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An analysis of the treatment effect of panitumumab on overall survival from a phase 3, randomized, controlled, multicenter trial (20020408) in patients with chemotherapy refractory metastatic colorectal cancer
Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor. Results from the primary analysis of a phase 3, randomized, controlled study showed a statistically significant improvement in progression-free survival for patients receiving panitumumab; however, ov...
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| Published in: | Targeted oncology 2013-06, Vol.8 (2), p.127-136 |
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| container_end_page | 136 |
| container_issue | 2 |
| container_start_page | 127 |
| container_title | Targeted oncology |
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| creator | Poulin-Costello, Melanie Azoulay, Laurent Van Cutsem, Eric Peeters, Marc Siena, Salvatore Wolf, Michael |
| description | Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor. Results from the primary analysis of a phase 3, randomized, controlled study showed a statistically significant improvement in progression-free survival for patients receiving panitumumab; however, overall survival was confounded by best supportive care (BSC) patients that crossed over to panitumumab therapy after disease progression. Three post hoc analyses are presented that approximate the panitumumab overall survival treatment effect in both the all-randomized and wild-type (WT)
KRAS
populations by using the BSC patients with mutant (MT)
KRAS
as the comparator group to discount the effect of crossover from BSC to panitumumab. The primary post hoc analysis showed a median overall survival of 6.4 months for all
KRAS
-evaluable patients randomized to panitumumab versus 4.4 months for patients with MT
KRAS
tumors randomized to BSC, yielding an adjusted hazard ratio (95 % CI) of 0.764 (0.598-0.977). Similar results were observed for the two secondary post hoc analyses. These analyses suggest a positive treatment effect of panitumumab in both the overall and WT
KRAS
patient populations consistent with an improvement in overall survival relative to BSC. |
| doi_str_mv | 10.1007/s11523-013-0271-z |
| format | article |
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KRAS
populations by using the BSC patients with mutant (MT)
KRAS
as the comparator group to discount the effect of crossover from BSC to panitumumab. The primary post hoc analysis showed a median overall survival of 6.4 months for all
KRAS
-evaluable patients randomized to panitumumab versus 4.4 months for patients with MT
KRAS
tumors randomized to BSC, yielding an adjusted hazard ratio (95 % CI) of 0.764 (0.598-0.977). Similar results were observed for the two secondary post hoc analyses. These analyses suggest a positive treatment effect of panitumumab in both the overall and WT
KRAS
patient populations consistent with an improvement in overall survival relative to BSC.</description><identifier>ISSN: 1776-2596</identifier><identifier>EISSN: 1776-260X</identifier><identifier>DOI: 10.1007/s11523-013-0271-z</identifier><identifier>PMID: 23625191</identifier><language>eng</language><publisher>Paris: Springer-Verlag</publisher><subject>Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Biological and medical sciences ; Biomedicine ; Colorectal Neoplasms - drug therapy ; Colorectal Neoplasms - genetics ; Colorectal Neoplasms - therapy ; Cross-Over Studies ; Disease-Free Survival ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Genes, ras ; Humans ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Neoplasm Metastasis ; Oncology ; Original Research ; Palliative Care - methods ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Survival Analysis ; Tumors</subject><ispartof>Targeted oncology, 2013-06, Vol.8 (2), p.127-136</ispartof><rights>The Author(s) 2013</rights><rights>2014 INIST-CNRS</rights><rights>Springer-Verlag France 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c500t-d5786bb970244bc4d6fd68ad8ff943ced6414b20a88f904880a7e0af4fc32ff83</citedby><cites>FETCH-LOGICAL-c500t-d5786bb970244bc4d6fd68ad8ff943ced6414b20a88f904880a7e0af4fc32ff83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27713658$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23625191$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Poulin-Costello, Melanie</creatorcontrib><creatorcontrib>Azoulay, Laurent</creatorcontrib><creatorcontrib>Van Cutsem, Eric</creatorcontrib><creatorcontrib>Peeters, Marc</creatorcontrib><creatorcontrib>Siena, Salvatore</creatorcontrib><creatorcontrib>Wolf, Michael</creatorcontrib><title>An analysis of the treatment effect of panitumumab on overall survival from a phase 3, randomized, controlled, multicenter trial (20020408) in patients with chemotherapy refractory metastatic colorectal cancer</title><title>Targeted oncology</title><addtitle>Targ Oncol</addtitle><addtitle>Target Oncol</addtitle><description>Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor. Results from the primary analysis of a phase 3, randomized, controlled study showed a statistically significant improvement in progression-free survival for patients receiving panitumumab; however, overall survival was confounded by best supportive care (BSC) patients that crossed over to panitumumab therapy after disease progression. Three post hoc analyses are presented that approximate the panitumumab overall survival treatment effect in both the all-randomized and wild-type (WT)
