title: VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801.
abstract: OBJECTIVE
  Our previous phase II trial for treating human T-lymphotropic virus type I-associated adult T-cell leukemia-lymphoma (ATLL) with vincristine, cyclophosphamide, doxorubicin, and prednisone (VCAP), doxorubicin, ranimustine, and prednisone (AMP), and vindesine, etoposide, carboplatin, and prednisone (VECP) showed promising results. To test the superiority of VCAP-AMP-VECP over biweekly cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), we conducted a randomized controlled trial exclusively for ATLL.
  
  
  METHODS
  Previously untreated patients with aggressive ATLL were assigned to receive either six courses of VCAP-AMP-VECP every 4 weeks or eight courses of biweekly CHOP. Both treatments were supported with granulocyte colony-stimulating factor and intrathecal prophylaxis.
  
  
  RESULTS
  A total of 118 patients were enrolled. The complete response (CR) rate was higher in the VCAP-AMP-VECP arm than in biweekly CHOP arm (40% v 25%, respectively; P = .020). Progression-free survival rate at 1 year was 28% in the VCAP-AMP-VECP arm compared with 16% in the CHOP arm (P = .100, two-sided P = .200). Overall survival (OS) at 3 years was 24% in the VCAP-AMP-VECP arm and 13% in the CHOP arm (P = .085, two-sided P = .169). For VCAP-AMP-VECP versus biweekly CHOP, grade 4 neutropenia, grade 4 thrombocytopenia, and grade 3 or 4 infection rates were 98% v 83%, 74% v 17%, and 32% v 15%, respectively. There were three toxic deaths in the VCAP-AMP-VECP arm.
  
  
  CONCLUSIONS
  The longer OS at 3 years and higher CR rate with VCAP-AMP-VECP compared with biweekly CHOP suggest that VCAP-AMP-VECP might be a more effective regimen at the expense of higher toxicities, providing the basis for future investigations in the treatment of ATLL.
authors.affiliation: Nagasaki University Graduate School of Biomedical Science, Nagasaki, Japan. tsukasak@net.nagasaki-u.ac.jp
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Tsukasaki
authors.forename: Atae
authors.initials: A
authors.lastname: Utsunomiya
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.forename: Takuya
authors.initials: T
authors.lastname: Fukushima
authors.forename: Yoshifusa
authors.initials: Y
authors.lastname: Takatsuka
authors.forename: Shuichi
authors.initials: S
authors.lastname: Ikeda
authors.forename: Masato
authors.initials: M
authors.lastname: Masuda
authors.forename: Haruhisa
authors.initials: H
authors.lastname: Nagoshi
authors.forename: Ryuzo
authors.initials: R
authors.lastname: Ueda
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tamura
authors.forename: Masayuki
authors.initials: M
authors.lastname: Sano
authors.forename: Saburo
authors.initials: S
authors.lastname: Momita
authors.forename: Kazunari
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Fumio
authors.initials: F
authors.lastname: Kawano
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hanada
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Masanori
authors.initials: M
authors.lastname: Shimoyama
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
authors.forename: Masao
authors.initials: M
authors.lastname: Tomonaga
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D015459:Leukemia-Lymphoma, Adult T-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009607:Nitrosourea Compounds / Q000008:administration & dosage; D011241:Prednisone / Q000008:administration & dosage; D015996:Survival Rate; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D009607:Nitrosourea Compounds; D016179:Granulocyte Colony-Stimulating Factor; D014750:Vincristine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D016190:Carboplatin; C020766:ranimustine; D011241:Prednisone