Objective: To assess the efficacy, safety, and related prognostic factors associated with the P-GemDOx regimen as a first-line treatment for patients with early-stage extranodal natural killer (NK) /T cell lymphoma (ENKTL) . Methods: A retrospective analysis was performed on sixty early-stage ENKTL patients treated with the P-GemDOx regimen who were admitted to the First Affiliated Hospital of Nanjing Medical University between August 2015 and May 2021. The Chi-square test or Fisher's exact test was used to compare group differences, and the Log-rank test was used to compare the differences in survival. Survival outcomes and prognostic factors were examined. Results: After completing 4 to 6 cycles of P-GemDOx chemotherapy, the overall response rate (ORR) was 88.3%, with forty-six patients (76.7% ) achieving complete response (CR). The 4-year progression-free survival (PFS) and overall survival (OS) rates were (66.3±7.1) % and (79.5±6.0) %, respectively. According to the PINK/PINK-E model, there was no significant difference in survival outcomes among risk groups. 23.3% of patients experienced progression of disease within 24 months (POD<24). OS estimates differed significantly (P<0.001) between the POD<24 group (n=14) and the POD≥24 group (n=46). Analysis showed that SUVmax > 12.8 at diagnosis, non-single nasal cavity infiltration, and response less than CR after 4-6 cycles all had a significant association with POD24. We used these data as the basis for predicting POD<24 international prognostic index (POD24-IPI). Patients were stratified into low-risk (no risk factors), intermediate-risk (one risk factor), or high risk (two or three risk factors). These groups were associated with 4-year OS rate of 100%, (85.6±9.7) %, and (65.0±10.2) %, respectively (P=0.014). The P-GemDOx regimen was well tolerated, with hematological toxicity being the main side effect. Conclusion: This study demonstrated that the P-GemDOx regimen is effective and safe in the first-line treatment of early-stage ENKTL, and POD24-IPI is a promising prognostic model.
目的： 探讨P-GemDOx方案一线治疗早期结外NK/T细胞淋巴瘤（ENKTL）患者的有效性、安全性以及相关预后因素。 方法： 回顾性分析2015年8月至2021年5月南京医科大学第一附属医院血液科收治的60例使用P-GemDOx方案治疗的早期初诊ENKTL患者的临床资料，使用χ(2)检验及Fisher确切概率法比较组间临床特征的差异，使用Log-rank检验比较组间生存差异，进行生存和预后因素分析。 结果： 60例患者在完成4～6个周期P-GemDOx方案治疗后，总缓解率（ORR）为88.3%，46例（76.7%）获得完全缓解（CR）。4年的无进展生存（PFS）率和总生存（OS）率分别为（66.3±7.1）%和（79.5±6.0）%。根据PINK/PINKE预后评分系统进行分组，各组间PFS和OS差异均无统计学意义。23.3%的患者24个月内出现疾病进展（POD<24），POD<24组（14例）和24个月内未出现疾病进展（POD≥24）组（46例）的OS期差异有统计学意义（P<0.001）。分析POD<24的危险因素，并在此基础上建立了预测POD<24的国际预后指数（POD24-IPI）预后分层模型（诊断时PET-CT检查存在病灶最大标准摄取值>12.8，1分；非单个鼻腔浸润，1分；4～6个周期治疗后疗效评估未达CR，1分；低危组，0分；中危组，1分；高危组，2～3分），低危、中、高危组4年OS率分别为100%、（85.6±9.7）%、（65.0±10.2）%（P＝0.014）。此外，P-GemDOx化疗方案临床应用的总体耐受良好，主要不良反应是血液学毒性。 结论： 在早期ENKTL患者中，P-GemDOx方案是一个安全且有效的一线治疗方案；POD24-IPI是一个良好的风险分层模型。.
Keywords: Lymphoma, extranodal NK-T-Cell; Pegaspargase; Prognosis; Survival.