A phase II study of high‐dose calcitriol combined with mitoxantrone and prednisone for androgen‐independent prostate cancer
OBJECTIVE To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high‐dose calcitriol (DN‐101) combined with mitoxantrone and glucocorticoids in androgen‐independent prostate cancer (AIPC). PATIENTS AND METHODS Nineteen patients with metastatic AIPC and no previous chem...
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| Veröffentlicht in: | BJU international 2008-12, Vol.102 (11), p.1601-1606 |
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| creator | Chan, Joseph S. Beer, Tomasz M. Quinn, David I. Pinski, Jacek K. Garzotto, Mark Sokoloff, Mitchell Dehaze, Daniel R. Ryan, Christopher W. |
| description | OBJECTIVE
To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high‐dose calcitriol (DN‐101) combined with mitoxantrone and glucocorticoids in androgen‐independent prostate cancer (AIPC).
PATIENTS AND METHODS
Nineteen patients with metastatic AIPC and no previous chemotherapy received DN‐101 180 µg orally on day 1 and mitoxantrone 12 mg/m2 intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate‐specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ‐C30 questionnaire, and pain and analgesic use were evaluated.
RESULTS
Five of 19 patients (26%; 95% confidence interval, CI, 9–51) achieved a ≥50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6–26) weeks. The overall median (95% CI) survival was 16 (6–26) months; 47 (21–73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea.
CONCLUSIONS
DN‐101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN‐101 does not appear to increase the toxicity of mitoxantrone. |
| doi_str_mv | 10.1111/j.1464-410X.2008.08017.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_21246541</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>21246541</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4287-bf97da99f76c831c9fe351aba3eb65f08a79bea7f46f31ae47d99bf7042c66033</originalsourceid><addsrcrecordid>eNqNkMGOFCEQQDtG466rv2C46G1aaBigDx7WzapjNvHiJt4IDcUOk24YgcnOnPQT_Ea_RNoZ16scoCheVZHXNIjgltT1ZtMSxtmCEfy17TCWLZaYiHb_qDl_eHj8N8Y9P2ue5bzBuCb48mlzRqSQHcX8vPl-ibZrnQGtViiXnT2g6NDa361__fhpY80bPRpfko8jMnEafACL7n1Zo8mXuNehpBgA6WDRNoENPs9XF9OcSvEOQm3kg4Ut1C2USsVcdJkbBwPpefPE6THDi9N50dy-v_5y9XFx8_nD6uryZmFYJ8VicL2wuu-d4EZSYnoHdEn0oCkMfOmw1KIfQAvHuKNEAxO27wcnMOsM55jSi-b1sW-d_20HuajJZwPjqAPEXVYd6RhfMlJBeQRN_WhO4NQ2-UmngyJYzfLVRs1e1exYzfLVH_lqX0tfnmbshgnsv8KT7Qq8OgE6V68uVQU-P3AdloJTLiv39sjd-xEO__0B9e7T7RzR34DzpQU</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>21246541</pqid></control><display><type>article</type><title>A phase II study of high‐dose calcitriol combined with mitoxantrone and prednisone for androgen‐independent prostate cancer</title><source>MEDLINE</source><source>Access via Wiley Online Library</source><creator>Chan, Joseph S. ; Beer, Tomasz M. ; Quinn, David I. ; Pinski, Jacek K. ; Garzotto, Mark ; Sokoloff, Mitchell ; Dehaze, Daniel R. ; Ryan, Christopher W.</creator><creatorcontrib>Chan, Joseph S. ; Beer, Tomasz M. ; Quinn, David I. ; Pinski, Jacek K. ; Garzotto, Mark ; Sokoloff, Mitchell ; Dehaze, Daniel R. ; Ryan, Christopher W.</creatorcontrib><description>OBJECTIVE
To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high‐dose calcitriol (DN‐101) combined with mitoxantrone and glucocorticoids in androgen‐independent prostate cancer (AIPC).
PATIENTS AND METHODS
Nineteen patients with metastatic AIPC and no previous chemotherapy received DN‐101 180 µg orally on day 1 and mitoxantrone 12 mg/m2 intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate‐specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ‐C30 questionnaire, and pain and analgesic use were evaluated.
RESULTS
Five of 19 patients (26%; 95% confidence interval, CI, 9–51) achieved a ≥50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6–26) weeks. The overall median (95% CI) survival was 16 (6–26) months; 47 (21–73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea.
