Bioequivalence of 20-mg once-daily tamoxifen relative to 10-mg twice-daily tamoxifen regimens for breast cancer
We studied the bioequivalence of a new once-daily regimen of tamoxifen citrate relative to the standard twice-daily regimen of tamoxifen citrate, an established antiestrogenic treatment for breast cancer. Of 30 women with breast cancer, 27 completed this open, two-period, crossover randomized trial....
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| Veröffentlicht in: | Journal of clinical oncology 1994-01, Vol.12 (1), p.50-54 |
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| container_title | Journal of clinical oncology |
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| creator | BUZDAR, A. U HORTOBAGYI, G. N PLOURDE, P. V FRYE, D HO, D BOOSER, D. J VALERO, V HOLMES, F. A BIRMINGHAM, B. K BUI, K CHIAO YEH |
| description | We studied the bioequivalence of a new once-daily regimen of tamoxifen citrate relative to the standard twice-daily regimen of tamoxifen citrate, an established antiestrogenic treatment for breast cancer.
Of 30 women with breast cancer, 27 completed this open, two-period, crossover randomized trial. During one 3-month period, patients took one standard 10-mg tamoxifen tablet twice daily; during the preceding or following 3-month period, patients took one of the new 20-mg tablets once daily. Pharmacokinetic profiles and safety parameters were assessed at the end of each 3-month treatment period.
Overall, measured concentrations of tamoxifen and its principal active metabolite, N-desmethyltamoxifen, remained relatively constant over the 24-hour sampling periods at the end of each treatment sequence. For both compounds, the percentage differences of the geometric means for all pharmacokinetic parameters indicated bioequivalence of the once-daily regimen of tamoxifen relative to the standard twice-daily regimen. Both treatment sequences were well tolerated; reported adverse events occurred at similar frequencies with the two treatment regimens.
The 20-mg tamoxifen tablet taken once daily was bioequivalent to the 10-mg tamoxifen tablet taken twice daily, with no difference in relative risk. The once-daily treatment is a simpler regimen and may facilitate compliance, which may enhance therapeutic outcomes during long-term treatment of breast cancer. |
| doi_str_mv | 10.1200/JCO.1994.12.1.50 |
| format | Article |
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Of 30 women with breast cancer, 27 completed this open, two-period, crossover randomized trial. During one 3-month period, patients took one standard 10-mg tamoxifen tablet twice daily; during the preceding or following 3-month period, patients took one of the new 20-mg tablets once daily. Pharmacokinetic profiles and safety parameters were assessed at the end of each 3-month treatment period.
Overall, measured concentrations of tamoxifen and its principal active metabolite, N-desmethyltamoxifen, remained relatively constant over the 24-hour sampling periods at the end of each treatment sequence. For both compounds, the percentage differences of the geometric means for all pharmacokinetic parameters indicated bioequivalence of the once-daily regimen of tamoxifen relative to the standard twice-daily regimen. Both treatment sequences were well tolerated; reported adverse events occurred at similar frequencies with the two treatment regimens.
The 20-mg tamoxifen tablet taken once daily was bioequivalent to the 10-mg tamoxifen tablet taken twice daily, with no difference in relative risk. The once-daily treatment is a simpler regimen and may facilitate compliance, which may enhance therapeutic outcomes during long-term treatment of breast cancer.</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.1994.12.1.50</identifier><identifier>PMID: 8270984</identifier><language>eng</language><publisher>Baltimore, MD: American Society of Clinical Oncology</publisher><subject>Administration, Oral ; Aged ; Analysis of Variance ; Antineoplastic agents ; Biological and medical sciences ; Breast Neoplasms - drug therapy ; Breast Neoplasms - metabolism ; Chemotherapy ; Drug Administration Schedule ; Female ; Humans ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Tamoxifen - administration & dosage ; Tamoxifen - analogs & derivatives ; Tamoxifen - blood ; Tamoxifen - pharmacokinetics ; Therapeutic Equivalency</subject><ispartof>Journal of clinical oncology, 1994-01, Vol.12 (1), p.50-54</ispartof><rights>1994 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c352t-9a096362bc3d8d6aa870ace2ceef7dd94ca19fe26fe3925cb6603fa41160a6d43</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3715,4009,27902,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=3894760$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/8270984$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>BUZDAR, A. U</creatorcontrib><creatorcontrib>HORTOBAGYI, G. N</creatorcontrib><creatorcontrib>PLOURDE, P. V</creatorcontrib><creatorcontrib>FRYE, D</creatorcontrib><creatorcontrib>HO, D</creatorcontrib><creatorcontrib>BOOSER, D. J</creatorcontrib><creatorcontrib>VALERO, V</creatorcontrib><creatorcontrib>HOLMES, F. A</creatorcontrib><creatorcontrib>BIRMINGHAM, B. K</creatorcontrib><creatorcontrib>BUI, K</creatorcontrib><creatorcontrib>CHIAO YEH</creatorcontrib><title>Bioequivalence of 20-mg once-daily tamoxifen relative to 10-mg twice-daily tamoxifen regimens for breast cancer</title><title>Journal of clinical oncology</title><addtitle>J Clin Oncol</addtitle><description>We studied the bioequivalence of a new once-daily regimen of tamoxifen citrate relative to the standard twice-daily regimen of tamoxifen citrate, an established antiestrogenic treatment for breast cancer.
