title: Phase II study of ABVd therapy for newly diagnosed clinical stage II-IV Hodgkin lymphoma: Japan Clinical Oncology Group study (JCOG 9305).
abstract: Although ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) therapy has been regarded as a standard of care for advanced-stage Hodgkin lymphoma (HL) since 1992, there has been no prospective data of ABVD therapy in Japan. To investigate the efficacy and safety of ABVd therapy with the lower dose of dacarbazine (250 mg/m(2)) in patients with newly diagnosed stage II-IV HL, Lymphoma Study Group of Japan Clinical Oncology Group conducted a phase II study. The primary endpoints were complete response rate (%CR) and progression-free survival (PFS). A total of 128 patients with age less than 70 years were enrolled and received 6-8 cycles of ABVd followed by radiation to initial bulky mass. The %CR in 118 eligible patients was 81.4% [95% confidence interval (CI) 73.1-87.9%]. Major toxicity was grade 4 neutropenia (45.3%). Grade 3 nausea/vomiting was the most frequent non-hematological toxicity (10.9%). Transient grade 4 constipation, infection (abscess), hypoxemia and hyperbilirubinemia were observed in 4 patients. No treatment-related death was observed. PFS and overall survival at 5 years were 78.4% (95% CI 70.9-85.9%) and 91.3% (95% CI 86.1-96.5%), respectively. In conclusion, ABVd is effective in Japanese patients with stage II-IV HL with acceptable toxicities (UMIN-CTR Number: C000000092).
authors.affiliation: Department of Hematology and Chemotherapy, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan. mi-ogura@naa.att.ne.jp
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Itoh
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.forename: Takeaki
authors.initials: T
authors.lastname: Takenaka
authors.forename: Tomoko
authors.initials: T
authors.lastname: Ohtsu
authors.forename: Yoshitoyo
authors.initials: Y
authors.lastname: Kagami
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Masataka
authors.initials: M
authors.lastname: Okamoto
authors.forename: Hideki
authors.initials: H
authors.lastname: Asaoku
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Sasaki
authors.forename: Chikara
authors.initials: C
authors.lastname: Mikuni
authors.forename: Masami
authors.initials: M
authors.lastname: Hirano
authors.forename: Takaaki
authors.initials: T
authors.lastname: Chou
authors.forename: Kazunori
authors.initials: K
authors.lastname: Ohnishi
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ohno
authors.forename: Kaori
authors.initials: K
authors.lastname: Nasu
authors.forename: Kenichi
authors.initials: K
authors.lastname: Okabe
authors.forename: Shuichi
authors.initials: S
authors.lastname: Ikeda
authors.forename: Shigeo
authors.initials: S
authors.lastname: Nakamura
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
authors.forename: Masanori
authors.initials: M
authors.lastname: Shimoyama
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D023381:Endpoint Determination; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D001761:Bleomycin; D014747:Vinblastine; D003606:Dacarbazine; D004317:Doxorubicin