Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Eur J Cancer. 2024 Sep;209:114239. doi: 10.1016/j.ejca.2024.114239. Epub 2024 Jul 21.
The monarchE and NATALEE trials demonstrated the benefit of CDK4/6 inhibitor (CDK4/6i) therapy in adjuvant breast cancer (BC) treatment. Patient selection, based on clinical characteristics, delineated those at high (monarchE) and high/intermediate recurrence risk (NATALEE). This study employed a historical patient cohort to describe the proportion and prognosis of patients eligible for adjuvant CDK4/6i trials.
Between 2009 and 2011, 3529 patients were enrolled in the adjuvant PreFace clinical trial (NCT01908556). Eligibility criteria included postmenopausal patients with hormone receptor-positive (HRpos) BC for whom a five-year upfront therapy with letrozole was indicated. Patients were categorized into prognostic groups according to monarchE and NATALEE inclusion criteria, and their invasive disease-free survival (iDFS) and overall survival (OS) were assessed.
Among 2891 HRpos patients, 384 (13.3 %) met the primary monarchE inclusion criteria. The majority (n = 261) qualified due to having ≥ 4 positive lymph nodes. For NATALEE, 915 out of 2886 patients (31.7 %) met the eligibility criteria, with 126 patients (13.7 %) being node-negative. Patients from monarchE with ≥ 4 positive lymph nodes and NATALEE with stage III BC exhibited the poorest prognosis (3-year iDFS rate 0.87). Patients ineligible for the trials demonstrated prognoses similar to the most favorable patient groups within the eligibility criteria.
Patient populations eligible for monarchE and NATALEE trials differed. Nearly a third of the postmenopausal HRpos population, previously under upfront letrozole treatment, met the NATALEE prognostic eligibility criteria. As certain eligible groups had a prognosis similar to non-eligible patients, it might be interesting to explore additional patient groups for CDK4/6i therapy.
monarchE 和 NATALEE 试验证明了 CDK4/6 抑制剂（CDK4/6i）治疗在辅助乳腺癌（BC）治疗中的益处。基于临床特征的患者选择，确定了高（monarchE）和高/中复发风险（NATALEE）的患者。本研究利用历史患者队列描述了符合辅助 CDK4/6i 试验条件的患者比例和预后。
2009 年至 2011 年，3529 名患者参加了辅助 PreFace 临床试验（NCT01908556）。入选标准包括绝经后激素受体阳性（HRpos）BC 患者，需要接受为期 5 年的来曲唑一线治疗。根据 monarchE 和 NATALEE 的纳入标准，患者被分为预后组，并评估其侵袭性无病生存（iDFS）和总生存（OS）。
在 2891 名 HRpos 患者中，384 名（13.3%）符合 monarchE 的主要纳入标准。大多数（n=261）因≥4 个阳性淋巴结而符合条件。对于 NATALEE，2886 名患者中有 915 名（31.7%）符合入选标准，其中 126 名（13.7%）淋巴结阴性。来自 monarchE 的≥4 个阳性淋巴结和 NATALEE 的 III 期 BC 患者预后最差（3 年 iDFS 率为 0.87）。不符合试验条件的患者预后与符合条件的最有利患者组相似。
符合 monarchE 和 NATALEE 试验条件的患者人群不同。近三分之一的绝经后 HRpos 人群，之前接受来曲唑一线治疗，符合 NATALEE 的预后纳入标准。由于某些符合条件的群体的预后与不符合条件的患者相似，因此探索 CDK4/6i 治疗的其他患者群体可能很有趣。
