How Much Rituximab Do We Need: A Multicenter, Randomized Trial Comparing 1, 3 or 6 Infusions of Rituximab Added to 6 Cycles of CHOP Chemotherapy in Untreated Patients with Advanced Follicular Non-Hodgkins Lymphoma (HD2000-Trial).
How Much Rituximab Do We Need: A Multicenter, Randomized Trial Comparing 1, 3 or 6 Infusions of Rituximab Added to 6 Cycles of CHOP Chemotherapy in Untreated Patients with Advanced Follicular Non-Hodgkins Lymphoma (HD2000-Trial).
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我们需要多少利妥昔单抗：一项多中心、随机试验，比较未治疗的晚期滤泡性非霍奇金淋巴瘤患者在 6 个周期的 CHOP 化疗中添加 1、3 或 6 次利妥昔单抗输注（HD2000 试验）。
DOI：
10.1182/blood.v104.11.4584.4584
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发表时间：
2004
期刊：
影响因子：
20.3
通讯作者：
A. Ho
中科院分区：
文献类型：
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作者：
M. Hensel;L. Scheuer;H. Salwender;J. Finke;Dieter Buerkle;H. Duerk;A. Kaebisch;R. Naumann;H. Staiger;I. Schmidt;M. Kornacker;E. Leo;J. Fischer;A. Ho
目的：据报道，化疗与嵌合抗 CD20 抗体利妥昔单抗联合治疗滤泡性淋巴瘤具有高度活性。在滤泡性 NHL 中诱导最大效果所需的利妥昔单抗频率和剂量尚未确定。为了评估在标准化疗中添加利妥昔单抗以达到最大缓解率的频率，我们启动了一项前瞻性随机多中心 II 期研究。方法：未接受化疗的 III/IV 期 CD20 阳性滤泡性 NHL 患者被随机分配接受 6 个疗程的标准 CHOP-21 化疗，并在第 0 天联合利妥昔单抗 375 mg/m2，仅第一个 CHOP 疗程（A 组）、前 3 个 CHOP 疗程（B 组）或全部 6 个 CHOP 疗程（C 组）。主要终点是通过 PCR 评估的最初 t(14;18) 阳性患者的骨髓和外周血分子缓解率。该研究的其他终点是总体和完全缓解率、毒性率和进展时间。结果：自2000年9月以来，共招募了104名患者，中位年龄为57岁（范围30-80岁）。 33 名患者被随机分配到 A 组，35 名患者被随机分配到 B 组，36 名患者被随机分配到 C 组。到目前为止，69 名患者在所有 6 个周期后已得到完整记录，并且可以评估副作用。所有三个治疗组均具有良好的耐受性。所有组中不良事件和 4 级毒性的发生率相似。治疗完成后 2 个月观察到 1 例因乙型肝炎而死亡。迄今为止，整个组的总缓解率 (ORR) 为 90%（69 例患者中的 62 例可评估），其中 20 例完全缓解，42 例部分缓解。结论：这项多中心、随机、II 期试验首次确定了联合免疫化疗中利妥昔单抗输注的最佳频率和剂量。在正在进行的试验的第一次中期分析中，在所有治疗组中都观察到类似的血液学、胃肠道和感染毒性。
Purpose: The combination of chemotherapy with the chimeric anti-CD20 antibody Rituximab has been reported to be highly active in the treatment of follicular lymphoma. The frequency and dosage of rituximab required to induce the maximum effect in follicular NHL is not defined. To evaluate how often rituximab should be added to standard chemotherapy to achieve maximum remission rates, we have initiated a prospective randomized multicenter phase II study. Methods : Patients (pts) with stage III/IV CD20 positive follicular NHL who were chemotherapy naive were randomly assigned to receive 6 courses of a standard CHOP-21 chemotherapy, accompanied by rituximab 375 mg/m2 at day 0 only with the first CHOP course (arm A), with the first 3 CHOP courses (arm B) or with all 6 CHOP courses (Arm C). The major endpoint was the rate of molecular remission in bone marrow and peripheral blood in initially t(14;18)-positive pts, assessed by PCR. Other endpoints of the study were overall and complete response rates, toxicity rate and time to progression. Results: Since September 2000, 104 pts with a median age of 57 years (range 30–80) were recruited. 33 pts were randomized to arm A, 35 to arm B and 36 to arm C. So far 69 pts have been documented completely after all 6 cycles and are evaluable for side effects. All three treatment arms were well tolerated. The incidence of adverse events and Grade 4 toxicity was similar in all groups. One treatment related death was observed 2 months after completion of therapy due to hepatitis B. The overall response rate (ORR) of the whole group, which was evaluable in 69 pts so far, was 90 % (62 of 69 pts), with 20 complete and 42 partial remissions. Conclusion: This multicenter, randomized, phase II trial addresses for the first time the optimal frequency and dosage of rituximab infusions in the combined immuno-chemotherapy. In the first interim analysis of the ongoing trial, similar hematologic, gastrointestinal and infectious toxicity was observed in all treatment arms.