Comparison of chlorambucil and prednisone versus cyclophosphamide, vincristine, and prednisone as initial treatment for chronic lymphocytic leukemia: long-term follow-up of an Eastern Cooperative Oncology Group randomized clinical trial.
Comparison of chlorambucil and prednisone versus cyclophosphamide, vincristine, and prednisone as initial treatment for chronic lymphocytic leukemia: long-term follow-up of an Eastern Cooperative Oncology Group randomized clinical trial.
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DOI：
10.1200/jco.1991.9.5.770
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发表时间：
1991-05
期刊：
影响因子：
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通讯作者：
B. Raphael;Janet Andersen;R. Silber;Martin M. Oken;D. Moore;J. Bennett;H. Bonner;Richard G. Hahn;W. Knospe;Joseph J. Mazza
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文献类型：
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作者：
B. Raphael;Janet Andersen;R. Silber;Martin M. Oken;D. Moore;J. Bennett;H. Bonner;Richard G. Hahn;W. Knospe;Joseph J. Mazza
东部肿瘤协作组（ECOG）进行了一项研究，其中晚期慢性淋巴细胞白血病（CLL）患者随机接受苯丁酸氮芥（第1天口服30 mg/m2）和泼尼松（80 mg，口服，第1 - 5天）（C + P），每2周一次，以及更强化的环磷酰胺方案（300 mg/m2，口服，第1 - 5天）、长春新碱（1.4 mg/m2，静脉内[IV]，第1天）和泼尼松（100 mg/m2，口服，第1 - 5天）（CVP），每3周一次。治疗持续长达18个月至最大反应。在122例合格患者中，60例接受C + P，62例接受CVP。中位随访时间为7年，C + P和CVP之间的生存期（4.8 v3.9年，P = 0.12）、完全缓解（CR）率（25% v23%; P = 0.83）或缓解持续时间（2.0 v1.9年; P = 0.78）无显著差异。尽管治疗时间延长，但毒性轻微。III期和IV期患者的长期中位生存期为4.1年，优于通常报道的上级。这可能源于持续治疗至最大缓解，而不是增加治疗强度。这些结果与其他研究者报告的环磷酰胺、多柔比星、长春新碱和泼尼松（CHOP）治疗的结果相当。数据表明，间歇性C + P给药至最大反应仍然是晚期CLL的标准治疗方法。
The Eastern Cooperative Oncology Group (ECOG) conducted a study in which patients with advanced chronic lymphocytic leukemia (CLL) were randomized between a regimen consisting of chlorambucil (30 mg/m2 orally day 1) and prednisone (80 mg orally days 1 to 5) (C + P) administered every 2 weeks and a more intensive regimen of cyclosphosphamide (300 mg/m2 orally days 1 to 5), vincristine (1.4 mg/m2 intravenously [IV] day 1), and prednisone (100 mg/m2 orally days 1 to 5) (CVP) given every 3 weeks. Treatment was continued for up to 18 months to maximal response. Of the 122 eligible patients, 60 received C + P, while 62 received CVP. With a median follow-up of 7 years, there were no significant differences in survival (4.8 v 3.9 years, P = .12), complete remission (CR) rate (25% v 23%; P = .83), or duration of response (2.0 v 1.9 years; P = .78) between C + P and CVP. Toxicity was modest despite the prolonged treatment. The long median survival of 4.1 years for stage III and IV patients is superior to that usually reported. This could stem from continuing treatment to maximal response rather than an increase in intensity of therapy. These results are comparable to those reported with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy by other investigators. The data suggest that intermittent C + P administered to maximal response continues to be the standard treatment approach for advanced CLL.