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ENGLISH ABSTRACT
氨柔比星治疗小细胞肺癌的疗效分析
王玉艳
刘莉
吴梅娜
仲佳
刘晓红
安同彤
赵军
段建春
王志杰
卓明磊
王洁
作者及单位信息
·
DOI： 10.3760/cma.j.issn.1001-0939.2015.04.006
Prognostic factors and response of chemotherapy including amrubicin in small cell lung cancer patients
Wang Yuyan
Liu Li
Wu Meina
Zhong Jia
Liu Xiaohong
An Tongtong
Zhao Jun
Duan Jianchun
Wang Zhijie
Zhou Minglei
Wang Jie
Authors Info & Affiliations
Wang Yuyan
Department 1 of Thoracic Oncology, Beijing Cancer Hospital, Beijing University Oncology College, Beijing 100142, China
Liu Li
Wu Meina
Zhong Jia
Liu Xiaohong
An Tongtong
Zhao Jun
Duan Jianchun
Wang Zhijie
Zhou Minglei
Wang Jie
·
DOI： 10.3760/cma.j.issn.1001-0939.2015.04.006
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摘要

目的探讨氨柔比星治疗小细胞肺癌(SCLC)的疗效、毒性及患者的预后。

方法收集北京大学肿瘤医院胸部肿瘤内1科2008年11月至2013年4月接受氨柔比星治疗的31例SCLC患者，其中男21例，女10例，年龄32～75岁，氨柔比星采用静脉注射单药(40 mg/m 2，第1～3天给药，间隔21 d)或联合顺铂(60 mg/m 2，第1天给药，间隔21 d)。一线化疗方案包括氨柔比星联合顺铂11例，依托泊苷联合铂类18例及其他方案2例；二线及以上方案包括氨柔比星20例，托泊替康14例及其他方案28例。分析临床特点与无疾病进展生存期和总生存期的关系。采用SPSS 16.0(统计分析软件16.0)软件进行统计分析。

结果氨柔比星联合顺铂和单药化疗的中位无疾病进展生存期分别为7.5个月(95% CI为6.2～8.8)和4.1个月(95% CI为1.2～7.0， P＝0.090)。一线化疗后3个月内进展的难治性患者16例，3个月以上进展的敏感性患者15例，中位总生存期分别为14.2个月(95% CI为11.1～17.3)和21.3个月(95% CI为15.7～26.9， P＝0.018)。一线化疗氨柔比星联合顺铂与依托泊苷联合铂类方案的中位无疾病进展生存期分别为7.5个月(95% CI为6.2～8.8)和4.6个月(95% CI为1.7～7.5， P＝0.055)。二线及以上接受氨柔比星、托泊替康或其他方案化疗的中位无疾病进展生存期分别为4.1个月(95% CI为1.2～7.0)、1.4个月(95% CI为0.8～2.0)和1.6个月(95% CI为1.2～1.9， P＝0.013)，在难治性患者中分别为5.6个月(95% CI为2.0～9.2)、1.4个月(95% CI为0.6～2.2)和1.4个月(95% CI为0.8～2.0)。

结论氨柔比星单药作为SCLC二线及以上治疗方案安全有效，对难治性患者治疗效果较好，提示其或可成为难治性SCLC优选药物之一。

小细胞肺癌;氨柔比星
ABSTRACT

ObjectiveTo evaluate the response, toxicity and prognostic factors of amrubicin in the therapy of small cell lung cancer (SCLC).

MethodsThirty-one SCLC patients treated with amrubicin in Beijing Cancer Hospital from Dec.2008 to Apr.2013, including 21 males and 10 females, aged from 32 to 75 years, were enrolled in this study. Amrubicin was injected intravenously with 40 mg/m 2 d1-3, Q21 d or combined with cisplatin 60 mg/m 2 d1, Q 21 d. The first line chemotherapy regimens included amrubicin plus cisplatin in 11 cases, etopside plus platin in 18 cases and other drugs in 2 cases. The second and more line chemotherapy treatments included amrubicin in 20 cases, topotican in 14 cases and others in 28 cases. SPSS 16.0 statistical analysis software was used to analyze the clinical characteristics and survivals.

