Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine–cisplatin plus necitumumab versus gemcitabine–cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer
SQUIRE demonstrated addition of necitumumab to gemcitabine and cisplatin significantly improved survival in patients with stage IV sq-NSCLC. Here, we report additional outcomes for the subpopulation of patients with tumor epidermal growth factor receptor (EGFR) protein expression. Patients with path...
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| creator | Paz-Ares, L. Socinski, M.A. Shahidi, J. Hozak, R.R. Soldatenkova, V. Kurek, R. Varella-Garcia, M. Thatcher, N. Hirsch, F.R. |
| description | SQUIRE demonstrated addition of necitumumab to gemcitabine and cisplatin significantly improved survival in patients with stage IV sq-NSCLC. Here, we report additional outcomes for the subpopulation of patients with tumor epidermal growth factor receptor (EGFR) protein expression.
Patients with pathologically confirmed stage IV sq-NSCLC were randomized 1:1 to receive a maximum of six 3-week cycles of gemcitabine (1250 mg/m2 i.v., days 1 and 8) and cisplatin (75 mg/m2 i.v., day 1) chemotherapy with or without necitumumab (800 mg i.v., days 1 and 8). Patients in the chemotherapy plus necitumumab group with no progression continued on necitumumab alone until disease progression or intolerable toxicity. SQUIRE included mandatory tissue collection. EGFR protein expression was detected by immunohistochemistry (IHC) in a central laboratory. Exploratory analyses were pre-specified for patients with EGFR protein expressing (EGFR > 0) and non-expressing (EGFR = 0) tumors.
A total of 982 patients [90% of intention-to-treat (ITT)] had evaluable IHC results. The large majority of these patients (95%) had tumor samples expressing EGFR protein; only 5% had tumors without detectable EGFR protein. Overall survival (OS) for EGFR > 0 patients was significantly longer in the necitumumab plus gemcitabine–cisplatin group than in the gemcitabine–cisplatin group {stratified hazard ratio (HR) 0.79 [95% confidence interval (CI) 0.69, 0.92; P = 0.002]; median 11.7 months (95% CI 10.7, 12.9) versus 10.0 months (8.9, 11.4)}. Additionally, an OS benefit was seen in all pre-specified subgroups in EGFR > 0 patients. However, OS HR for EGFR = 0 was 1.52. Adverse events of interest with the largest difference between treatment groups in EGFR > 0 patients (Grade ≥3) were hypomagnesemia (10% versus |
| doi_str_mv | 10.1093/annonc/mdw214 |
| format | Article |
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Patients with pathologically confirmed stage IV sq-NSCLC were randomized 1:1 to receive a maximum of six 3-week cycles of gemcitabine (1250 mg/m2 i.v., days 1 and 8) and cisplatin (75 mg/m2 i.v., day 1) chemotherapy with or without necitumumab (800 mg i.v., days 1 and 8). Patients in the chemotherapy plus necitumumab group with no progression continued on necitumumab alone until disease progression or intolerable toxicity. SQUIRE included mandatory tissue collection. EGFR protein expression was detected by immunohistochemistry (IHC) in a central laboratory. Exploratory analyses were pre-specified for patients with EGFR protein expressing (EGFR > 0) and non-expressing (EGFR = 0) tumors.
A total of 982 patients [90% of intention-to-treat (ITT)] had evaluable IHC results. The large majority of these patients (95%) had tumor samples expressing EGFR protein; only 5% had tumors without detectable EGFR protein. Overall survival (OS) for EGFR > 0 patients was significantly longer in the necitumumab plus gemcitabine–cisplatin group than in the gemcitabine–cisplatin group {stratified hazard ratio (HR) 0.79 [95% confidence interval (CI) 0.69, 0.92; P = 0.002]; median 11.7 months (95% CI 10.7, 12.9) versus 10.0 months (8.9, 11.4)}. Additionally, an OS benefit was seen in all pre-specified subgroups in EGFR > 0 patients. However, OS HR for EGFR = 0 was 1.52. Adverse events of interest with the largest difference between treatment groups in EGFR > 0 patients (Grade ≥3) were hypomagnesemia (10% versus <1%) and skin rash (6% versus <1%).
In line with SQUIRE ITT, addition of necitumumab to gemcitabine–cisplatin significantly prolonged OS and was generally well tolerated in the subpopulation of patients with EGFR-expressing advanced sq-NSCLC. The benefit from addition of necitumumab to chemotherapy was not apparent in this analysis for the small subgroup of patients with non-EGFR-expressing tumors.
