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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
8
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pubmed:dateCreated |
1999-1-21
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pubmed:abstractText |
Exemestane is an irreversible, steroidal, oral aromatase inhibitor under evaluation in postmenopausal women with advanced breast cancer. A phase I study was conducted in 27 postmenopausal patients who were candidates for hormone therapy because they had advanced breast cancer and estrogen receptor-positive or unknown status. Most patients were moderately or heavily pretreated. Cohorts of at least three patients received sequentially escalating daily oral doses of 5-600 mg. The median duration of exemestane treatment was 13 weeks (range: 3-166 weeks). The maximal tolerated dose was not reached because of lack of treatment-related grade 3 or 4 toxicity. The most common adverse events, including those not related to treatment, were mild to moderate headache (44% of patients), dizziness (33%), nausea (33%), hot flushes (30%) and tumor-related pain (30%). There were three complete and four partial responses for an objective response rate of 26% (95% CI: 11.1-46.3%) in the intent-to-treat population; the median duration of response was 74 weeks (95% CI: 48-99 weeks). Exemestane, at the dose of 25 mg, maximally suppressed estradiol, estrone and estrone sulfate serum levels to 13, 5 and 10% of baseline, respectively. Exemestane appears to suppress estrogen, be well tolerated and have antitumor activity in postmenopausal women with advanced breast cancer. A large, safe therapeutic window of up to 600 mg was defined. In view of its safety and estrogen-suppression profiles, the most favorable effects were observed at the 25 mg daily dose.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Androstadienes,
http://linkedlifedata.com/resource/pubmed/chemical/Antineoplastic Agents,
http://linkedlifedata.com/resource/pubmed/chemical/Estrogen Antagonists,
http://linkedlifedata.com/resource/pubmed/chemical/Estrogens,
http://linkedlifedata.com/resource/pubmed/chemical/exemestane
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pubmed:status |
MEDLINE
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pubmed:month |
Sep
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pubmed:issn |
0959-4973
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
9
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
675-83
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:9823425-Adult,
pubmed-meshheading:9823425-Aged,
pubmed-meshheading:9823425-Androstadienes,
pubmed-meshheading:9823425-Antineoplastic Agents,
pubmed-meshheading:9823425-Breast Neoplasms,
pubmed-meshheading:9823425-Dizziness,
pubmed-meshheading:9823425-Dose-Response Relationship, Drug,
pubmed-meshheading:9823425-Estrogen Antagonists,
pubmed-meshheading:9823425-Estrogens,
pubmed-meshheading:9823425-Female,
pubmed-meshheading:9823425-Headache,
pubmed-meshheading:9823425-Humans,
pubmed-meshheading:9823425-Middle Aged,
pubmed-meshheading:9823425-Nausea,
pubmed-meshheading:9823425-Postmenopause
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pubmed:year |
1998
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pubmed:articleTitle |
Safety, activity and estrogen inhibition by exemestane in postmenopausal women with advanced breast cancer: a phase I study.
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pubmed:affiliation |
UZ Gasthuisberg, Dienst Gezwelziekten, Leuven, Belgium.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Research Support, Non-U.S. Gov't,
Clinical Trial, Phase I
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