title: Bortezomib in combination with CHOP as first-line treatment for patients with stage III/IV peripheral T-cell lymphomas: a multicentre, single-arm, phase 2 trial.
abstract: BACKGROUND
  We performed a phase II study to evaluate the efficacy of bortezomib in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) as first-line treatment for patients with stage III/IV peripheral T-cell lymphomas (PTCLs) based on our phase I study results.
  
  
  METHODS
  Patients received bortezomib on days 1 and 8 at a dose of 1.6 mg/m(2) in addition to CHOP every 3 weeks for a total of six cycles.
  
  
  RESULTS
  Forty-six patients were enrolled: PTCL, not otherwise specified (PTCL-NOS, n=16), extranodal NK/T-cell lymphoma, nasal type (ENKTL, n=10), angioimmunoblastic T-cell lymphoma (AITL, n=8), ALK-negative anaplastic large-cell lymphoma (ALCL, n=6), cutaneous T-cell lymphoma (CTCL, n=5) and hepatosplenic T-cell lymphoma (n=1). Thirty patients achieved complete response (CR, 65%) and the overall response rate was 76% (35/46). Although the CR rate of ENKTL was only 30% (3/10), three subtypes of PTCLs (PTCL-NOS, AITL and ALCL) showed 87% of overall response rate (ORR) (26/30) and 73% of CR rate (22/30). However, the 3-year overall survival and progression-free survival were 47% and 35%, respectively due to frequent relapse after remission. Grade 3/4 leucopenia was the most frequent toxicity whereas neurotoxicity was tolerable: grade 1 or 2 of peripheral neuropathy.
  
  
  CONCLUSIONS
  The combined treatment of bortezomib and CHOP is an effective and feasible regimen for advanced-stage PTCLs other than ENKTL, with acceptable toxicity. However, future studies exploring new drug combinations are warranted to overcome relapse after remission.
authors: Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors: Seok Jin
authors: SJ
authors: Kim
authors: Dok Hyun
authors: DH
authors: Yoon
authors: Hye Jin
authors: HJ
authors: Kang
authors: Jin Seok
authors: JS
authors: Kim
authors: Seong Kyu
authors: SK
authors: Park
authors: Hyo Jung
authors: HJ
authors: Kim
authors: Jeeyun
authors: J
authors: Lee
authors: Baek-Yeol
authors: BY
authors: Ryoo
authors: Young Hyeh
authors: YH
authors: Ko
authors: Jooryung
authors: J
authors: Huh
authors: Woo Ick
authors: WI
authors: Yang
authors: Hee Kyung
authors: HK
authors: Kim
authors: Soo Kee
authors: SK
authors: Min
authors: Seung-Sook
authors: SS
authors: Lee
authors: In-Gu
authors: IG
authors: Do
authors: Cheolwon
authors: C
authors: Suh
authors: Won Seog
authors: WS
authors: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage / Q000009:adverse effects; D000069286:Bortezomib; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016328:NF-kappa B / Q000378:metabolism; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D001897:Boronic Acids; D016328:NF-kappa B; D011719:Pyrazines; D014750:Vincristine; D000069286:Bortezomib; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone