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| |  Consolidation With Radiolabeled MAb Delays Progression of Advanced Follicular Lymphoma: Presented at EHA By Emma Hitt, PhD COPENHAGEN, Denmark -- June 15, 2008 -- In patients with advanced follicular lymphoma (FL) responsive to first-line induction treatment, consolidation with 90Y-ibritumomab tiuxetan resulted in a high conversion rate of partial to complete responses regardless of type of treatment received during induction. In addition, progression-free survival (PFS) was extended by 2 years overall and increased in all prognosis subgroups. These are the findings of the First-Line Indolent Trial (FIT) reported here June 14 by John A. Radford, MD, Cancer Research Campaign Department, Medical Oncology Christie Hospital, Manchester, United Kingdom, and colleagues at the 13th Congress of the European Hematology Association (EHA). According to Dr. Radford and colleagues, radiolabeled monoclonal antibodies (MAbs) have the potential to improve the quality of response when used in consolidation therapy. A prospective, randomised trial was performed to evaluate the efficacy and safety of consolidation with 90Y-ibritumomab tiuxetan compared with observation in patients with advanced FL in first remission after induction treatment. After induction with chemotherapy or rituximab chemoimmunotherapy, patients were randomised to receive either 90Y-ibritumomab tiuxetan (n = 208), including 250 mg/m2 rituximab on day -7 and day 0, followed by 90Y-ibritumomab tiuxetan 14.8 MBq/kg; max 1,184 MBq on day 0, or to a control group of no further treatment (n = 206). Patients were followed for a median of 3.5 years. Median PFS was significantly higher for the treatment group versus the control group: 37 months versus 13 months (P < .0001; hazard ratio [HR] 0.463). In patients who had achieved a partial response after induction, the median PFS was 29.7 months versus 6.3 months in the control group (P < .0001; HR 0.304). Among complete responders, PFS was 54 months versus 29.5 months (P = .0154; HR 0.613). In patients with low-risk Follicular Lymphoma International Prognostic Index (FLIPI) scores, the median PFS was not reached in the treatment arm compared with 24 months in the control arm (P = .0502; HR 0.599). Intermediate-risk patients demonstrated a significant PFS benefit: 54 versus 11 months (P < .0001; HR 0.227), while high-risk patients trended toward a PFS benefit (24 vs 6.5 mo, P = .0789; HR 0.587). "No difference in overall survival between groups was observed at the current follow-up," noted Dr. Radford during the presentation. After consolidation with 90Y-ibritumomab tiuxetan, 77% of the patients who achieved partial response after induction converted to a complete response. Adverse events with 90Y-ibritumomab tiuxetan were mostly haematologic. Grade 3/4 thrombocytopenia was observed in 60.8%; grade 3/4 neutropenia in 66.7%; and grade 3/4 anaemia in 7% (grade 1/2 anaemia observed in 82.8%). Grade 3/4 infections were noted in 8% of patients receiving treatment compared with 2% in the control arm. Quality of life was comparable between groups. "The FIT shows that [90Y-ibritumomab tiuxetan] can be given safely after a variety of full-course chemotherapies and is well tolerated by patients," Dr. Radford said in an interview. "We were very encouraged by the results; although, we must keep in mind that only a minority of patients had received rituximab-chemotherapy for induction treatment." Phase 2 studies indicate that similar progression rates can be obtained after R-CHOP [rituximab + cyclophosphamide, doxorubicin, vincristine, prednisone] compared with CHOP alone, but a phase 3 trial evaluating [90Y-ibritumomab tiuxetan] after rituximab chemoimmunotherapy is needed, he said. "A key question is how rituximab maintenance therapy may further improve these results; results of the PRIMA [Primary Rituximab and Maintenance] study eagerly awaited," he said. [Presentation title: Results From the Randomized Phase 3 First-Line Indolent Trial (FIT) of Consolidation of First Remission With 90y-Ibritumomab Tiuxetan in Advanced Follicular Non-Hodgkin's Lymphoma (FL). Abstract 433.]
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