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左亚叶酸和5-氟尿嘧啶治疗晚期乳腺癌:一项II期研究。

L-folinic acid and 5-fluorouracil in the treatment of advanced breast cancer: a phase II study.

作者信息

Zaniboni A, Meriggi F, Arcangeli G, Marpicati P, Montini E, Simoncini E, Marini G

机构信息

Servizio di Oncologia, Spedali Civili, Brescia, Italy.

出版信息

Ann Oncol. 1993;4 Suppl 2:41-3. doi: 10.1093/annonc/4.suppl_2.s41.

DOI:10.1093/annonc/4.suppl_2.s41
PMID:8353103
Abstract

BACKGROUND

The combination of 5-fluorouracil (5-FU) and folinic acid (FA) is an active combination for the treatment of advanced breast cancer (ABC). Theoretically, the biologically active isomer of FA, 1-FA, should be more effective than racemic FA in modulating 5-FU activity.

PATIENTS AND METHODS

Thirty-three patients (pts) with ABC, all previously treated with an anthracycline-based combination for advanced disease were treated with 1-FA: 100 mg/m2 i.v. and 5-FU: 370 mg/m2 i.v. for 5 consecutive days every 4 weeks.

RESULTS

Three complete remission (CR) and 11 partial remission (PR) were obtained for an overall response rate of 42% (95% CI = 25-59). Median duration of response was 10 months, median survival was 15 months for responders, 11 months for NC and 3 for PD. Eleven pts experienced a WHO grade III-IV oral mucositis (33%), 6 pts had grade III and one grade IV diarrhea, two pts had grade IV neutropenia resulting in one toxic death.

CONCLUSIONS

In this heavily pretreated population of pts with ABC, this regimen showed an interesting activity with substantial toxicity. Both the response rate and the pattern of side-effects seem similar to those experienced with the racemic mixture of d,1-FA. Modulated 5-FU warrants an increasing consideration in the treatment of breast cancer.

摘要

背景

5-氟尿嘧啶(5-FU)与亚叶酸(FA)联合使用是治疗晚期乳腺癌(ABC)的一种有效组合。从理论上讲,FA的生物活性异构体1-FA在调节5-FU活性方面应比消旋FA更有效。

患者与方法

33例ABC患者,均曾接受过基于蒽环类药物的晚期疾病联合治疗,接受1-FA治疗:静脉注射100mg/m²,5-FU:静脉注射370mg/m²,每4周连续5天。

结果

获得3例完全缓解(CR)和11例部分缓解(PR),总缓解率为42%(95%CI = 25-59)。缓解的中位持续时间为10个月,缓解者的中位生存期为15个月,病情稳定(NC)者为11个月,疾病进展(PD)者为3个月。11例患者出现世界卫生组织III-IV级口腔黏膜炎(33%),6例患者出现III级,1例出现IV级腹泻,2例患者出现IV级中性粒细胞减少症,导致1例中毒死亡。

结论

在这群经过大量预处理的ABC患者中,该方案显示出有趣的活性,但毒性较大。缓解率和副作用模式似乎与消旋d,1-FA混合物相似。经调节的5-FU在乳腺癌治疗中值得越来越多的考虑。

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