Integrated data from 2 randomized, double‐blind, placebo‐controlled, phase 3 trials of active cellular immunotherapy with sipuleucel‐T in advanced prostate cancer
BACKGROUND: Sipuleucel‐T is an investigational active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. The safety and efficacy of sipuleucel‐T was evaluated in 2 identically designed, randomized, double‐blind, placebo‐controlled trials (D9901 and D9902...
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| Veröffentlicht in: | Cancer 2009-08, Vol.115 (16), p.3670-3679 |
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| creator | Higano, Celestia S. Schellhammer, Paul F. Small, Eric J. Burch, Patrick A. Nemunaitis, John Yuh, Lianng Provost, Nicole Frohlich, Mark W. |
| description | BACKGROUND:
Sipuleucel‐T is an investigational active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. The safety and efficacy of sipuleucel‐T was evaluated in 2 identically designed, randomized, double‐blind, placebo‐controlled trials (D9901 and D9902A) conducted in men with advanced prostate cancer.
METHODS:
A total of 225 patients were randomized in D9901 or D9902A to sipuleucel‐T (n = 147) or placebo (n = 78), given as 3 intravenous infusions approximately 2 weeks apart. Patients were followed for survival until death or a prespecified cutoff of 36 months after randomization.
RESULTS:
In the integrated analysis of D9901 and D9902A, patients randomized to sipuleucel‐T demonstrated a 33% reduction in the risk of death (hazard ratio, 1.50; 95% confidence interval, 1.10‐2.05; P = .011; log‐rank). The treatment effect remained strong after performing adjustments for imbalances in baseline prognostic factors, poststudy treatment chemotherapy use, and non–prostate cancer‐related deaths. Additional support for the activity of sipuleucel‐T is provided by the correlation between a measure of the product's potency, CD54 up‐regulation, and overall survival. The most common adverse events associated with treatment were chills, pyrexia, headache, asthenia, dyspnea, vomiting, and tremor. These events were primarily grade 1 and 2, with durations of 1 to 2 days.
CONCLUSIONS:
The integrated results of D9901 and D9902A demonstrate a survival benefit for patients treated with sipuleucel‐T compared with those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk‐benefit ratio for sipuleucel‐T in patients with advanced prostate cancer. Cancer 2009. © 2009 American Cancer Society.
The integrated results of 2 randomized studies demonstrate a survival benefit for patients treated with sipuleucel‐T compared with those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk‐benefit ratio for sipuleucel‐T in patients with advanced prostate cancer. |
| doi_str_mv | 10.1002/cncr.24429 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_745903568</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>745903568</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3899-cc667d8045b444ee4c9413779106a2258de6a9ced6d70b8cd106f43b02907fc83</originalsourceid><addsrcrecordid>eNp9kc2KFDEUhYMoTs_oxgeQbEQQa8xf_WQ5NDoODAoygrsildyyI6mkTFIztCsfwcfwuXwSU3ajO1fhXD7OOeEg9ISSc0oIe6W9judMCCbvoQ0lsq0IFew-2hBCuqoW_NMJOk3pS5Etq_lDdEJlzZtOkg36eeUzfI4qg8FGZYXHGCbMcFTehMl-A_MSm7AMDn59_zE464uendIwhHLQwecYnFupeacSYI5ztMolHEasdLa3gDU4tzgVsZ2mxYe8g6jmPb6zeYeTnRcHS0GK2w22Hitzq7wubeYYUi69sF51fIQejMUXHh_fM_Txzeub7dvq-v3l1fbiutK8k7LSumla0xFRD0IIAKGloLxtJSWNYqzuDDRKFv_GtGTotCn3UfCBMEnaUXf8DD0_-Jb8rwuk3E82rV9QHsKS-lbUkvC6WckXB1KXpinC2M_RTirue0r6dZh-Hab_M0yBnx5tl2EC8w89LlGAZ0dAJa3cWAbQNv3lGO0YYUwUjh64O-tg_5_Ifvtu--EQ_hu-FqtV</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>745903568</pqid></control><display><type>article</type><title>Integrated data from 2 randomized, double‐blind, placebo‐controlled, phase 3 trials of active cellular immunotherapy with sipuleucel‐T in advanced prostate cancer</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Wiley Free Content</source><source>Alma/SFX Local Collection</source><creator>Higano, Celestia S. ; Schellhammer, Paul F. ; Small, Eric J. ; Burch, Patrick A. ; Nemunaitis, John ; Yuh, Lianng ; Provost, Nicole ; Frohlich, Mark W.</creator><creatorcontrib>Higano, Celestia S. ; Schellhammer, Paul F. ; Small, Eric J. ; Burch, Patrick A. ; Nemunaitis, John ; Yuh, Lianng ; Provost, Nicole ; Frohlich, Mark W.</creatorcontrib><description>BACKGROUND:
Sipuleucel‐T is an investigational active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. The safety and efficacy of sipuleucel‐T was evaluated in 2 identically designed, randomized, double‐blind, placebo‐controlled trials (D9901 and D9902A) conducted in men with advanced prostate cancer.
