The Third Department of Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, Hebei, China.
Internal Medicine, AMITA Health Saint Joseph Hospital Chicago, 2900 N. Lake Shore Drive, Chicago, IL, 60657, USA.
BMC Gastroenterol. 2022 Mar 14;22(1):121. doi: 10.1186/s12876-022-02199-9.
Previous studies have confirmed that systemic immune-inflammatory index (SII) and prognostic nutritional index (PNI) can predict the prognosis and chemotherapy efficacy of various malignant tumors. However, to the best of our knowledge, no study investigated the SII combined with PNI score to predict the efficacy of anti-programmed death 1 (anti-PD-1) antibody sintilimab and XELOX regimen (capecitabine plus oxaliplatin) in the treatment of locally advanced gastric cancer. This study aims to evaluate the predictive value of pre-treatment SII-PNI score on the sensitivity of sintilimab immunotherapy combined with XELOX chemotherapy in patients with locally advanced gastric cancer.
We registered a prospective clinical study involving 30 locally advanced gastric cancer patients from March 2020 to July 2021. The pre-treatment SII and PNI were calculated from peripheral blood samples, and the cut-off value was calculated by receiver operating characteristic. The SII-PNI score ranged from 0 to 2 and were categorized into the following: score of 2, high SII (≥ 568.5) and low PNI (≤ 52.7); score of 1, either high SII or low PNI; score of 0, no high SII nor low PNI.
All patients were evaluated by RECIST1.1 criteria after four cycles of sintilimab immunotherapy combined with XELOX chemotherapy, including 5 patients with TRG 3 and 25 patients with non-TRG 3. The SII-PNI score of non-TRG 3 patients was significantly lower than that of TRG 3 patients (P = 0.017). The medial progression free survival of patients with low SII-PNI score was significantly better than that of patients with high SII-PNI score (P < 0.001). Multivariate analysis showed that SII-PNI score was an independent prognostic factor for predicting progression-free survival (P = 0.003).
The pre-treatment SII-PNI score is a significant indicator for predicting chemosensitivity of locally advanced patients after sintilimab immunotherapy combined with XELOX chemotherapy, which can help to identify high-risk groups and predict prognosis.
The registered name of the trial is "Prospective clinical study of sintilimab combined with chemotherapy for neoadjuvant therapy in locally advanced gastric cancer". Its Current Controlled Trials number is ChiCTR2000030414. Its date of registration is 01/03/2020.
先前的研究已经证实，全身性免疫炎症指数（SII）和预后营养指数（PNI）可以预测各种恶性肿瘤的预后和化疗疗效。然而，据我们所知，尚无研究探讨 SII 联合 PNI 评分预测抗程序性死亡 1（抗 PD-1）抗体信迪利单抗和 XELOX 方案（卡培他滨联合奥沙利铂）治疗局部晚期胃癌疗效的作用。本研究旨在评估治疗前 SII-PNI 评分对局部晚期胃癌患者接受信迪利单抗免疫治疗联合 XELOX 化疗敏感性的预测价值。
我们注册了一项前瞻性临床研究，纳入了 2020 年 3 月至 2021 年 7 月期间的 30 名局部晚期胃癌患者。外周血样本计算 SII 和 PNI，通过受试者工作特征曲线计算截断值。SII-PNI 评分范围为 0 至 2 分，并分为以下几种：评分 2 分，高 SII（≥568.5）和低 PNI（≤52.7）；评分 1 分，高 SII 或低 PNI；评分 0 分，既无高 SII 也无低 PNI。
所有患者在接受信迪利单抗免疫治疗联合 XELOX 化疗 4 个周期后均按 RECIST1.1 标准进行评估，包括 5 例 TRG3 患者和 25 例非 TRG3 患者。非 TRG3 患者的 SII-PNI 评分明显低于 TRG3 患者（P=0.017）。低 SII-PNI 评分患者的中位无进展生存期明显优于高 SII-PNI 评分患者（P<0.001）。多因素分析显示，SII-PNI 评分是预测无进展生存期的独立预后因素（P=0.003）。
治疗前 SII-PNI 评分是预测信迪利单抗免疫治疗联合 XELOX 化疗后局部晚期患者化疗敏感性的重要指标，有助于识别高危人群并预测预后。
该试验的注册名称为“信迪利单抗联合化疗治疗局部晚期胃癌新辅助治疗的前瞻性临床研究”。其当前的对照试验编号为 ChiCTR2000030414。其注册日期为 2020 年 1 月 3 日。
