Abstract
Introduction: The combination of rituximab with conventional chemotherapy is superior to rituximab therapy alone. Maintanence of chemo-immunotherapy, done for two years at a fixed interval based on pharmacokinetics of Rituximab, may give long term remission improving disease free intervals.
Rationale: MoAb therapy works not only by recruitment of FcR but also by complement dependent cytotoxicity(CDC) and growth arrest and/or apoptosis.
Methodology: This was an open label study. Pts with follicular and diffuse small cleaved-cell NHL stage III and IV were eligible. Induction chemotherapy consists of Cytoxan 650 mg/m2 iv, Vincristine 1mg/m2, Prednisone 50mg/m2 po for 7 days, repeated Q3 weeks. Rituximab was given 375mg/m2 iv Q week for 6 weeks. After 10 weeks of completion of Rituximab, pts were maintained on Rituximab 375 mg/m2 iv Q week for 6 weeks with only one chemotherapy in week 3. CT/PET scan done Q 3 months.
Results: 42 patients; 20 females and 22 males, median age 58. 18 stage III and 24 stage IV. 91%(38/42) went into CR with induction and 1st maintanence therapy. Remaining 4 went into remission after all 6 sessions. Only 3 have relapsed of which 1 is in CR again with reinduction. Thus 39/42 are in CR for a median of 47 months. The toxicity was minimal, with 5% fever chills and hypotension. All responded well to premedication with tagamet and corticosteroid; given iv. 2% incidence of neutropenia. Two patients had sepsis.
Conclusions: 1. The induction and maintanence with Rituximab with addition of chemotherapy is synergistic. 2. It has prolonged the disease free survival. 3. Time to disease progression is prolonged and the final duration of remission is not reached. 4. The toxicity is acceptable, though the treatment is expensive. 5. This chemo-immunotherapy may eliminate microscopic disease and avoid stemcell transplant and associated mortality and morbidity.
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