Phase II study of ABVd therapy for newly diagnosed clinical stage II-IV Hodgkin lymphoma: Japan Clinical Oncology Group study (JCOG 9305)

Michinori Ogura, Kuniaki Itoh, Tomohiro Kinoshita, Haruhiko Fukuda, Takeaki Takenaka, Tomoko Ohtsu, Yoshitoyo Kagami, Kensei Tobinai, Masataka Okamoto, Hideki Asaoku, Tsuneo Sasaki, Chikara Mikuni, Masami Hirano, Takaaki Chou, Kazunori Ohnishi, Hitoshi Ohno, Kaori Nasu, Kenichi Okabe, Shuichi Ikeda, Shigeo NakamuraTomomitsu Hotta, Masanori Shimoyama

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10 Citations (Scopus)

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/m2) 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).

Original languageEnglish
Pages (from-to)713-724
Number of pages12
JournalInternational Journal of Hematology
Volume92
Issue number5
DOIs
Publication statusPublished - 12-2010

All Science Journal Classification (ASJC) codes

  • Hematology

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