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

• Published in: Annals of oncology Vol. 22; no. 6; pp. 1382 - 1391
• Main Authors: Ohmachi, K., Tobinai, K., Kobayashi, Y., Itoh, K., Nakata, M., Shibata, T., Morishima, Y., Ogura, M., Suzuki, T., Ueda, R., Aikawa, K., Nakamura, S., Fukuda, H., Shimoyama, M., Hotta, T.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.06.2011; Oxford University Press
• Subjects: Adolescent; Adult; Aged; aggressive non-Hodgkin’s lymphoma; Antibodies, Monoclonal - therapeutic use; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; CHOP-14; CHOP-21; Cyclophosphamide - administration & dosage; Cyclophosphamide - adverse effects; Cyclophosphamide - therapeutic use; Disease-Free Survival; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Doxorubicin - therapeutic use; Female; Hematologic and hematopoietic diseases; Humans; Japan; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Lymphoma, Non-Hodgkin - drug therapy; Lymphoma, Non-Hodgkin - pathology; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; phase III trial; Prednisone - administration & dosage; Prednisone - adverse effects; Prednisone - therapeutic use; Vincristine - administration & dosage; Vincristine - adverse effects; Vincristine - therapeutic use; Asia; Japan; CHOP-21; aggressive non-Hodgkin’s lymphoma; phase III trial; CHOP-14; Antineoplastic agent; Phase III trial; Human; Drug combination; Malignant hemopathy; Malignant tumor; Non Hodgkin lymphoma; Chemotherapy; Treatment; Cancerology; Lymphoproliferative syndrome; aggressive non-Hodgkin's lymphoma; Therapeutic protocol; Comparative study; Cancer; High malignancy
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdq619

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. 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). 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. Dose-intensification strategy involving interval shortening of CHOP did not prolong PFS in advanced, aggressive NHL.