CONCLUSIONS
DN‐101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN‐101 does not appear to increase the toxicity of mitoxantrone.</description><identifier>ISSN: 1464-4096</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/j.1464-410X.2008.08017.x</identifier><identifier>PMID: 18782306</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adenocarcinoma - drug therapy ; Administration, Oral ; Aged ; Aged, 80 and over ; Androgens - metabolism ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; calcitriol ; Calcitriol - administration & dosage ; DN‐101 ; Gynecology. Andrology. Obstetrics ; Humans ; Infusions, Intravenous ; Male ; Male genital diseases ; Medical sciences ; Middle Aged ; mitoxantrone ; Mitoxantrone - administration & dosage ; Nephrology. Urinary tract diseases ; Prednisone - administration & dosage ; prostate cancer ; Prostate-Specific Antigen - metabolism ; Prostatic Neoplasms - drug therapy ; Quality of Life ; Treatment Outcome ; Tumors ; Tumors of the urinary system ; Urinary tract. Prostate gland</subject><ispartof>BJU international, 2008-12, Vol.102 (11), p.1601-1606</ispartof><rights>2008 THE AUTHORS. JOURNAL COMPILATION © 2008 BJU INTERNATIONAL</rights><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4287-bf97da99f76c831c9fe351aba3eb65f08a79bea7f46f31ae47d99bf7042c66033</citedby><cites>FETCH-LOGICAL-c4287-bf97da99f76c831c9fe351aba3eb65f08a79bea7f46f31ae47d99bf7042c66033</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1464-410X.2008.08017.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1464-410X.2008.08017.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,27926,27927,45576,45577</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20876368$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18782306$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chan, Joseph S.</creatorcontrib><creatorcontrib>Beer, Tomasz M.</creatorcontrib><creatorcontrib>Quinn, David I.</creatorcontrib><creatorcontrib>Pinski, Jacek K.</creatorcontrib><creatorcontrib>Garzotto, Mark</creatorcontrib><creatorcontrib>Sokoloff, Mitchell</creatorcontrib><creatorcontrib>Dehaze, Daniel R.</creatorcontrib><creatorcontrib>Ryan, Christopher W.</creatorcontrib><title>A phase II study of high‐dose calcitriol combined with mitoxantrone and prednisone for androgen‐independent prostate cancer</title><title>BJU international</title><addtitle>BJU Int</addtitle><description>OBJECTIVE
To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high‐dose calcitriol (DN‐101) combined with mitoxantrone and glucocorticoids in androgen‐independent prostate cancer (AIPC).
PATIENTS AND METHODS
Nineteen patients with metastatic AIPC and no previous chemotherapy received DN‐101 180 µg orally on day 1 and mitoxantrone 12 mg/m2 intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate‐specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ‐C30 questionnaire, and pain and analgesic use were evaluated.
RESULTS
Five of 19 patients (26%; 95% confidence interval, CI, 9–51) achieved a ≥50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6–26) weeks. The overall median (95% CI) survival was 16 (6–26) months; 47 (21–73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea.
CONCLUSIONS
DN‐101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN‐101 does not appear to increase the toxicity of mitoxantrone.</description><subject>Adenocarcinoma - drug therapy</subject><subject>Administration, Oral</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Androgens - metabolism</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>calcitriol</subject><subject>Calcitriol - administration & dosage</subject><subject>DN‐101</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Male genital diseases</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>mitoxantrone</subject><subject>Mitoxantrone - administration & dosage</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Prednisone - administration & dosage</subject><subject>prostate cancer</subject><subject>Prostate-Specific Antigen - metabolism</subject><subject>Prostatic Neoplasms - drug therapy</subject><subject>Quality of Life</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Tumors of the urinary system</subject><subject>Urinary tract. Prostate gland</subject><issn>1464-4096</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkMGOFCEQQDtG466rv2C46G1aaBigDx7WzapjNvHiJt4IDcUOk24YgcnOnPQT_Ea_RNoZ16scoCheVZHXNIjgltT1ZtMSxtmCEfy17TCWLZaYiHb_qDl_eHj8N8Y9P2ue5bzBuCb48mlzRqSQHcX8vPl-ibZrnQGtViiXnT2g6NDa361__fhpY80bPRpfko8jMnEafACL7n1Zo8mXuNehpBgA6WDRNoENPs9XF9OcSvEOQm3kg4Ut1C2USsVcdJkbBwPpefPE6THDi9N50dy-v_5y9XFx8_nD6uryZmFYJ8VicL2wuu-d4EZSYnoHdEn0oCkMfOmw1KIfQAvHuKNEAxO27wcnMOsM55jSi-b1sW-d_20HuajJZwPjqAPEXVYd6RhfMlJBeQRN_WhO4NQ2-UmngyJYzfLVRs1e1exYzfLVH_lqX0tfnmbshgnsv8KT7Qq8OgE6V68uVQU-P3AdloJTLiv39sjd-xEO__0B9e7T7RzR34DzpQU</recordid><startdate>200812</startdate><enddate>200812</enddate><creator>Chan, Joseph S.