Clinical outcome of an prospective, multicentre, randomized, phase III non-inferiority clinical trial for patients with extranodal NK/T cell lymphoma treated by P-Gemox or AspaMetDex
Hematological Oncology Jun 19, 2019
Huang H, et al. - In this clinical study, P-Gemox plus thalidomide vs AspaMetDex followed by extensive involved field radiotherapy (EIFRT) was examined for its efficacy as first-line treatment for newly diagnosed stage I/II patients and as salvage regimen for newly diagnosed stage III/IV or relapsed/refractory extranodal natural killer/T-cell lymphoma (ENKTL). In this prospective, multicentre, randomized, phase III, non-inferiority clinical trial that was performed at 12 centers in China, 165 patients were randomly assigned; 85 patients received P-Gemox+thalidomide regimen (Group A: Pegaspargase 2000U/m2; im d1, Gemcitabine 1000mg/m2; iv drip, d1, d8. Oxaliplatin 130mg/m2; ivdrip, d1, thalidomide 100mg/d po, for one year.), 80 patients received AspaMetDex regimen (Group B: Pegaspargase 2000U/m2; im, d1, Methotrexate 3000mg/ m2; civ 6-hour d1, calcium folinate 30mg iv, q6h, until reach safe serum MTX concentration, Dexamethasone 40mg/d ivdrip, d1-4.). In patients with stage I/II ENKTL, promising efficacy of induction chemotherapy of both P-Gemox+Thalidomide and AspaMetDex regimen followed by EIFRT was noted. The two regimens showed little difference in response and survival. Researchers noted unsatisfied survival outcome for advanced or relapsed patients using both regimens. Meanwhile, P-Gemox+ Thalidomide vs AspaMetDex was less toxic and was more convenient in administration in outpatients’ clinics.
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