Sintilimab, pegaspargase, and anlotinib as induction therapy for advanced-stage NKTCL: a multicenter phase II study - PubMed
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- #LEAP regimen
- #Phase II trial
- #NKTCL
- Sintilimab, pegaspargase, and anlotinib (LEAP regimen) tested as induction therapy for advanced-stage extranodal natural killer/T-cell lymphoma (NKTCL).
- Multicenter phase II trial involving 37 newly diagnosed stage IV patients, median age 64.
- Complete remission (CR) rate at week 24 was 72.9%, exceeding the prespecified 55% threshold.
- Estimated 4-year progression-free survival (PFS) and overall survival (OS) were 56.6% and 75.2%, respectively.
- Autologous hematopoietic stem cell transplantation (auto-HSCT) post-CR reduced relapse rates (17.6% vs 60.0%) and improved PFS.
- Grade ≥3 adverse events included neutropenia (10.8%) and hyperbilirubinemia (10.8%), with no treatment discontinuations or deaths due to toxicity.
- LEAP regimen showed manageable toxicity and potential for curative-intent therapy in advanced-stage NKTCL unsuitable for high-dose methotrexate (HD-MTX).
- Study registered at ClinicalTrials.gov (NCT04004572).