Zhang Xiaofang, He Mingyang, Zheng Guanghua, Bai Junjun
Department of Clinical Laboratory, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, Shanxi, People's Republic of China.
Department of Thoracic Surgery, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, Shanxi, People's Republic of China.
BMC Cancer. 2025 Jul 21;25(1):1197. doi: 10.1186/s12885-025-14445-w.
The Ki-67 protein is frequently employed in pathological immunohistochemistry to indicate cell proliferation activity. The principal aim of this study was to examine the impact of stratified management of Ki-67 on the clinicopathological characteristics and prognosis of patients with small-cell lung cancer (SCLC).
A total of 175 patients with SCLC who underwent surgical treatment were included in the study, with available data on the results of postoperative immunohistochemistry of the Ki-67 protein. A retrospective analysis was conducted to investigate the correlation between the protein and various clinicopathological features of SCLC, as well as its impact on survival.
The cut-off value for the Ki-67 level was determined to be 75% through receiver operating characteristic (ROC) analysis. An elevated Ki-67 level was found to be associated with preoperative chemotherapy (χ2 = 4.980, P = 0.028), preoperative radiotherapy (χ2 = 4.600, P = 0.032), T stage (χ2 = 4.173, P = 0.041), TNM staging (χ2 = 10.472, P = 0.005), and lymph node involvement (χ2 = 16.721, P < 0.0001). The results of the survival analysis indicated that patients with SCLC exhibiting high levels of Ki-67 had a poorer prognosis than those with low Ki-67 levels (P = 0.0004). This was particularly evident in patients aged 60 years or older (P = 0.034), in males (P = 0.046), smoking for a minimum of 30 years (P < 0.001), advanced T staging (T3 + T4) (P = 0.031), lymph node involvement (P = 0.038), and TNM staging (P = 0.015), were associated with poorer outcomes. The univariate Cox regression analysis indicated that exposure to tobacco consumption (P = 0.040), pathologic T stage (P = 0.047), lymph node metastasis (P = 0.002), TNM staging [Stage I vs. II (P = 0.016), Stage I vs. III (P = 0.003)], and Ki-67 positive rate (P < 0.001) were the factors related to prognosis in SCLC. The results of the multivariate regression analysis indicated that T stage(HR: 1.519, 95% CI: 1.116-2.015, P = 0.022), TNM staging[Stage I vs. III (HR: 2.310, 95% CI: 1.320-4.040, P < 0.001)], and Ki-67 expression(HR: 1.405, 95% CI: 1.025-1.810, P < 0.001) was identified as an additional risk factor for SCLC-related mortality.
In summary, the Ki-67 protein is not only strongly associated with the malignant characteristics of SCLC, but also the stratification of Ki-67 has significant implications for the treatment and prognosis of patients with small-cell lung cancer.
Not applicable.
Ki-67蛋白常用于病理免疫组织化学以指示细胞增殖活性。本研究的主要目的是探讨Ki-67分层管理对小细胞肺癌（SCLC）患者临床病理特征和预后的影响。
本研究纳入175例接受手术治疗的SCLC患者，有术后Ki-67蛋白免疫组化结果的可用数据。进行回顾性分析以研究该蛋白与SCLC各种临床病理特征之间的相关性及其对生存的影响。
通过受试者工作特征（ROC）分析确定Ki-67水平的临界值为75%。发现Ki-67水平升高与术前化疗（χ2 = 4.980，P = 0.028）、术前放疗（χ2 = 4.600，P = 0.032）、T分期（χ2 = 4.173，P = 0.041）、TNM分期（χ2 = 10.472，P = 0.005）和淋巴结受累（χ2 = 16.721，P < 0.0001）相关。生存分析结果表明，Ki-67水平高的SCLC患者预后比Ki-67水平低的患者差（P = 0.0004）。这在60岁及以上的患者（P = 0.034）、男性患者（P = 0.046）、吸烟至少30年的患者（P < 0.001）、晚期T分期（T3 + T4）（P = 0.031）、淋巴结受累（P = 0.038）和TNM分期（P = 0.015）中尤为明显，这些情况与较差的预后相关。单因素Cox回归分析表明，吸烟暴露（P = 0.040）、病理T分期（P = 0.047）、淋巴结转移（P = 0.002）、TNM分期[I期与II期（P = 0.016），I期与III期（P = 0.003）]以及Ki-67阳性率（P < 0.001）是SCLC预后的相关因素。多因素回归分析结果表明，T分期（HR：1.519，95%CI：1.116 - 2.015，P = 0.022）、TNM分期[I期与III期（HR：2.310，95%CI：1.320 - 4.040，P < 0.001）]以及Ki-67表达（HR：1.405，95%CI：1.025 - 1.810，P < 0.001）被确定为SCLC相关死亡的额外危险因素。
总之，Ki-67蛋白不仅与SCLC的恶性特征密切相关，而且Ki-67分层对小细胞肺癌患者的治疗和预后具有重要意义。
不适用。
