A Phase II trial of leuprolide acetate in patients with advanced epithelial ovarian carcinoma: A Gynecologic Oncology Group study

D. S. Miller, M. F. Brady, R. J. Barrett

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Abstract

Twenty-five evaluable patients with advanced or recurrent epithelial ovarian carcinoma that was no longer controllable with surgery, radiation therapy, and/or chemotherapy were treated with leuprolide acetate, a gonadotropin-releasing hormone agonist, 1 mg subcutaneously daily. One partial response (4%) was observed among the 25 patients. The upper 95% confidence bound of the response rate is 17.6%. Fifteen patients (60%) exhibited stable disease for at least 8 weeks, and 9 patients (36%) developed progressive cancer while receiving treatment. The regimen was well tolerated with no patient experiencing life-threatening toxicity. Mild toxicities included leukopenia in 2 patients (8%), thrombocytopenia in 2 patients (8%), gastrointestinal toxicity in 5 patients (20%), anemia in 4 patients (16%), hot flashes in 1 patient (4%), and facial swelling in 1 patient (4%). Thus, leuprolide acetate was well tolerated but has insignificant activity in treating patients with chemotherapy-refractory ovarian adenocarcinoma.

Original languageEnglish (US)
Pages (from-to)125-128
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume15
Issue number2
DOIs
StatePublished - Jan 1 1992
Externally publishedYes

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Leuprolide
Carcinoma
Hot Flashes
Drug Therapy
Leukopenia
Gonadotropin-Releasing Hormone
Anemia

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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abstract = "Twenty-five evaluable patients with advanced or recurrent epithelial ovarian carcinoma that was no longer controllable with surgery, radiation therapy, and/or chemotherapy were treated with leuprolide acetate, a gonadotropin-releasing hormone agonist, 1 mg subcutaneously daily. One partial response (4{\%}) was observed among the 25 patients. The upper 95{\%} confidence bound of the response rate is 17.6{\%}. Fifteen patients (60{\%}) exhibited stable disease for at least 8 weeks, and 9 patients (36{\%}) developed progressive cancer while receiving treatment. The regimen was well tolerated with no patient experiencing life-threatening toxicity. Mild toxicities included leukopenia in 2 patients (8{\%}), thrombocytopenia in 2 patients (8{\%}), gastrointestinal toxicity in 5 patients (20{\%}), anemia in 4 patients (16{\%}), hot flashes in 1 patient (4{\%}), and facial swelling in 1 patient (4{\%}). Thus, leuprolide acetate was well tolerated but has insignificant activity in treating patients with chemotherapy-refractory ovarian adenocarcinoma.",
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