Treatment options specifically for patients with locally advanced pancreatic adenocarcinoma (LAPC) are scare and chemotherapy alone delivers limited efficacy. Immunotherapy and radiotherapy are potential effective treatments for LAPC, and both of them may synergize with chemotherapy. Therefore, in this prospective cohort study, we compared the efficacy and safety of nab-paclitaxel plus gemcitabine combined with anti-programmed cell death (PD-1) immunotherapy and radiotherapy (hereafter, combination treatment) versus nab-paclitaxel plus gemcitabine (chemotherapy alone) in the treatment of LAPC. In the combination group, participants received conventional fractionated radiotherapy with doses ranging from 54 to 63 Gy in 28 fractions, intravenous camrelizumab 200 mg once every 3 weeks, and intravenous nab-paclitaxel plus gemcitabine on day 1 and 8 of a 21-day cycle for eight cycles until disease progression, death or unacceptable toxicity. In the chemotherapy group, participants received intravenous nab-paclitaxel plus gemcitabine on day 1 and 8 of a 21-day cycle for eight cycles. From April, 2020 to December, 2021, 96 participants with LAPC were prospectively enrolled with 32 received combination treatment and 64 received chemotherapy alone at a single center. The combination treatment yielded significantly longer median overall-survival (22.3 months vs. 18.6 months, P = 0.031) and progression-free survival (12.0 months vs. 10.5 months, P = 0.043) than chemotherapy alone did. And the incidence of severe adverse events was not significantly different between the combination group and chemotherapy group (P = 0.856). In conclusion, nab-paclitaxel plus gemcitabine combined with anti-PD-1 immunotherapy and radiotherapy was effective and safe for LAPC patients, and it warrants further investigation in larger randomized trials.

中文翻译：

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白蛋白结合型紫杉醇和吉西他滨联合卡瑞利珠单抗和放疗与单用白蛋白结合型紫杉醇和吉西他滨治疗局部晚期胰腺腺癌：一项前瞻性队列研究


专门针对局部晚期胰腺癌 (LAPC) 患者的治疗选择很少，而且单独化疗的疗效有限。免疫疗法和放射疗法是 LAPC 的潜在有效治疗方法，并且两者都可能与化疗产生协同作用。因此，在这项前瞻性队列研究中，我们比较了白蛋白结合型紫杉醇加吉西他滨联合抗程序性细胞死亡（PD-1）免疫治疗和放疗（以下简称联合治疗）与白蛋白结合型紫杉醇加吉西他滨（单独化疗）的疗效和安全性。 ) 治疗 LAPC。在联合组中，参与者接受常规分割放疗，剂量范围为 54 至 63 Gy，分 28 次，静脉注射卡瑞利珠单抗 200 mg，每 3 周一次，并在 21 天周期的第 1 天和第 8 天静脉注射白蛋白结合型紫杉醇加吉西他滨。八个周期直至疾病进展、死亡或不可接受的毒性。在化疗组中，参与者在 21 天周期的第 1 天和第 8 天接受静脉注射白蛋白结合型紫杉醇加吉西他滨，共 8 个周期。从 2020 年 4 月到 2021 年 12 月，前瞻性招募了 96 名 LAPC 参与者，其中 32 名接受联合治疗，64 名在单一中心接受单独化疗。与单独化疗相比，联合治疗的中位总生存期（22.3 个月 vs. 18.6 个月，P = 0.031）和无进展生存期（12.0 个月 vs. 10.5 个月，P = 0.043）显着延长。联合组与化疗组严重不良事件发生率无显着差异（P=0.856）。 总之，白蛋白结合型紫杉醇联合吉西他滨联合抗PD-1免疫治疗和放疗对LAPC患者有效且安全，值得在更大规模的随机试验中进一步研究。