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表柔比星治疗晚期恶性黑色素瘤的II期研究

Phase II study of epirubicin in advanced malignant melanoma.

作者信息

Lopez M, Perno C F, Papaldo P, Di Lauro L, Ganzina F, Barduagni A

出版信息

Invest New Drugs. 1984;2(3):315-7. doi: 10.1007/BF00175383.

DOI:10.1007/BF00175383
PMID:6595241
Abstract

Twenty patients with advanced malignant melanoma refractory to conventional chemotherapy, were entered into a Phase II study of epirubicin, one of the new doxorubicin analogues. The drug was given at a dose of 90 mg/m2 IV every 3 weeks. One partial response and three disease stabilizations were observed. Nausea and vomiting and alopecia were common. Mild to moderate leukopenia occurred in 6 patients. Three cases of reversible ST-T changes were recorded. The observed response rate of 5% with a 39.2% probability of a true response rate greater than or equal to 10%, does not suggest that epirubicin, in the dose and schedule chosen, is active in metastatic malignant melanoma.

摘要

二十例对传统化疗难治的晚期恶性黑色素瘤患者进入了一项关于表柔比星(一种新的阿霉素类似物)的II期研究。该药物以每3周静脉注射90mg/m²的剂量给药。观察到1例部分缓解和3例病情稳定。恶心、呕吐和脱发很常见。6例患者出现轻度至中度白细胞减少。记录到3例可逆性ST-T改变。观察到的缓解率为5%,真实缓解率大于或等于10%的概率为39.2%,这并不表明所选择剂量和给药方案的表柔比星对转移性恶性黑色素瘤有活性。

相似文献

1
Phase II study of epirubicin in advanced malignant melanoma.表柔比星治疗晚期恶性黑色素瘤的II期研究
Invest New Drugs. 1984;2(3):315-7. doi: 10.1007/BF00175383.
2
Epirubicin in colorectal cancer. A phase II study of the early clinical trials group (EORTC).
Invest New Drugs. 1985;3(1):63-6. doi: 10.1007/BF00176826.
3
A phase-II clinical trial of 4'-epi-doxorubicin in advanced solid tumors.4'-表阿霉素用于晚期实体瘤的II期临床试验。
Cancer Chemother Pharmacol. 1984;12(3):179-82. doi: 10.1007/BF00256541.
4
[Therapeutic activity of epirubicin in malignant melanoma and non-Hodgkin's lymphoma].表柔比星在恶性黑色素瘤和非霍奇金淋巴瘤中的治疗活性
Clin Ter. 1984 Apr 15;109(1):31-5.
5
Phase II clinical evaluation of 4'-epi-doxorubicin.
Cancer Treat Rep. 1983 Apr;67(4):337-41.
6
[Phase II study of epirubicin on gastric cancer--a cooperative study of the Tokai Cancer Chemotherapy Group].表柔比星治疗胃癌的II期研究——东海癌症化疗组合作研究
Gan To Kagaku Ryoho. 1986 Jul;13(7):2440-5.
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Epirubicin has modest single-agent activity in head and neck cancer but limited activity in metastatic melanoma and colorectal cancer: phase II studies by the Eastern Cooperative Oncology Group.表柔比星对头颈部癌有一定的单药活性,但对转移性黑色素瘤和结直肠癌的活性有限:东部肿瘤协作组的II期研究。
Am J Clin Oncol. 1998 Oct;21(5):509-12. doi: 10.1097/00000421-199810000-00019.
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[A phase II study of epirubicin in malignant lymphoma].
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