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Abstract：
UNASSIGNED: To investigate the efficacy and safety differences between the cisplatin + paclitaxel (TP) and cisplatin + fluorouracil (PF) regimens in combination with or without immune checkpoint inhibitors (ICIs) in advanced esophageal squamous cell carcinoma (ESCC) first-line treatment and prognostic factors.
UNASSIGNED: We selected the medical records of patients with late stage ESCC admitted to the hospital between 2019 and 2021. Based on the first-line treatment regimen, control groups were divided into chemotherapy plus ICIs (n = 243) and non-ICIs (n = 171), 119 (49%) in the TP + ICIs group, 124 (51%) in the PF + ICIs group, 83 (48.5%) in the TP group, and 88 (51.5%) in the PF group in the control group. We analyzed and compared factors related to efficacy, safety, or response to toxicity and prognosis across four subgroups.
UNASSIGNED: The overall objective response rate (ORR) and disease control rate (DCR) of the TP plus ICIs group were 42.1% (50/119) and 97.5% (116/119), respectively, which were 6.6% and 7.2% higher than those of the PF plus ICIs group. Patients in the TP combined with ICIs group had higher overall survival (OS) and progression-free survival (PFS) than those in the PF combined with ICIs group [hazard ratio (HR) = 1.702, 95% confidence interval (CI): 0.767-1.499, p = 0.0167 and HR = 1.158, 95% CI: 0.828-1.619, p = 0.0055] ORR and DCR were 15.7% (13/83) and 85.5% (71/83) in the TP chemotherapy alone group, significantly higher than the PF group [13.6% (12/88) and 72.2% (64/88)] (p < 0.05), OS and PFS were also better in patients treated with TP regimen chemotherapy than PF (HR = 1.173, 95% CI: 0.748-1.839, p = 0.0014 and HR = 0.1.245, 95% CI: 0.711-2.183, p = 0.0061). Furthermore, following the combination of TP and PF diets with ICIs, the OS of the patients was higher than that of the group treated with chemotherapy alone (HR = 0.526, 95% CI: 0.348-0.796, p = 0.0023 and HR = 0.781, 95% CI: 0.0.491-1.244, p < 0.001). Regression analysis showed that the neutrophil-to-lymphocyte ratio (NLR), the control nuclear status score (CONUT), and the systematic immune inflammation index (SII) were independent prognostic factors for the efficacy of immunotherapy (p < 0.05). The overall incidence of treatment-associated adverse events (TRAEs) was 79.4% (193/243) and 60.8% (104/171) in the experimental and control groups, respectively, and there was no statistically significant difference in TRAEs between TP + ICIs (80.6%) and PF + ICIs (78.2%) (61.4%) and PF groups (60.2%) (p > 0.05). Overall, 21.0% (51/243) of patients in the experimental group experienced immune-related adverse events (irAEs), and all of these adverse effects were tolerated or remitted following drug treatment without affecting follow-up.
UNASSIGNED: The TP regimen was associated with better PFS and OS with or without ICIs. Furthermore, high CONUT scores, high NLR ratios, and high SII were found to be associated with poor prognosis in combination immunotherapy.
UNASSIGNED: We selected the medical records of patients with late stage ESCC admitted to the hospital between 2019 and 2021. Based on the first-line treatment regimen, control groups were divided into chemotherapy plus ICIs (n = 243) and non-ICIs (n = 171), 119 (49%) in the TP + ICIs group, 124 (51%) in the PF + ICIs group, 83 (48.5%) in the TP group, and 88 (51.5%) in the PF group in the control group. We analyzed and compared factors related to efficacy, safety, or response to toxicity and prognosis across four subgroups.
UNASSIGNED: The overall objective response rate (ORR) and disease control rate (DCR) of the TP plus ICIs group were 42.1% (50/119) and 97.5% (116/119), respectively, which were 6.6% and 7.2% higher than those of the PF plus ICIs group. Patients in the TP combined with ICIs group had higher overall survival (OS) and progression-free survival (PFS) than those in the PF combined with ICIs group [hazard ratio (HR) = 1.702, 95% confidence interval (CI): 0.767-1.499, p = 0.0167 and HR = 1.158, 95% CI: 0.828-1.619, p = 0.0055] ORR and DCR were 15.7% (13/83) and 85.5% (71/83) in the TP chemotherapy alone group, significantly higher than the PF group [13.6% (12/88) and 72.2% (64/88)] (p < 0.05), OS and PFS were also better in patients treated with TP regimen chemotherapy than PF (HR = 1.173, 95% CI: 0.748-1.839, p = 0.0014 and HR = 0.1.245, 95% CI: 0.711-2.183, p = 0.0061). Furthermore, following the combination of TP and PF diets with ICIs, the OS of the patients was higher than that of the group treated with chemotherapy alone (HR = 0.526, 95% CI: 0.348-0.796, p = 0.0023 and HR = 0.781, 95% CI: 0.0.491-1.244, p < 0.001). Regression analysis showed that the neutrophil-to-lymphocyte ratio (NLR), the control nuclear status score (CONUT), and the systematic immune inflammation index (SII) were independent prognostic factors for the efficacy of immunotherapy (p < 0.05). The overall incidence of treatment-associated adverse events (TRAEs) was 79.4% (193/243) and 60.8% (104/171) in the experimental and control groups, respectively, and there was no statistically significant difference in TRAEs between TP + ICIs (80.6%) and PF + ICIs (78.2%) (61.4%) and PF groups (60.2%) (p > 0.05). Overall, 21.0% (51/243) of patients in the experimental group experienced immune-related adverse events (irAEs), and all of these adverse effects were tolerated or remitted following drug treatment without affecting follow-up.