</creator><creator>Beer, Tomasz M.</creator><creator>Quinn, David I.</creator><creator>Pinski, Jacek K.</creator><creator>Garzotto, Mark</creator><creator>Sokoloff, Mitchell</creator><creator>Dehaze, Daniel R.</creator><creator>Ryan, Christopher W.</creator><general>Blackwell Publishing Ltd</general><general>Wiley-Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>200812</creationdate><title>A phase II study of high‐dose calcitriol combined with mitoxantrone and prednisone for androgen‐independent prostate cancer</title><author>Chan, Joseph S. ; Beer, Tomasz M. ; Quinn, David I. ; Pinski, Jacek K. ; Garzotto, Mark ; Sokoloff, Mitchell ; Dehaze, Daniel R. ; Ryan, Christopher W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4287-bf97da99f76c831c9fe351aba3eb65f08a79bea7f46f31ae47d99bf7042c66033</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Administration, Oral</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Androgens - metabolism</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>calcitriol</topic><topic>Calcitriol - administration & dosage</topic><topic>DN‐101</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Male genital diseases</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>mitoxantrone</topic><topic>Mitoxantrone - administration & dosage</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Prednisone - administration & dosage</topic><topic>prostate cancer</topic><topic>Prostate-Specific Antigen - metabolism</topic><topic>Prostatic Neoplasms - drug therapy</topic><topic>Quality of Life</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Tumors of the urinary system</topic><topic>Urinary tract. Prostate gland</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chan, Joseph S.</creatorcontrib><creatorcontrib>Beer, Tomasz M.</creatorcontrib><creatorcontrib>Quinn, David I.</creatorcontrib><creatorcontrib>Pinski, Jacek K.</creatorcontrib><creatorcontrib>Garzotto, Mark</creatorcontrib><creatorcontrib>Sokoloff, Mitchell</creatorcontrib><creatorcontrib>Dehaze, Daniel R.</creatorcontrib><creatorcontrib>Ryan, Christopher W.</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>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chan, Joseph S.</au><au>Beer, Tomasz M.</au><au>Quinn, David I.</au><au>Pinski, Jacek K.</au><au>Garzotto, Mark</au><au>Sokoloff, Mitchell</au><au>Dehaze, Daniel R.</au><au>Ryan, Christopher W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase II study of high‐dose calcitriol combined with mitoxantrone and prednisone for androgen‐independent prostate cancer</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2008-12</date><risdate>2008</risdate><volume>102</volume><issue>11</issue><spage>1601</spage><epage>1606</epage><pages>1601-1606</pages><issn>1464-4096</issn><eissn>1464-410X</eissn><abstract>OBJECTIVE
To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high‐dose calcitriol (DN‐101) combined with mitoxantrone and glucocorticoids in androgen‐independent prostate cancer (AIPC).
PATIENTS AND METHODS
Nineteen patients with metastatic AIPC and no previous chemotherapy received DN‐101 180 µg orally on day 1 and mitoxantrone 12 mg/m2 intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate‐specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ‐C30 questionnaire, and pain and analgesic use were evaluated.
RESULTS
Five of 19 patients (26%; 95% confidence interval, CI, 9–51) achieved a ≥50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6–26) weeks. The overall median (95% CI) survival was 16 (6–26) months; 47 (21–73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea.
CONCLUSIONS
DN‐101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN‐101 does not appear to increase the toxicity of mitoxantrone.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>18782306</pmid><doi>10.1111/j.1464-410X.2008.08017.x</doi><tpages>6</tpages></addata></record> |
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| subjects | Adenocarcinoma - drug therapy Administration, Oral Aged Aged, 80 and over Androgens - metabolism Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences calcitriol Calcitriol - administration & dosage DN‐101 Gynecology. Andrology. Obstetrics Humans Infusions, Intravenous Male Male genital diseases Medical sciences Middle Aged mitoxantrone Mitoxantrone - administration & dosage Nephrology. Urinary tract diseases Prednisone - administration & dosage prostate cancer Prostate-Specific Antigen - metabolism Prostatic Neoplasms - drug therapy Quality of Life Treatment Outcome Tumors Tumors of the urinary system Urinary tract. Prostate gland |
| title | A phase II study of high‐dose calcitriol combined with mitoxantrone and prednisone for androgen‐independent prostate cancer |
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