title: A phase I study of everolimus and CHOP in newly diagnosed peripheral T-cell lymphomas.
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.
authors: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong Gangnam-gu, Seoul, 135-710, South Korea.
authors: Seok Jin
authors: SJ
authors: Kim
authors: Hye Jin
authors: HJ
authors: Kang
authors: Jin Seok
authors: JS
authors: Kim
authors: Hyeon-Seok
authors: HS
authors: Eom
authors: Jooryung
authors: J
authors: Huh
authors: Young Hyeh
authors: YH
authors: Ko
authors: Jongtae
authors: J
authors: Lee
authors: Dong-Seok
authors: DS
authors: Yim
authors: Soo-Youn
authors: SY
authors: Lee
authors: Weon Seo
authors: WS
authors: Park
authors: Woo Ick
authors: WI
authors: Yang
authors: Seung-Sook
authors: SS
authors: Lee
authors: Cheolwon
authors: C
authors: Suh
authors: Won Seog
authors: WS
authors: Kim
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D004334:Drug Administration Schedule; D000068338:Everolimus; D006801:Humans; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy* / Q000378:metabolism; D020714:Maximum Tolerated Dose; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics
chemical_list: D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D000068338:Everolimus; D011241:Prednisone; D020123:Sirolimus
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