Cooperative Oncology Group 0. The median dose administered was 170.5 mg (108 - 240 mg) and the median follow-up was 3 months (range: 1 - 38). A median of four cycles of pembrolizumab (range: 1 - 56) were administered as monotherapy. The reason for treatment discontinuation was mainly due to disease progression in 38.70% of patients or death in 30.64%. As first-line pembrolizumab monotherapy, median progression-free survival was 7.7 months (95% CI: 3.66 - 11.73) (N = 33). With respect to patients who were treated in second-third-line treatment, median progression-free survival was 3.5 months (95% CI: 2.40 - 4.59) (N=29). As to overall survival, pembrolizumab-treated patients as first-line treatment reached 19 months median OG (95% CI: 13.36 - 24.63) (N = 33) and those treated in second-third-line treatment got 11 months (95% CI: 3.4 - 18.5). A total of 64.51% of patients presented some adverse events to pembrolizumab however, only, 9.38% of them were grade 3. CONCLUSION: Pembrolizumab represents an effective and feasible alternative in terms of progression-free survival. It is a well-tolerated treatment option.

Economic evaluation of the GENESIS-SEFH report of olaratumab with doxorubicin in soft tissue sarcoma in advanced stages.

OBJECTIVE: The economic evaluation of the drug olaratumab is carried out in the treatment of soft tissue sarcoma. METHOD: The data were analyzed following the recommendations contained in  the MADRE program of the GENESIS-SEFH report model. RESULTS: Progression free survival and overall survival results published in the  pivotal clinical trial; Tap, WD. et al. (2016) were improvement of 2.5 months in  median progression free survival (primary endpoint) HR = 0.672; IC95%  (0.442-1.021) and gain of 11.8 months in median OS (secondary endpoint) HR  = 0.463; IC95% (0.301-0.710). A cost-effectiveness analyses was performed  considering 2 scenarios; scenario 1: with use of whole vials and scenario 2: use  of whole vials and associating non-pharmacological costs (day hospital visits,  mucositis, neutropenia and dexrazoxane use). In both cases we considered the  cost of drugs and the efficacy data of the pivotal clinical trial. In Scenario 1, we  would have an Incremental-Cost-Effectiveness-Ratio of €28,443.81/month of  progression-free survival and €72,560.74 per year of life gained and in scenario  2 we would have an incremental-cost-effectivenessratio of €30,879.79/  progression-free survival and €78,774.99/ year of life gained. The budgetary  impact of this drug would range from €61,759.592 to €92,639.388 estimated to  be 800 to 1,200 patients likely to receive treatment in Spain. CONCLUSIONS: Olaratumab is a drug that provides a significant benefit in overall  survival but not in progression free survival. To be used in soft tissue sarcoma  and to be cost-effective, the acquisition cost of the 500 mg vial should be  between €101.91 and €506.54 and that of the 190 mg vial between €39.31 and  €195.37.

Objetivo: Desarrollar la evaluación económica del fármaco olaratumab en el  tratamiento del sarcoma de partes blandas.Método: Los datos se analizaron siguiendo las recomendaciones contenidas en  el programa MADRE del modelo de informe GENESIS-SEFH.Resultados: Los resultados de supervivencia libre de progresión y supervivencia global publicados en el ensayo clínico pivotal: Tapm WD. et al.  (2016) fueron: la ganancia en supervivencia libre de progresión (variable  principal) en términos absolutos fue de 2,5 meses, HR = 0,672; IC95% (0,442- 1,021). La ganancia absoluta en supervivencia global (variable secundaria) fue  de 11,8 meses, HR = 0,463; IC95% (0,301-0,710). Se realizó un análisis coste- efectividad considerando dos escenarios; escenario uno: sin aprovechamiento de viales; y escenario dos: sin aprovechamiento de viales y asociando costes no  farmacológicos. En ambos casos se consideraron los costes de adquisición de los medicamentos y los datos de eficacia del ensayo clínico pivotal. En el primero  determinamos una ratio coste-efectividad-incremental de 28.443,81 euros/mes  libre de progresión ganado y 72.560,74 euros/año de vida ganado. En el  segundo obtenemos una ratio coste-efectividad incremental de 30.879,79 euros libre de progresión ganado y 78.774,99 euros/año de vida ganado. El  impacto económico estatal, por tanto, se situaría entre 61.759.592 millones de  euros y 92.639.388 de euros, considerando una población diana de 800-1.200  pacientes a nivel nacional.Conclusiones: Olaratumab es un fármaco que aporta un beneficio significativo  en la supervivencia global, no así en la supervivencia libre de progresión. Para  poder utilizarse en el sarcoma de partes blancas y que resultase costeefectivo, el coste de adquisición del vial de 500 mg debería situarse entre 101,91 y 506,54  euros y el del vial de 190 mg entre 39,31 y 195,37 euros.