First-line systemic therapeutic options for advanced esophageal squamous cell carcinoma (ESCC) are limited. In this multicenter, double-blind phase 3 trial, a total of 551 patients with previously untreated, locally advanced or metastatic ESCC and PD-L1 combined positive score of ≥1 were randomized (2:1) to receive serplulimab (an anti-PD-1 antibody; 3 mg/kg) or placebo (on day 1), plus cisplatin (50 mg/m2) (on day 1) and continuous infusion of 5-fluorouracil (1,200 mg/m2) (on days 1 and 2), once every 2 weeks. The study met the primary endpoints. At the prespecified final analysis of progression-free survival (PFS) assessed by the blinded independent radiological review committee, serplulimab plus chemotherapy significantly improved PFS compared with placebo plus chemotherapy (median PFS of 5.8 months and 5.3 months, respectively; hazard ratio, 0.60; 95% confidence interval, 0.48–0.75; P < 0.0001). At the prespecified interim analysis of overall survival (OS), serplulimab plus chemotherapy also significantly prolonged OS compared with placebo plus chemotherapy (median OS of 15.3 months and 11.8 months, respectively; hazard ratio, 0.68; 95% confidence interval, 0.53–0.87; P = 0.0020). Grade 3 or higher treatment-related adverse events occurred in 201 (53%) and 81 (48%) patients in the serplulimab plus chemotherapy group and the placebo plus chemotherapy group, respectively. Serplulimab plus chemotherapy administered every 2 weeks significantly improved PFS and OS in patients with previously untreated, PD-L1-positive advanced ESCC, with a manageable safety profile. This study is registered with ClinicalTrials.gov (NCT03958890).
PurposeSystemic inflammation and immune dysfunction have been proved to be significantly associated with cancer progression and metastasis in colorectal cancer (CRC). The aim of this retrospective study was to investigate the association between preoperative systemic immune-inflammation index (SII) and postoperative liver metastasis in CRC.Patients and methodsThis retrospective study evaluated 182 patients with CRC who underwent surgical resection. The inflammation-based prognostic factors, including SII, neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), lymphocyte to monocyte ratio (LMR) and prognostic nutritional index (PNI), were calculated based on preoperative laboratory data. The univariate and multivariate logistic regression analysis was performed to identify the risk factors correlated with postoperative liver metastasis in CRC. Receiver operating characteristic (ROC) curves and decision curve analysis (DCA) were respectively used to assess the predictive ability and clinical usefulness of SII for postoperative liver metastasis in CRC.ResultsThe univariate and multivariable analysis confirmed SII was independently correlated with postoperative liver metastasis in CRC (p<0.001), and the ROC and DCA analysis demonstrated SII was superior to other inflammation-based factors in terms of predictive ability.ConclusionSII is an independent predictive indicator of postoperative liver metastasis for patients with colorectal cancer.
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