Abstract |
A phase I multicenter evaluation of a novel antiestrogen, toremifene, was undertaken in postmenopausal women with various advanced difficult-to-treat malignancies. One hundred and seven women were treated at one of six dosage levels (10, 20, 40, 60, 200, or 400 mg/d orally) for at least 8 weeks. Weekly evaluations for toxicity were conducted. The most common side effects were nausea (31%), vomiting (12%), and hot flashes (29%). Five patients were removed from the study for possible adverse reactions: three patients experienced hypercalcemia; one experienced tremulousness, fatigue, and inability to think clearly; and one had vaginal bleeding. Twelve patients died while on study, 11 with disease progression and one with a pulmonary embolus. Sex hormone-binding globulin (SHBG) levels increased and there was a modest decline in serum antithrombin III levels. Four of 48 assessable patients had partial responses: three with breast cancer and one with endometrial cancer. Toremifene was generally well tolerated at the doses tested.
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Authors | J T Hamm, D C Tormey, P C Kohler, D Haller, M Green, I Shemano |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 9
Issue 11
Pg. 2036-41
(Nov 1991)
ISSN: 0732-183X [Print] United States |
PMID | 1834808
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents
- Estrogen Antagonists
- Gonadotropins
- Sex Hormone-Binding Globulin
- Tamoxifen
- Toremifene
- Antithrombin III
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Antithrombin III
(drug effects)
- Drug Evaluation
- Estrogen Antagonists
(adverse effects, therapeutic use)
- Female
- Gonadotropins
(blood)
- Humans
- Middle Aged
- Neoplasms
(drug therapy)
- Sex Hormone-Binding Globulin
(drug effects)
- Tamoxifen
(adverse effects, analogs & derivatives, therapeutic use)
- Toremifene
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