聚乙二醇化脂质体多柔比星联合异环磷酰胺治疗晚期转移性软组织肉瘤  

Pegylated liposomal doxorubincin combined with ifosfamide as first-line treatment for patients with advanced or metastatic soft tissue sarcoma

作　　者：刘欣 张晓伟 王惠杰 吴向华 罗志国[1,2] 

机构地区：[1]复旦大学附属肿瘤医院肿瘤内科 [2]复旦大学上海医学院肿瘤学系,上海200032

出　　处：《中国癌症杂志》2017年第9期687-692,共6页China Oncology

摘　　要：背景与目的:软组织肉瘤一旦出现远处转移,预后极差,中位生存时间不到1年。多柔比星联合异环磷酰胺(ifosfamide,IFO)(AI方案)是晚期软组织肉瘤常用的一线联合治疗方案。聚乙二醇脂质体多柔比星(pegylated liposomal doxorubicin,PLD)活性成分为盐酸多柔比星,药物包裹在脂质体中,可减少多柔比星的临床毒性反应。该研究探讨PLD联合IFO治疗晚期转移性软组织肉瘤的临床疗效和安全性。方法:选取晚期转移性软组织肉瘤患者25例,使用PLD联合IFO方案,PLD剂量30 mg/m^2,静脉滴注,第1天;IFO剂量1.8 g/m^2,静脉滴注,第1~5天;美司钠360 mg/m^2,用IFO时0、4和8 h,21 d为1个周期。结果:所有患者化疗1~8个周期,中位周期数4。25例患者中部分缓解9例(36%),疾病稳定12例(48%),疾病进展4例(16%),疾病控制率(完全缓解+部分缓解+疾病稳定)为84%(21/25)。中位无进展生存时间为7.3个月(95%CI:4.6~10.0个月)。由于失访病例较多,中位总生存时间未随访到。化疗后3/4级不良反应包括白细胞下降(20%)、粒细胞下降(28%)、贫血(4%)和呕吐(4%)。只有1例患者治疗过程中予以减量。结论:临床应用PLD联合IFO方案治疗晚期转移性软组织肉瘤疗效确切,且毒性反应较轻,值得进一步深入研究。Background and purpose： Patient with metastatic soft tissue sarcoma has a poor prognosis with median survival time of less than 1 year. Doxombicin combined with ifosfamide （IFO） （AI regimen） is frequently used in the first-line treatment for patients with metastatic soft tissue sarcoma. Pegylated liposomal doxorubicin （PLD） is the liposomal formulation of doxorubicin and has exhibited less toxicity. Therefore our study was aimed to evaluate the efficacy and safety of PLD combined with IFO as the first-line treatment for patients with advanced or metastatic soft tissue sarcoma （STS）. Methods： A total of 25 chemotherapy-naive patients with advanced or metastatic STS were enrolled in this study between November 2013 and December 2015. All patients received treatment of PLD 30 mg/m2, dl, plus IFO 1.8 g/mE, dl-5, repeatedly every 21 days. Results： All patients received 1-8 cycles of treatment, at a median of 4 cycles. Among 25 patients, partial response was observed in 9 patients （36%）, stable disease （SD） was observed in 12 patients （48%） and progressive disease （PD） in 4 patients （16%）. The disease control rate （DCR, CR＋PR＋SD） was 84%. The median progression-free survival （PFS） was 7.3 months （95%CI, 4.6 to 10.0 months）. The grade 3/4 toxicities included leukopenia （20%）, neutropenia （28%）, anemia （4%） and vomiting （4%）. Conclusion： Combination therapy comprising PLD and IFO was effective and well tolerated as first-line treatment for patients with advanced or metastatic STS, which warrants further research.

关 键 词：聚乙二醇化脂质体多柔比星 异环磷酰胺 晚期 转移性 软组织肉瘤 

分 类 号：R738.6[医药卫生—肿瘤]