METHODS:
A total of 225 patients were randomized in D9901 or D9902A to sipuleucel‐T (n = 147) or placebo (n = 78), given as 3 intravenous infusions approximately 2 weeks apart. Patients were followed for survival until death or a prespecified cutoff of 36 months after randomization.
RESULTS:
In the integrated analysis of D9901 and D9902A, patients randomized to sipuleucel‐T demonstrated a 33% reduction in the risk of death (hazard ratio, 1.50; 95% confidence interval, 1.10‐2.05; P = .011; log‐rank). The treatment effect remained strong after performing adjustments for imbalances in baseline prognostic factors, poststudy treatment chemotherapy use, and non–prostate cancer‐related deaths. Additional support for the activity of sipuleucel‐T is provided by the correlation between a measure of the product's potency, CD54 up‐regulation, and overall survival. The most common adverse events associated with treatment were chills, pyrexia, headache, asthenia, dyspnea, vomiting, and tremor. These events were primarily grade 1 and 2, with durations of 1 to 2 days.
CONCLUSIONS:
The integrated results of D9901 and D9902A demonstrate a survival benefit for patients treated with sipuleucel‐T compared with those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk‐benefit ratio for sipuleucel‐T in patients with advanced prostate cancer. Cancer 2009. © 2009 American Cancer Society.
The integrated results of 2 randomized studies demonstrate a survival benefit for patients treated with sipuleucel‐T compared with those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk‐benefit ratio for sipuleucel‐T in patients with advanced prostate cancer.</description><identifier>ISSN: 0008-543X</identifier><identifier>EISSN: 1097-0142</identifier><identifier>DOI: 10.1002/cncr.24429</identifier><identifier>PMID: 19536890</identifier><identifier>CODEN: CANCAR</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc., A Wiley Company</publisher><subject>Adenocarcinoma - pathology ; Adenocarcinoma - therapy ; Aged ; Aged, 80 and over ; APC8015 ; Biological and medical sciences ; Cancer Vaccines - therapeutic use ; Disease Progression ; Double-Blind Method ; Humans ; Immunity, Active ; immunotherapy ; Male ; Medical sciences ; Middle Aged ; Neoplasm Metastasis ; Nephrology. Urinary tract diseases ; Placebos ; prostate cancer ; Prostatic Neoplasms - pathology ; Prostatic Neoplasms - therapy ; Provenge ; sipuleucel‐T ; Time Factors ; Tissue Extracts - adverse effects ; Tissue Extracts - therapeutic use ; Tumors ; Tumors of the urinary system ; Urinary tract. Prostate gland ; vaccine</subject><ispartof>Cancer, 2009-08, Vol.115 (16), p.3670-3679</ispartof><rights>Copyright © 2009 American Cancer Society</rights><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3899-cc667d8045b444ee4c9413779106a2258de6a9ced6d70b8cd106f43b02907fc83</citedby><cites>FETCH-LOGICAL-c3899-cc667d8045b444ee4c9413779106a2258de6a9ced6d70b8cd106f43b02907fc83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fcncr.24429$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fcncr.24429$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,777,781,1412,1428,27905,27906,45555,45556,46390,46814</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21820224$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19536890$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Higano, Celestia S.</creatorcontrib><creatorcontrib>Schellhammer, Paul F.</creatorcontrib><creatorcontrib>Small, Eric J.</creatorcontrib><creatorcontrib>Burch, Patrick A.</creatorcontrib><creatorcontrib>Nemunaitis, John</creatorcontrib><creatorcontrib>Yuh, Lianng</creatorcontrib><creatorcontrib>Provost, Nicole</creatorcontrib><creatorcontrib>Frohlich, Mark W.</creatorcontrib><title>Integrated data from 2 randomized, double‐blind, placebo‐controlled, phase 3 trials of active cellular immunotherapy with sipuleucel‐T in advanced prostate cancer</title><title>Cancer</title><addtitle>Cancer</addtitle><description>BACKGROUND:
Sipuleucel‐T is an investigational active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. The safety and efficacy of sipuleucel‐T was evaluated in 2 identically designed, randomized, double‐blind, placebo‐controlled trials (D9901 and D9902A) conducted in men with advanced prostate cancer.
METHODS:
A total of 225 patients were randomized in D9901 or D9902A to sipuleucel‐T (n = 147) or placebo (n = 78), given as 3 intravenous infusions approximately 2 weeks apart. Patients were followed for survival until death or a prespecified cutoff of 36 months after randomization.
