Phase II study of liposomal doxorubicin in patients with advanced colorectal cancer.
Phase II study of liposomal doxorubicin in patients with advanced colorectal cancer.
复制标题
脂质体阿霉素治疗晚期结直肠癌的 II 期研究。
DOI：
10.1097/00000421-200102000-00019
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发表时间：
2001
期刊：
影响因子：
--
通讯作者：
Zalupski,MM
中科院分区：
文献类型：
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作者：
Shields,AF;Lange,LM;Zalupski,MM
Doxil是一种多柔比星脂质体制剂，可延长活性药物的体内药理学暴露。我们试图验证这一假设，即这种新制剂将导致改善结肠直肠癌患者的疗效。既往接受过治疗的晚期结直肠癌患者有资格参加本试验。治疗方法为多西他赛45 mg/m2静脉滴注，每3周1次。17名患者进入试验，他们接受了中位两个周期的治疗。没有一个患者对治疗有部分反应。病情稳定是最佳缓解，1例患者在疾病进展前接受了17个周期的治疗。该疗法耐受性良好，只有两名患者因手足综合征而减少剂量。4例患者在输注期间发生过敏反应，但通过适当的术前用药和减慢输注速度，治疗能够顺利恢复。任何患者均未发生大于I级的中性粒细胞减少症或血小板减少症。尽管Doxil在该剂量和时间表下耐受性良好，但它在该组患者中不是活性药物。多柔比星单独或与其他药物联合治疗对多柔比星敏感的癌症值得进一步研究。
Doxil is a liposomal preparation of doxorubicin that results in prolonged pharmacologic exposure in vivo to the active agent. We sought to test the hypothesis that this new formulation would result in improved efficacy in patients with colorectal cancer. Patients with advanced colorectal cancer who had received prior therapy were eligible for the trial. Treatment consisted of Doxil 45 mg/m 2 intravenously every 3 weeks. Seventeen patients entered the trial and they received a median of two cycles of treatment. None of the patients had a partial response to treatment. Stable disease was the best response, and one patient received therapy for 17 cycles before her disease progressed. The therapy was well tolerated, with only two patients having the dose decreased because of hand–foot syndrome. Four patients experienced allergic reactions during the infusion, but with appropriate premedication and slowing of the infusion, treatment was able to be resumed without difficulty. No greater than grade I neutropenia or thrombocytopenia developed in any patient. Although Doxil was well tolerated at this dose and schedule, it was not an active agent in this group of patients. Doxil alone or in combination with other agents is worthy of further study in cancers responsive to doxorubicin.