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Recombinant interferon-alpha2b added to oral cyclophosphamide either as induction or maintenance in treatment-naive follicular lymphoma: final analysis of CALGB 8691.

Publication ,  Journal Article
Smith, SM; Johnson, J; Cheson, BD; Canellos, G; Petroni, G; Oken, M; Duggan, D; Hurd, D; Gockerman, JP; Parker, B; Prchal, J; Peterson, BA ...
Published in: Leuk Lymphoma
October 2009

Recombinant interferon alpha-2b (IFN-alpha2) 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-alpha2 at 2 x 106 IU/m2 three times per week, followed by a second randomization between IFN-alpha2 maintenance (2 x 106 IU/m2 three times weekly) versus observation in treatment-naïve patients with follicular lymphoma (FL). Five hundred eighty-one patients were randomized to either CPA (n = 293) or CPA plus IFN-alpha2 (n = 288). One hundred five responding patients were randomized to observation and 99 to maintenance IFN-alpha2. 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-alpha2 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-alpha2-containing arms. Despite the small benefit in EFS in patients with PR randomized to IFN-alpha2 maintenance, we conclude that the addition of low dose IFN-alpha2 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.

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Published In

Leuk Lymphoma

DOI

EISSN

1029-2403

Publication Date

October 2009

Volume

50

Issue

10

Start / End Page

1606 / 1617

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Failure
  • Survival Analysis
  • Recombinant Proteins
  • Neoplasms, Second Primary
  • Middle Aged
  • Male
  • Lymphoma, Follicular
  • Interferon-alpha
  • Interferon alpha-2
 

Citation

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Smith, S. M., Johnson, J., Cheson, B. D., Canellos, G., Petroni, G., Oken, M., … Eastern Cooperative Oncology Group, . (2009). Recombinant interferon-alpha2b added to oral cyclophosphamide either as induction or maintenance in treatment-naive follicular lymphoma: final analysis of CALGB 8691. Leuk Lymphoma, 50(10), 1606–1617. https://doi.org/10.1080/10428190903093807
Smith, S. M., J. Johnson, B. D. Cheson, G. Canellos, G. Petroni, M. Oken, D. Duggan, et al. “Recombinant interferon-alpha2b added to oral cyclophosphamide either as induction or maintenance in treatment-naive follicular lymphoma: final analysis of CALGB 8691.Leuk Lymphoma 50, no. 10 (October 2009): 1606–17. https://doi.org/10.1080/10428190903093807.
Smith SM, Johnson J, Cheson BD, Canellos G, Petroni G, Oken M, et al. Recombinant interferon-alpha2b added to oral cyclophosphamide either as induction or maintenance in treatment-naive follicular lymphoma: final analysis of CALGB 8691. Leuk Lymphoma. 2009 Oct;50(10):1606–17.
Smith, S. M., et al. “Recombinant interferon-alpha2b added to oral cyclophosphamide either as induction or maintenance in treatment-naive follicular lymphoma: final analysis of CALGB 8691.Leuk Lymphoma, vol. 50, no. 10, Oct. 2009, pp. 1606–17. Pubmed, doi:10.1080/10428190903093807.
Smith SM, Johnson J, Cheson BD, Canellos G, Petroni G, Oken M, Duggan D, Hurd D, Gockerman JP, Parker B, Prchal J, Peterson BA, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group. Recombinant interferon-alpha2b added to oral cyclophosphamide either as induction or maintenance in treatment-naive follicular lymphoma: final analysis of CALGB 8691. Leuk Lymphoma. 2009 Oct;50(10):1606–1617.

Published In

Leuk Lymphoma

DOI

EISSN

1029-2403

Publication Date

October 2009

Volume

50

Issue

10

Start / End Page

1606 / 1617

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Failure
  • Survival Analysis
  • Recombinant Proteins
  • Neoplasms, Second Primary
  • Middle Aged
  • Male
  • Lymphoma, Follicular
  • Interferon-alpha
  • Interferon alpha-2