Anti-PD-1 antibody (Tislelizumab) combined with gemcitabine and oxaliplatin for extranodal NK/T-cell lymphoma failing asparaginase: A multicenter phase II trial

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2025-01-01 DOI:10.1016/j.ejca.2024.115155

Kaiyang Ding , Hailing Liu , Lixia Sheng , Jie Ma , Xiaohui Zhang , Hongming Huang , Wei Shi , Hongling Peng , Lei Cao , Wei Wu , Jianyong Li , Lei Fan

{"title":"Anti-PD-1 antibody (Tislelizumab) combined with gemcitabine and oxaliplatin for extranodal NK/T-cell lymphoma failing asparaginase: A multicenter phase II trial","authors":"Kaiyang Ding , Hailing Liu , Lixia Sheng , Jie Ma , Xiaohui Zhang , Hongming Huang , Wei Shi , Hongling Peng , Lei Cao , Wei Wu , Jianyong Li , Lei Fan","doi":"10.1016/j.ejca.2024.115155","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Extranodal natural killer/T-cell lymphoma (ENKTCL) is almost always fatal after the failure of asparaginase. This phase II study aimed to investigate the efficacy and safety of tislelizumab combined with gemcitabine and oxaliplatin (Tisle-GemOx) in patients with ENKTCL failing asparaginase.</div></div><div><h3>Methods</h3><div>Eligible patients received Tisle-GemOx as initial induction for 6–8 cycles at 21-day intervals. Responders continued tislelizumab maintenance every two months for two years. The primary endpoint was the best complete response rate (CRR).</div></div><div><h3>Results</h3><div>As of September 2023, 32 patients were enrolled in our study. Among the 30 efficacy-evaluable patients, the best CRR was 60 %, meeting the primary efficacy endpoint. With a median follow-up of 22.6 months, the median progression-free survival (PFS) was 7.4 months and the 1-year PFS rate was 46.4 %. Subgroup analyses showed that shorter PFS was associated with previous lines of chemotherapy ≥ 2 (P = 0.034) and concomitant hemophagocytic lymphohistiocytosis (P = 0.040). Pseudo-progression was observed in three patients (10 %). The most common grade ≥ 3 toxicities were lymphopenia (25 %) and anemia (15.6 %).</div></div><div><h3>Conclusions</h3><div>Tisle-GemOx exhibits promising anti-tumor activity and manageable toxicities as a salvage therapy for ENKTCL failing asparaginase. Further long-term follow-up is necessary to evaluate the durability of the response with tislelizumab maintenance in this patient population.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"214 ","pages":"Article 115155"},"PeriodicalIF":7.6000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0959804924017623","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Extranodal natural killer/T-cell lymphoma (ENKTCL) is almost always fatal after the failure of asparaginase. This phase II study aimed to investigate the efficacy and safety of tislelizumab combined with gemcitabine and oxaliplatin (Tisle-GemOx) in patients with ENKTCL failing asparaginase.

Methods

Eligible patients received Tisle-GemOx as initial induction for 6–8 cycles at 21-day intervals. Responders continued tislelizumab maintenance every two months for two years. The primary endpoint was the best complete response rate (CRR).

Results

As of September 2023, 32 patients were enrolled in our study. Among the 30 efficacy-evaluable patients, the best CRR was 60 %, meeting the primary efficacy endpoint. With a median follow-up of 22.6 months, the median progression-free survival (PFS) was 7.4 months and the 1-year PFS rate was 46.4 %. Subgroup analyses showed that shorter PFS was associated with previous lines of chemotherapy ≥ 2 (P = 0.034) and concomitant hemophagocytic lymphohistiocytosis (P = 0.040). Pseudo-progression was observed in three patients (10 %). The most common grade ≥ 3 toxicities were lymphopenia (25 %) and anemia (15.6 %).

Conclusions

Tisle-GemOx exhibits promising anti-tumor activity and manageable toxicities as a salvage therapy for ENKTCL failing asparaginase. Further long-term follow-up is necessary to evaluate the durability of the response with tislelizumab maintenance in this patient population.

查看原文本刊更多论文

抗pd -1抗体（Tislelizumab）联合吉西他滨和奥沙利铂治疗结外NK/ t细胞淋巴瘤失败天冬酰胺酶：一项多中心II期试验

背景：结外自然杀伤/ t细胞淋巴瘤（ENKTCL）在天冬酰胺酶失效后几乎总是致命的。这项II期研究旨在研究tislelizumab联合吉西他滨和奥沙利铂（Tisle-GemOx）治疗ENKTCL失败天门汀酶患者的有效性和安全性。方法：符合条件的患者接受Tisle-GemOx作为初始诱导，每21天间隔6-8个周期。应答者每两个月继续维持tislelizumab两年。主要终点为最佳完全缓解率。结果：截至2023年9月，32例患者入组我们的研究。在30例可评价疗效的患者中，最佳CRR为60%，达到主要疗效终点。中位随访22.6个月，中位无进展生存期（PFS）为7.4个月，1年PFS率为46.4%。亚组分析显示，较短的PFS与既往化疗≥2次（P = 0.034）和伴随的噬血细胞淋巴组织细胞增多症（P = 0.040）有关。3例（10%）患者出现假进展。最常见的≥3级毒性是淋巴细胞减少（25%）和贫血（15.6%）。结论：Tisle-GemOx具有良好的抗肿瘤活性和可控的毒性，可作为ENKTCL失效天门汀酶的补救疗法。需要进一步的长期随访来评估在该患者群体中维持tislelizumab的反应的持久性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.