Affiliation:
1. Sun Yat-sen University Cancer Center
2. the First Affiliated Hospital of Gannan Medical College
3. The First People’s Hospital of Foshan
4. Imperial College London
Abstract
Abstract
Background The prognosis of extra-nodal NK-/T-cell lymphoma (ENKTL) is poor and the best therapy controversial. We studied safety and efficacy of a new combined modality therapy.Methods Phase-2 study of peg-asparaginase, etoposide and gemcitabine (PEG) and involved field radiation therapy (IFRT) in newly-diagnosed subjects with early-stage ENKTL. 2–6 course of PEG were given depending on response followed by IFRT. The primary endpoint were complete response(CR),partial response(PR),and objective response rate(ORR) after IFRT. Secondary endpoints included progression-free survival (PFS), survival and adverse events.Results 34 consecutive subjects who were Ann Arbor stage-I/-II were enrolled. 3 subjects progressed on PEG, the remaining 31 received IFRT. The ORR was 88.2%(30/34),included 28(82.4%)complete and 2 ༈5.8%༉ partial responses. At a median follow-up of 56.0 months (Interquartile Range [IQR], 36.0-66.9 months),the 5-year PFS and survival were 87.4% (95% Confidence Interval [CI],69.5%-94.8%) and 97.1% (95%CI,80.1%-99.6%). Most adverse events were haematological and easily managed.Conclusions PEG followed by IFRT is a safe and effective initial therapy for low-stage ENKTL, with similar toxicity and response rates, but higher progression-free survival(PFS) and overall survival(OS) rates compared to other regimens, providing an effective and tolerable new regimen for the newly diagnosed early-stage ENKTL.This conclusion needs validation in a randomized controlled trial.
Publisher
Research Square Platform LLC
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