Shao Xiying, Zheng Yabing, Cao Wenming, Shen Xiabo, Li Guangliang, Chen Junqing, Huang Yuan, Huang Ping, Shi Lei, Ye Weiwu, Zou Weibin, Lou Caijin, Lei Lei, Huang Jian, Chen Zhanhong, Wang Xiaojia
Department of Medical Oncology (Breast Cancer), Cancer Hospital of the University of Chinese Academy of Sciences/Zhejiang Cancer Hospital, Hangzhou, China.
Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences, Hangzhou, China.
Ann Transl Med. 2021 Apr;9(8):707. doi: 10.21037/atm-21-1340.
Palbociclib combined with endocrine therapy has been approved as a front-line treatment for hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC). A key challenge remains to uncover biomarkers to identify those patients who may benefit from palbociclib treatment.
We retrospectively analyzed the values of Ki67 and progesterone receptor (PR) as detected by immunohistochemistry in 81 ABC patients with palbociclib and hormone therapy treatment, and evaluated the impact on progression-free survival (PFS).
In the total population, women with Ki67 ≥14% had marginally significantly shorter PFS than those with Ki67 <14% (P=0.062). Patients with Ki67 ≥30% had significantly shorter PFS than those with Ki67 <30% (P=0.048). Meanwhile, PR ≥20% was associated with longer PFS. Moreover, the change of Ki67 or PR from primary tissue to metastatic lesions was related to PFS. As for the hormone therapy subgroup, there were significant associations between Ki67 and PR levels and PFS in the aromatase inhibitors (AIs) subgroup. Patients with Ki67 ≥14% or Ki67 ≥30% had shorter PFS than those with Ki67 <14% or Ki67 <30%, respectively (P=0.024, P<0.001). Additionally, the change of Ki67 or PR from primary tissue to metastatic lesions was related to PFS. When both Ki67 and PR were considered, there were significant differences between the different cohorts. Compared with patients with Ki67 ≥14% and PR <20%, those with Ki67 <14% and PR ≥20% had significantly longer PFS. In addition, patients with Ki67 <30% and PR ≥20% had significantly longer PFS than those with Ki67 ≥30% and PR <20%. Furthermore, in the AI cohort, patients with Ki67 <14% and PR ≥20% had significantly longer PFS than those with Ki67 ≥14% and PR <20%. Women with Ki67 <30% and PR ≥20% had significantly longer PFS than those with Ki67 ≥30% and PR <20%.
The present study indicates that both Ki67 and PR have great impacts on palbociclib and hormone therapy and may contribute to selecting more effective partners for palbociclib.
帕博西尼联合内分泌治疗已被批准作为激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）晚期乳腺癌（ABC）的一线治疗方案。一个关键挑战仍然是发现生物标志物，以识别那些可能从帕博西尼治疗中获益的患者。
我们回顾性分析了81例接受帕博西尼和激素治疗的ABC患者经免疫组织化学检测的Ki67和孕激素受体（PR）值，并评估了其对无进展生存期（PFS）的影响。
在总体人群中，Ki67≥14%的女性患者的PFS略显著短于Ki67<14%的患者（P=0.062）。Ki67≥30%的患者的PFS显著短于Ki67<30%的患者（P=0.048）。同时，PR≥20%与更长的PFS相关。此外，Ki67或PR从原发组织到转移病灶的变化与PFS有关。至于激素治疗亚组，在芳香化酶抑制剂（AIs）亚组中，Ki67和PR水平与PFS之间存在显著关联。Ki67≥14%或Ki67≥30%的患者的PFS分别短于Ki67<14%或Ki67<30%的患者（P=0.024，P<0.001）。此外，Ki67或PR从原发组织到转移病灶的变化与PFS有关。当同时考虑Ki67和PR时，不同队列之间存在显著差异。与Ki67≥14%且PR<20%的患者相比，Ki67<14%且PR≥20%的患者的PFS显著更长。此外，Ki67<30%且PR≥20%的患者的PFS显著长于Ki67≥30%且PR<20%的患者。此外，在AI队列中，Ki67<14%且PR≥20%的患者的PFS显著长于Ki67≥14%且PR<20%的患者。Ki67<30%且PR≥20%的女性患者的PFS显著长于Ki67≥30%且PR<20%的患者。
本研究表明，Ki67和PR对帕博西尼和激素治疗均有重大影响，可能有助于为帕博西尼选择更有效的联合治疗方案。
