Feasibility study of gemcitabine plus docetaxel in advanced or recurrent uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan
Feasibility study of gemcitabine plus docetaxel in advanced or recurrent uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan
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DOI：
10.1007/s10147-013-0627-5
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发表时间：
2014-10-01
影响因子：
3.3
通讯作者：
Yaegashi, Nobuo
中科院分区：
文献类型：
--
作者：
Takano, Tadao;Niikura, Hitoshi;Yaegashi, Nobuo
子宫平滑肌肉瘤（LMS）和未分化子宫内膜肉瘤（UES）是罕见的侵袭性恶性肿瘤。两者的治疗方法相似;然而，很少有化疗药物有效。最近，吉西他滨（900 mg/m2，第1天和第8天）加多西他赛（100 mg/m2，第8天）与粒细胞集落刺激因子（G-CSF，150 μ g/m2，第9-15天）的组合已被证明在LMS中具有活性。在日本，150 μ g/m2剂量的预防性G-CSF和100 mg/m2剂量的多西他赛均未被批准使用。因此，我们评估了900 mg/m2吉西他滨+70 mg/m2多西他赛联合方案治疗日本晚期或复发性LMS和UES患者，无预防性G-CSF支持。符合条件的晚期或复发性LMS和UES女性患者接受900 mg/m2吉西他滨第1天和第8天治疗，70 mg/m2多西他赛第8天治疗，每3周一次。主要终点是总体反应率，定义为完全或部分反应。在11名入选的妇女中，10名被评估为反应。观察到1例完全缓解和2例部分缓解（30%），另外4例（40%）疾病稳定。平均无进展生存期为5.4个月（范围1.3-24.8个月），总生存期为14个月（范围5.3-38.4个月）。4级中性粒细胞减少是主要毒性（50%）。中位周期数为5（范围2-18）。22个周期（44%）使用G-CSF。吉西他滨+多西他赛方案不需要预防性G-CSF支持，在晚期或复发性LMS和UES的日本患者中是耐受的，并且非常有效。
Uterine leiomyosarcoma (LMS) and undifferentiated endometrial sarcoma (UES) are rare, aggressive malignancies. Both are treated similarly; however, few chemotherapy agents are effective. Recently, the combination of gemcitabine (900 mg/m(2), days 1 and 8) plus docetaxel (100 mg/m(2), day 8) with granulocyte colony-stimulating factor (G-CSF, 150 mu g/m(2), days 9-15) has been shown to have activity in LMS. In Japan, neither prophylactic G-CSF at a dose of 150 mu g/m(2) nor docetaxel at a dose of 100 mg/m(2) are approved for use. For this reason, we evaluated the combination of 900 mg/m(2) gemcitabine plus 70 mg/m(2) docetaxel regimen without prophylactic G-CSF support in advanced or recurrent LMS and UES in Japanese patients.Eligible women with advanced or recurrent LMS and UES were treated with 900 mg/m(2) gemcitabine on days 1 and 8, plus 70 mg/m(2) docetaxel on day 8, every 3 weeks. The primary endpoint was overall response rate, defined as a complete or partial response.Of the eleven women enrolled, 10 were evaluated for a response. One complete response and 2 partial responses were observed (30 %) with an additional 4 (40 %) having stable disease. Mean progression-free survival was 5.4 months (range 1.3-24.8 months), and overall survival was 14 months (range 5.3-38.4 months). Grade 4 neutropenia was the major toxicity (50 %). The median number of cycles was 5 (range 2-18). Twenty-two cycles (44 %) employed G-CSF.The gemcitabine plus docetaxel regimen without prophylactic G-CSF support was tolerable and highly efficacious in Japanese patients with advanced or recurrent LMS and UES.