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非聚乙二醇化脂质体多柔比星(MyocetTM)联合(R-COMP)化疗治疗老年弥漫性大 B 细胞淋巴瘤(DLBCL):来自 II 期 EUR018 试验的结果。

Nonpegylated liposomal doxorubicin (MyocetTM) combination (R-COMP) chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL): results from the phase II EUR018 trial.

机构信息

Department of Oncology and Haematology, University of Modena and Reggio Emilia, Modena, Italy.

Department of Haematology, University Hospital of Salamanca, Salamanca, Spain.

出版信息

Ann Oncol. 2010 Jul;21(7):1492-1499. doi: 10.1093/annonc/mdp544. Epub 2009 Dec 11.

DOI:10.1093/annonc/mdp544
PMID:20007997
Abstract

BACKGROUND

To evaluate the activity and safety of nonpegylated liposomal doxorubicin (Myocet) when substituted for doxorubicin in the R-CHOP regimen (R-COMP).

PATIENTS AND METHODS

Seventy-five elderly patients with diffuse large B-cell lymphoma (DLBCL) were studied. Only patients with left ventricular ejection fraction (LVEF) > or =50% were allowed. R-COMP regimen was administered every 3 weeks for three cycles, followed by additional five cycles in case of complete response (CR) or partial response.

RESULTS

From November 2002 to April 2005, 75 patients were registered, of which 72 were evaluated. Median age was 72 years (range 61-83); 56% of patients had high or high-intermediate International Prognostic Index score. Median LVEF at baseline was 61%. Thirty-eight patients had history of abnormal cardiovascular conditions. The overall response rate was 71%, with a CR rate of 57%. After a median follow-up of 33 months, the 3-year overall survival, failure-free survival, and progression-free survival rates were 72%, 39%, and 69%, respectively. Neutropenia (54%) was the most frequent grade 3-4 adverse event (AE); 21% of patients experienced cardiac AEs, graded as 3-4 in 4% of the cases.

CONCLUSION

R-COMP is an effective regimen for the treatment of DLBCL in elderly patients, with an acceptable tolerability profile.

摘要

背景

评估非聚乙二醇化脂质体阿霉素(Myocet)替代 R-CHOP 方案(R-COMP)中的阿霉素的活性和安全性。

患者和方法

75 例老年弥漫性大 B 细胞淋巴瘤(DLBCL)患者接受了研究。仅允许左心室射血分数(LVEF)≥50%的患者入组。R-COMP 方案每 3 周给药 3 个周期,在完全缓解(CR)或部分缓解时,再给予另外 5 个周期。

结果

2002 年 11 月至 2005 年 4 月,共登记了 75 例患者,其中 72 例进行了评估。中位年龄为 72 岁(范围 61-83 岁);56%的患者具有高或高-中危国际预后指数评分。基线时 LVEF 的中位数为 61%。38 例患者有异常心血管病史。总体缓解率为 71%,CR 率为 57%。中位随访 33 个月后,3 年总生存率、无失败生存率和无进展生存率分别为 72%、39%和 69%。中性粒细胞减少症(54%)是最常见的 3-4 级不良事件(AE);21%的患者发生了心脏 AE,4%的患者为 3-4 级。

结论

R-COMP 是治疗老年 DLBCL 的有效方案,具有可接受的耐受性。

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