ORLANDOPreliminary results of a French study show improved event-free survival for patients with indolent non-Hodgkin’s lymphoma (NHL) who received high-dose chemotherapy with purged autologous stem cell transplantation as first-line therapy, compared with conventional standard therapy.
Eric Deconinck, MD, of Besançon University Hospital, and his associates in the GOELAMS group, reported the preliminary findings of the multicenter randomized phase III study at the 43rd Annual Meeting of the American Society of Hematology (ASH abstract 3573).
At the time of the ASH meeting, the GOELAMS 064 protocol, begun in April 1994, had enrolled 172 patients (age 18 to 60) with newly diagnosed stage II bulky or stage III/IV follicular lymphoma and at least one criteria of high tumor burden. Stage IV NHL was diagnosed in 70% of patients. A total of 144 patients had been analyzed at the time of the ASH presentation, and 124 were evaluable.
Sixty-six patients received standard CHVP (cyclophosphamide, doxorubicin(Drug information on doxorubicin), teniposide(Drug information on teniposide), prednisone(Drug information on prednisone)) chemotherapy plus interferon-alfa-2b (IFN, Intron A) at a dose of 5 × 106 three times a week. They received CHVP monthly for 6 months, then every other month for a total of 12 courses over 18 months.
Fifty-eight patients randomized to high-dose therapy/transplant received three cycles of VCAP (vindesine 3 mg/m² on day 1, cyclophosphamide(Drug information on cyclophosphamide) 1,500 mg/m² on day 2, Adriamycin 80 mg/m² on day 2, and prednisolone(Drug information on prednisolone) 80 mg/m² on days 1 to 5).
The 43 patients in complete or very good partial remission were mobilized after the second or third VCAP cycle with one cycle of IMVP16 (ifosfamide, methotrexate(Drug information on methotrexate), etoposide(Drug information on etoposide)). The 15 patients in partial remission or relapse received two cycles of DHAP (dexamethasone, cytarabine(Drug information on cytarabine), cisplatin(Drug information on cisplatin)) before harvest and stem cell transplant if possible.
Peripheral blood stem cells or bone marrow was harvested followed by B cell purging via negative selection (with immunomagnetic beads) or positive selection (with CD34+ selection).