CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma:: a randomised controlled trial by the MabThera International Trial (MInT) Group
CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma:: a randomised controlled trial by the MabThera International Trial (MInT) Group
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DOI：
10.1016/s1470-2045(06)70664-7
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发表时间：
2006-05-01
期刊：
影响因子：
51.1
通讯作者：
Loeffler, Markus
中科院分区：
文献类型：
--
作者：
Pfreundschuh, Michael;Trumper, Lorenz;Loeffler, Markus
背景利妥昔单抗联合不同CHOP（环磷酰胺、多柔比星、长春新碱和泼尼松）样化疗方案在预后良好的年轻弥漫性大B细胞淋巴瘤患者中的作用仍有待确定。我们的目的是比较CHOP样化疗和利妥昔单抗与CHOP样化疗单独在这些patients.Methods 824例患者谁是来自18个国家，年龄18-60岁，谁没有危险因素或一个危险因素，根据年龄调整的国际预后指数（IPI），II-IV期疾病，或I期疾病与散装入组。这些患者被随机分配到6个周期的CHOP样化疗和利妥昔单抗（n = 413）或6个周期的CHOP样化疗单独（n = 411）。大体积和结节部位接受额外放疗。主要终点是无事件生存期;次要终点是反应、治疗进展、无进展生存期、总生存期和毒性反应频率。按意向治疗和符合方案进行分析。该试验在www.example.com注册http://www.clinicaltrials.gov，NCT 00064116。结果中位随访34个月后（范围0.03-61），与仅接受化疗的患者相比，接受化疗和利妥昔单抗治疗的患者3年无事件生存率增加（79% [95%CI 75-83] vs 59% [54-64];组间差异20% [13-27]，对数秩p < 0.0001），3年总生存率增加（93% [90-95] vs 84% [80-88];组间差异9% [3-13]，对数秩p = 0.0001）。无事件生存率受治疗组、是否存在体积大的疾病和年龄调整的IPI的影响：化疗和利妥昔单抗治疗后，有利亚组（即IPI = 0，无体积）可以从不利亚组（即IPI = 1或体积大，或两者兼而有之）中定义。两组在不良事件发生率上无差异。解释利妥昔单抗加CHOP治疗6个周期对预后良好的年轻弥漫性大B细胞淋巴瘤患者是有效的治疗方法。两个预后亚组的定义允许为这些患者提供更精确的治疗方法。
Background The role of rituximab in combination with different CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy regimens in young patients with good-prognosis diffuse large-B-cell lymphoma remains to be defined. We aimed to compare CHOP-like chemotherapy and rituximab with CHOP-like chemotherapy alone in these patients.Methods 824 patients who were from 18 countries; aged 18-60 years; and who had no risk factors or one risk factor according to age-adjusted International Prognostic Index (IPI), stage II-IV disease, or stage I disease with bulk were enrolled. These patients were randomly assigned to six cycles of CHOP-like chemotherapy and rituximab (n = 413) or to six cycles of CHOP-like chemotherapy alone (n = 411). Bulky and extranodal sites received additional radiotherapy. The primary endpoint was event-free survival; secondary endpoints were response, progression under therapy, progression-free survival, overall survival, and frequency of toxic effects. Analyses were done by intention to treat and per protocol. This trial is registered at http://www.clinicaltrials.gov, NCT 00064116.Findings After a median follow-up of 34 months (range 0.03-61), patients assigned chemotherapy and rituximab had increased 3-year event-free survival compared with those assigned chemotherapy alone (79% [95% CI 75-83] vs 59% [54-64]; difference between groups 20% [13-27], log-rank p < 0.0001), and had increased 3-year overall survival (93% [90-95] vs 84% [80-88]; difference between groups 9% [3-13], log-rank p = 0.0001). Event-free survival was affected by treatment group, presence of bulky disease, and age-adjusted IPI: after chemotherapy and rituximab, a favourable subgroup (ie, IPI = 0, no bulk) could be defined from a less-favourable subgroup (ie, IPI = 1 or bulk, or both). Groups did not differ in the frequency of adverse events.Interpretation Rituximab added to six cycles of CHOP is an effective treatment for young patients with good-prognosis diffuse large-B-cell lymphoma. The definition of two prognostic subgroups allows for a more refined therapeutic approach for these patients.