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

Authors
 Seok Jin Kim  ;  Hye Jin Kang  ;  Jin Seok 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 
Citation
 INVESTIGATIONAL NEW DRUGS, Vol.31(6) : 1514-1521, 2013 
Journal Title
 INVESTIGATIONAL NEW DRUGS 
ISSN
 0167-6997 
Issue Date
2013
MeSH
Antineoplastic Combined Chemotherapy Protocols/administration & dosage* ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics ; Cyclophosphamide/administration & dosage ; Cyclophosphamide/adverse effects ; Cyclophosphamide/pharmacokinetics ; Doxorubicin/administration & dosage ; Doxorubicin/adverse effects ; Doxorubicin/pharmacokinetics ; Drug Administration Schedule ; Everolimus ; Humans ; Lymphoma, T-Cell, Peripheral/drug therapy* ; Lymphoma, T-Cell, Peripheral/metabolism ; Maximum Tolerated Dose ; Prednisone/administration & dosage ; Prednisone/adverse effects ; Prednisone/pharmacokinetics ; Sirolimus/administration & dosage ; Sirolimus/adverse effects ; Sirolimus/analogs & derivatives* ; Sirolimus/pharmacokinetics ; Vincristine/administration & dosage ; Vincristine/adverse effects ; Vincristine/pharmacokinetics
Keywords
Everolimus ; CHOP ; T-cell lymphoma
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/m(2) cyclophosphamide, 50 mg/m(2) doxorubicin, and 1.4 mg/m(2) (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.
Full Text
https://link.springer.com/article/10.1007%2Fs10637-013-0015-z
DOI
10.1007/s10637-013-0015-z
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jin Seok(김진석) ORCID logo https://orcid.org/0000-0001-8986-8436
Yang, Woo Ick(양우익) ORCID logo https://orcid.org/0000-0002-6084-5019
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/158423
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