Phase II study of PEG-Intron in combination with chemotherapy for the treatment of first line patients with follicular lymphoma who need to be treated

6571 Background & Methods: This phase II study combined PEG-Intron to CHVP in place of interferon alfa-2b in untreated patients with follicular lymphoma and high-risk criteria (B symptoms, poor PS, high LDH or β2-microglobulin levels, or high tumor burden defined as disseminated lymph nodes >3 cm, one lymph node >7 cm, pleura or ascites, splenomegaly, or organ compression). Treatment comprised 12 cycles of CHVP (cyclophosphamide 600 mg/m2, doxorubicin 25 mg/m2, VP16 100 mg/m2, and prednisone 40 mg/m2 x 5 days) plus PEG-Intron 35 μg (or 50 μg for pts >70 kg) once a week over the 18 months. PEG-Intron is a pegylated derivative of Intron A with a longer half-life that may be administered once a week. The objective of the study was to evaluate the efficacy and tolerability of PEG-Intron by historical comparison with patients treated with Intron A in the GELF-94 study. Results: 79 patients have been included: 9% had bulky stage II, 12% stage III, and 79% stage IV. 25% had B symptoms, 15% poor performance statu...