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Post-Transplant Events

Randomized trial of low-dose interleukin-2 vs cyclosporine A and interferon-γ after high-dose chemotherapy with peripheral blood progenitor support in women with high-risk primary breast cancer

Bone Marrow Transplantation volume 40, pages 267–272 (2007)Cite this article

Abstract

High-risk primary breast cancer patients treated with high-dose chemotherapy (HDC) and stem cell support (SCS) have shown prolonged disease-free survival (DFS) in many studies; however, only one trial has demonstrated an overall survival benefit (OS). We hypothesize that the period following myeloablative therapy is ideal for immunologic manipulation and studied the effects of two different methods of immunotherapy following HDC with SCS aimed at the window of immune reconstitution. Seventy-two women with high-risk stage II or III breast cancer were randomized following HDC to receive either interleukin 2 (IL-2) at 1 million units/m2 SQ daily for 28 days or combined cyclosporine A (CsA) at 1.25 mg/kg intravenously daily from day 0 to +28 and interferon gamma (IFN-γ) 0.025 mg/m2 SQ every 2 days from day +7 to +28. At a median follow-up of 67 months, no significant difference was observed in DFS or OS between the two treatment groups. The IL-2 arm had a 59% DFS (95% CI (0.45, 0.78)) and a 72% OS (95% CI (0.58, 0.88)) at 5 years. The CsA/INF-γ arm had a similar outcome with a 55% DFS (95% CI (0.40, 0.76)) and a 78% OS (95% CI (0.65, 0.94)) at 5 years. Treatment was well tolerated, without increased toxicity.

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Acknowledgements

We thank our patients and their families for supporting this trial. We also thank the nursing staff of 5GS for their professionalism and compassion.

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Authors and Affiliations

  1. Weill Medical College of Cornell University, New York, NY, USA

    L T Vahdat & D Donovan

  2. New York University Cancer Institute, New York, NY, USA

    D J Cohen & A Tiersten

  3. Division of Medical Oncology, Herbert Irving Comprehensive Cancer Center of Columbia University College of Physicians and Surgeons, New York, NY, USA

    D Zipin, D Savage & G Nichols

  4. Bennett Cancer Center Stamford Hospital, Stamford, CT, USA

    K S Lo

  5. Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA

    A Troxel

  6. Johns Hopkins University School of Medicine, Baltimore, MD, USA

    C S Hesdorffer

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  1. L T Vahdat
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Correspondence to L T Vahdat.

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Vahdat, L., Cohen, D., Zipin, D. et al. Randomized trial of low-dose interleukin-2 vs cyclosporine A and interferon-γ after high-dose chemotherapy with peripheral blood progenitor support in women with high-risk primary breast cancer. Bone Marrow Transplant 40, 267–272 (2007). https://doi.org/10.1038/sj.bmt.1705692

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  • DOI: https://doi.org/10.1038/sj.bmt.1705692

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