TY - JOUR
T1 - Feasibility study of gemcitabine plus docetaxel in advanced or recurrent uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan
AU - Takano, Tadao
AU - Niikura, Hitoshi
AU - Ito, Kiyoshi
AU - Nagase, Satoru
AU - Utsunomiya, Hiroki
AU - Otsuki, Takeo
AU - Toyoshima, Masafumi
AU - Tokunaga, Hideki
AU - Kaiho-Sakuma, Michiko
AU - Shiga, Naomi
AU - Nagai, Tomoyuki
AU - Tanaka, Sota
AU - Otsuki, Ai
AU - Kurosawa, Hiroki
AU - Shigeta, Shogo
AU - Tsuji, Keita
AU - Yamaguchi, Takuhiro
AU - Yaegashi, Nobuo
PY - 2014/10/16
Y1 - 2014/10/16
N2 - Background: 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/m2, days 1 and 8) plus docetaxel (100 mg/m2, day 8) with granulocyte colony-stimulating factor (G-CSF, 150 μg/m2, days 9–15) has been shown to have activity in LMS. In Japan, neither prophylactic G-CSF at a dose of 150 μg/m2nor docetaxel at a dose of 100 mg/m2are approved for use. For this reason, we evaluated the combination of 900 mg/m2gemcitabine plus 70 mg/m2docetaxel regimen without prophylactic G-CSF support in advanced or recurrent LMS and UES in Japanese patients.Methods: Eligible women with advanced or recurrent LMS and UES were treated with 900 mg/m2gemcitabine on days 1 and 8, plus 70 mg/m2docetaxel on day 8, every 3 weeks. The primary endpoint was overall response rate, defined as a complete or partial response.Results: 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.Conclusion: 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.
AB - Background: 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/m2, days 1 and 8) plus docetaxel (100 mg/m2, day 8) with granulocyte colony-stimulating factor (G-CSF, 150 μg/m2, days 9–15) has been shown to have activity in LMS. In Japan, neither prophylactic G-CSF at a dose of 150 μg/m2nor docetaxel at a dose of 100 mg/m2are approved for use. For this reason, we evaluated the combination of 900 mg/m2gemcitabine plus 70 mg/m2docetaxel regimen without prophylactic G-CSF support in advanced or recurrent LMS and UES in Japanese patients.Methods: Eligible women with advanced or recurrent LMS and UES were treated with 900 mg/m2gemcitabine on days 1 and 8, plus 70 mg/m2docetaxel on day 8, every 3 weeks. The primary endpoint was overall response rate, defined as a complete or partial response.Results: 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.Conclusion: 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.
KW - Chemotherapy
KW - Docetaxel
KW - G-CSF
KW - Gemcitabine
KW - Japanese patients
KW - Uterine leiomyosarcoma
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U2 - 10.1007/s10147-013-0627-5
DO - 10.1007/s10147-013-0627-5
M3 - Article
C2 - 24149774
AN - SCOPUS:84919386754
VL - 19
SP - 897
EP - 905
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
SN - 1341-9625
IS - 5
ER -