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Overall survival of CDK4/6-inhibitors-based treatments in clinically relevant subgroups of metastatic breast cancer: systematic review and meta-analysis

A partir d’une revue systématique de la littérature (6 études, 3 421 patientes), cette méta-analyse évalue l’efficacité, du point de vue de la survie globale, des inhibiteurs anti-CDK4/6 chez des patientes atteintes d’un cancer du sein de stade métastatique, selon certaines spécificités (sous-type moléculaire de la tumeur, statut ménopausique, nombre de lignes de traitements, etc.)

Background : CDK4/6-inhibitors (CDK4/6i)+endocrine therapy (ET) prolonged progression-free survival as first/second-line therapy for hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC) prognosis. Given the recent publication of overall survival (OS) data for the three CDK4/6i, we performed a meta-analysis to identify a more precise and reliable benefit from such treatments in specific clinical subgroups. Methods : We conducted a systematic literature search to select all available phase II/III randomized clinical trials of CDK4/6i+ET reporting OS data in first/second-line therapy of HR+/HER2-negative pre/postmenopausal MBC. A random effect model was applied for the analyses. Heterogeneity was assessed with I2 statistic. Subgroup analysis were performed to explore the effect of study-level factors. The project was registered in the Open Science Framework database (doi: 10.17605/OSF.IO/TNZQP). Results : Six studies were included in our analyses (3,421 patients). A clear OS benefit was observed in patients without (HR:0.68, 95%CI:0.54–0.85, I2=0.0%) and with visceral involvement (HR:0.76, 95%CI:0.65–0.89, I2=0.0%), with ?3 metastatic sites (HR:0.75, 95%CI:0.60–0.94, I2=11.6%), in endocrine resistant (HR:0.79, 95%CI:0.67-0.93, I2=14.4%). and sensitive subset (HR:0.73, 95%CI:0.61-0.88, I2=0.0%), for age <65 (HR:0.80, 95%CI:0.67-0.95, I2=0.0%) and ?65 years (HR:0.71, 95%CI:0.53-0.95, I2=44.4%), in postmenopausal (HR:0.75, 95%CI:0.66-0.86, I2=0.0%) and pre/perimenopausal setting (HR:0.76, 95%CI:0.60-0.96, I2=0.0%), as well as in CT-naïve patients (HR:0.72, 95%CI:0.55–0.93, I2=0.0%). Conclusions : CDK4/6i+ET combinations compared to ET alone improve OS independent of age, menopausal status, endocrine sensitiveness and visceral involvement, and should be preferred as upfront therapy instead of endocrine monotherapy.

Journal of the National Cancer Institute

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