TY - JOUR
T1 - Phase II study of mitomycin, doxorubicin, and cisplatin in the treatment of advanced uterine leiomyosarcoma
T2 - A Gynecologic Oncology Group study
AU - Edmonson, John H.
AU - Blessing, John A.
AU - Cosin, Jonathan A.
AU - Miller, David Scott
AU - Cohn, David E.
AU - Rotmensch, Jacob
N1 - Funding Information:
This study was supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gyneco- logic Oncology Group Statistical and Data Center (CA 37517). The following Gynecologic Oncology Group institutions participated in this study: University of Alabama at Birmingham, Duke University Medical Center, University of Minnesota Medical School, Colorado Gynecologic Oncology Group P.C., University of California at Los Angeles, University of Pennsylvania Cancer Center, Milton S. Hershey Medical Center, University of Cincinnati, University of North Carolina School of Medicine, University of Texas Southwestern Medical Center at Dallas, Wake Forest University School of Medicine, University of California Medical Center at Irvine, SUNY Downstate Medical Center, Community Clinical Oncology Program, State University of New York at Stony Brook, Columbus Cancer Council, Fox Chase Cancer Center, Medical University of South Carolina, University of Virginia, University of Chicago, Thomas Jefferson University Hospital, Tampa Bay Cancer Consortium, North Shore University Hospital, and Brookview Research, Inc.
PY - 2002
Y1 - 2002
N2 - Objective. Because of preliminary observations favoring the use of mitomycin, doxorubicin, and cisplatin (MAP) chemotherapy in leiomyosarcomas, the Gynecologic Oncology Group (GOG) decided to conduct a phase II clinical trial of this combination regimen in patients with advanced disease. Methods. Patients with histologically confirmed uterine leiomyosarcoma who had not previously received cytotoxic drugs were considered for participation in this clinical trial. Eligible patients had measurable disease, GOG performance status 0-2, and adequate bone marrow, renal, and hepatic function according to standard criteria. Mitomycin 8 mg/m2 and doxorubicin 40 mg/m2 were each given by iv injection followed immediately by cisplatin 60 mg/m2 in 1 liter of 0.45% saline plus mannitol 25 g. Patients who remained free from tumor progression or intolerable toxicity received at least three, to a maximum of six, cycles of MAP. Results. Forty-one patients were registered, of whom 4 were determined ineligible (wrong cell type, 2; wrong site of origin, 1; inadequate pathology material, 1). Thirty-five of the 37 were evaluable for response after receiving from one to six (median three) cycles of MAP. Three patients (9%) achieved a complete response and 5 (14%) exhibited a partial response. The most common adverse effects were leukopenia (33 patients) and thrombocytopenia (30 patients). Pulmonary toxicity was seen in 10 patients and was a factor in the clinical deterioration and death of 2. Conclusions. MAP is active against advanced uterine leiomyosarcomas, but not remarkably so. Despite its low therapeutic index, this novel, possibly interactive, combination may serve as a forerunner to regimens that more efficiently exploit the enhancement of sarcoma cell kill under hypoxic conditions.
AB - Objective. Because of preliminary observations favoring the use of mitomycin, doxorubicin, and cisplatin (MAP) chemotherapy in leiomyosarcomas, the Gynecologic Oncology Group (GOG) decided to conduct a phase II clinical trial of this combination regimen in patients with advanced disease. Methods. Patients with histologically confirmed uterine leiomyosarcoma who had not previously received cytotoxic drugs were considered for participation in this clinical trial. Eligible patients had measurable disease, GOG performance status 0-2, and adequate bone marrow, renal, and hepatic function according to standard criteria. Mitomycin 8 mg/m2 and doxorubicin 40 mg/m2 were each given by iv injection followed immediately by cisplatin 60 mg/m2 in 1 liter of 0.45% saline plus mannitol 25 g. Patients who remained free from tumor progression or intolerable toxicity received at least three, to a maximum of six, cycles of MAP. Results. Forty-one patients were registered, of whom 4 were determined ineligible (wrong cell type, 2; wrong site of origin, 1; inadequate pathology material, 1). Thirty-five of the 37 were evaluable for response after receiving from one to six (median three) cycles of MAP. Three patients (9%) achieved a complete response and 5 (14%) exhibited a partial response. The most common adverse effects were leukopenia (33 patients) and thrombocytopenia (30 patients). Pulmonary toxicity was seen in 10 patients and was a factor in the clinical deterioration and death of 2. Conclusions. MAP is active against advanced uterine leiomyosarcomas, but not remarkably so. Despite its low therapeutic index, this novel, possibly interactive, combination may serve as a forerunner to regimens that more efficiently exploit the enhancement of sarcoma cell kill under hypoxic conditions.
KW - Mitomycin + doxorubicin + cisplatin (MAP)
KW - Uterine leiomyosarcoma
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U2 - 10.1006/gyno.2002.6661
DO - 10.1006/gyno.2002.6661
M3 - Article
C2 - 12051882
AN - SCOPUS:0036084166
SN - 0090-8258
VL - 85
SP - 507
EP - 510
JO - Gynecologic oncology
JF - Gynecologic oncology
IS - 3
ER -