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, 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
N1 - Funding Information:
This study was supported, in part, by the Coordination, Support and Training Program for Translational Research, by the Kurokawa Cancer Research Foundation, by the Tohoku Gynecologic Cancer Unit, by the Japan Clinical Oncology Group, by a grant-in-aid from the Ministry of Education, Culture, Sports, Science and Technology, and by a grant-in-aid from the Ministry of Health, Labor and Welfare, Japan.
Publisher Copyright:
© 2013, Japan Society of Clinical Oncology.
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 -