KRAS
populations by using the BSC patients with mutant (MT)
KRAS
as the comparator group to discount the effect of crossover from BSC to panitumumab. The primary post hoc analysis showed a median overall survival of 6.4 months for all
KRAS
-evaluable patients randomized to panitumumab versus 4.4 months for patients with MT
KRAS
tumors randomized to BSC, yielding an adjusted hazard ratio (95 % CI) of 0.764 (0.598-0.977). Similar results were observed for the two secondary post hoc analyses. These analyses suggest a positive treatment effect of panitumumab in both the overall and WT
KRAS
patient populations consistent with an improvement in overall survival relative to BSC.</description><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Biomedicine</subject><subject>Colorectal Neoplasms - drug therapy</subject><subject>Colorectal Neoplasms - genetics</subject><subject>Colorectal Neoplasms - therapy</subject><subject>Cross-Over Studies</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Genes, ras</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Neoplasm Metastasis</subject><subject>Oncology</subject><subject>Original Research</subject><subject>Palliative Care - methods</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. 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Liver. Pancreas. Abdomen</topic><topic>Genes, ras</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Neoplasm Metastasis</topic><topic>Oncology</topic><topic>Original Research</topic><topic>Palliative Care - methods</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Survival Analysis</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Poulin-Costello, Melanie</creatorcontrib><creatorcontrib>Azoulay, Laurent</creatorcontrib><creatorcontrib>Van Cutsem, Eric</creatorcontrib><creatorcontrib>Peeters, Marc</creatorcontrib><creatorcontrib>Siena, Salvatore</creatorcontrib><creatorcontrib>Wolf, Michael</creatorcontrib><collection>Springer Nature OA Free Journals</collection><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>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>ProQuest Health and Medical</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Family Health Database (Proquest)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Targeted oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Poulin-Costello, Melanie</au><au>Azoulay, Laurent</au><au>Van Cutsem, Eric</au><au>Peeters, Marc</au><au>Siena, Salvatore</au><au>Wolf, Michael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An analysis of the treatment effect of panitumumab on overall survival from a phase 3, randomized, controlled, multicenter trial (20020408) in patients with chemotherapy refractory metastatic colorectal cancer</atitle><jtitle>Targeted oncology</jtitle><stitle>Targ Oncol</stitle><addtitle>Target Oncol</addtitle><date>2013-06-01</date><risdate>2013</risdate><volume>8</volume><issue>2</issue><spage>127</spage><epage>136</epage><pages>127-136</pages><issn>1776-2596</issn><eissn>1776-260X</eissn><abstract>Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor. Results from the primary analysis of a phase 3, randomized, controlled study showed a statistically significant improvement in progression-free survival for patients receiving panitumumab; however, overall survival was confounded by best supportive care (BSC) patients that crossed over to panitumumab therapy after disease progression. Three post hoc analyses are presented that approximate the panitumumab overall survival treatment effect in both the all-randomized and wild-type (WT)
KRAS
populations by using the BSC patients with mutant (MT)
KRAS
as the comparator group to discount the effect of crossover from BSC to panitumumab. The primary post hoc analysis showed a median overall survival of 6.4 months for all
KRAS
-evaluable patients randomized to panitumumab versus 4.4 months for patients with MT
KRAS
tumors randomized to BSC, yielding an adjusted hazard ratio (95 % CI) of 0.764 (0.598-0.977). Similar results were observed for the two secondary post hoc analyses. These analyses suggest a positive treatment effect of panitumumab in both the overall and WT
KRAS
patient populations consistent with an improvement in overall survival relative to BSC.</abstract><cop>Paris</cop><pub>Springer-Verlag</pub><pmid>23625191</pmid><doi>10.1007/s11523-013-0271-z</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| source | Springer Nature |
| subjects | Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Biological and medical sciences Biomedicine Colorectal Neoplasms - drug therapy Colorectal Neoplasms - genetics Colorectal Neoplasms - therapy Cross-Over Studies Disease-Free Survival Female Gastroenterology. Liver. Pancreas. Abdomen Genes, ras Humans Male Medical sciences Medicine Medicine & Public Health Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) Neoplasm Metastasis Oncology Original Research Palliative Care - methods Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Survival Analysis Tumors |
| title | An analysis of the treatment effect of panitumumab on overall survival from a phase 3, randomized, controlled, multicenter trial (20020408) in patients with chemotherapy refractory metastatic colorectal cancer |
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