RESUMEN
OBJECTIVES: The S-REAL study aimed to assess the effectiveness of durvalumab as consolidation therapy after definitive chemoradiotherapy (CRT) in a real-world cohort of patients with locally advanced, unresectable stage III non-small cell lung cancer (LA-NSCLC) included in a Spanish early access program (EAP). METHODS: In this multicentre, observational, retrospective study we analysed data from patients treated in 39 Spanish hospitals, who started intravenous durvalumab (10 mg/kg every 2 weeks) between September 2017 and December 2018. The primary endpoint was progression-free survival (PFS). Secondary endpoints included patient characterization and adverse events of special interest (AESI). RESULTS: A total of 244 patients were followed up for a median of 21.9 months [range 1.2-34.7]. Median duration of durvalumab was 45.5 weeks (11.4 months) [0-145]. Median PFS was 16.7 months (95% CI 12.2-25). No remarkable differences in PFS were observed between patients with programmed cell death-ligand 1 (PD-L1) expression ≥ 1% or < 1% (16.7 versus 15.6 months, respectively). However, PFS was higher in patients who had received prior concurrent CRT (cCRT) versus sequential CRT (sCRT) (20.6 versus 9.4 months). AESIs leading to durvalumab discontinuation were registered in 11.1% of patients. CONCLUSIONS: These results are in line with prior published evidence and confirm the benefits of durvalumab in the treatment of LA-NSCLC patients in a real-world setting. We also observed a lower incidence of important treatment-associated toxicities, such as pneumonitis, compared with the pivotal phase III PACIFIC clinical study.
Asunto(s)
Anticuerpos Monoclonales , Carcinoma de Pulmón de Células no Pequeñas , Quimioradioterapia , Neoplasias Pulmonares , Humanos , Carcinoma de Pulmón de Células no Pequeñas/terapia , Carcinoma de Pulmón de Células no Pequeñas/patología , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Masculino , Femenino , Neoplasias Pulmonares/terapia , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/mortalidad , Estudios Retrospectivos , Anciano , Persona de Mediana Edad , España , Anticuerpos Monoclonales/uso terapéutico , Adulto , Anciano de 80 o más Años , Antineoplásicos Inmunológicos/uso terapéutico , Estadificación de Neoplasias , Supervivencia sin Progresión , Quimioterapia de Consolidación , Antígeno B7-H1/antagonistas & inhibidoresRESUMEN
Immune checkpoint inhibitors (ICIs), including those targeting programmed cell death 1 (PD-1), its ligand 1 (PD-L1), or cytotoxic T-lymphocyte antigen 4 (CTLA-4) have become the standard treatment for several malignancies, including lung cancer. However, some patient populations have been routinely excluded from clinical trials or are underrepresented in these studies, as is the case of elderly patients or patients with poor performance status, brain metastases, solid organ transplant, autoimmune diseases, chronic viral infections (such as human immunodeficiency virus or chronic viral hepatitis B and C), or organ dysfunction. Thus, the safety and efficacy of ICIs in these special populations is still unclear, despite regulatory approval of these agents. This review analyzes and summarizes the available information on the efficacy and safety of ICIs in these special populations, focusing on patients with lung cancer.
Asunto(s)
Neoplasias Encefálicas , Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Anciano , Antígeno B7-H1 , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Humanos , Inhibidores de Puntos de Control Inmunológico , Neoplasias Pulmonares/tratamiento farmacológicoAsunto(s)
Antimetabolitos Antineoplásicos/efectos adversos , Capecitabina/efectos adversos , Pancreatitis/inducido químicamente , Abdomen Agudo/inducido químicamente , Adenocarcinoma/complicaciones , Adenocarcinoma/tratamiento farmacológico , Adenocarcinoma/cirugía , Anciano , Capecitabina/administración & dosificación , Terapia Combinada , Fenofibrato/uso terapéutico , Humanos , Hipertrigliceridemia/inducido químicamente , Hipertrigliceridemia/complicaciones , Hipertrigliceridemia/tratamiento farmacológico , Hipolipemiantes/uso terapéutico , Masculino , Oxaliplatino/administración & dosificación , Pravastatina/uso terapéutico , Neoplasias del Colon Sigmoide/complicaciones , Neoplasias del Colon Sigmoide/tratamiento farmacológico , Neoplasias del Colon Sigmoide/cirugíaAsunto(s)
Coriocarcinoma/tratamiento farmacológico , Neoplasias Uterinas/tratamiento farmacológico , Antineoplásicos/uso terapéutico , Coriocarcinoma/patología , Coriocarcinoma/secundario , Femenino , Humanos , Neoplasias Pulmonares/secundario , Persona de Mediana Edad , Resultado del Tratamiento , Neoplasias Uterinas/patología , Neoplasias Uterinas/secundarioRESUMEN
No disponible
Asunto(s)
Humanos , Femenino , Persona de Mediana Edad , Coriocarcinoma/diagnóstico por imagen , Metrorragia/diagnóstico por imagen , Metrorragia/cirugía , Coriocarcinoma/tratamiento farmacológico , Pronóstico , Factores de Riesgo , Histerectomía/métodos , Enfermedad Trofoblástica Gestacional/diagnóstico , Enfermedad Trofoblástica Gestacional/patología , Gonadotropina Coriónica/análisisRESUMEN
No disponible