![]() Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e.Contraindication to any cytotoxic drug contained in the chemotherapy regimen.Hypersensitivity to bortezomib, boron, or mannitol.epidural cord compression, superior vena caval syndrome). Patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids or single agent chemotherapy for an urgent local problem at diagnosis (e.g. Ability to understand and willingness to sign a written informed consent document.Total bilirubin 80% unconjugated hyperbilirubinemia without other known cause) unless impairment is due to organ involvement by lymphoma. Creatinine less than or equals to 2x ULN or creatinine clearance more than or equals to 50 ml/min AST and ALT less than or equals to 3x ULN. Laboratory tests: ANC more than or equals to 1000/mm3, platelet more than or equals to 75,000/mm3.Confirmed pathological diagnosis by the Department of Pathology SGH/NUH/TTSH. ![]() ![]() Why Should I Register and Submit Results?.Molecular remissions were documented in two patients with mantle cell NHL.īased on the results of this pilot study, we conclude that the R-GIFOX regimen is feasible, tolerable, effective and able to mobilize peripheral stem cells in patients with relapsed and refractory aggressive NHL. Failure-free survival was 79.6% at median follow-up of 6 months (range 2-12). Hematologic and extra-hematologic toxicity was tolerable. Effective CD34(+) cell mobilization was obtained in four of six eligible patients and two had ASCT. The overall response rate assessed after three courses of R-GIFOX was 77%, with seven complete responses and three partial responses. Thirteen patients completed at least three courses of therapy and were evaluable for response. The median number of R-GIFOX courses delivered was 4 (range 1-6). Patients had received a median of two previous treatment lines (range 1-4). Responses were evaluated by the integrated FDG-PET/IWC criteria after the third course and at the end of the entire program.įourteen patients (median age 63 years, range 37-78 years) with relapsed (n = 9) or primary progressive (n = 5) aggressive (diffuse large cell, mantle cell, follicular G3), advanced (stage IV 71%), poor risk (IPI 3-5 50%) NHL were accrued in this pilot study. Treatment was given every 2 weeks with G-CSF support (5 microg/kg/day or 10 microg/kg/day at the end of the third course for stem cell mobilization). R-GIFOX consisted of rituximab (375 mg/m(2) on day 1), gemcitabine (1000 mg/m(2) on day 2), oxaliplatin (130 mg/m(2) on day 3) and ifosfamide (5 g/m(2) on day 3) as a 24-h single infusion in patients aged 65 years. Patients were scheduled to receive three courses of therapy followed by mobilization and ASCT or three more courses if ineligible for ASCT. We evaluated the clinical activity, toxicity and mobilizing capacity of a new salvage regimen, which combines gemcitabine and oxaliplatin with ifosfamide and rituximab (R-GIFOX) in patients with relapsed and refractory CD20(+) NHL. Since high-dose therapy (HDT) with autologous stem cell transplantation (ASCT) can cure a proportion of such patients, provided that a substantial tumor shrinkage is achieved, the development of more effective and less toxic salvage regimens remains a major challenge. The prognosis of patients with aggressive non-Hodgkin's lymphoma (NHL) relapsing or progressing after front-line therapy remains poor.
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