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Abstract：
UNASSIGNED: Immune checkpoint inhibitors (ICIs) have recently been increasingly used in cancer treatment, whereas their clinical application in biliary tract cancer (BTC) patients is uncommon. This study aimed to evaluate the efficacy and safety of ICIs plus capecitabine and oxaliplatin (CAPOX) in the treatment of BTC patients.
UNASSIGNED: This retrospective study reviewed 26 unresectable or advanced BTC patients who received ICIs plus CAPOX. The treatment continued until disease progression, uncontrollable adverse event (AE) occurrence, intolerable toxicity occurrence, or voluntary withdrawal.
UNASSIGNED: The median treatment cycles were 5.5 [interquartile range (IQR): 3.8-8.0]. Complete response, partial response, stable disease, and progressive disease rates were 0.0%, 46.2%, 23.1%, and 30.8%, respectively. Objective response rate (ORR) and disease control rate (DCR) were 46.2% and 69.2%, correspondingly. Regarding survival, the median progression-free survival (PFS) and overall survival (OS) were 6.1 (95% CI: 4.4-7.7) months and 16.5 (95% CI: 5.0-28.0) months; moreover, the 1-year PFS and OS rates were 21.5% and 54.3%, respectively. An Eastern Cooperative Oncology Group (ECOG) score of 1-3 (vs. 0) was associated with declined DCR, PFS, and OS (all p < 0.050). The most common AEs of ICIs plus CAPOX were thrombocytopenia (61.5%), neutropenia (26.9%), and reactive cutaneous capillary endothelial proliferation (RCCEP) (23.1%). Moreover, 13 (50.0%) patients suffered from grade 3-4 AEs, including thrombocytopenia (50.0%), neutropenia (7.7%), liver dysfunction (7.7%), and RCCEP (3.8%). Notably, the majority of AEs were controllable.
UNASSIGNED: ICIs plus CAPOX chemotherapy exhibit a good efficacy and a manageable safety profile in the treatment of patients with unresectable or advanced BTC.
UNASSIGNED: This retrospective study reviewed 26 unresectable or advanced BTC patients who received ICIs plus CAPOX. The treatment continued until disease progression, uncontrollable adverse event (AE) occurrence, intolerable toxicity occurrence, or voluntary withdrawal.
UNASSIGNED: The median treatment cycles were 5.5 [interquartile range (IQR): 3.8-8.0]. Complete response, partial response, stable disease, and progressive disease rates were 0.0%, 46.2%, 23.1%, and 30.8%, respectively. Objective response rate (ORR) and disease control rate (DCR) were 46.2% and 69.2%, correspondingly. Regarding survival, the median progression-free survival (PFS) and overall survival (OS) were 6.1 (95% CI: 4.4-7.7) months and 16.5 (95% CI: 5.0-28.0) months; moreover, the 1-year PFS and OS rates were 21.5% and 54.3%, respectively. An Eastern Cooperative Oncology Group (ECOG) score of 1-3 (vs. 0) was associated with declined DCR, PFS, and OS (all p < 0.050). The most common AEs of ICIs plus CAPOX were thrombocytopenia (61.5%), neutropenia (26.9%), and reactive cutaneous capillary endothelial proliferation (RCCEP) (23.1%). Moreover, 13 (50.0%) patients suffered from grade 3-4 AEs, including thrombocytopenia (50.0%), neutropenia (7.7%), liver dysfunction (7.7%), and RCCEP (3.8%). Notably, the majority of AEs were controllable.
UNASSIGNED: ICIs plus CAPOX chemotherapy exhibit a good efficacy and a manageable safety profile in the treatment of patients with unresectable or advanced BTC.
摘要：
未经证实：免疫检查点抑制剂（ICIs）最近越来越多地用于癌症治疗，而它们在胆道癌（BTC）患者中的临床应用并不常见。本研究旨在评估ICIs联合卡培他滨和奥沙利铂（CAPOX）治疗BTC患者的疗效和安全性。
UNASSIGNED：这项回顾性研究回顾了26例接受ICIs联合CAPOX治疗的不可切除或晚期BTC患者。治疗一直持续到疾病进展，无法控制的不良事件（AE）发生，无法耐受的毒性发生，或自愿退出。
UNASSIGNED：中位治疗周期为5.5[四分位距（IQR）：3.8-8.0]。完整的响应,部分响应,疾病稳定,疾病进展率为0.0%，46.2%,23.1%,和30.8%，分别。客观缓解率(ORR)和疾病控制率(DCR)分别为46.2%和69.2%,相应地。关于生存,中位无进展生存期(PFS)和总生存期(OS)分别为6.1(95%CI:4.4-7.7)个月和16.5(95%CI:5.0-28.0)个月;1年PFS和OS率分别为21.5%和54.3%，分别。东部肿瘤协作组（ECOG）得分为1-3（vs.0)与DCR下降有关，PFS,和OS（所有p<0.050）。ICI加CAPOX最常见的不良事件是血小板减少症（61.5%），中性粒细胞减少症（26.9%），和反应性皮肤毛细血管内皮增生（RCCEP）（23.1％）。此外，13例(50.0%)患者患有3-4级不良事件，包括血小板减少症（50.0%），中性粒细胞减少症(7.7%),肝功能异常（7.7%），和RCCEP（3.8%）。值得注意的是,大多数AE是可控的。
UNASSIGNED：ICIs联合CAPOX化疗在不可切除或晚期BTC患者的治疗中表现出良好的疗效和可控的安全性。
UNASSIGNED：这项回顾性研究回顾了26例接受ICIs联合CAPOX治疗的不可切除或晚期BTC患者。治疗一直持续到疾病进展，无法控制的不良事件（AE）发生，无法耐受的毒性发生，或自愿退出。
UNASSIGNED：中位治疗周期为5.5[四分位距（IQR）：3.8-8.0]。完整的响应,部分响应,疾病稳定,疾病进展率为0.0%，46.2%,23.1%,和30.8%，分别。客观缓解率(ORR)和疾病控制率(DCR)分别为46.2%和69.2%,相应地。关于生存,中位无进展生存期(PFS)和总生存期(OS)分别为6.1(95%CI:4.4-7.7)个月和16.5(95%CI:5.0-28.0)个月;1年PFS和OS率分别为21.5%和54.3%，分别。东部肿瘤协作组（ECOG）得分为1-3（vs.0)与DCR下降有关，PFS,和OS（所有p<0.050）。ICI加CAPOX最常见的不良事件是血小板减少症（61.5%），中性粒细胞减少症（26.9%），和反应性皮肤毛细血管内皮增生（RCCEP）（23.1％）。此外，13例(50.0%)患者患有3-4级不良事件，包括血小板减少症（50.0%），中性粒细胞减少症(7.7%),肝功能异常（7.7%），和RCCEP（3.8%）。值得注意的是,大多数AE是可控的。
UNASSIGNED：ICIs联合CAPOX化疗在不可切除或晚期BTC患者的治疗中表现出良好的疗效和可控的安全性。
