Takano Tadao, Niikura Hitoshi, Ito Kiyoshi, Nagase Satoru, Utsunomiya Hiroki, Otsuki Takeo, Toyoshima Masafumi, Tokunaga Hideki, Kaiho-Sakuma Michiko, Shiga Naomi, Nagai Tomoyuki, Tanaka Sota, Otsuki Ai, Kurosawa Hiroki, Shigeta Shogo, Tsuji Keita, Yamaguchi Takuhiro, Yaegashi Nobuo
Clinical Research, Innovation, and Education Center, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan,
Int J Clin Oncol. 2014 Oct;19(5):897-905. doi: 10.1007/s10147-013-0627-5. Epub 2013 Oct 24.
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 μg/m(2), days 9-15) has been shown to have activity in LMS. In Japan, neither prophylactic G-CSF at a dose of 150 μg/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.
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，有效的化疗药物很少。最近，已证明吉西他滨（900mg/m²，第1天和第8天）联合多西他赛（100mg/m²，第8天）加粒细胞集落刺激因子（G-CSF，150μg/m²，第9-15天）对LMS有活性。在日本，150μg/m²剂量的预防性G-CSF和100mg/m²剂量的多西他赛均未获批使用。因此，我们评估了在日本晚期或复发性LMS和UES患者中，900mg/m²吉西他滨联合70mg/m²多西他赛方案且无预防性G-CSF支持的疗效。
符合条件的晚期或复发性LMS和UES女性患者，每3周接受一次治疗，第1天和第8天给予900mg/m²吉西他滨，第8天给予70mg/m²多西他赛。主要终点是总缓解率，定义为完全缓解或部分缓解。
入组的11名女性中，10名接受了疗效评估。观察到1例完全缓解和2例部分缓解（30%），另外4例（40%）病情稳定。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%）使用了G-CSF。
在日本晚期或复发性LMS和UES患者中，无预防性G-CSF支持的吉西他滨加多西他赛方案耐受性良好且疗效显著。
