RESUMEN
BACKGROUND: 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. PATIENTS AND METHODS: 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. RESULTS: 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 < 0.001). The most frequently reported toxicities were neutropenia, asthenia, thrombopenia and anemia. CONCLUSIONS: 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.
Asunto(s)
Antineoplásicos Hormonales/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Fulvestrant/administración & dosificación , Piperazinas/administración & dosificación , Piridinas/administración & dosificación , Inhibidores de la Aromatasa/administración & dosificación , Neoplasias de la Mama/metabolismo , Neoplasias de la Mama/mortalidad , Ensayos de Uso Compasivo , Femenino , Humanos , Persona de Mediana Edad , Posmenopausia , Premenopausia , Supervivencia sin Progresión , Receptores de Estrógenos/metabolismo , Receptores de Progesterona/metabolismo , Estudios Retrospectivos , España , Tamoxifeno/administración & dosificación , Resultado del TratamientoRESUMEN
El cáncer de próstata es una enfermedad frecuente en el hombre. Es la segunda causa de mortalidad por cáncer después del cáncer del pulmón. Los casos de estadío T-1 y T-2 de la clasificación TNM son susceptibles de tratamiento curativo. La prostatectomía radical es el tratamiento quirúrgico de elección. Actualmente se puede realizar por vía laparoscópica. Se reportan 2 casos de prostatectomía radical por abordaje laparoscópico en el servicio de Urología del Instituto Guatemalteco de Seguridad Social. Paciente de 72 años con próstata aumentada de tamaño grado I consistencia blanda con nódulo en el lóbulo derecho T-2a. Biopsia prostática trans-rectal reporta adenocarcinoma de próstata moderadamente diferenciado con sumatoria de...