Gemcitabine/Docetaxel Combination as Second-line Treatment for 11 Advanced Soft Tissue Sarcoma Patients
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摘要:
目的 探讨吉西他滨联合多西他赛治疗晚期软组织肉瘤的临床疗效。 方法 收集11例对一线化疗药物耐药的晚期软组织肉瘤患者，应用吉西他滨（剂量为900 mg/m2，第1和第8天）联合多西他赛（剂量为100 mg/m2，第8天）每3周重复给药。如患者曾经接受放疗，吉西他滨剂量减为675 mg/m2，多西他赛剂量减为75 mg/m2。 结果 接受化疗的患者总有效率（CR+PR+SD）为54.5%。中位随访时间为19（1~36）个月，中位总生存期为15.4个月（95%CI：8.012~21.598）和中位无进展生存期为8.4个月（95%CI：7.342~8.768）。12个月和36个月的生存率分别是81.8%和27.3%。吉西他滨联合多西他赛治疗软组织肉瘤最常见的非血液学不良反应是黏膜炎，对症处理明显好转。 结论 吉西他滨联合多西他赛作为二线化疗药物治疗晚期软组织肉瘤患者具有较好的临床疗效，且有较好的耐受性，本研究结论为该方案的大样本临床试验提供了依据。 Abstract:Objective To investigate the promising anti-tumor effects of gemcitabine and/or docetaxel on metastatic or unresectable soft tissue sarcomas. Methods Data of 11 patients with advanced soft tissue sarcomas refractory to first-line chemotherapy treatment were enrolled in this study. They received gemcitabine alone or gemcitabine/docetaxel combination as follows: 900 mg/m2 gemcitabine on days 1 and 8, and 100 mg/m2 docetaxel on day 8. The regimen was repeated every 3 weeks. When irradiation was conducted before drug therapy, the doses were reduced to 675 mg/m2 gemcitabine on days 1 and 8, and 75 mg/m2 docetaxel on day 8. The regimen was repeated every 3 weeks. Results The gemcitabine/docetaxel combination was well tolerated. The most commonly observed hematologic toxicity of the combined therapy was neutropenia (45.5 %). The most common non-hematologic toxicity observed was mucositis (45.5 %). The overall response was 45.5%. Follow-ups ranging from 1 month to 36 months (median = 19 months) revealed that the median overall survival time was 15.4 months (95% CI = 8.012 - 21.598) and the median progression-free survival time was 8.4 months (95 % CI = 7.342 - 8.768). The one- and two-year survival rates were 81.8 % and 27.3 %, respectively. Conclusion Conclusion: A gemcitabine/docetaxel regimen as second-line treatment for patients with advanced soft tissues sarcomas is effective and has acceptable toxicities. These results should be evaluated in a large-sample Ⅲ trial. -
Key words:
- Advanced soft tissue sarcomas /
- Second-line chemotherapy /
- Gemcitabine /
- Docetaxel
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图 1 化疗患者的无病生存曲线及总生存曲线
A：无病生存曲线；B：总生存曲线
Figure 1. Disease-free survival and total survival curves of patients undergoing chemotherapy
表 1 11例接受吉西他滨联合多西他赛化疗患者的临床资料
Table 1. Clinical data of 11 patients subjected to gemcitabine/docetaxel combination chemotherapy
表 2 吉西他滨联合多西他赛化疗引起的不良反应 例（%）
Table 2. The hematologic toxicity of gemcitabine/docetaxel combination
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