title: Phase III trial of CHOP-21 versus CHOP-14 for aggressive non-Hodgkin's lymphoma: final results of the Japan Clinical Oncology Group Study, JCOG 9809.
abstract: BACKGROUND
  CHOP-21 has remained the standard chemotherapy for aggressive non-Hodgkin's lymphoma (NHL), and dose intensification is a potential strategy for improving therapeutic results. We conducted a phase III trial to determine whether dose-dense strategy involving interval shortening of CHOP (CHOP-14) is superior to CHOP-21.
  
  
  METHODS
  A total of 323 previously untreated patients (aged 15-69 years) with stages II-IV aggressive NHL were randomized. The primary end point was progression-free survival (PFS).
  
  
  RESULTS
  Treatment compliance was comparable in both study arms. At 7-year follow-up, no substantial differences were observed in PFS and overall survival (OS) between CHOP-21 (n = 161) and CHOP-14 (n = 162) arms. Median PFS was 2.8 and 2.6 years with CHOP-21 and CHOP-14, respectively (one-sided log-rank P = 0.79). Eight-year OS and PFS rates were 56% and 42% [95% confidence interval (CI) 47% to 64% and 34% to 49%], respectively, with CHOP-21 and 55% and 38% (95% CI 47% to 63% and 31% to 46%), respectively, with CHOP-14. Subgroup analyses showed no remarkable differences in PFS or OS for patients stratified as per the International Prognostic Index or by age.
  
  
  CONCLUSIONS
  Dose-intensification strategy involving interval shortening of CHOP did not prolong PFS in advanced, aggressive NHL.
authors.affiliation: Division of Hematology, Department of Internal Medicine, Tokai University, Isehara. Electronic address: 8jmmd004@is.icc.u-tokai.ac.jp.
authors.forename: K
authors.initials: K
authors.lastname: Ohmachi
authors.affiliation: Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo.
authors.forename: K
authors.initials: K
authors.lastname: Tobinai
authors.affiliation: Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo.
authors.forename: Y
authors.initials: Y
authors.lastname: Kobayashi
authors.affiliation: Division of Hematology and Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: K
authors.initials: K
authors.lastname: Itoh
authors.affiliation: Division of Hematology and Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: M
authors.initials: M
authors.lastname: Nakata
authors.affiliation: JCOG Data Center, Center for Cancer Control and Information Services, National Cancer Center, Tokyo.
authors.forename: T
authors.initials: T
authors.lastname: Shibata
authors.affiliation: Department of Hematology and Chemotherapy, Aichi Cancer Center, Nagoya.
authors.forename: Y
authors.initials: Y
authors.lastname: Morishima
authors.affiliation: Department of Hematology and Chemotherapy, Aichi Cancer Center, Nagoya.
authors.forename: M
authors.initials: M
authors.lastname: Ogura
authors.affiliation: Division of Hematology, Shiga Medical Center for Adults, Moriyama.
authors.forename: T
authors.initials: T
authors.lastname: Suzuki
authors.affiliation: Second Department of Internal Medicine, Nagoya City University, Nagoya.
authors.forename: R
authors.initials: R
authors.lastname: Ueda
authors.affiliation: Division of Hematology, National Hospital Organization Hokkaido Cancer Center, Sapporo.
authors.forename: K
authors.initials: K
authors.lastname: Aikawa
authors.affiliation: Department of Pathology, Aichi Cancer Center, Nagoya.
authors.forename: S
authors.initials: S
authors.lastname: Nakamura
authors.affiliation: JCOG Data Center, Center for Cancer Control and Information Services, National Cancer Center, Tokyo.
authors.forename: H
authors.initials: H
authors.lastname: Fukuda
authors.affiliation: Division of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Shimoyama
authors.affiliation: Division of Hematology, Department of Internal Medicine, Tokai University, Isehara; Division of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Hotta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007564:Japan; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone