title: Clinical trials for malignant lymphoma in Japan.
abstract: The results of the clinical trials by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG) and those of the industry-supported trials mainly conducted by the members of JCOG-LSG are summarized. In the treatment of advanced aggressive non-Hodgkin's lymphoma (NHL), we investigated the efficacy of granulocyte colony-stimulating factor (G-CSF)-supported, dose-intensified strategies. Based on the results of a randomized phase II study (JCOG9505), we conducted a phase III study, JCOG9809, comparing CHOP and biweekly CHOP. However, JCOG9809 was terminated early based on the results of a planned interim analysis, because it was deemed highly unlikely that biweekly CHOP would be superior to standard CHOP. For aggressive ATL, a G-CSF-supported, dose-intensified, multi-agent regimen (JCOG9303; LSG15) showed superior efficacy to our historical controls. To establish a new standard for ATL, we conducted a phase III study, JCOG9801, comparing LSG15 and biweekly CHOP. To develop new agents for lymphoid malignancies, we focused on irinotecan hydrochloride, interferon-alpha, cladribine and oral fludarabine. Among them, cladribine and oral fludarabine are promising for indolent B-cell malignancies. The Japanese phase I and II studies of rituximab, a chimeric anti-CD20 monoclonal antibody, in relapsed indolent and aggressive B-NHL showed high efficacy with minimal toxicities, which led us to conduct combination studies with chemotherapy for B-NHL. In addition, a phase I study of a radiolabeled anti-CD20 antibody (ibritumomab tiuxetan) was completed in 2003, and a phase II study for indolent B-NHL will be initiated. The multicenter trials by the JCOG-LSG and industry-supported new agent studies will contribute to further improvement in the treatment of malignant lymphoma.
authors.affiliation: Hematology Division, National Cancer Center Hospital, Tokyo 104-0045, Japan. ktobinai@ncc.go.jp
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007564:Japan; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D015337:Multicenter Studies as Topic; D011241:Prednisone / Q000008:administration & dosage; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D000911:Antibodies, Monoclonal; D016179:Granulocyte Colony-Stimulating Factor; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone