Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2- advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP).

This study evaluated efficacy and safety of palbociclib, a CDK4/6 inhibitor, in heavily-pretreated hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) patients during the compassionate use program in Spain from February 2015 to November 2017. Patient data were collected retrospectively from 35 hospitals in Spain. Patients with HR+/HER2- mBC who had progressed on ≥4 treatments for advanced disease were eligible. A total of 219 patients received palbociclib in combination with aromatase inhibitors (110; 50.2%), fulvestrant (87; 39.7%), tamoxifen (8; 3.6%) or as single agent (10; 4.6%). Mean age of the patients was 58 years; 31 patients (16.1%) were premenopausal and 162 (83.9%) were postmenopausal at the beginning of treatment with palbociclib. Patients had received a median of 3 previous lines of endocrine therapy (ET) for advanced disease. Real-world tumor response (rwTR) and clinical benefit rate were 5.9% (n = 13) and 46.2% (n = 101), respectively. The median real world progression-free survival (rwPFS) was 6.0 months (95% CI 5.7-7.0) and the median overall survival was 19.0 months (95% CI 16.4-21.7). Subgroup analysis revealed a significant difference in median rwPFS in patients treated with palbociclib plus fulvestrant depending on the duration of prior treatment with fulvestrant monotherapy (>6 versus ≤6 months; HR 1.93, 95% CI 1.37-2.73, p 6 versus ≤6 months; HR 1.93, 95% CI 1.37-2.73, p  Palbociclib can be an effective and safe treatment option in patients with heavily pretreated endocrine-sensitive mBC, especially in those with longer PFS to previous ET

