A pegasparaginase-based chemotherapy regimen showed promising preliminary results when compared to a regimen that was L-asparaginase-based in patients with newly diagnosed advanced-stage (III/IV) extranodal natural killer T-cell lymphoma (NKTCL).
The pegasparaginase-based regimen consisted of dexamethasone, cisplatin, gemcitabine, and pegaspargase, while the L-asparaginase-based regimen consisted of dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide.
The open-label, multicenter, randomized clinical trial included 80 patients aged 14 to 70 who had newly diagnosed extranodal NKTCL in stages III/IV and had an Eastern Cooperative Oncology Group performance status of zero to two. The median age was 43 years, and most patients (64%) were male. Patients were randomized 1:1 to receive the pegasparaginase-based or L-asparaginase-based treatment. The treatments were given every 21 days for six cycles.
The overall response rate was significantly higher in the pegasparaginase-based group (90%) than in the L-asparaginase-based group (60%; P=.002). The three-year progression-free survival (PFS) and five-year overall survival (OS) rates were higher in the pegasparaginase-based arm than in the L-asparaginase-based arm (three-year PFS, 56.6% vs 41.8%; five-year OS, 74.3% vs 51.7%).
The median PFS was not reached at a median follow-up of 41.5 months in the pegasparaginase-based arm and was 6.8 months in the L-asparaginase-based arm (hazard ratio [HR], 0.42; 95% CI, 0.23-0.77; P=.004). The median OS was not reached in the pegasparaginase-based arm and was 75.2 months in the L-asparaginase-based arm (HR, 0.41; 95% CI, 0.19-0.89; P=.02).
Leukopenia and neutropenia were reported in more patients in the L-asparaginase-based arm (85% and 85%, respectively) than in the pegasparaginase-based arm (62.5% and 65%, respectively).
“In this randomized clinical trial, the [pegasparaginase-based] regimen showed promising preliminary results for patients with newly diagnosed local advanced [extranodal NKTCL],” the authors, led by Xinhua Wang, MD, PhD, of The First Affiliated Hospital of Zhengzhou University, concluded. “A confirmation trial based on larger population is warranted.”
Wang X, Zhang L, Liu X, et al. Efficacy and safety of a pegasparaginase-based chemotherapy regimen vs an L-asparaginase-based chemotherapy regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma: a randomized clinical trial. JAMA Oncol. 2022;8(7):1035-1041. doi:10.1001/jamaoncol.2022.1968