Outcomes of Patients Treated with SVILE versus P-GemOx Regimens for Newly Diagnosed Extranodal Nature Killer/T-Cell Lymphoma, Nasal Type: A Prospective, Randomly Controlled Study

Abstract

Background: This prospective, randomly controlled study was designed to compare the efficacy and safety of the novel SVILE regimen and the commonly used P-GemOx regimen for the patients with newly diagnosed extranodal natural killer/T-cell lymphoma, nasal type (ND-ENTKL). Methods: 103 ND-ENTKL patients were enrolled and classified into stage I/II (n = 69) and stage III/IV (n = 34). Patients were randomly assigned to three cycles of SVILE (experimental group) or P-GemOx (control group) chemotherapy followed by involved field radiotherapy (IFRT) and two to three cycles of consolidation chemotherapy. The primary endpoint was the overall response rate (ORR) and the secondary study endpoints were the complete response (CR) rate, progression-free survival (PFS), and overall survival (OS). The safety index was the incidence of adverse events in both groups. Findings: There were no significant differences in baseline characteristics between the experimental group (SVILE, n=52) and control group (P-GemOx, n=51). The ORRs in the two groups were 86.5% vs. 88.2% (P = 0.967), 91.7% vs. 97.0% for stage I/II and 75.0% vs. 72.2% for stage III/IV. The CR rate in the experimental vs. control groups was 78.8% vs. 84.3%. The CR rates in the two groups were 83.4% vs. 97.0% for stage I/II and 68.8% vs. 61.1% for stage III/IV. There were no significant differences. The median follow-up time of the experimental and control groups were 30 and 29 months, respectively. There was no significant difference between the groups on PFS and OS. The 3-year follow-up PFS and OS values for the experimental and control groups were 75.4% vs. 83.9% and 77.5% vs. 88.2%. There were no significant differences in PFS and OS among patients with stage I/II and stage III/IV. The 3-year PFS and OS of patients in the experimental and control groups with stage I/II were 88.3% vs. 93.3% and 84.9% vs. 97.0%. The 1-year follow-up PFS and OS values of patients in the experimental and control groups with stage III/IV were 46.2% vs. 65.7% and 61.1% vs. 72.2%. The main adverse events of the two groups were hematological toxicity, hypofibrinogenemia, and liver injury. Patients recovered quickly after symptomatic treatment with no treatment-related deaths. Interpretation: SVILE and P-GemOx combined with radiotherapy and consolidation chemotherapy have positive short-term and long-term effects in patients with ND-ENTKL and are well tolerated. SVILE and P-GemOx do not significantly differ in terms of ORR, making the SVILE regimen deserving of further study. Trial Registration: This study is registered with Chinese Clinical Trial Registry (CHiCTR), number CHiCTR-IPC-14005745. Funding Statement: This study was approved, funded and supervised by Beijing Municipal Science & Technology Commission. No.Z151100004015089. Declaration of Interests: No potential conflict of interest was reported by the authors. Ethics Approval Statement: This study was reviewed and approved by the ethics committee of our institute with the number of TRECKY2015-016. It complies with ethical standards.