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醋酸椭圆玫瑰树碱挽救治疗晚期乳腺癌的II期研究。

Phase II study of elliptinium acetate salvage treatment of advanced breast cancer.

作者信息

Rouëssé J, Spielmann M, Turpin F, Le Chevalier T, Azab M, Mondésir J M

机构信息

Centre René Huguenin, Saint Cloud, France.

出版信息

Eur J Cancer. 1993;29A(6):856-9. doi: 10.1016/s0959-8049(05)80424-1.

DOI:10.1016/s0959-8049(05)80424-1
PMID:8484977
Abstract

Elliptinium acetate (Celiptium) is an intercalating agent belonging to the ellipticine family. This agent has demonstrated clinical activity as salvage treatment in breast cancer using a weekly regimen. However, its clinical use was hampered by important toxicities such as xerostomia and immune-mediated haemolytic reactions due to development of anti-elliptinium IgM antibodies. We have studied 83 patients previously treated for metastatic breast cancer using elliptinium acetate with a different schedule: 80 mg/m2 daily for 3 consecutive days every 21 days. In 80 evaluable patients, an objective response (complete + partial response) was obtained in 5 of 30 patients with visceral metastases (13%), in 6 of 21 patients with soft tissue metastases (29%), and in 3 of 20 patients with mixed metastases (15%). The overall objective response rate was 14/80 (18%, 95% confidence interval = 10-26%). Moderate to severe xerostomia occurred in 10% of patients, while no anti-elliptinium antibodies or haemolytic reactions were detected using this schedule. No significant haematological toxicity, as usually reported with this drug, was observed. Elliptinium acetate has modest but definite activity as salvage treatment of breast cancer. The 3-week schedule seems as active as and less toxic than the weekly schedule.

摘要

醋酸椭圆玫瑰树碱(喜树碱)是一种属于玫瑰树碱家族的嵌入剂。该药物已被证明在乳腺癌挽救治疗中使用每周给药方案具有临床活性。然而,由于抗醋酸椭圆玫瑰树碱IgM抗体的产生,其临床应用受到诸如口干症和免疫介导的溶血反应等重要毒性的阻碍。我们研究了83例先前使用不同给药方案的醋酸椭圆玫瑰树碱治疗转移性乳腺癌的患者:每21天连续3天每天80mg/m²。在80例可评估患者中,30例内脏转移患者中有5例(13%)、21例软组织转移患者中有6例(29%)以及20例混合转移患者中有3例(15%)获得了客观缓解(完全缓解+部分缓解)。总体客观缓解率为14/80(18%,95%置信区间=10-26%)。10%的患者出现中度至重度口干症,而使用该给药方案未检测到抗醋酸椭圆玫瑰树碱抗体或溶血反应。未观察到通常报道的该药物显著的血液学毒性。醋酸椭圆玫瑰树碱作为乳腺癌挽救治疗具有适度但明确的活性。3周给药方案似乎与每周给药方案一样有效且毒性更小。

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Phase II study of elliptinium acetate salvage treatment of advanced breast cancer.醋酸椭圆玫瑰树碱挽救治疗晚期乳腺癌的II期研究。
Eur J Cancer. 1993;29A(6):856-9. doi: 10.1016/s0959-8049(05)80424-1.
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Elliptinium acetate in metastatic breast cancer--a phase II study.醋酸椭圆玫瑰树碱治疗转移性乳腺癌——一项II期研究。
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Phase II study of elliptinium in advanced breast cancer.椭圆玫瑰树碱用于晚期乳腺癌的II期研究。
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