ResultsThe median progression free survival (PFS) of patients receiving amrubicin plus cisplatin and single amrubicin were 7.5 months (95% CI: 6.2 to 8.8) and 4.1 months (95% CI: 1.2 to 7.0) respectively ( P=0.090). There were 16 refractory patients whose disease progressed within 3 months after first line chemotherapy and 15 sensitive patients who had tumor progression after more than 3 months; the median survival time (MST) were 14.2 months (95% CI 11.1-17.3) and 21.3 months (95% CI 15.7-26.9) respectively( P=0.018). Patients treated with amrubicin plus cisplatin as first line therapy had a prolonged median PFS compared with etopside plus platin, which were 7.5 months (95% CI: 6.2-8.8) vs. 4.6 months(95% CI: 1.7-7.5)( P=0.055). Patients received amrubicin, topotican or other drugs as second or more line therapy had median PFS of 4.1 months(95% CI: 1.2-7.0), 1.4 months(95% CI: 0.8-2.0)and 1.6 months(95% CI: 1.2-1.9) respectively( P=0.013), while the median PFS was 5.6 months (95% CI: 2.0-9.2), 1.4 months (95% CI: 0.6-2.2) and 1.4 months(95% CI: 0.8-2.0)( P=0.005 and 0.003)in refractory patients.

ConclusionsAmrubicin as second or more line treatment was shown to be an effective and safe drug for SCLC patients with a significant survival benefit compared with other drugs, especially in refractory patients. It suggested that amrubicin might be one of the preferred therapies for refractory SCLC.

Small cell lung Cancer;Amrubicin
Wang Jie, Email: mocdef.3ab61ixuhlz

Wang Yuyan and Liu Li are equally contributed to this article.

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引用本文

王玉艳,刘莉,吴梅娜,等. 氨柔比星治疗小细胞肺癌的疗效分析[J]. 中华结核和呼吸杂志,2015,38(4)：261-266.

DOI:10.3760/cma.j.issn.1001-0939.2015.04.006

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近十余年来，非小细胞肺癌药物治疗突飞猛进 [ 1 , 2 ]，但小细胞肺癌(small cell lung cancer，SCLC)的治疗进展缓慢 [ 3 , 4 , 5 ]。依托泊苷联合铂类仍是SCLC一线标准方案 [ 6 ]，但远期疗效不佳，多数患者于化疗停止6个月内进展 [ 7 ]。目前标准二线治疗药物仅有托泊替康，但疗效较一线治疗差，对耐药性复发的SCLC疗效甚微 [ 8 ]。探寻新型治疗方案已成为改善SCLC患者预后的希望。氨柔比星为新型蒽环霉素类药物，对DNA拓扑异构酶Ⅱ具有强抑制作用，其体内活性代谢产物氨柔比星醇的细胞毒性是原型的5～200倍，而心脏和肾脏的迟发性毒性小 [ 9 , 10 , 11 ]。
氨柔比星作为单药一线方案或联合铂类治疗广泛期SCLC的有效率为73.0%～87.8% [ 12 , 13 , 14 ]。我国近期研究结果提示氨柔比星联合顺铂与依托泊苷联合顺铂方案治疗广泛期SCLC的有效率分别为69.8%和57.3% [ 15 ]。氨柔比星作为二线及以上方案治疗敏感性和难治性SCLC的有效率分别为43%～53%和17%～60%，中位总生存期分别为10.4～12.0个月和6.8～11.0个月 [ 16 , 17 , 18 ]。对于难治性患者，氨柔比星的有效率及无进展生存期均明显优于托泊替康 [ 16 ]。目前氨柔比星尚未通过中国国家食品药品监督管理总局批准，国内相关研究报道甚少。本中心31例SCLC患者曾接受该药物治疗(20例外购于日本，11例参加盐酸氨柔比星联合顺铂化疗与依托泊苷联合顺铂化疗对照治疗广泛期SCLC的Ⅲ期临床试验，方案编号为D0750018，本中心为参加单位之一)，我们对其进行临床特征和生存随访分析，探讨影响其疗效和预后的相关因素，以期为指导SCLC患者的临床治疗决策、判断预后提供参考依据。
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备注信息
A
王洁，Email： mocdef.3ab61ixuhlz
B

王玉艳与刘莉对本文有同等贡献

C
北京肿瘤医院病理科孙宇医生、放射影像科汪宁医生在病理诊断、影像评估及统计学方面给予的帮助
D
国家自然科学基金杰出青年基金 (81025012)
北京市卫生系统学科带头人 (2011-2-22)
教育部高等学校博士学科点专项科研基金新教师类基金 (20100001120124)
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