Recombinant interferon-α2b added to oral cyclophosphamide either as induction or maintenance in treatment-naive follicular lymphoma: Final analysis of CALGB 8691

S. M. Smith, J. Johnson, B. D. Cheson, G. Canellos, G. Petroni, M. Oken, D. Duggan, D. Hurd, J. P. Gockerman, B. Parker, J. Prchal, B. A. Peterson

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6 Scopus citations

Abstract

Recombinant interferon alpha-2b (IFN-α2) has direct and indirect antiproliferative effects in lymphoma, and may augment cytotoxicity when combined with chemotherapy. CALGB 8691 is a randomized study of daily oral cyclophosphamide (CPA) at 100 mg/m2 with or without IFN-α2 at 2 × 106 IU/m2 three times per week, followed by a second randomization between IFN-α2 maintenance (2 × 106 IUm2 three times weekly) versus observation in treatment-nave patients with follicular lymphoma FL. Five hundred eighty-one patients were randomized to either CPA (n = 293) or CPA plus IFN-α2 (n = 288). One hundred five responding patients were randomized to observation and 99 to maintenance IFN-α2. With a median follow-up of 11.5 years, the median event-free and overall survival (OS) for CPA induction alone were 2.5 years (95% CI 2.2, 3.0) and 9 years (95% CI 7.7, 10.2), compared to 2.4 years (95% CI 2.1, 3.1) and 8.4 years (95% CI 7.5, 11.1) for the combination arm (p = NS). Patients with a partial response (PR) and randomized to observation had the worst outcome (event-free survival (EFS) 1.8 years versus 3.9 years; p = 0.002). Patients with a PR randomized to IFN-α2 had a similar EFS to compared to patients with complete response CR, but this did not translate into a survival advantage. Myelosuppression was increased in IFN-α2-containing arms. Despite the small benefit in EFS in patients with PR randomized to IFN-α2 maintenance, we conclude that the addition of low dose IFN-α2 did not significantly improve the response rate, duration of response, event-free, or OS obtained with single-agent daily oral CPA in patients with previously untreated FL.

Original languageEnglish (US)
Pages (from-to)1606-1617
Number of pages12
JournalLeukemia and Lymphoma
Volume50
Issue number10
DOIs
StatePublished - 2009

Keywords

  • Cyclophosphamide
  • Follicular lymphoma
  • Interferon
  • Maintenance

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