TY - JOUR
T1 - Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma
T2 - Results of a phase II trial
AU - Hensley, Martee L.
AU - Maki, Robert
AU - Venkatraman, E.
AU - Geller, Gennifer
AU - Lovegren, Meghan
AU - Aghajanian, Carol
AU - Sabbatini, Paul
AU - Tong, William
AU - Barakat, Richard
AU - Spriggs, David R.
PY - 2002/6/15
Y1 - 2002/6/15
N2 - Purpose: Few chemotherapy agents are active in leiomyosarcoma (LMS), particularly LMS that has progressed after doxorubicin treatment. We sought to determine the response to gemcitabine plus docetaxel among patients with LMS. Patients and Methods: Patients with unresectable LMS of uterine (n = 29) or other (n = 5) primary sites who did not respond to zero to two prior chemotherapy regimens were enrolled onto a phase II study of gemcitabine 900 mg/m2 intravenously (IV) on days 1 and 8 plus docetaxel 100 mg/m2 IV on day 8 with granulocyte colony-stimulating factor given subcutaneously on days 9 to 15, delivered every 21 days. Patients with prior pelvic radiation received 25% lower doses of both agents. Gemcitabine was delivered over 30 or 90 minutes in cycles 1 and 2 and by 90-minute infusion in all subsequent cycles. Pharmacokinetic studies assessed in vivo differences in gemcitabine concentrations with different rates of infusion. Results: Thirty-four patients (median age, 55 years; range, 32 to 74 years) have enrolled. Fourteen had received prior pelvic radiation. Sixteen of 34 patients had progressed after doxorubicin-based therapy; 18 had no prior chemotherapy. Among 34 patients, complete response was observed in three patients and partial response in 15, for an overall response rate of 53% (95% confidence interval, 35% to 70%). Seven patients had stable disease. Fifty percent of patients previously treated with doxorubicin responded. Hematologic toxicity was common (neutropenic: grade 3, 15%; grade 4, 6%; thrombocytopenia: grade 3, 26%; grade 4, 3%), but neutropenic fever (6%) and bleeding events (0%) were rare. The median time to progression was 5.6 months (range, 4 to 10 months). Conclusion: Gemcitabine plus docetoxel is tolerable and highly active in treated and untreated patients with LMS.
AB - Purpose: Few chemotherapy agents are active in leiomyosarcoma (LMS), particularly LMS that has progressed after doxorubicin treatment. We sought to determine the response to gemcitabine plus docetaxel among patients with LMS. Patients and Methods: Patients with unresectable LMS of uterine (n = 29) or other (n = 5) primary sites who did not respond to zero to two prior chemotherapy regimens were enrolled onto a phase II study of gemcitabine 900 mg/m2 intravenously (IV) on days 1 and 8 plus docetaxel 100 mg/m2 IV on day 8 with granulocyte colony-stimulating factor given subcutaneously on days 9 to 15, delivered every 21 days. Patients with prior pelvic radiation received 25% lower doses of both agents. Gemcitabine was delivered over 30 or 90 minutes in cycles 1 and 2 and by 90-minute infusion in all subsequent cycles. Pharmacokinetic studies assessed in vivo differences in gemcitabine concentrations with different rates of infusion. Results: Thirty-four patients (median age, 55 years; range, 32 to 74 years) have enrolled. Fourteen had received prior pelvic radiation. Sixteen of 34 patients had progressed after doxorubicin-based therapy; 18 had no prior chemotherapy. Among 34 patients, complete response was observed in three patients and partial response in 15, for an overall response rate of 53% (95% confidence interval, 35% to 70%). Seven patients had stable disease. Fifty percent of patients previously treated with doxorubicin responded. Hematologic toxicity was common (neutropenic: grade 3, 15%; grade 4, 6%; thrombocytopenia: grade 3, 26%; grade 4, 3%), but neutropenic fever (6%) and bleeding events (0%) were rare. The median time to progression was 5.6 months (range, 4 to 10 months). Conclusion: Gemcitabine plus docetoxel is tolerable and highly active in treated and untreated patients with LMS.
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U2 - 10.1200/JCO.2002.11.050
DO - 10.1200/JCO.2002.11.050
M3 - Article
C2 - 12065559
AN - SCOPUS:0037096747
SN - 0732-183X
VL - 20
SP - 2824
EP - 2831
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 12
ER -