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Evaluation of paclitaxel in previously treated leiomyosarcoma of the uterus: a gynecologic oncology group study.

AbstractOBJECTIVE:
The purpose of this phase II trial was to evaluate the efficacy of intravenous paclitaxel in patients with recurrent or advanced leiomyosarcoma of the uterus.
METHODS:
To be eligible, patients with recurrent or persistent leiomyosarcoma of the uterus were to have measurable disease not previously treated with paclitaxel and adequate hematologic (WBC >or=3000/microl, platelet count >or=100000/microl), renal (serum creatinine <or=2.0 mg%), and hepatic (bilirubin <or= 1.5 x institutional normal) functions. Paclitaxel was given at a dose of 175 mg/m(2) (135 mg/m(2) for patients with prior radiotherapy) intravenously over 3 h every 3 weeks.
RESULTS:
Fifty-three patients were entered on this study; 48 were evaluable for toxicity and response. Fifteen had prior irradiation and 39 had prior chemotherapy. A median of 2 (range: 1-12) courses was given. Grade 4 neutropenia occurred in 3 (6.3%) patients. No grade 4 thrombocytopenia was reported and no deaths were attributable to therapy. Four (8.4%) patients had a complete or partial response and 22.9% had stable disease.
CONCLUSIONS:
Although toxicity was minimal, this regimen demonstrated modest activity in patients with previously treated advanced or recurrent leiomyosarcoma of the uterus.
AuthorsDonald G Gallup, John A Blessing, Willie Andersen, Mark A Morgan, Gynecologic Oncology Group Study
JournalGynecologic oncology (Gynecol Oncol) Vol. 89 Issue 1 Pg. 48-51 (Apr 2003) ISSN: 0090-8258 [Print] United States
PMID12694653 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Antineoplastic Agents, Phytogenic
  • Paclitaxel
Topics
  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic (adverse effects, therapeutic use)
  • Female
  • Humans
  • Leiomyosarcoma (drug therapy)
  • Middle Aged
  • Neoplasm Recurrence, Local (drug therapy)
  • Paclitaxel (adverse effects, therapeutic use)
  • Uterine Neoplasms (drug therapy)

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