RESUMO
BACKGROUND: Limited data are available regarding the real-world effectiveness and safety of Cyclin Dependent Kinase 4/6 inhibitor (CDK4/6i) (palbociclib/ribociclib) just as a first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2â) metastatic breast cancer (MBC). OBJECTIVE: To assess whether clinical or demographic characteristics limit access to first-line CDK4/6i treatment in clinical practice in the Autonomous Community of Andalusia (Spain) between November 2017 and April 2020. In addition, effectiveness will be described in an exploratory analysis. METHODS: Physicians from 12 centers participated in selecting demographic and clinical characteristics, treatment, and outcome data from women with HR + /HER2- MBC treated with or without CDK4/6i in addition to hormonal in the first-line setting, in a 3:1 proportion. Kaplan-Meier analysis estimated progression-free rates (PFRs) and survival rates (SRs). RESULTS: A total of 212 patients were included, of whom 175 (82.5%) were in the CDK4/6i treatment group and 37 (17.5%) were in the non-CDK4/6i treatment group (control group). Patients in the CDK 4/6i treatment group were younger (p = 0.0011), the biopsies of the metastatic site at the moment of the relapse were most commonly performed (p = 0.0454), and had multiple metastatic sites (p = 0.0025). The clinical benefit rate (CBR) was 82.3% in the CDK4/6i group and 67.8% in the control group. Median time to a progression event or death (PFS) was 20.4 months (95%CI 15.6-28) in the CDK4/6i group and 12.1 months (95%CI 7.9-not reached) in the control group. CONCLUSIONS: Younger patients, biopsies of metastatic disease and with multiple metastatic sites were more frequently treated with CDK4/6i in our daily clinical practice.
RESUMO
El bloqueo paravertebral se está popularizando como técnica anestésica en diversos procedimientos sobre la mama. La cirugía de la mama se asocia a una alta incidencia postoperatoria de náuseas, vómitos y dolor. Estudios recientes han demostrado un efecto beneficioso de esta técnica, no solo en la reducción del dolor postoperatorio, la incidencia de cuadros eméticos y el porcentaje de pacientes afectadas de dolor crónico posquirúrgico al año de la intervención quirúrgica con valores estadísticamente significativos. Un estudio reciente demuestra que las recurrencias de pacientes con cáncer de mama a los 36 meses tras cirugía es menor en aquellas pacientes intervenidas con anestesia combinada (paravertebral torácica y general) respecto al grupo intervenido solo con anestesia general. Estos estudios demuestran un importante beneficio del bloqueo paravertebral y que debiera considerarse parte del plan anestésico de la cirugía mamaria(AU)
Paravertebral blocks are becoming increasingly popular, especially as an anesthetic adjunct for breast procedures. Major breast cancer surgery is associated with a high incidence of postoperative nausea, vomiting and pain. Recent studies have demonstrated a benefit from preoperative placement of a paravertebral block, not only in reducing acute postoperative pain, but also in producing statistically significant reductions in the percentage of patients that develop chronic postsurgical pain 1 year after surgery. Another study found that the breast cancer recurrence rate at 36 months after surgery was lower in the paravertebral group than in a group receiving general anesthesia alone. These studies provide additional reasons for including this block in the anesthetic technique for breast surgery(AU)
