A phase i study of everolimus and CHOP in newly diagnosed peripheral T-cell lymphomas

Seok Jin Kim, Hye Jin Kang, Jinseok Kim, Hyeon Seok Eom, Jooryung Huh, Young Hyeh Ko, Jongtae Lee, Dong Seok Yim, Soo Youn Lee, Weon Seo Park, Woo Ick Yang, Seung Sook Lee, Cheolwon Suh, Won Seog Kim

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Abstract

Background We performed a phase I study to determine the dose and safety of everolimus as a combination chemotherapy in peripheral T-cell lymphoma (PTCL). Methods Four dose levels (2.5 to 10 mg) of everolimus from days 1 to 14 with CHOP (750 mg/m2 cyclophosphamide, 50 mg/m2 doxorubicin, and 1.4 mg/m2 (maximum 2 mg) vincristine on day 1, and 100 mg/day prednisone on days 1 to 5) every 21 days were planned. Results Fifteen patients newly diagnosed with stage III/IV PTCL were enrolled. One of 6 patients at dose level 2 (5 mg everolimus) had grade 3 hepatotoxicity and 3 of 6 patients at level 3 (7.5 mg everolimus) had grade 4 hematologic toxicities (two grade 4 thrombocytopenia and one grade 4 neutropenia with fever lasting more than 3 days). The recommended dose of everolimus for combination was 5 mg. There were no differences in steady state trough concentrations of everolimus between cycles 1 and 2 for all three dose levels. All evaluable patients achieved response (8 complete and 6 partial). Conclusions Everolimus (5 mg) can be safely combined with CHOP leading to a feasible and effective regimen for PTCL. The subsequent phase II is now in progress.

Original languageEnglish
Pages (from-to)1514-1521
Number of pages8
JournalInvestigational New Drugs
Volume31
Issue number6
DOIs
Publication statusPublished - 2013 Dec 1

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All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

Cite this

Kim, S. J., Kang, H. J., Kim, J., Eom, H. S., Huh, J., Ko, Y. H., Lee, J., Yim, D. S., Lee, S. Y., Park, W. S., Yang, W. I., Lee, S. S., Suh, C., & Kim, W. S. (2013). A phase i study of everolimus and CHOP in newly diagnosed peripheral T-cell lymphomas. Investigational New Drugs, 31(6), 1514-1521. https://doi.org/10.1007/s10637-013-0015-z