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异环磷铂与卡铂治疗晚期乳腺癌的随机II期试验。欧洲癌症研究与治疗组织早期临床试验组和欧洲癌症研究与治疗组织数据中心。

Randomized phase II trial of iproplatin and carboplatin in advanced breast cancer. The EORTC Early Clinical Trials Group and the EORTC Data Center.

作者信息

Vermorken J B, Gundersen S, Clavel M, Smyth J F, Dodion P, Renard J, Kaye S B

机构信息

Free University Hospital, Amsterdam, The Netherlands.

出版信息

Ann Oncol. 1993 Apr;4(4):303-6. doi: 10.1093/oxfordjournals.annonc.a058487.

DOI:10.1093/oxfordjournals.annonc.a058487
PMID:8518220
Abstract

BACKGROUND

The observed activity of cisplatin in breast cancer and its unattractive toxicity profile in palliative treatment warranted further study of platinum analogues in this disease.

PATIENTS AND METHODS

Sixty-two patients with recurrent or metastatic breast cancer, 61 of whom had been previously treated with chemotherapy, were randomly assigned to therapy with either iproplatin (n = 32) or carboplatin (n = 30). Both platinum analogues were administered intravenously, iproplatin at a dose of 240 mg/m2 every 4 weeks and carboplatin at a dose of 450 mg/m2 every 5 weeks.

RESULTS

Only two patients responded to iproplatin (7%) for durations of 21 and 61 weeks, and one patient responded to carboplatin (3%) for a duration of 64 weeks. All responses were complete. At the given dose schedules carboplatin was more myelosuppressive than iproplatin. Non-hematologic toxicities included nausea and vomiting (93% vs. 90%), diarrhea (20% vs. 10%) and hemorrhage (16% vs. 10%) for iproplatin and carboplatin, respectively. Two patients developed alopecia with carboplatin. No renal toxicity was observed.

CONCLUSIONS

Both iproplatin and carboplatin have limited activity in previously treated women with advanced breast cancer when given in conventional dosages.

摘要

背景

顺铂在乳腺癌中的观察到的活性及其在姑息治疗中不理想的毒性特征,促使对铂类类似物在该疾病中的进一步研究。

患者与方法

62例复发性或转移性乳腺癌患者,其中61例先前接受过化疗,被随机分配接受异环磷酰胺(n = 32)或卡铂(n = 30)治疗。两种铂类类似物均通过静脉给药,异环磷酰胺剂量为每4周240mg/m²,卡铂剂量为每5周450mg/m²。

结果

仅2例患者对异环磷酰胺有反应(7%),持续时间分别为21周和61周,1例患者对卡铂有反应(3%),持续时间为64周。所有反应均为完全缓解。在给定的剂量方案下,卡铂比异环磷酰胺的骨髓抑制作用更强。非血液学毒性方面,异环磷酰胺和卡铂分别有恶心和呕吐(93%对90%)、腹泻(20%对10%)和出血(16%对10%)。2例接受卡铂治疗的患者出现脱发。未观察到肾毒性。

结论

对于先前接受过治疗的晚期乳腺癌女性患者,按常规剂量给予异环磷酰胺和卡铂时,二者的活性均有限。

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