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环磷酰胺、阿霉素、长春新碱和泼尼松(CHOP方案)对比顺铂、依托泊苷、博来霉素和泼尼松(CisEBP方案)治疗晚期高度恶性非霍奇金淋巴瘤的III期试验。丹麦淋巴瘤研究组。

Phase III trial of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) versus cisplatin, etoposide, bleomycin and prednisone (CisEBP) for the treatment of advanced non-Hodgkin's lymphoma of high grade malignancy. The Danish Lymphoma Study Group.

作者信息

Andersen J, Thorling K, Bentzen S M, Brincker H, Christensen B E, Pedersen M

机构信息

Department of Oncology, Aarhus Kommunehospital, Denmark.

出版信息

Acta Oncol. 1990;29(8):995-9. doi: 10.3109/02841869009091789.

DOI:10.3109/02841869009091789
PMID:1703769
Abstract

The trial included 85 previously untreated patients (median age 61 years) with stage III or IV non-Hodgkin's lymphoma (NHL) of the subtypes centrocytic lymphoma, diffuse centroblastic lymphoma, immunocytoma, immunoblastic lymphoma, or unclassified lymphoma of high grade malignancy. The patients were randomized to 9 monthly treatment cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or CisEBP (cisplatin, bleomycin, etoposide, prednisone). Patients who had failed to achieve even a partial response (PR) after the completion of 2 cycles were switched to the alternative regimen. Complete response (CR) on primary treatment was obtained in 70% (55-83%) of CHOP-treated patients and in 25% (13-41%) of CisEBP-treated patients (p = 0.0004). Secondary CHOP treatment produced CR in 7 (30%) of 24 patients and secondary CisEBP treatment led to CR in 2 (15%) of 14 patients. The median survival was 3.4 years in the CHOP arm and 2.6 years in the CisEBP arm (p = 0.78). Hematologic toxicity was mainly leukocytopenia and anemia in both treatment arms. Non-hematological toxicity was slight, and late toxicity was insignificant. Three treatment-related deaths were noted. We conclude that CHOP induces more remissions than CisEBP in advanced lymphomas of high grade malignancy.

摘要

该试验纳入了85例先前未接受过治疗的患者(中位年龄61岁),他们患有III期或IV期非霍奇金淋巴瘤(NHL),亚型包括中心细胞性淋巴瘤、弥漫性中心母细胞性淋巴瘤、免疫细胞瘤、免疫母细胞性淋巴瘤或高度恶性的未分类淋巴瘤。患者被随机分为接受9个周期的CHOP(环磷酰胺、阿霉素、长春新碱、泼尼松)或CisEBP(顺铂、博来霉素、依托泊苷、泼尼松)治疗。在完成2个周期治疗后未能达到部分缓解(PR)的患者改用另一种治疗方案。CHOP治疗组70%(55%-83%)的患者在初始治疗时获得完全缓解(CR),CisEBP治疗组为25%(13%-41%)(p = 0.0004)。24例接受二线CHOP治疗的患者中有7例(30%)获得CR,14例接受二线CisEBP治疗的患者中有2例(15%)获得CR。CHOP治疗组的中位生存期为3.4年,CisEBP治疗组为2.6年(p = 0.78)。两个治疗组的血液学毒性主要为白细胞减少和贫血。非血液学毒性较轻,晚期毒性不明显。记录到3例与治疗相关的死亡。我们得出结论,在高度恶性的晚期淋巴瘤中,CHOP诱导的缓解比CisEBP更多。

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