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一线化疗联合或不联合表柔比星治疗晚期软组织肉瘤患者的疗效与毒性比较。

Comparison of efficacy and toxicity of first line chemotherapy with or without epirubicin for patients with advanced stage soft tissue sarcoma.

作者信息

Cao Jie, Huang Xin-En, Liu Jin, Wu Xue-Yan, Lu Yan-Yan

机构信息

Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University and Jiangsu Institute of Cancer Research, Nanjing, China E-mail :

出版信息

Asian Pac J Cancer Prev. 2013;14(12):7171-7. doi: 10.7314/apjcp.2013.14.12.7171.

Abstract

PURPOSE

To compare the safety and efficacy of first-line chemotherapy regimen with or without doxorubicin in treating patients with advanced soft tissue sarcoma (STS).

PATIENTS AND METHODS

We retrospectively analyzed a cohort of 56 patients histologically confirmed with STS who were treated at Jiangsu Cancer Hospital and Research Institute from July 2011 to June 2012.The basic element of first line chemotherapy contained epirubicin in group B and lacked epirubicin in group A. Response was assessed using RECIST criteria. The Kaplan-Meier method was used to estimate progress free survival (PFS).

RESULTS

According to RECIST criteria , patients in group treated by chemotherapy without epirubicin, the objective response (OR) ratio was 6.5 % (CR0%+PR6.5%). Disease control rate (DCR=CR+PR+SD) was 25.8% with a median follow-up of 14.6 months, including 2 patients achieving a partial response (PR 6.5%) and a stable response (SD 19.4%) in 6. In group B with epirubicin based regimens, no patient had complete response, PR (28 %) was observed in 7 and SD (24 %) in 6. DCR was observed in 13 patients (52%). By Fisher's exact test, the DCR difference between the two groups was statistically significant (p=0.046). In group A, median PFS was 3.0 months (95%CI:2.1-3.8), compared with 4.0 months (95% CI:3.03- 4.97) in group B (p=0.0397 by log-rank test). Epirubicin based chemotherapy and ECOG performance status 0-1 were identified as favorable factors for progression in our cohort of patients. Differences of nonhematologic and hematologic toxicities were not statistically significant between the two groups, and the addition of epirobicin was not associated with cardiac toxicity (p=0.446).

CONCLUSION

Our study demonstrates that epirubicin-based chemotherapy is effective and well tolerated, and is superior to chemotherapy without epirubicin regarding efficacy. Therefore it is recommended that epirubicin-based chemotherapy should be considered as first line for patients with advanced STS.

摘要

目的

比较含或不含多柔比星的一线化疗方案治疗晚期软组织肉瘤(STS)患者的安全性和疗效。

患者与方法

我们回顾性分析了2011年7月至2012年6月在江苏省肿瘤医院及研究所接受治疗的56例经组织学确诊为STS的患者队列。一线化疗的基本要素在B组中包含表柔比星,而A组中不含表柔比星。使用RECIST标准评估反应。采用Kaplan-Meier方法估计无进展生存期(PFS)。

结果

根据RECIST标准,在接受不含表柔比星化疗的组中,客观缓解(OR)率为6.5%(完全缓解0%+部分缓解6.5%)。疾病控制率(DCR=完全缓解+部分缓解+疾病稳定)为25.8%,中位随访时间为14.6个月,其中2例患者达到部分缓解(部分缓解率6.5%),6例患者疾病稳定(疾病稳定率19.4%)。在以表柔比星为基础方案的B组中,无患者达到完全缓解,7例患者观察到部分缓解(部分缓解率28%),6例患者疾病稳定(疾病稳定率24%)。13例患者观察到疾病控制率(52%)。通过Fisher精确检验,两组之间的疾病控制率差异具有统计学意义(p=0.046)。在A组中,中位PFS为3.0个月(95%CI:2.1-3.8),而B组为4.0个月(95%CI:3.03-4.97)(对数秩检验p=0.0397)。在我们的患者队列中,以表柔比星为基础的化疗和ECOG体能状态0-1被确定为疾病进展的有利因素。两组之间非血液学和血液学毒性的差异无统计学意义,并且添加表柔比星与心脏毒性无关(p=0.446)。

结论

我们的研究表明,以表柔比星为基础的化疗有效且耐受性良好,在疗效方面优于不含表柔比星的化疗。因此,建议将以表柔比星为基础的化疗作为晚期STS患者的一线治疗方案。

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