Walter Christina B, Hartkopf Andreas D, Hein Alexander, Fasching Peter A, Kolberg Hans-Christian, Hadji Peyman, Tesch Hans, Häberle Lothar, Ettl Johannes, Lüftner Diana, Wallwiener Markus, Müller Volkmar, Beckmann Matthias W, Michel Laura L, Belleville Erik, Huebner Hanna, Uhrig Sabrina, Goossens Chloë, Wimberger Pauline, Hielscher Carsten, Meyer Julia, Mundhenke Christoph, Kurbacher Christian, Wuerstlein Rachel, Untch Michael, Janni Wolfgang, Taran Florin-Andrei, Lux Michael P, Wallwiener Diethelm, Brucker Sara Y, Schneeweiss Andreas, Fehm Tanja N, Fremd Carlo
Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Department of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Breast. 2025 Apr;80:104412. doi: 10.1016/j.breast.2025.104412. Epub 2025 Feb 5.
Patients with first-line metastatic breast cancer (MBC) comprise patients with de novo metastases (dnMBC) or recurrent disease after primary breast cancer (rMBC). This analysis aimed to explore the prognostic value of dnMBC versus rMBC overall and particularly in subgroups according to age and metastasis site, in addition to other prognostic clinicopathological parameters in a first-line, hormone receptor (HR)-positive, HER2-negative (HRpos/HER2neg) population.
Within the prospective PRAEGNANT MBC registry (NCT02338167), 508 HRpos/HER2neg patients, receiving first-line treatment for advanced disease, were identified. Clinicopathological parameters (age, body mass index, performance status, tumor grading, metastasis site and therapy) were assessed according to metastatic status (dnMBC, rMBC within 5 years of primary diagnosis (rMBC <5 years), rMBC after more than 5 years (rMBC ≥5 years)). Cox regression analyses were performed to investigate whether metastatic status influences progression-free survival (PFS) and overall survival (OS).
De novo metastatic disease was present in 180 patients (35.4 %), whereas 132 patients (26.0 %) had rMBC <5 years and 196 patients (38.6 %) had rMBC ≥5 years. Patients with dnMBC had the most favorable prognosis. Relative to dnMBC, hazard ratios for PFS were 1.75 (95%CI: 1.31-2.34) in rMBC<5 years and 1.25 (95%CI: 0.94-1.65) for rMBC ≥5 years. Subgroup-specific differences were not observed.
HRpos/HER2neg first-line MBC patients have a more favorable prognosis if the disease was previously not treated. This difference was similar across all examined clinicopathological parameters. It may therefore be beneficial to incorporate MBC categories as a stratification factor in clinical trials.
一线转移性乳腺癌(MBC)患者包括初发转移患者(dnMBC)或原发性乳腺癌后复发患者(rMBC)。本分析旨在探讨dnMBC与rMBC总体的预后价值,特别是在按年龄和转移部位划分的亚组中的预后价值,以及一线激素受体(HR)阳性、人表皮生长因子受体2阴性(HRpos/HER2neg)人群中的其他预后临床病理参数。
在前瞻性PRAEGNANT MBC注册研究(NCT02338167)中,确定了508例接受晚期疾病一线治疗的HRpos/HER2neg患者。根据转移状态(dnMBC、初次诊断后5年内的rMBC(rMBC<5年)、5年后的rMBC(rMBC≥5年))评估临床病理参数(年龄、体重指数、体能状态、肿瘤分级、转移部位和治疗)。进行Cox回归分析以研究转移状态是否影响无进展生存期(PFS)和总生存期(OS)。
180例患者(35.4%)存在初发转移疾病,而132例患者(26.0%)有rMBC<5年,196例患者(38.6%)有rMBC≥5年。dnMBC患者的预后最有利。相对于dnMBC,rMBC<5年的PFS风险比为1.75(95%CI:1.31-2.34),rMBC≥5年的为1.25(95%CI:0.94-1.65)。未观察到亚组特异性差异。
如果疾病此前未接受过治疗,HRpos/HER2neg一线MBC患者的预后更有利。在所有检查的临床病理参数中,这种差异相似。因此,在临床试验中将MBC类别作为分层因素可能有益。