PDF(Pubmed)
Abstract：
Background: Large Cell Neuroendocrine Carcinoma (LCNEC) is a high-grade malignancy with limited treatment options. Despite promising results of immunotherapy in non-small cell and small cell lung cancers, its benefit in LCNEC remains elusive. Methods: We included 24 patients diagnosed with stage IV LCNEC from the Moffitt Cancer Center database who received systemic therapy between January 2016 and May 2021. Group A comprised patients who received first-line CT and ICI (anti-PD-1 or anti-PD-L1 therapy for ICI, n = 11), and Group B received first-line CT only (n = 13). The collected data encompassed overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and toxicities since treatment initiation. Results: Kaplan-Meier survival analysis revealed median OS was 56 weeks (95%CI = 22.2-89.8) and 28 weeks (95% CI=16.3-39.7) in groups A and B, respectively. Log-rank test showed the difference was statistically significant (p=0.029). Median PFS was 32 weeks (95%CI=14.7-49.3) in group A and 20 weeks (95% CI=13.8-26.2) in groups B, but the difference was not statistically significant (p= 0.136). Univariate Cox analysis confirmed that the addition of ICI to CT significantly improved OS in patients with stage IV LCNEC (HR=0.35, 95% CI=0.13-0.95, p = 0.039). The ORR (63.6% vs 45.4%, p= 0.670) and DCR (81.8% vs 63.6%, p= 0.635) tended to be higher in group A than in group B but the difference was not statistically significant. Importantly, the combined treatment demonstrated a satisfactory safety profile, with only two patients reporting grade 2 or higher adverse events. Conclusions: Our results suggest that the combination of immunotherapy with chemotherapy holds potential for improving outcomes in stage IV LCNEC. Despite the retrospective nature and limited sample size of our study, these preliminary findings provide a valuable insight into the potential of immunotherapy in LCNEC treatment and encourage further research through larger, prospective trials.
摘要：
背景：大细胞神经内分泌癌（LCNEC）是一种高度恶性肿瘤，治疗选择有限。尽管免疫疗法在非小细胞和小细胞肺癌中取得了有希望的结果，它在LCNEC的好处仍然难以捉摸。方法：我们纳入了Moffitt癌症中心数据库中诊断为IV期LCNEC的24例患者，这些患者在2016年1月至2021年5月之间接受了系统治疗。A组包括接受一线CT和ICI（ICI的抗PD-1或抗PD-L1治疗，n=11）的患者，B组仅接受一线CT检查(n=13)。收集的数据包括总生存期(OS)，无进展生存期（PFS），客观反应率（ORR），疾病控制率（DCR），以及治疗开始后的毒性。结果：Kaplan-Meier生存分析显示，A组和B组的中位OS分别为56周（95CI=22.2-89.8）和28周（95％CI=16.3-39.7）。分别。Log-rank检验显示差异有统计学意义(p=0.029)。A组PFS中位数为32周(95CI=14.7-49.3),B组PFS中位数为20周(95%CI=13.8-26.2),但差异无统计学意义(p=0.136)。单因素Cox分析证实，在IV期LCNEC患者中增加ICI可显着改善OS（HR=0.35，95％CI=0.13-0.95，p=0.039）。ORR（63.6%对45.4%，p=0.670）和DCR（81.8%对63.6%，p=0.635）A组倾向于高于B组，但差异无统计学意义。重要的是,联合治疗表现出令人满意的安全性，只有两名患者报告2级或更高的不良事件。结论：我们的结果表明，免疫治疗与化疗的结合具有改善IV期LCNEC预后的潜力。尽管我们的研究是回顾性的，样本量有限，这些初步发现为LCNEC治疗中免疫治疗的潜力提供了有价值的见解，并鼓励通过更大规模的进一步研究，前瞻性试验。
