Clinical outcomes and toxicity in patients with hormone receptor-positive and HER-2 negative metastatic breast cancer treated with palbociclib and endocrine therapy: a real-world study
10.3760/cma.j.cn112152-20211013-00759
- VernacularTitle:哌柏西利联合内分泌药物治疗激素受体阳性人表皮生长因子受体2阴性晚期乳腺癌的真实世界研究
- Author:
Yuan YUAN
1
;
Ying PENG
;
Sainan HU
;
Yu QIAN
;
Lili ZHANG
Author Information
1. 江苏省肿瘤医院 江苏省肿瘤防治研究所 南京医科大学附属肿瘤医院内科，南京 210009
- Keywords:
Breast neoplasms;
Palbociclib;
Endocrine therapy;
Hormone receptor;
Human epidermal growth factor receptor-2;
Efficacy;
Adverse effect
- From:
Chinese Journal of Oncology
2022;44(8):882-887
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To demonstrate the clinical efficiency and safety of palbociclib combined with endocrine therapy in the treatment of hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER-2) negative advanced breast cancer patients.Methods:A total of 95 breast cancer patients with HR-positive/HER-2 negative underwent palbociclib combined with endocrine in Jiangsu Cancer Hospital from Octorber, 2018 to Novermber, 2020 were retrospectively recruited. The short-term and long-term efficacy and adverse reactions were summarized. The primary end point was progressive free survival (PFS) and the second end points were disease control rate (DCR), objective response rate (ORR), clinical benefit rate (CBR). Log rank test and Cox proportional hazards regression model were used to analyze the influencing factors of PFS in patients.Results:The ORR, DCR and CBR of 95 patients were 29.5%, 88.4% and 72.6%, respectively. The total median PFS for palbociclib plus endocrine therapy was 10.4 months. The univariate analysis showed that visceral metastasis, the line number of palbociclib treatment and the sensitivity of endocrine therapy were associated with the PFS of patients who received palbociclib combined with endocrine ( P<0.05). The multivariate Cox regression analysis showed that the sensitivity of endocrine therapy and visceral metastasis were the independent influencing factors of PFS in patients receiving palbociclib combined with endocrine therapy. Compared with patients with visceral metastasis, HR of patients with non-visceral metastases was 3.118 (95% CI: 1.405-7.236). Compared with endocrine therapy sensitive patients, the HR of patients with primary and secondary resistance to endocrine therapy were 4.455 (95% CI: 1.380-14.385) and 1.4566 (95% CI: 0.488-4.346), respectively. The main adverse reaction was hematological toxicity. The leukopenia, neutrophilsand thrombocytopenia were main manifestations, which incidence rates were 78.9% (75/95), 85.3% (81/95) and 72.6% (69/95), respectively and the incidence rates of grade 3 to 4 of these manifestations were 27.4% (26/95), 51.6% (49/95) and 20.0% (19/95), respectively. Conclusion:Among patients with HR-positive/HER-2 negative advanced breast cancer, the treatment of palbociclib combined with endocrine drugs has yielded good clinical effects and the toxicity is manageable.
