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

Research output: Contribution to journalArticle

9 Citations (Scopus)

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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Peripheral T-Cell Lymphoma
Vincristine
Prednisone
Everolimus
Combination Drug Therapy
Neutropenia
Doxorubicin
Cyclophosphamide
Fever
Safety

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

Cite this

Kim, Seok Jin ; Kang, Hye Jin ; Kim, Jinseok ; Eom, Hyeon Seok ; Huh, Jooryung ; Ko, Young Hyeh ; Lee, Jongtae ; Yim, Dong Seok ; Lee, Soo Youn ; Park, Weon Seo ; Yang, Woo Ick ; Lee, Seung Sook ; Suh, Cheolwon ; Kim, Won Seog. / A phase i study of everolimus and CHOP in newly diagnosed peripheral T-cell lymphomas. In: Investigational New Drugs. 2013 ; Vol. 31, No. 6. pp. 1514-1521.
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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.",
author = "Kim, {Seok Jin} and Kang, {Hye Jin} and Jinseok Kim and Eom, {Hyeon Seok} and Jooryung Huh and Ko, {Young Hyeh} and Jongtae Lee and Yim, {Dong Seok} and Lee, {Soo Youn} and Park, {Weon Seo} and Yang, {Woo Ick} and Lee, {Seung Sook} and Cheolwon Suh and Kim, {Won Seog}",
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Kim, SJ, Kang, HJ, Kim, J, Eom, HS, Huh, J, Ko, YH, Lee, J, Yim, DS, Lee, SY, Park, WS, Yang, WI, Lee, SS, Suh, C & Kim, WS 2013, 'A phase i study of everolimus and CHOP in newly diagnosed peripheral T-cell lymphomas', Investigational New Drugs, vol. 31, no. 6, pp. 1514-1521. https://doi.org/10.1007/s10637-013-0015-z

A phase i study of everolimus and CHOP in newly diagnosed peripheral T-cell lymphomas. / Kim, Seok Jin; Kang, Hye Jin; Kim, Jinseok; Eom, Hyeon Seok; Huh, Jooryung; Ko, Young Hyeh; Lee, Jongtae; Yim, Dong Seok; Lee, Soo Youn; Park, Weon Seo; Yang, Woo Ick; Lee, Seung Sook; Suh, Cheolwon; Kim, Won Seog.

In: Investigational New Drugs, Vol. 31, No. 6, 01.12.2013, p. 1514-1521.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A phase i study of everolimus and CHOP in newly diagnosed peripheral T-cell lymphomas

AU - Kim, Seok Jin

AU - Kang, Hye Jin

AU - Kim, Jinseok

AU - Eom, Hyeon Seok

AU - Huh, Jooryung

AU - Ko, Young Hyeh

AU - Lee, Jongtae

AU - Yim, Dong Seok

AU - Lee, Soo Youn

AU - Park, Weon Seo

AU - Yang, Woo Ick

AU - Lee, Seung Sook

AU - Suh, Cheolwon

AU - Kim, Won Seog

PY - 2013/12/1

Y1 - 2013/12/1

N2 - 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.

AB - 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.

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