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骨转移对免疫检查点抑制剂治疗晚期非小细胞肺癌效果的影响

Effect of bone metastasis on efficacy of immune checkpoint inhibitors in treatment of advanced non-small cell lung cancer

    摘要
  • 摘要:
    目的 探讨骨转移对免疫检查点抑制剂(ICI)治疗晚期非小细胞肺癌(NSCLC)效果的影响。
    方法 回顾性选取248例接受ICI治疗的晚期NSCLC患者作为研究对象, 根据是否伴有骨转移分为骨转移组110例和非骨转移组138例。比较骨转移组与非骨转移组的临床特征、客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)和总生存期(OS), 并通过Cox比例风险回归模型分析骨转移等因素与NSCLC患者生存预后的相关性。从研究对象中选取60例伴有骨转移的初治NSCLC患者，其中30例采用ICI联合常规化疗(联合组), 30例采用常规化疗(化疗组)，比较2组患者的治疗效果和治疗相关不良事件(TEAE)发生率。
    结果 骨转移组与非骨转移组患者的ORR、DCR比较，差异均无统计学意义(P>0.05); 骨转移组患者的PFS(5.53个月)短于非骨转移组(7.72个月)，差异有统计学意义(χ2=3.674, P=0.045); 骨转移组患者的OS(16.98个月)与非骨转移组(17.56个月)比较，差异无统计学意义(χ2=1.333, P=0.248)。多因素Cox回归分析显示, 骨转移是NSCLC患者PFS的独立影响因素(HR=1.52, 95%CI: 1.10~1.98, P=0.003), 但不是OS的独立影响因素(P>0.05)。联合组患者的ORR、DCR依次为43.33%、93.33%, 分别高于化疗组的26.67%、76.67%, 差异有统计学意义(P < 0.05); 联合组患者的PFS长于化疗组，差异有统计学意义(χ2=4.023, P=0.036), 2组患者的OS比较，差异无统计学意义(χ2=1.235, P=0.267); 2组患者的TEAE总发生率、≥3级TEAE发生率比较, 差异均无统计学意义(P>0.05)。
    结论 尽管骨转移的发生对ICI治疗晚期NSCLC的效果具有不利影响，但伴有骨转移的患者通过ICI联合化疗仍能获得优于单纯化疗的疗效。

     

    Abstract:
    Objective To investigate the effect of bone metastasis on the efficacy of immune checkpoint inhibitors (ICI) in treatment of advanced non-small cell lung cancer (NSCLC).
    Methods A retrospective analysis was conducted in 248 patients with advanced NSCLC who received ICI therapy. The patients were divided into bone metastasis group (110 cases) and non-bone metastasis group (138 cases) based on the presence of bone metastasis. Clinical characteristics, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were compared between the two groups. The correlations of factors such as bone metastasis with the survival prognosis of NSCLC patients were analyzed using the Cox proportional hazards regression model. A total of 60 treatment-naive NSCLC patients with bone metastasis were selected from research objects, with 30 patients receiving ICI combined with conventional chemotherapy (combination group) and 30 patients receiving conventional chemotherapy alone (chemotherapy group). The therapeutic effects and incidence of treatment emergent adverse events (TEAE) were compared between the two groups.
    Results There were no statistically significant differences in ORR and DCR between the bone metastasis and non-bone metastasis groups (P>0.05). The PFS of the bone metastasis group (5.53 months) was shorter than that of the non-bone metastasis group (7.72 months) (χ2=3.674, P=0.045). However, there was no statistically significant difference in OS between the bone metastasis group and the non-bone metastasis group (16.98 versus 17.56 months, χ2=1.333, P=0.248). Multivariate Cox regression analysis showed that bone metastasis was an independent prognostic factor for PFS in NSCLC patients (HR=1.52, 95%CI, 1.10 to 1.98, P=0.003), but not a prognostic factor for OS (P>0.05). The ORR and DCR in the combination group were 43.33% and 93.33%, respectively, which were higher than 26.67% and 76.67% in the chemotherapy group (P < 0.05). The PFS in the combination group was longer than that in the chemotherapy group (χ2=4.023, P=0.036). However, there was no statistically significant difference in OS between the two groups (χ2=1.235, P=0.267). There were no statistically significant differences in the overall incidence of TEAEs or the incidence of ≥grade 3 TEAE between the two groups (P>0.05).
    Conclusion Although the occurrence of bone metastasis has an adverse effect on the efficacy of ICI therapy in advanced NSCLC, patients with bone metastasis can still achieve better therapeutic effects through ICI combined with chemotherapy compared with chemotherapy alone.

     

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