Of 30 women with breast cancer, 27 completed this open, two-period, crossover randomized trial. During one 3-month period, patients took one standard 10-mg tamoxifen tablet twice daily; during the preceding or following 3-month period, patients took one of the new 20-mg tablets once daily. Pharmacokinetic profiles and safety parameters were assessed at the end of each 3-month treatment period.
Overall, measured concentrations of tamoxifen and its principal active metabolite, N-desmethyltamoxifen, remained relatively constant over the 24-hour sampling periods at the end of each treatment sequence. For both compounds, the percentage differences of the geometric means for all pharmacokinetic parameters indicated bioequivalence of the once-daily regimen of tamoxifen relative to the standard twice-daily regimen. Both treatment sequences were well tolerated; reported adverse events occurred at similar frequencies with the two treatment regimens.
The 20-mg tamoxifen tablet taken once daily was bioequivalent to the 10-mg tamoxifen tablet taken twice daily, with no difference in relative risk. The once-daily treatment is a simpler regimen and may facilitate compliance, which may enhance therapeutic outcomes during long-term treatment of breast cancer.</description><subject>Administration, Oral</subject><subject>Aged</subject><subject>Analysis of Variance</subject><subject>Antineoplastic agents</subject><subject>Biological and medical sciences</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - metabolism</subject><subject>Chemotherapy</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Tamoxifen - administration & dosage</subject><subject>Tamoxifen - analogs & derivatives</subject><subject>Tamoxifen - blood</subject><subject>Tamoxifen - pharmacokinetics</subject><subject>Therapeutic Equivalency</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1994</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkL1vFDEQxS0ECpdAT4PkAtHt4Y-1vS7hFJKgSGlAorPmvOOLI-85sffy8d_jkEtoqEZP83tvNI-QD5wtuWDsy4_VxZJb2ze15EvFXpEFV8J0xij1miyYkaLjg_z9lhzWesUY7wepDsjBIAyzQ78g-VvMeLOLt5Bw65HmQAXrpg3NTXUjxPRAZ5jyfQy4pQUTzPEW6Zwp_4vNd_G_3CZOuK005ELXBaHO1ENLLO_ImwCp4vv9PCK_vh__XJ125xcnZ6uv552XSsydBWa11GLt5TiMGmAwDDwKjxjMONreA7cBhQ4orVB-rTWTAXrONQM99vKIfH7KvS75Zod1dlOsHlOCLeZddUZLoZRQDWRPoC-51oLBXZc4QXlwnLnHjl3r2D123JTjTrFm-bjP3q0nHF8M-1Lb_tN-D9VDCqV9HusLJgfbG83-YZdxc3kXC7o6QUotVLgrn5-v_QGNQJHe</recordid><startdate>19940101</startdate><enddate>19940101</enddate><creator>BUZDAR, A. 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K ; BUI, K ; CHIAO YEH</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c352t-9a096362bc3d8d6aa870ace2ceef7dd94ca19fe26fe3925cb6603fa41160a6d43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1994</creationdate><topic>Administration, Oral</topic><topic>Aged</topic><topic>Analysis of Variance</topic><topic>Antineoplastic agents</topic><topic>Biological and medical sciences</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - metabolism</topic><topic>Chemotherapy</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Tamoxifen - administration & dosage</topic><topic>Tamoxifen - analogs & derivatives</topic><topic>Tamoxifen - blood</topic><topic>Tamoxifen - pharmacokinetics</topic><topic>Therapeutic