Canzian Jacopo, Gentile Damiano, De Sanctis Rita, Jacobs Flavia, Benvenuti Chiara, Gaudio Mariangela, Gerosa Riccardo, Saltalamacchia Giuseppe, Torrisi Rosalba, Masci Giovanna, Tinterri Corrado, Zambelli Alberto
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.
Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy.
Oncologist. 2025 May 8;30(5). doi: 10.1093/oncolo/oyaf061.
The NATALEE trial expanded the use of adjuvant cyclin-dependent kinase 4/6 inhibitors beyond the MonarchE trial's criteria for early breast cancer (eBC). We conducted a retrospective analysis comparing a large real-world (RW) cohort of 762 consecutive eBC patients with those enrolled in the NATALEE and MonarchE randomized controlled trials (RCTs) to evaluate differences in eligibility. Our analysis revealed that 41.7% of RW patients met NATALEE's eligibility criteria, significantly more than the 21.8% who met MonarchE's criteria, reflecting NATALEE's broader indication. Real-world patients were older, had less advanced tumors, and were less likely to be treated with adjuvant chemotherapy compared to the RCT populations. None of the RW patients was deemed eligible for ribociclib based solely on high genomic risk. These findings underscore significant differences in clinical characteristics and potential treatment eligibility, highlighting the need for critical assessment of RCTs results in clinical practice.
NATALEE试验将辅助性细胞周期蛋白依赖性激酶4/6抑制剂的使用范围扩大到了MonarchE试验早期乳腺癌（eBC）标准之外。我们进行了一项回顾性分析，将762例连续的eBC患者组成的大型真实世界（RW）队列与纳入NATALEE和MonarchE随机对照试验（RCT）的患者进行比较，以评估入选标准的差异。我们的分析显示，41.7%的RW患者符合NATALEE的入选标准，显著高于符合MonarchE标准的21.8%，这反映了NATALEE更广泛的适应症。与RCT人群相比，真实世界的患者年龄更大，肿瘤进展程度更低，接受辅助化疗的可能性更小。没有一名RW患者仅基于高基因组风险就被认为符合瑞博西尼治疗条件。这些发现强调了临床特征和潜在治疗资格的显著差异，突出了在临床实践中对RCT结果进行批判性评估的必要性。