Anales de Edafología y Agrobiología Tomo 41 Número 7-8

Suelos. Empleo de mpleo del coeficiente de correlacion para la seleccion de caracteristicas en taxonomia numerica de suelos, por F. Monturiol Rodríguez y. L. Alcala Del Olmo B.-- Modelos dinamicos en el estudio de la genesis del suelo p o r J. E. Garcia Hernandez.-- A computer-based soil evaluation system for assessing soil productivity p o r D. de la Rosa.-- Relaciones fisico-quimicas y espectrales del suelo p o r Jose L. Labrandero.-- procesos de alteracion; genesis y estabilidad mineral de suelos volcanicos (volcan de piedrabuena, ciudad real) II. caracteres fisicos y fisico-quimicos p o r Martín De Vidales, J. L., Sanz, J., Casas, J., Rodríguez Sanchidrian, J. Y, Guerra Delgado, A.-- Significado de la presencia de horizontes bt en suelos de las facies de madrid. aproximacion para explicar el contenido de arcilla en este tipo de horizontes p o r Jimenez Ballesta, R. Martin De Vidales. J. L. y Garcia Gimenez, R.-- Actividad enzima tica y microbiana en diversos andosoles de tenerife p o r J. M. Lozano, P. T. C. Carvalho Y F. Velasco.-- Estudio de la variabilidad de poblaciones de nema todos fitoparasitos de limonero. l. tylenchulus semipenetrans Cobb por Ortuño Martinez, A.Hernansaez Rabay, A., Gomez Gomez, J. y Abrisqueta Garcia, J. M.-- Estudio climatico de la hoja topografica 1:50.000 905 de linares (Jaen) p o r G. Delgado y J. Aguilar.-- Estudio del sistema SI(oh)4-AI+ -Mg2+ -Na+ -h20 a temperatura y presion ordinarias. l. precipit acion de silicio, aluminio y magnesio por Reyes, M., Huertas, F., Linares, J. y Reyes, E. -- Estudio del sistema SI(oh)4-AI+ -Mg2+ -Na+ -h20 a temperatura y presion ordinarias. II. Composicion quimica y mineralogica de los precipitados, por Reyes, M., Huertas, F., Linares, J. y Reyes, E.-- Fertilidad. estudio comparativo sobre nitrificaciones en un suelo de regadio frente a uno de secano por F. Gallardo-Lara. A. Molina-Diaz Y E. Esteban-Velasco.-- Consideraciones sobre la utilizacion de la tecnica extractiv a de burriel y hernando para la evaluacion del p asimilable en suelos por J. A. Díez.—Nutrición y Fisiología Vegetal. Balance nutriente evolutivo: aplicaciones por O. Carpena Artes y R. O. Carpena Ruiz.-- Estudio de algunos aspectos ecofisiologicos en el analisis de la produccion de grano en los cultivos de cebada (gen. Hordeum l) II. Efecto del nitrogeno y del azufre por via foliar por L. F. Garcia Del Moral, J. M. Ramos y L. Recalde-Manrique y L. Recalde Martinez.- Evolucion de la fraccion organica y mineral de un pastizal de la marisma del guadalquivir. ii. fraccion organica de la vegetación por Hernandez, J. M., Barroso, M., Chaves, M. y Murillo, J. M.-- Evolucion de la fraccion organica y mineral de una pradera halofita de la marisma del guadalquivir. III. relaciones fisiológicas Por Barroso, M., Hernandez, J. M., Murillo, J. M. Y Chaves, M.-- Ordenacion automatica de comunidades de pastizal. un ejemplo de su validez con la eliminacion de las especies menos abundantes por A. Puerto Martin, M. Rico Rodriguez, B. Redondo Prieto y J. M. Gomez Gutierrez.-- Produccion y extraccion de bioelementos en pastizales naturales y especies pratenses cultivadas por B. García Criado. A. Garcia Ciudad, M. I. Montalvo Hernandez y L. Garcia Criado.-- Precocidad en tomate para consumo en fresco por J. Cuartero Y F. Nuez.-- Estudio de la nutricion del cultivo del haba (Vicia faba L.) por Eduardo Esteban Velasco. Francisco Gallardo-Lara y Josefa Robles Fernandez.-- Relaciones proteinas y lipidos con niveles de bioelementos edaficos en semillas de leguminosas por Ortuño Martinez, A. Hernansaez Rabay, A. Y Abrisqueta Garcia. J. M.-- Influencia del pretratamiento de semillas de girasol con boro sobre la germinacion y primeras fases de desarrollo de la planta por Jimenez. F. y Aguilar, A.-- Determinacion de la variedad de patata (solanum tuberosum l.) por analisis electroforetico de las proteinas del tuberculo. por J. Lopez-Gorgé, A. Chueca y M. Vilchez.-- Cambios metabolicos durante el proceso de maduracion de la uva (vitis vinifera, l. var. palomino) en la zona del marco de jerez de la frontera (cadiz) por L. Catalina, C. Mazuelos, R. Romero Y R. Sarmiento.-- Datos nomenclaturales y ecologicos sobre taxones españoles del genero satureja (labiatae) por Salvador Rivas-Martinez.—Trabajos recapitulativos.-- La Rizosfera: Interacciones Microbio-Planta por J. M. Barea y C. Azcon-Aguilar.-- MÉtodos de a tomizacion electrotermica en espectrofotometria de absorcion atomica revisión por M. D. Mingorance y M. Lachica.—Notas.Peer reviewe

Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer

Background: The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. Patients and methods: One thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone receptor-positive cancers. Statistical significance for OS at this IA required P < 0.015. Results: With a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; P = 0.009]. Four-year OS was 89.8% in the olaparib group and 86.4% in the placebo group (Δ 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for the olaparib group versus placebo group was 82.7% versus 75.4% (Δ 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Δ 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myeloid leukemia or myelodysplastic syndrome. Conclusion: With 3.5 years of median follow-up, OlympiA demonstrates statistically significant improvement in OS with adjuvant olaparib compared with placebo for gBRCA1/2pv-associated EBC and maintained improvements in the previously reported, statistically significant endpoints of IDFS and DDFS with no new safety signals

Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer

International audienc