RESULTS:
In the integrated analysis of D9901 and D9902A, patients randomized to sipuleucel‐T demonstrated a 33% reduction in the risk of death (hazard ratio, 1.50; 95% confidence interval, 1.10‐2.05; P = .011; log‐rank). The treatment effect remained strong after performing adjustments for imbalances in baseline prognostic factors, poststudy treatment chemotherapy use, and non–prostate cancer‐related deaths. Additional support for the activity of sipuleucel‐T is provided by the correlation between a measure of the product's potency, CD54 up‐regulation, and overall survival. The most common adverse events associated with treatment were chills, pyrexia, headache, asthenia, dyspnea, vomiting, and tremor. These events were primarily grade 1 and 2, with durations of 1 to 2 days.
CONCLUSIONS:
The integrated results of D9901 and D9902A demonstrate a survival benefit for patients treated with sipuleucel‐T compared with those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk‐benefit ratio for sipuleucel‐T in patients with advanced prostate cancer. Cancer 2009. © 2009 American Cancer Society.
The integrated results of 2 randomized studies demonstrate a survival benefit for patients treated with sipuleucel‐T compared with those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk‐benefit ratio for sipuleucel‐T in patients with advanced prostate cancer.</description><subject>Adenocarcinoma - pathology</subject><subject>Adenocarcinoma - therapy</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>APC8015</subject><subject>Biological and medical sciences</subject><subject>Cancer Vaccines - therapeutic use</subject><subject>Disease Progression</subject><subject>Double-Blind Method</subject><subject>Humans</subject><subject>Immunity, Active</subject><subject>immunotherapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Placebos</subject><subject>prostate cancer</subject><subject>Prostatic Neoplasms - pathology</subject><subject>Prostatic Neoplasms - therapy</subject><subject>Provenge</subject><subject>sipuleucel‐T</subject><subject>Time Factors</subject><subject>Tissue Extracts - adverse effects</subject><subject>Tissue Extracts - therapeutic use</subject><subject>Tumors</subject><subject>Tumors of the urinary system</subject><subject>Urinary tract. Prostate gland</subject><subject>vaccine</subject><issn>0008-543X</issn><issn>1097-0142</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc2KFDEUhYMoTs_oxgeQbEQQa8xf_WQ5NDoODAoygrsildyyI6mkTFIztCsfwcfwuXwSU3ajO1fhXD7OOeEg9ISSc0oIe6W9judMCCbvoQ0lsq0IFew-2hBCuqoW_NMJOk3pS5Etq_lDdEJlzZtOkg36eeUzfI4qg8FGZYXHGCbMcFTehMl-A_MSm7AMDn59_zE464uendIwhHLQwecYnFupeacSYI5ztMolHEasdLa3gDU4tzgVsZ2mxYe8g6jmPb6zeYeTnRcHS0GK2w22Hitzq7wubeYYUi69sF51fIQejMUXHh_fM_Txzeub7dvq-v3l1fbiutK8k7LSumla0xFRD0IIAKGloLxtJSWNYqzuDDRKFv_GtGTotCn3UfCBMEnaUXf8DD0_-Jb8rwuk3E82rV9QHsKS-lbUkvC6WckXB1KXpinC2M_RTirue0r6dZh-Hab_M0yBnx5tl2EC8w89LlGAZ0dAJa3cWAbQNv3lGO0YYUwUjh64O-tg_5_Ifvtu--EQ_hu-FqtV</recordid><startdate>20090815</startdate><enddate>20090815</enddate><creator>Higano, Celestia S.</creator><creator>Schellhammer, Paul F.</creator><creator>Small, Eric J.</creator><creator>Burch, Patrick A.</creator><creator>Nemunaitis, John</creator><creator>Yuh, Lianng</creator><creator>Provost, Nicole</creator><creator>Frohlich, Mark W.</creator><general>Wiley Subscription Services, Inc., A Wiley Company</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>7T5</scope><scope>7U1</scope><scope>7U2</scope><scope>C1K</scope><scope>H94</scope></search><sort><creationdate>20090815</creationdate><title>Integrated data from 2 randomized, double‐blind, placebo‐controlled, phase 3 trials of active cellular immunotherapy with sipuleucel‐T in advanced prostate cancer</title><author>Higano, Celestia S. ; Schellhammer, Paul F. ; Small, Eric J. ; Burch, Patrick A. ; Nemunaitis, John ; Yuh, Lianng ; Provost, Nicole ; Frohlich, Mark W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3899-cc667d8045b444ee4c9413779106a2258de6a9ced6d70b8cd106f43b02907fc83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adenocarcinoma - pathology</topic><topic>Adenocarcinoma - therapy</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>APC8015</topic><topic>Biological and medical sciences</topic><topic>Cancer Vaccines - therapeutic use</topic><topic>Disease Progression</topic><topic>Double-Blind Method</topic><topic>Humans</topic><topic>Immunity, Active</topic><topic>immunotherapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Metastasis</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Placebos</topic><topic>prostate cancer</topic><topic>Prostatic Neoplasms - pathology</topic><topic>Prostatic Neoplasms - therapy</topic><topic>Provenge</topic><topic>sipuleucel‐T</topic><topic>Time Factors</topic><topic>Tissue Extracts - adverse effects</topic><topic>Tissue Extracts - therapeutic use</topic><topic>Tumors</topic><topic>Tumors of the urinary system</topic><topic>Urinary tract. Prostate gland</topic><topic>vaccine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Higano, Celestia S.