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OBSERVATION VS INTENSIVE CHEMOTHERAPY FOR INDOLENT LYMPHOMA

OBSERVATION VS INTENSIVE CHEMOTHERAPY FOR INDOLENT LYMPHOMA
惰性淋巴瘤的观察与强化化疗
批准号:
2464510
负责人:
B L GAUSE
金额:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至

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中文摘要
翻译
这项研究是12年前设计的,目的是比较 两种截然不同的治疗方法的长期存活率 未经治疗的惰性淋巴瘤患者:观察或 延迟治疗(观察和等待)与初始强化联合治疗 使用ProMACE/MOPP柔韧疗法进行化疗以完全缓解, 然后进行固定性改良全结节放疗。到目前为止在那里 在无病存活率或总体上没有显著差异 存活率,尽管完全应答率存在差异 在两个随机组之间,76%的患者被随机分配到 强化治疗获得完全缓解,与完全缓解率相比 在观察一段时间后接受治疗的患者中有37%。中位随访率 时间是八年,比中位生存期(10年)要短 有这些诊断的患者。继续跟踪可能会显示出对 病人的一个子集。 有必要进行更长时间的随访,以确定是否有生存 不同治疗方法之间的差异。病人 随机化到WW的手臂将继续被交叉并根据 协议。
英文摘要
This study was designed twelve years ago to compare the efficacy and the long-term survival of two very different therapeutic approaches towards previously untreated patients with indolent lymphoma: observation or delayed therapy (watch and wait) vs. initial intensive combination chemotherapy with ProMACE/MOPP flexitherapy to complete remission, followed by consolidative modified total nodal irradiation. To date there are no significant differences in disease-free survival or overall survival, although there are differences in complete response rates between the two randomized groups with 76% of patients randomized to intensive therapy achieving a complete response compared to a CR rate of 37% in those treated after a period of observation. The median follow-up time is eight years, shorter than the median survival (10 years) of patients with these diagnoses. Continued follow-up may show a benefit for a subset of patients. Longer follow-up is necessary to determine if there is a survival difference between the different treatment approaches. Patients randomized to the WW arm will continue to be crossed over and treated per protocol.
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