Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease:: a randomised trial
Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease:: a randomised trial
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DOI：
10.1016/s0140-6736(02)08938-9
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发表时间：
2002-06-15
期刊：
影响因子：
168.9
通讯作者：
Diehl, V
中科院分区：
文献类型：
--
作者：
Schmitz, N;Pfistner, B;Diehl, V
背景大剂量化疗后自体造血干细胞移植（BEAM-HSCT）常用于治疗复发性霍奇金病患者。方法161例年龄在16 ~ 60岁的复发性霍奇金病患者随机分为两个周期的Dexa-BEAM（地塞米松、卡莫司汀、依托泊苷、阿糖胞苷和美法仑）和两个疗程的Dexa-BEAM或大剂量BEAM和造血干细胞移植。仅化疗敏感性疾病患者（两个疗程Dexa-BEAM治疗后完全或部分缓解）继续接受进一步治疗。主要终点是化疗敏感性疾病患者无治疗失败。结果17例患者在随机分组后被排除在研究之外（10例给予Dexa-BEAM，7例给予BEAM-HSCT）。中位随访时间为39个月（lQR 3-78）。接受BEAM-HSCT的患者（55%）3年时无治疗失败率显著优于接受Dexa-BEAM的患者（34%;差异-21%，95%CI-39.87至-2.13; p=0.019）。给予任何治疗的患者的总生存率没有显着差异。解释高剂量BEAM和造血干细胞移植提高了化疗敏感的霍奇金病首次复发患者的治疗失败的自由，无论最初缓解的长度。
Background High-dose chemotherapy followed by transplantation of autologous haemopoietic stem cells (BEAM-HSCT) is frequently used to treat patients with relapsed Hodgkin's disease. We aimed to compare this treatment with conventional aggressive chemotherapy without stem-cell transplantation (Dexa-BEAM),Methods 161 patients between 16 and 60 years of age with relapsed Hodgkin's disease were randomly assigned two cycles of Dexa-BEAM (dexamethasone and carmustine, etoposide, cytarabine, and melphalan) and either two further courses of Dexa-BEAM or high-dose BEAM and transplantation of haemopoietic stem cells. Only patients with chemosensitive disease (complete or partial remission after two courses of Dexa-BEAM) proceeded to further treatment. The primary endpoint was freedom from treatment failure for patients with chemosensitive disease. Analysis was per protocol.Findings 17 patients were excluded from the study after randomisation (ten given Dexa-BEAM and seven given BEAM-HSCT). Median follow-up was 39 months (lQR 3-78). Freedom from treatment failure at 3 years was significantly better for patients given BEAM-HSCT (55%) than for those on Dexa-BEAM (34%; difference -21%, 95% CI -39.87 to -2.13; p=0.019). Overall survival of patients given either treatment did not differ significantly.Interpretation High-dose BEAM and transplantation of haemopoietic stem cells improves freedom from treatment failure in patients with chemosensitive first relapse of Hodgkin's disease irrespective of length of initial remission.