Abstract | OBJECTIVE: METHODS: Patients with histologically confirmed persistent or recurrent leiomyosarcomas of the uterus with documented disease progression after appropriate local therapy were invited to participate in this study. Bidimensionally measurable disease, GOG performance status of 0, 1, or 2 (Karnofsky 80-100) was required; all patients must have failed local therapeutic measures and be considered incurable. Other eligibility criteria included adequate hepatic, renal, and hematologic function. Patients were ineligible if they had received previous chemotherapy or had other noncutaneous malignancies. Patients received liposomal doxorubicin 50 mg/m2 IV over 1 h. Courses were repeated every 4 weeks until disease progression or adverse side effects supervened. RESULTS: Thirty-five patients were entered into this study between May 2000 and June 2001. Three patients were determined ineligible because of wrong pathological cell type or inadequate pathology information and one was inevaluable for lack of data. Median age was 52 years (range 36-78 years). GOG performance status was 2 in 1 instance, 1 in 15 cases, and 0 in 15 others. Eleven patients (35.5%) had received radiotherapy. A median of 2.0 courses was given (range 1-8). Five patients (16.1%) experienced grade 3 or 4 neutropenia, and seven (22.6%) had grade 3 or 4 anemia. Two patients developed grade 3 and one patient developed grade 4 cardiovascular adverse events, not necessarily drug related. There were seven cases of grade 3 or 4 gastrointestinal toxicity and two patients developed grade 3 dermatologic toxicity. One complete (3.2%) and four partial (12.9%) responses were reported. Ten patients (32.3%) had stable disease, 15 (48.4%) had increasing disease, and response could not be assessed in 1 (3.2%). CONCLUSION:
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Authors | Gregory Sutton, John Blessing, Parviz Hanjani, Paul Kramer, Gynecologic Oncology Group |
Journal | Gynecologic oncology
(Gynecol Oncol)
Vol. 96
Issue 3
Pg. 749-52
(Mar 2005)
ISSN: 0090-8258 [Print] United States |
PMID | 15721421
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Antibiotics, Antineoplastic
- Doxorubicin
|
Topics |
- Adult
- Aged
- Antibiotics, Antineoplastic
(adverse effects, therapeutic use)
- Doxorubicin
(adverse effects, therapeutic use)
- Female
- Humans
- Leiomyosarcoma
(drug therapy)
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy)
- Uterine Neoplasms
(drug therapy)
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