UNASSIGNED: The TP regimen was associated with better PFS and OS with or without ICIs. Furthermore, high CONUT scores, high NLR ratios, and high SII were found to be associated with poor prognosis in combination immunotherapy.
摘要：
■探讨顺铂+紫杉醇(TP)和顺铂+氟尿嘧啶(PF)联合或不联合免疫检查点抑制剂(ICIs)治疗晚期食管鳞状细胞癌(ESCC)一线治疗的疗效和安全性差异及预后因素。
■我们选择了2019年至2021年间住院的晚期ESCC患者的病历。在一线治疗方案的基础上，对照组分为化疗加ICIs（n=243）和非ICIs（n=171），TP+ICIs组119人（49%），PF+ICIs组124人（51%），TP组83例（48.5%），PF组88例(51.5%)，对照组88例(51.5%)。我们分析并比较了与疗效相关的因素，安全,或对四个亚组的毒性反应和预后。
■TP加ICIs组的总体客观缓解率（ORR）和疾病控制率（DCR）分别为42.1％（50/119）和97.5％（116/119），分别,分别比PF加ICI组高出6.6%和7.2%。TP联合ICIs组患者的总生存期（OS）和无进展生存期（PFS）高于PF联合ICIs组[风险比（HR）=1.702，95％置信区间（CI）：0.767-1.499，p=0.0167和HR=1.158，95％CI：0.828-1.619，p=0.0055]ORR和DCR分别为15.7％（13/83）显著高于PF组[13.6%(12/88)和72.2%(64/88)](p<0.05),TP方案化疗患者的OS和PFS也优于PF（HR=1.173，95％CI：0.748-1.839，p=0.0014，HR=0.1.245，95％CI：0.711-2.183，p=0.0061）。此外，在TP和PF饮食与ICIs相结合之后，患者的OS高于单纯化疗组(HR=0.526,95%CI:0.348-0.796,p=0.0023,HR=0.781,95%CI:0.0.491-1.244,p<0.001).回归分析显示，中性粒细胞与淋巴细胞比率（NLR），控制核状态评分(CONUT)，而系统免疫炎症指数(SII)是影响免疫治疗疗效的独立预后因素(p<0.05)。试验组和对照组治疗相关不良事件(TRAEs)的总发生率分别为79.4%(193/243)和60.8%(104/171),分别,TP+ICIs组(80.6%)与PF+ICIs组(78.2%)(61.4%)和PF组(60.2%)之间的TRAE差异无统计学意义(p>0.05)。总的来说,实验组中21.0%（51/243）的患者出现免疫相关不良事件（irAE），药物治疗后,所有这些不良反应均可耐受或缓解,且不影响随访.
■TP方案在有或没有ICIs的情况下与更好的PFS和OS相关。此外，CONUT高分,高NLR比率，发现高SII与联合免疫治疗的不良预后相关。
■我们选择了2019年至2021年间住院的晚期ESCC患者的病历。在一线治疗方案的基础上，对照组分为化疗加ICIs（n=243）和非ICIs（n=171），TP+ICIs组119人（49%），PF+ICIs组124人（51%），TP组83例（48.5%），PF组88例(51.5%)，对照组88例(51.5%)。我们分析并比较了与疗效相关的因素，安全,或对四个亚组的毒性反应和预后。
■TP加ICIs组的总体客观缓解率（ORR）和疾病控制率（DCR）分别为42.1％（50/119）和97.5％（116/119），分别,分别比PF加ICI组高出6.6%和7.2%。TP联合ICIs组患者的总生存期（OS）和无进展生存期（PFS）高于PF联合ICIs组[风险比（HR）=1.702，95％置信区间（CI）：0.767-1.499，p=0.0167和HR=1.158，95％CI：0.828-1.619，p=0.0055]ORR和DCR分别为15.7％（13/83）显著高于PF组[13.6%(12/88)和72.2%(64/88)](p<0.05),TP方案化疗患者的OS和PFS也优于PF（HR=1.173，95％CI：0.748-1.839，p=0.0014，HR=0.1.245，95％CI：0.711-2.183，p=0.0061）。此外，在TP和PF饮食与ICIs相结合之后，患者的OS高于单纯化疗组(HR=0.526,95%CI:0.348-0.796,p=0.0023,HR=0.781,95%CI:0.0.491-1.244,p<0.001).回归分析显示，中性粒细胞与淋巴细胞比率（NLR），控制核状态评分(CONUT)，而系统免疫炎症指数(SII)是影响免疫治疗疗效的独立预后因素(p<0.05)。试验组和对照组治疗相关不良事件(TRAEs)的总发生率分别为79.4%(193/243)和60.8%(104/171),分别,TP+ICIs组(80.6%)与PF+ICIs组(78.2%)(61.4%)和PF组(60.2%)之间的TRAE差异无统计学意义(p>0.05)。总的来说,实验组中21.0%（51/243）的患者出现免疫相关不良事件（irAE），药物治疗后,所有这些不良反应均可耐受或缓解,且不影响随访.
■TP方案在有或没有ICIs的情况下与更好的PFS和OS相关。此外，CONUT高分,高NLR比率，发现高SII与联合免疫治疗的不良预后相关。
