Patel Ram, Mathews John, Hamm Caroline, Kulkarni Swati, Gupta Rasna, Opperman Tarquin, Chiong John Dean, Nasser Abdullah
Schulich School of Medicine and Dentistry, Western University, London, ON N6A 3K7, Canada.
Department of Medical Oncology, Windsor Regional Hospital, Windsor, ON N8W 1L9, Canada.
Curr Oncol. 2025 Jan 20;32(1):52. doi: 10.3390/curroncol32010052.
CDK4/6 inhibitors in combination with aromatase inhibitors (AIs) are the standard first-line treatment for hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer. Landmark trials have demonstrated a comparable progression-free survival (PFS) across CDK4/6 inhibitors, but the overall survival (OS) outcomes have varied. This study aimed to evaluate the real-world PFS and OS for palbociclib and ribociclib when combined with AIs in patients with HR+/HER2- advanced breast cancer.
This was a retrospective chart review of adult patients with HR+/HER2- metastatic breast cancer treated at a single academic center between 1 January 2015 and 1 December 2022. The baseline demographics, clinical characteristics, and treatment details were extracted. A Kaplan-Meier analysis was used to estimate the PFS and OS, and differences between the treatment groups were assessed using the log-rank test. Cox proportional hazards models were constructed to adjust for confounding factors.
Seventy-five patients were included in the final analysis. The cohort was predominantly female (98.7%) and postmenopausal (77.3%), with 52.0% having de novo stage IV disease. Palbociclib was prescribed to 74.7% of the patients, and ribociclib to 25.3%. The patients receiving ribociclib were significantly younger (57.6 vs. 67.5 years, = 0.013) and more likely to be premenopausal (42.1% vs. 5.4%, < 0.001). The real-world median PFS and OS for palbociclib were 20.3 months (95% CI: 14.8-46) and 37.2 months (95% CI: 20.3-not reached [NR]), respectively. For ribociclib, the median PFS and OS were not reached. The Cox proportional hazards models adjusting for age and menopausal status found no significant differences between ribociclib and palbociclib for the PFS (HR = 0.92, = 0.86) or OS (HR = 0.95, = 0.92).
In this real-world analysis, palbociclib demonstrated a median PFS consistent with the results from landmark trials, although the observed OS was shorter. The ribociclib-treated patients had a numerically longer PFS and OS compared with those treated with palbociclib, but the differences were not statistically significant. The discontinuation rates were similar between the two groups.
细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂联合芳香化酶抑制剂（AI）是激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）转移性乳腺癌的标准一线治疗方案。具有里程碑意义的试验表明，不同CDK4/6抑制剂的无进展生存期（PFS）相当，但总生存期（OS）结果有所不同。本研究旨在评估哌柏西利和瑞博西利与AI联合应用于HR+/HER2-晚期乳腺癌患者的真实世界PFS和OS。
这是一项对2015年1月1日至2022年12月1日在单一学术中心接受治疗的HR+/HER2-转移性乳腺癌成年患者的回顾性病历审查。提取了基线人口统计学、临床特征和治疗细节。采用Kaplan-Meier分析来估计PFS和OS，并使用对数秩检验评估治疗组之间的差异。构建Cox比例风险模型以调整混杂因素。
75例患者纳入最终分析。该队列主要为女性（98.7%）且为绝经后（77.3%），52.0%为初发IV期疾病。74.7%的患者使用哌柏西利，25.3%的患者使用瑞博西利。接受瑞博西利治疗的患者明显更年轻（57.6岁对67.5岁，P = 0.013），且更可能为绝经前（42.1%对5.4%，P < 0.001）。哌柏西利的真实世界中位PFS和OS分别为20.3个月（95%CI：14.8 - 46）和37.2个月（95%CI：20.3 - 未达到[NR]）。瑞博西利的中位PFS和OS未达到。调整年龄和绝经状态的Cox比例风险模型发现，瑞博西利和哌柏西利在PFS（风险比[HR] = 0.92，P = 0.86）或OS（HR = 0.95，P = 0.92）方面无显著差异。
在这项真实世界分析中，哌柏西利的中位PFS与具有里程碑意义的试验结果一致，尽管观察到的OS较短。与接受哌柏西利治疗的患者相比，接受瑞博西利治疗的患者PFS和OS在数值上更长，但差异无统计学意义。两组的停药率相似。
