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Therapy

Primary therapy with single agent bortezomib as induction, maintenance and re-induction in patients with high-risk myeloma: results of the ECOG E2A02 trial

Leukemia volume 24, pages 1406–1411 (2010)Cite this article

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Abstract

Single agent bortezomib results in response rates of 51% in patients with newly diagnosed multiple myeloma and is touted to be especially effective in high-risk disease. We are the first to prospectively explore single agent bortezomib as primary therapy (induction, maintenance and re-induction) without consolidative autologous stem cell transplant in a cohort selected to have high-risk multiple myeloma. Patients received eight cycles of induction, followed by maintenance bortezomib every other week, indefinitely. Patients relapsing on maintenance had the full induction schedule resumed. On an intention-to-treat basis, the response rate (⩾partial response) was 48%. Among seven patients who progressed on maintenance bortezomib and received re-induction, two responded to the treatment. With a median follow-up of 48.2 months, 1- and 2-year overall survival probabilities were 88% (95% confidence interval (CI) 79–98%) and 76% (95% CI 60–86%), respectively. Median progression-free survival was 7.9 months (95% CI 5.8–12.0). Twenty-three and thirty-four patients had ⩾grade 3 hematological and non-hematological toxicity, respectively, with treatment-emergent neuropathy in 7% with motor grade 1–2, 56% with sensory grade 1–2 and 2% with grade 3, and in 14% with neuropathic pain grade 1–2 and 2% with grade 3. In high-risk patients, upfront bortezomib results in response rates that are comparable to those reported for unselected cohorts, but single agent bortezomib is not sufficient as primary therapy.

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Authors and Affiliations

  1. Department of Hematology, Mayo Clinic, Rochester, MN, USA

    A Dispenzieri & P R Greipp

  2. Department of Biostatistics, Eastern Cooperative Oncology Group, Boston, MA, USA

    S Jacobus

  3. Division of Multiple Myeloma, Hackensack University Medical Center, Hackensack, NJ, USA

    D H Vesole

  4. Department of Hematology, University of Wisconsin, Madison, WI, USA

    N Callandar

  5. Department of Hematology/Oncology, Mayo Clinic, Scottsdale, AZ, USA

    R Fonseca

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  1. A Dispenzieri
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Correspondence to A Dispenzieri.

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Dispenzieri, A., Jacobus, S., Vesole, D. et al. Primary therapy with single agent bortezomib as induction, maintenance and re-induction in patients with high-risk myeloma: results of the ECOG E2A02 trial. Leukemia 24, 1406–1411 (2010). https://doi.org/10.1038/leu.2010.129

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