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Annals of Oncology Advance Access originally published online on August 9, 2008
Annals of Oncology 2008 19(12):2079-2083; doi:10.1093/annonc/mdn431
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

phase I and pharmacokinetics

Phase I study of proteasome inhibitor bortezomib plus CHOP in patients with advanced, aggressive T-cell or NK/T-cell lymphoma

J. Lee1, C. Suh2, H. J. Kang3, B.-Y. Ryoo3, J. Huh4, Y. H. Ko5, H.-S. Eom6, K. Kim1, K. Park1 and W. S. Kim1,*

1 Division of Hematology–Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
2 Division of Oncology, Department of Internal Medicine, Asan Medical Center, Ulsan University College of Medicine
3 Division of Hematology–Oncology, Department of Internal Medicine, Korea Cancer Center Hospital
4 Department of Diagnostic Pathology, Asan Medical Center, University of Ulsan College of Medicine
5 Department of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
6 Hematology–Oncology Clinic, Center for Specific Organs Cancer, National Cancer Center, Goyang, Korea

* Correspondence to: Dr W. S. Kim, Division of Hematology–Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-dong Kangnam-Gu, Seoul 135-710, Korea. Tel: +82-2-3410-6548; Fax: +82-2-3410-0041; E-mail: wskimsmc{at}skku.edu

The aim of the study was to determine the maximum tolerated dose (MTD) and safety of the combination of bortezomib and cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) as first-line therapy in advanced, aggressive T-cell lymphoma. Patients received increasing doses of bortezomib on days 1 and 8 (weekly schedule, 1.0, 1.3, and 1.6 mg/m2/dose) in addition to 750 mg/m2 cyclophosphamide, 50 mg/m2 doxorubicin, 1.4 mg/m2 vincristine on day 1 and 100 mg/day prednisolone on days 1 to 5, every 3 weeks. Six cycles of therapy administered every 21 days were planned. Thirteen patients, who had stage III/IV chemonaive aggressive T-cell lymphoma, received a total of 55 cycles of treatment. One patient experienced hematologic dose-limiting toxicity (grade 4 neutropenia associated with febrile episode) at the 1.0 mg/m2/dose of bortezomib. There was no dose-limiting non-hematologic toxicity. The MTD was not reached at 1.6 mg/m2 dose level of bortezomib. The overall complete remission rate in all patients was 61.5% (95% confidence interval = 31.6–86.1). Bortezomib can be safely combined with CHOP chemotherapy and constitutes an active regimen in advanced-stage, aggressive T-cell lymphoma patients. The recommended dose for subsequent phase II studies of bortezomib plus CHOP is 1.6 mg/m2/dose of bortezomib on days 1 and 8 every 3 weeks as first-line treatment.

Key words: bortezomib, chemotherapy, non-Hodgkin's lymphoma

Received for publication April 4, 2008. Revision received June 13, 2008. Accepted for publication June 19, 2008.


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