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`PubMed
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`Abstract '
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`J Urol. 1989 Ju|;142(1):89-91.
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`High dose ketoconazole for the treatment of hormone
`refractory metastatic prostate carcinoma: 16 cases and
`review of the literature.
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`Jubelirer SJ1, Hogan T.
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`'-"Author information
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`Abstract
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`We treated 16 patients who had hormone refractory metastatic prostate
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`cancer with 400 mg. ketoconazole orally every 8 hours. None of the patients
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`had an objective response, although 6 (37.5 per cent) had stable disease (2
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`of whom had a subjective decrease in bone pain). The median duration of
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`stable disease was 6.8 months (range 2 to 12 months) and side effects were
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`seen in 14 patients. Nausea, vomiting or anorexia was noted in 10 patients,
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`rash and pruritus in 2, transient abnormal liver function tests in 1 and
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`transient pulmonary infiltrates in 1. Nine prior studies investigating the use of
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`ketoconazole in hormone refractory metastatic prostate cancer were
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`reviewed. Only 1 complete response was reported. A partial response was
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`noted in 14 per cent of the patients. Most of the patients had stable or
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`progressive disease. High dose ketoconazole as a single agent appears to
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`have limited use in patients who have failed prior systemic therapy.
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`PMID: 2659829 [PubMed — indexed for MEDLINE]
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`.;':I
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`3-
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`Publication Types, MeSH Terms, Substances
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`Link0ut - more resources
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`http://www.ncbi.n|m .nih.gov/pubmed/2659829
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`MYLAN PHARMS. INC. EXHIBIT 1028 PAGE 1
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`11/12/2015 High dose ketoconazole for the treatment of hormone refractory metastatic prostate carcinoma: 16 cases and review of the literature. - PubMed - N...
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