Sreenath Nihanthy D, Pandalanghat Suresh, Kapoor Amul, Govind Rajath, Kaushik M R, Nair Rajesh, Bhuva Dipen, Rathore Anvesh, Kumar Manish, Mulajker Deepak
Saroj Gupta Cancer Centre & Research Institute, Kolkata, India.
Medicine & Medical Oncology, Army Hospital (R&R), New Delhi, India.
BMC Cancer. 2025 Aug 18;25(1):1337. doi: 10.1186/s12885-025-14270-1.
Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, such as Palbociclib and Ribociclib, have significantly improved outcomes for patients with hormone receptor-positive, HER2-negative (HR+/HER2-) advanced breast cancer. Although clinical trials have established the efficacy of these agents globally, real-world data from India is limited. This study compares the clinical effectiveness and safety profiles of Palbociclib and Ribociclib in a cohort of Indian patients.
This prospective study included 60 patients with metastatic HR+/HER2- breast cancer treated at Army hospitals and research centers in India between 2020 and 2023. Progression-free survival (PFS), overall survival (OS), and safety profiles were analyzed to assess the real-world performance of Palbociclib and Ribociclib. Patients were treated with either Palbociclib or Ribociclib in combination with standard endocrine therapy.
Among the 60 patients, the median PFS was 39.40 months for the Palbociclib group and 42.93 months for the Ribociclib group (p = 0.26), indicating no statistically significant difference. The median OS was 41.98 months in the Palbociclib group and 45.51 months in the Ribociclib group (p = 0.15), with Ribociclib showing a slight but non-significant survival advantage. The most common adverse event was neutropenia, which occurred in 26% of patients receiving Palbociclib and 23% of patients on Ribociclib. Deranged liver function tests (LFTs) and fatigue were also reported in both groups.
Palbociclib and Ribociclib demonstrated comparable efficacy and safety profiles in this Indian cohort. While no statistically significant differences in PFS or OS were observed, the data suggest a marginal survival benefit with Ribociclib. These findings underscore the importance of individualized treatment plans in HR+/HER2- breast cancer, taking into consideration patient-specific factors. Larger studies with longer follow-up are needed to further clarify the nuances between these two agents.
细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂，如帕博西尼和瑞博西尼，已显著改善激素受体阳性、人表皮生长因子受体2阴性（HR+/HER2-）晚期乳腺癌患者的治疗效果。尽管临床试验已在全球范围内证实了这些药物的疗效，但来自印度的真实世界数据有限。本研究比较了帕博西尼和瑞博西尼在一组印度患者中的临床有效性和安全性。
这项前瞻性研究纳入了2020年至2023年期间在印度军队医院和研究中心接受治疗的60例转移性HR+/HER2-乳腺癌患者。分析无进展生存期（PFS）、总生存期（OS）和安全性，以评估帕博西尼和瑞博西尼的真实世界表现。患者接受帕博西尼或瑞博西尼联合标准内分泌治疗。
在60例患者中，帕博西尼组的中位PFS为39.40个月，瑞博西尼组为42.93个月（p = 0.26），表明无统计学显著差异。帕博西尼组的中位OS为41.98个月，瑞博西尼组为45.51个月（p = 0.15），瑞博西尼显示出轻微但不显著的生存优势。最常见的不良事件是中性粒细胞减少，接受帕博西尼治疗的患者中有26%发生，接受瑞博西尼治疗的患者中有23%发生。两组均报告了肝功能检查异常和疲劳。
在这个印度队列中，帕博西尼和瑞博西尼表现出相当的疗效和安全性。虽然在PFS或OS方面未观察到统计学显著差异，但数据表明瑞博西尼有轻微的生存获益。这些发现强调了在HR+/HER2-乳腺癌个体化治疗方案中考虑患者特定因素的重要性。需要进行更大规模、随访时间更长的研究来进一步阐明这两种药物之间的细微差别。