</creatorcontrib><creatorcontrib>Schellhammer, Paul F.</creatorcontrib><creatorcontrib>Small, Eric J.</creatorcontrib><creatorcontrib>Burch, Patrick A.</creatorcontrib><creatorcontrib>Nemunaitis, John</creatorcontrib><creatorcontrib>Yuh, Lianng</creatorcontrib><creatorcontrib>Provost, Nicole</creatorcontrib><creatorcontrib>Frohlich, Mark 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>Immunology Abstracts</collection><collection>Risk Abstracts</collection><collection>Safety Science and Risk</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Higano, Celestia S.</au><au>Schellhammer, Paul F.</au><au>Small, Eric J.</au><au>Burch, Patrick A.</au><au>Nemunaitis, John</au><au>Yuh, Lianng</au><au>Provost, Nicole</au><au>Frohlich, Mark W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Integrated data from 2 randomized, double‐blind, placebo‐controlled, phase 3 trials of active cellular immunotherapy with sipuleucel‐T in advanced prostate cancer</atitle><jtitle>Cancer</jtitle><addtitle>Cancer</addtitle><date>2009-08-15</date><risdate>2009</risdate><volume>115</volume><issue>16</issue><spage>3670</spage><epage>3679</epage><pages>3670-3679</pages><issn>0008-543X</issn><eissn>1097-0142</eissn><coden>CANCAR</coden><abstract>BACKGROUND:
Sipuleucel‐T is an investigational active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. The safety and efficacy of sipuleucel‐T was evaluated in 2 identically designed, randomized, double‐blind, placebo‐controlled trials (D9901 and D9902A) conducted in men with advanced prostate cancer.
METHODS:
A total of 225 patients were randomized in D9901 or D9902A to sipuleucel‐T (n = 147) or placebo (n = 78), given as 3 intravenous infusions approximately 2 weeks apart. Patients were followed for survival until death or a prespecified cutoff of 36 months after randomization.
RESULTS:
In the integrated analysis of D9901 and D9902A, patients randomized to sipuleucel‐T demonstrated a 33% reduction in the risk of death (hazard ratio, 1.50; 95% confidence interval, 1.10‐2.05; P = .011; log‐rank). The treatment effect remained strong after performing adjustments for imbalances in baseline prognostic factors, poststudy treatment chemotherapy use, and non–prostate cancer‐related deaths. Additional support for the activity of sipuleucel‐T is provided by the correlation between a measure of the product's potency, CD54 up‐regulation, and overall survival. The most common adverse events associated with treatment were chills, pyrexia, headache, asthenia, dyspnea, vomiting, and tremor. These events were primarily grade 1 and 2, with durations of 1 to 2 days.
CONCLUSIONS:
The integrated results of D9901 and D9902A demonstrate a survival benefit for patients treated with sipuleucel‐T compared with those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk‐benefit ratio for sipuleucel‐T in patients with advanced prostate cancer. Cancer 2009. © 2009 American Cancer Society.
The integrated results of 2 randomized studies demonstrate a survival benefit for patients treated with sipuleucel‐T compared with those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk‐benefit ratio for sipuleucel‐T in patients with advanced prostate cancer.</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc., A Wiley Company</pub><pmid>19536890</pmid><doi>10.1002/cncr.24429</doi><tpages>10</tpages></addata></record> |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Wiley Free Content; Alma/SFX Local Collection |
| subjects | Adenocarcinoma - pathology Adenocarcinoma - therapy Aged Aged, 80 and over APC8015 Biological and medical sciences Cancer Vaccines - therapeutic use Disease Progression Double-Blind Method Humans Immunity, Active immunotherapy Male Medical sciences Middle Aged Neoplasm Metastasis Nephrology. Urinary tract diseases Placebos prostate cancer Prostatic Neoplasms - pathology Prostatic Neoplasms - therapy Provenge sipuleucel‐T Time Factors Tissue Extracts - adverse effects Tissue Extracts - therapeutic use Tumors Tumors of the urinary system Urinary tract. Prostate gland vaccine |
| title | Integrated data from 2 randomized, double‐blind, placebo‐controlled, phase 3 trials of active cellular immunotherapy with sipuleucel‐T in advanced prostate cancer |
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