Department of Hematology and Chemotherapy, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan.
Int J Hematol. 2010 Dec;92(5):713-24. doi: 10.1007/s12185-010-0712-8. Epub 2010 Nov 16.
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).
虽然 ABVD（多柔比星、博来霉素、长春碱和达卡巴嗪）疗法自 1992 年以来一直被认为是晚期霍奇金淋巴瘤（HL）的标准治疗方法，但在日本尚无 ABVD 疗法的前瞻性数据。为了研究 ABVd 低剂量（250mg/m2）达卡巴嗪在新诊断的 II-IV 期 HL 患者中的疗效和安全性，日本临床肿瘤学组淋巴瘤研究组进行了一项 II 期研究。主要终点为完全缓解率（%CR）和无进展生存期（PFS）。共纳入 128 例年龄小于 70 岁的患者，接受 6-8 周期 ABVd 治疗，随后对初始大肿块进行放疗。118 例合格患者的%CR 为 81.4%[95%可信区间（CI）73.1-87.9%]。主要毒性为 4 级中性粒细胞减少症（45.3%）。3 级恶心/呕吐是最常见的非血液学毒性（10.9%）。4 例患者出现短暂 4 级便秘、感染（脓肿）、低氧血症和高胆红素血症。无治疗相关死亡。5 年 PFS 和总生存率分别为 78.4%（95%CI70.9-85.9%）和 91.3%（95%CI86.1-96.5%）。结论，ABVd 对日本 II-IV 期 HL 患者有效，毒性可接受（UMIN-CTR 编号：C000000092）。
