Interim analysis of a prospective multicenter phase II study for advanced‐stage or relapsed/refractory natural killer/T cell lymphoma
Year: 2023
Type: conference-abstract
Abstract: Background: Advanced-stage or relapsed/refractory (r/r) natural killer/T cell lymphoma (NKTCL) has a poor prognosis. The anti-programmed death 1 (PD-1) antibody has demonstrated satisfactory efficacy and good tolerance in treating r/r NKTCL. In this report, we present the interim analysis results of a prospective multicenter phase II study. Methods: Patients with advanced-stage or r/r NKTCL were eligible for participation. The DAPT regimen chemotherapy was administered as the protocol treatment, which included dexamethasone 10 mg on days 1–3, azacytidine 100 mg on days 1–5, pegaspargase 3750 IU on day 1, and tislelizumab 200 mg on day 6. Cycles were repeated every 21 days. The primary endpoint was the overall response rate (ORR) after the protocol treatment. Results: A total of 29 eligible patients were enrolled, with a median age of 52 years (range, 35 to 72 years) and a male-to-female ratio of 2.2:1. Eighteen patients had newly diagnosed disease with stage IV, while 11 had r/r disease. Among 21 patients with available response, the ORR and complete response rates were 76% and 33% for the entire cohort, 85% and 39% for newly diagnosed stage IV disease, and 63% and 25% for r/r disease, respectively. Six patients underwent autologous hematopoietic stem cell transplantation. The median progression-free survival was 10.7 months (range, 1.3–20.9 months). The most common adverse events were neutropenia (17%), elevated alanine aminotransferase (13%), and decreased fibrinogen (10%). No treatment-related deaths were observed. Conclusion: The DAPT regimen chemotherapy is an effective and tolerable treatment for advanced-stage or r/r NKTCL. The research was funded by: Clinical research fund for distinguished young scholars of Beijing Cancer Hospital (Grant No. QNJJ202106 Keywords: Aggressive T-cell non-Hodgkin lymphoma, Combination Therapies No conflicts of interests pertinent to the abstract.
Source: Hematological Oncology
DOI: 10.1002/hon.3164_370
Institutions: Peking University Cancer Hospital, Peking University International Hospital, Lanzhou University Second Hospital, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, China-Japan Friendship Hospital, Fourth Hospital of Hebei Medical University, Inner Mongolia Medical College Hospital, Inner Mongolia Medical University, Chifeng Municipal Hospital, Nanfang Hospital, Southern Medical University, Guangdong Provincial Hospital of Chinese Medicine
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4380079752