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六甲蜜胺用于铂耐药和铂难治性卵巢癌:妇科肿瘤学组II期试验

Altretamine (hexamethylmelamine) in platinum-resistant and platinum-refractory ovarian cancer: a Gynecologic Oncology Group phase II trial.

作者信息

Markman M, Blessing J A, Moore D, Ball H, Lentz S S

机构信息

Department of Hematology/Medical Oncology, Cleveland Clinic Cancer Center, Cleveland Clinic Foundation, Ohio 44195, USA.

出版信息

Gynecol Oncol. 1998 Jun;69(3):226-9. doi: 10.1006/gyno.1998.5016.

Abstract

OBJECTIVES

In an effort to critically examine the antitumor activity of altretamine (hexamethylmelamine) as salvage therapy of platinum-refractory ovarian cancer, the Gynecologic Oncology Group initiated a Phase II trial of the agent administered in this clinical setting.

METHODS

Altretamine was administered at a dose of 260 mg/m2 orally for 14 days in a 28-day course. Treatment was continued until disease progression or unacceptable side effects prevented further therapy. A total of 36 patients (median age: 56.5) were treated on this trial, of whom 33 were evaluable for toxicity and 30 for response. All patients had previously received either cisplatin or carboplatin and paclitaxel.

RESULTS

The major side effect was emesis (grade 3-4, 7/33, 21%). The objective response rate was 10% (one complete response, two partial responses).

CONCLUSION

We conclude that altretamine has limited activity in platinum-refractory ovarian cancer.

摘要

目的

为了严格检验六甲蜜胺作为铂耐药卵巢癌挽救治疗的抗肿瘤活性,妇科肿瘤学组开展了一项在此临床背景下使用该药物的II期试验。

方法

六甲蜜胺以260mg/m²的剂量口服给药14天,每28天为一个疗程。治疗持续进行,直至疾病进展或出现不可接受的副作用而无法继续治疗。本试验共治疗了36例患者(中位年龄:56.5岁),其中33例可评估毒性,30例可评估疗效。所有患者此前均接受过顺铂或卡铂以及紫杉醇治疗。

结果

主要副作用为呕吐(3-4级,7/33,21%)。客观缓解率为10%(1例完全缓解,2例部分缓解)。

结论

我们得出结论,六甲蜜胺在铂耐药卵巢癌中的活性有限。

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