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卡培他滨与环磷酰胺联合治疗转移性乳腺癌患者的剂量

Dosage of capecitabine and cyclophosphamide combination therapy in patients with metastatic breast cancer.

作者信息

Ohno Shinji, Mitsuyama Shoshu, Tamura Kazuo, Nishimura Reiki, Tanaka Maki, Hamada Yuzo, Kuroki Shoji

机构信息

Department of Breast Oncology, National Kyushu Cancer Center Hospital, 3-1-1 Notame, Minami-ku, Fukuoka 811-1395, Japan.

出版信息

Anticancer Res. 2007 Mar-Apr;27(2):1009-13.

PMID:17465235
Abstract

BACKGROUND

Capecitabine is a highly effective and well-tolerated treatment for metastatic breast cancer (MBC) and extends survival when combined with docetaxel. Capecitabine and cyclophosphamide are orally administered and have preclinical synergy and non-overlapping toxicities.

PATIENTS AND METHODS

Sixteen pretreated MBC patients received escalating doses of oral capecitabine 628 to 829 mg/m2 twice daily (bid) plus oral cyclophosphamide 33 to 50 mg/m2 bid, on days 1 to 14 every 21 days.

RESULTS

Among the ten patients receiving capecitabine/cyclophosphamide 829/33 mg/m2 bid on days 1 to 14, two experienced dose-limiting toxicities (DLT, treatment delay > 1 week due to grade 2 leukopenia). Because neither patient developed further grade > 1 toxicity and none of the patients experienced grade 3/4 toxicities or further DLTs, this dose level is the recommended regimen, producing partial responses in two of five evaluable patients.

CONCLUSION

The recommended all oral capecitabine/cyclophosphamide combination regimen is well tolerated and active in MBC, and is being evaluated in a phase II study in anthracycline-pretreated MBC.

摘要

背景

卡培他滨是转移性乳腺癌(MBC)一种高效且耐受性良好的治疗药物,与多西他赛联合使用时可延长生存期。卡培他滨和环磷酰胺均为口服给药,具有临床前协同作用且毒性不重叠。

患者与方法

16例经预处理的MBC患者每21天的第1至14天接受递增剂量的口服卡培他滨628至829mg/m²,每日两次(bid),加口服环磷酰胺33至50mg/m²,每日两次。

结果

在第1至14天接受卡培他滨/环磷酰胺829/33mg/m² bid的10例患者中,2例出现剂量限制性毒性(DLT,因2级白细胞减少导致治疗延迟>1周)。由于这两名患者均未出现进一步的>1级毒性,且无患者出现3/4级毒性或进一步的DLT,因此该剂量水平为推荐方案,在5例可评估患者中有2例产生部分缓解。

结论

推荐的全口服卡培他滨/环磷酰胺联合方案耐受性良好,对MBC有效,目前正在蒽环类药物预处理的MBC的II期研究中进行评估。

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