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BACKGROUND: To further characterize survival benefit with first-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone, we report updated data from the phase III CheckMate 9LA trial with a 2-year minimum follow-up. PATIENTS AND METHODS: Adult patients were treatment naïve, with stage IV/recurrent non-small-cell lung cancer, no known sensitizing EGFR/ALK alterations, and an Eastern Cooperative Oncology Group performance status ≤1. Patients were randomized 1 : 1 to nivolumab 360 mg every 3 weeks plus ipilimumab 1 mg/kg every 6 weeks with two cycles of chemotherapy, or four cycles of chemotherapy. Updated efficacy and safety outcomes are reported, along with progression-free survival (PFS) after next line of treatment (PFS2), treatment-related adverse events (TRAEs) by treatment cycle, and efficacy outcomes in patients who discontinued all treatment components in the experimental arm due to TRAEs. RESULTS: With a median follow-up of 30.7 months, nivolumab plus ipilimumab with chemotherapy continued to prolong overall survival (OS) versus chemotherapy. Median OS was 15.8 versus 11.0 months [hazard ratio 0.72 (95% confidence interval 0.61-0.86)]; 2-year OS rate was 38% versus 26%. Two-year PFS rate was 20% versus 8%. ORR was 38% versus 25%, respectively; 34% versus 12% of all responses were ongoing at 2 years. Median PFS2 was 13.9 versus 8.7 months. Improved efficacy outcomes in the experimental versus control arm were observed across most subgroups, including by programmed death-ligand 1 and histology. No new safety signals were observed; onset of grade 3/4 TRAEs was mostly observed during the first two treatment cycles in the experimental arm. In patients who discontinued all components of nivolumab plus ipilimumab with chemotherapy treatment due to TRAEs (n = 61) median OS was 27.5 months; 56% of responders had an ongoing response ≥1 year after discontinuation. CONCLUSIONS: With a 2-year minimum follow-up, nivolumab plus ipilimumab with two cycles of chemotherapy provided durable efficacy benefits over chemotherapy with a manageable safety profile and remains an efficacious first-line treatment of advanced non-small-cell lung cancer.
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Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Humanos , Ipilimumab/efectos adversos , Neoplasias Pulmonares/tratamiento farmacológico , Recurrencia Local de Neoplasia , Nivolumab/efectos adversosRESUMEN
The advent of smartphones and tablets, means that we can constantly get information on our current geographical location. These devices include not only GPS/GNSS chipsets but also mass-market inertial platforms that can be used to plan activities, share locations on social networks, and also to perform positioning in indoor and outdoor scenarios. This paper shows the performance of smartphones and their inertial sensors in terms of gaining information about the user's current geographical locatio n considering an indoor navigation scenario. Tests were carried out to determine the accuracy and precision obtainable with internal and external sensors. In terms of the attitude and drift estimation with an updating interval equal to 1 s, 2D accuracies of about 15 cm were obtained with the images. Residual benefits were also obtained, however, for large intervals, e.g. 2 and 5 s, where the accuracies decreased to 50 cm and 2.2 m, respectively.
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Objetivos: evaluar nivel de hemoglonina previo a quimioterapia (Qt.) en cáncer de ovario como factor pronóstico de tiempo libre de progresión a la primera línea. Materiales y métodos: se analizaron retrospectivamente 58 pacientes (ptes) del Instituto Oncológico de Córdoba. Se definió anemia como hemoglobina menor a 12 g/dl. Se tomaron 2 grupos, el primero con anemia previa a la Qt. versus el segundo sin anemia. Se obtuvieron curvas de tiempo libre de progresión (TLP) y de supervivencia global (SG) con Kaplan Meier. El análisis de variables con Chi cuadrado y test t de Student. Resultados: anemia pre Qt.: 32 (55%). Sin anemia: 26 (45%). Todas tratadas con platino. TLP medio de 15; SG en anemia: 28,4; sin anemia: 59,8 meses. No se encontró asociación entre Hb y estadio, enfermedad residual, CA 125 inicial y patrón de recaída. Un alto porcentaje de ptes. sin anemia (88,5%) realizaron más de 4 ciclos de Qt. comparado con las anémicas (66%-p=0,04). Se observó mayor porcentaje de respuesta completa (RC) en ptes. sin anemia 54% vs 22%. Ptes. con anemia presentaron 60% de progresión de enfermedad vs. 30% en ptes. con nivel mayor de 12. Existe asociación significativa entre Hb y respuesta a Qt. (p = 0,01). Los que han manifestado beneficio clínico, tienen en mayor proporción de Hb mayor a 12. Las anémicas tienen 4 veces más posibilidades de presentar progresión. Conclusión: las ptes. sin anemia tuvieron un TLP y SG más prolongado y una mejor respuesta que las ptes. con anemia estadísticamente significativa. Palabras claves: cáncer de ovario - anemia - recaída - factor pronóstico - hemoglobina.
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Humanos , Adulto , Femenino , Persona de Mediana Edad , Neoplasias Ováricas/diagnóstico , Anemia , Hemoglobina A , Neoplasias Ováricas/tratamiento farmacológico , Pronóstico , Progresión de la Enfermedad , Recurrencia , Estudios RetrospectivosRESUMEN
The influence of hepatitis B virus (HBV) on the natural history of human immunodeficiency virus (HIV) infection was evaluated in a prospective study of 347 HIV-positive, AIDS-free individuals infected through injecting drug use and sex and with known seroconversion dates. End points were CD4+ cell count < 200 x 10(6) cell/L and AIDS diagnosis. At entry, 229 had seromarkers to HBV; during the study, 107 had a CD4+ cell count < 200 x 10(6) cells/L and 66 developed AIDS. HBsAg chronic carriers, HBV infection-free subjects and those with baseline evidence of prior HBV infection did not differ in rates of progression to end points. Sexual transmission of HIV was significant predictor of CD4+ cell decline to < 200 x 10(6) cells/l [Hazard ratio (HZ): 1.56, 95% confidence interval (CI): 1.06-2.29, p = 0.0232] and progression to AIDS (HZ: 1.91, CI: 1.17-3.11, p = 0.0091). 15 HIV-positive and HBV infection-free patients had HBV seroconversion. They did not differ from those who remained HBV infection-free in rates of progression to end points, but 40% of them became HBsAg chronic carriers. These results suggest that HBV has no influence on progression of HIV disease, but that patients who have HIV before their HBV infection are more likely to become HBsAg chronic carriers than those who are infected with HBV before HIV.