Equivalency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>BUZDAR, A. U</creatorcontrib><creatorcontrib>HORTOBAGYI, G. N</creatorcontrib><creatorcontrib>PLOURDE, P. V</creatorcontrib><creatorcontrib>FRYE, D</creatorcontrib><creatorcontrib>HO, D</creatorcontrib><creatorcontrib>BOOSER, D. J</creatorcontrib><creatorcontrib>VALERO, V</creatorcontrib><creatorcontrib>HOLMES, F. A</creatorcontrib><creatorcontrib>BIRMINGHAM, B. K</creatorcontrib><creatorcontrib>BUI, K</creatorcontrib><creatorcontrib>CHIAO YEH</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>BUZDAR, A. U</au><au>HORTOBAGYI, G. N</au><au>PLOURDE, P. V</au><au>FRYE, D</au><au>HO, D</au><au>BOOSER, D. J</au><au>VALERO, V</au><au>HOLMES, F. A</au><au>BIRMINGHAM, B. K</au><au>BUI, K</au><au>CHIAO YEH</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bioequivalence of 20-mg once-daily tamoxifen relative to 10-mg twice-daily tamoxifen regimens for breast cancer</atitle><jtitle>Journal of clinical oncology</jtitle><addtitle>J Clin Oncol</addtitle><date>1994-01-01</date><risdate>1994</risdate><volume>12</volume><issue>1</issue><spage>50</spage><epage>54</epage><pages>50-54</pages><issn>0732-183X</issn><eissn>1527-7755</eissn><abstract>We studied the bioequivalence of a new once-daily regimen of tamoxifen citrate relative to the standard twice-daily regimen of tamoxifen citrate, an established antiestrogenic treatment for breast cancer.
Of 30 women with breast cancer, 27 completed this open, two-period, crossover randomized trial. During one 3-month period, patients took one standard 10-mg tamoxifen tablet twice daily; during the preceding or following 3-month period, patients took one of the new 20-mg tablets once daily. Pharmacokinetic profiles and safety parameters were assessed at the end of each 3-month treatment period.
Overall, measured concentrations of tamoxifen and its principal active metabolite, N-desmethyltamoxifen, remained relatively constant over the 24-hour sampling periods at the end of each treatment sequence. For both compounds, the percentage differences of the geometric means for all pharmacokinetic parameters indicated bioequivalence of the once-daily regimen of tamoxifen relative to the standard twice-daily regimen. Both treatment sequences were well tolerated; reported adverse events occurred at similar frequencies with the two treatment regimens.
The 20-mg tamoxifen tablet taken once daily was bioequivalent to the 10-mg tamoxifen tablet taken twice daily, with no difference in relative risk. The once-daily treatment is a simpler regimen and may facilitate compliance, which may enhance therapeutic outcomes during long-term treatment of breast cancer.</abstract><cop>Baltimore, MD</cop><pub>American Society of Clinical Oncology</pub><pmid>8270984</pmid><doi>10.1200/JCO.1994.12.1.50</doi><tpages>5</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Journal of clinical oncology, 1994-01, Vol.12 (1), p.50-54 |
| issn | 0732-183X 1527-7755 |
| language | eng |
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| source | MEDLINE; American Society of Clinical Oncology Online Journals; Journals@Ovid Ovid Autoload |
| subjects | Administration, Oral Aged Analysis of Variance Antineoplastic agents Biological and medical sciences Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Chemotherapy Drug Administration Schedule Female Humans Medical sciences Middle Aged Pharmacology. Drug treatments Tamoxifen - administration & dosage Tamoxifen - analogs & derivatives Tamoxifen - blood Tamoxifen - pharmacokinetics Therapeutic Equivalency |
| title | Bioequivalence of 20-mg once-daily tamoxifen relative to 10-mg twice-daily tamoxifen regimens for breast cancer |
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