Phase 2 trial of rituximab plus hyper-CVAD alternating with rituximab plus methotrexate-cytarabine for relapsed or refractory aggressive mantle cell lymphoma

Authors

  • Michael Wang MD,

    1. Department of Lymphoma & Myeloma, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Luis Fayad MD,

    1. Department of Lymphoma & Myeloma, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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    • Luis Fayad is a speaker for and receives research support from Genetech.

  • Fernando Cabanillas MD,

    1. Department of Medical Oncology, King Juan Carlos I Cancer Center, Auxilio Mutuo Hospital, San Juan, Puerto Rico
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  • Fredrick Hagemeister MD,

    1. Department of Lymphoma & Myeloma, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Peter McLaughlin MD,

    1. Department of Lymphoma & Myeloma, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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    • Peter McLaughlin receives research support from Berles, Biogen IDEC, Genentech, Shering-Plough, Integrated Therapeutics, OSI, Millennium, and Bayer. In addition, he is a consultant to Millennium and Berlex and is on the speakers' bureaus of Co-Med Communications, Physicians Education Resource, Cogenix, and Health Science Communications.

  • Maria A Rodriguez MD,

    1. Department of Lymphoma & Myeloma, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Larry W. Kwak MD,

    1. Department of Lymphoma & Myeloma, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Yuhong Zhou MD,

    1. Department of Medical Oncology, Zhongshan Hospital, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
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  • Hagop Kantarjian MD,

    1. Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Jorge Romaguera MD

    Corresponding author
    1. Department of Lymphoma & Myeloma, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
    • Department of Lymphoma and Myeloma, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 429, Houston, TX 77030===

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    • Jorge Romaguera designed and performed the research for this article. Michael Wang performed research, contributed vital new reagents or analytical tools, analyzed data, and wrote this article. The remainder of the authors performed research and contributed patients to the clinical trial.

    • Fax: 713-794-5656


Abstract

BACKGROUND.

Relapsed or refractory mantle cell lymphoma has a very poor prognosis. The authors evaluated the response rates and survival times of patients treated with an intense regimen known to be effective against untreated aggressive mantle cell lymphoma: rituximab plus hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with rituximab plus methotrexate-cytarabine.

METHODS.

In this prospective, open-label, phase 2 study, patients received this combination for 6 to 8 cycles. Twenty-nine patients were evaluable for response.

RESULTS.

The median number of cycles received was 5 (range, 1-7 cycles), and the overall response rate was 93% (45% complete response [CR] or CR unconfirmed [CRu] and 48% partial response [PR]). All 5 patients previously resistant to treatment had a response (1 CR, 4 PR), and both patients whose disease did not change in response to prior therapy had PRs. Toxic events occurring in response to the 104 cycles given included neutropenic fever (11%), grade 3 or 4 neutropenia (74%), and grade 3 or 4 thrombocytopenia (63%). There were no deaths from toxicity. At a median follow-up of 40 months (range, 5-48 months), the median failure-free survival time was 11 months with no plateau in the survival curve.

CONCLUSIONS.

This combination chemotherapy was effective for refractory/relapsed mantle cell lymphoma. Cancer 2008. © 2008 American Cancer Society.

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