High-dose, therapy improves progression-free survival and survival in relapsed follicular non-Hodgkin's lymphoma: Results from the randomized European CUP trial
High-dose, therapy improves progression-free survival and survival in relapsed follicular non-Hodgkin's lymphoma: Results from the randomized European CUP trial
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DOI：
10.1200/jco.2003.10.023
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发表时间：
2003-11-01
影响因子：
45.3
通讯作者：
Kvalheim, G
中科院分区：
文献类型：
--
作者：
Schouten, HC;Qian, W;Kvalheim, G
（目的）：在一项随机临床试验中，确定在复发滤泡性非霍奇金淋巴瘤患者的无进展生存期（PFS）和总生存期（OS）方面，高剂量治疗（HDT）后自体干细胞移植是否比标准治疗更有效；并评估b细胞清除干细胞移植物对PFS和OS的额外价值。（患者和方法）栏下：患者接受三个周期的化疗。骨髓浸润有限的应答患者有资格随机分配到三个进一步的化疗周期(C)，未清除的HDT (U)或清除的HDT（13）。（结果）柱状图：1993年8月至1997年4月，来自国际36个中心的140例患者登记，其中99例随机分配。未随机分组的原因包括患者拒绝接受诱导治疗、早期进展或死亡。中位随访69个月，PFS和OS的log-rank P值为。0037和。079年,分别。对于PFS， U与C、P与C、P与U的风险比（95% Cls）分别为0.33（0.16 ~ 0.70）、0.38（0.19 ~ 0.79）和1.02（0.51 ~ 2.05）。C与U + P的风险比（95% CId）为0.30（0.15 ~ 0.61）。OS的风险比（95% ci）分别为0.43（0.18 ~ 1.06）、0.43（0.18 ~ 1.02）和0.72（0.32 ~ 1.63）。C与U + P的风险比（95% CI）为0.40（0.18 ~ 0.89）。Kaplan-Meier估计C、U和P的2年PFS （95% ci）分别为26%（8%至44%）、58%（37%至79%）和55%（34%至75%）。C、U和P的4年OS分别为46%（25%至67%）、71%（52%至91%）和77%（605%至95%）。（结论）柱下：HDT显著改善PFS和CIS。没有明确的证据表明通过净化有益。(C) 2003年由美国临床肿瘤学会出版。
(Purpose) under bar: To determine, in a randomized clinical trial, whether high-dose therapy (HDT) followed by autologous stem-cell transplantation is more effective than standard treatment with regard to progression-free survival (PFS) and overall survival (OS) in patients with relapsed follicular non-Hodgkin's lymphoma; and to assess the additional value of B-cell purging of the stem-cell graft with regards to PFS and OS.(Patients and Methods) under bar: patients received three cycles of chemotherapy. Responding patients with limited bone marrow infiltration were eligible for random assignment to three further cycles of chemotherapy (C), unpurged HDT (U), or purged HDT (13).(Results) under bar: Between August 1993 and April 1997, 140 patients were registered from 36 centers internationally, and 99 were randomly assigned. Reasons for not randomizing included patient refusal, early progression, or death on induction therapy. With a 69-month median follow-up, the log-rank P value for PFS and OS were .0037 and .079, respectively. For PFS, the hazard ratios (95% Cls) for U versus C, P versus C, and P versus U were 0.33 (0.16 to 0.70), 0.38 (0.19 to 0.79), and 1.02 (0.51 to 2.05), respectively. The hazard ratio (95% CId) for C versus U + P was 0.30 (0.15 to 0.61). Hazard ratios (95% CIs) for OS were 0.43 (0.18 to 1.06), 0.43 (0.18 to 1.02), and 0.72 (0.32 to 1.63). For C versus U + P, the hazard ratio (95% CI) was 0.40 (0.18 to 0.89). Kaplan-Meier estimates (95% CIs) of 2-year PFS for C, U, and P were 26% (8% to 44%), 58% (37% to 79%), and 55% (34% to 75%), respectively. OS at 4 years for C, U, and P are 46% (25% to 67%), 71% (52% to 91%), and 77% (605% to 95%) respectively.(Conclusion) under bar: HDT significantly improves PFS and CIS. There is no clear evidence of benefit through purging. (C) 2003 by American Society of Clinical Oncology.