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高剂量表柔比星用于铂类预处理过的卵巢癌患者:欧洲癌症研究与治疗组织-妇科癌症协作组的经验

High-dose epirubicin in platinum-pretreated patients with ovarian carcinoma: the EORTC-GCCG experience.

作者信息

Vermorken J B, Kobierska A, van der Burg M E, Chevallier B, Zanaboni F, ten Bokkel Huinink W W, Forni M, Pawinski A, van der Putten E, Bolis G

机构信息

Department of Oncology, Free University Hospital Amsterdam, The Netherlands.

出版信息

Eur J Gynaecol Oncol. 1995;16(6):433-8.

PMID:8536757
Abstract

BACKGROUND

A dose-response relationship for doxorubicin in ovarian cancer (OC) cell lines has been demonstrated in vitro. However, this has never been carefully addressed in the clinic. These data and the more favourable toxicity profile of the anthracycline analogue epirubicin were reasons to study high-dose epirubicin (HDE) in OC patients who relapsed on/after platinum-based chemotherapy. This was done both in a phase I/II feasibility study (n = 27; HDE dose 120-200 mg/m2 q3 weeks) and a still ongoing straightforward phase II study (n = 91; HDE dose 150-180 mg/m2 q 3 weeks).

RESULTS

Responses were observed at all dose levels. Overall 24 of the 118 patients responded (20%), which is much higher than reported with lower doses (7% with doses of 60-110 mg/m2). The most important side effects were myelosuppression, alopecia, nausea and vomiting and mucositis.

CONCLUSION

HDE is tolerable and has activity in second-line after platinum-based chemotherapy in OC patients.

摘要

背景

阿霉素在卵巢癌细胞系中的剂量反应关系已在体外得到证实。然而,这在临床上从未得到仔细研究。这些数据以及蒽环类类似物表柔比星更有利的毒性特征,是在铂类化疗后复发的卵巢癌患者中研究高剂量表柔比星(HDE)的原因。这在一项I/II期可行性研究(n = 27;HDE剂量120 - 200 mg/m²,每3周一次)和一项仍在进行的直接II期研究(n = 91;HDE剂量150 - 180 mg/m²,每3周一次)中进行。

结果

在所有剂量水平均观察到反应。118例患者中共有24例有反应(20%),这远高于低剂量时报道的反应率(60 - 110 mg/m²剂量时为7%)。最重要的副作用是骨髓抑制、脱发、恶心呕吐和黏膜炎。

结论

高剂量表柔比星在卵巢癌患者铂类化疗后的二线治疗中是可耐受的且具有活性。

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