NCT00981058.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdw214</identifier><identifier>PMID: 27207107</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject><![CDATA[Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - genetics ; Carcinoma, Non-Small-Cell Lung - pathology ; Carcinoma, Squamous Cell - drug therapy ; Carcinoma, Squamous Cell - genetics ; Carcinoma, Squamous Cell - pathology ; Cisplatin - administration & dosage ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Disease-Free Survival ; EGFR expressing ; ErbB Receptors - antagonists & inhibitors ; ErbB Receptors - genetics ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; necitumumab ; Neoplasm Staging ; Original ; Protein Kinase Inhibitors - administration & dosage ; squamous NSCLC ; SQUIRE ; Treatment Outcome]]></subject><ispartof>Annals of oncology, 2016-08, Vol.27 (8), p.1573-1579</ispartof><rights>2016 THE AUTHORS</rights><rights>The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.</rights><rights>The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c435t-e0aae7873d9a239cfc237d42a8546ef49600ccdbff72fc3138933871777141393</citedby><cites>FETCH-LOGICAL-c435t-e0aae7873d9a239cfc237d42a8546ef49600ccdbff72fc3138933871777141393</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27207107$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Paz-Ares, L.</creatorcontrib><creatorcontrib>Socinski, M.A.</creatorcontrib><creatorcontrib>Shahidi, J.</creatorcontrib><creatorcontrib>Hozak, R.R.</creatorcontrib><creatorcontrib>Soldatenkova, V.</creatorcontrib><creatorcontrib>Kurek, R.</creatorcontrib><creatorcontrib>Varella-Garcia, M.</creatorcontrib><creatorcontrib>Thatcher, N.</creatorcontrib><creatorcontrib>Hirsch, F.R.</creatorcontrib><title>Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine–cisplatin plus necitumumab versus gemcitabine–cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>SQUIRE demonstrated addition of necitumumab to gemcitabine and cisplatin significantly improved survival in patients with stage IV sq-NSCLC. Here, we report additional outcomes for the subpopulation of patients with tumor epidermal growth factor receptor (EGFR) protein expression.
Patients with pathologically confirmed stage IV sq-NSCLC were randomized 1:1 to receive a maximum of six 3-week cycles of gemcitabine (1250 mg/m2 i.v., days 1 and 8) and cisplatin (75 mg/m2 i.v., day 1) chemotherapy with or without necitumumab (800 mg i.v., days 1 and 8). Patients in the chemotherapy plus necitumumab group with no progression continued on necitumumab alone until disease progression or intolerable toxicity. SQUIRE included mandatory tissue collection. EGFR protein expression was detected by immunohistochemistry (IHC) in a central laboratory. Exploratory analyses were pre-specified for patients with EGFR protein expressing (EGFR > 0) and non-expressing (EGFR = 0) tumors.
A total of 982 patients [90% of intention-to-treat (ITT)] had evaluable IHC results. The large majority of these patients (95%) had tumor samples expressing EGFR protein; only 5% had tumors without detectable EGFR protein. Overall survival (OS) for EGFR > 0 patients was significantly longer in the necitumumab plus gemcitabine–cisplatin group than in the gemcitabine–cisplatin group {stratified hazard ratio (HR) 0.79 [95% confidence interval (CI) 0.69, 0.92; P = 0.002]; median 11.7 months (95% CI 10.7, 12.9) versus 10.0 months (8.9, 11.4)}. Additionally, an OS benefit was seen in all pre-specified subgroups in EGFR > 0 patients. However, OS HR for EGFR = 0 was 1.52. Adverse events of interest with the largest difference between treatment groups in EGFR > 0 patients (Grade ≥3) were hypomagnesemia (10% versus <1%) and skin rash (6% versus <1%).
In line with SQUIRE ITT, addition of necitumumab to gemcitabine–cisplatin significantly prolonged OS and was generally well tolerated in the subpopulation of patients with EGFR-expressing advanced sq-NSCLC. The benefit from addition of necitumumab to chemotherapy was not apparent in this analysis for the small subgroup of patients with non-EGFR-expressing tumors.
NCT00981058.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - genetics</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Carcinoma, Squamous Cell - genetics</subject><subject>Carcinoma, Squamous Cell - pathology</subject><subject>Cisplatin - administration & dosage</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Disease-Free Survival</subject><subject>EGFR expressing</subject><subject>ErbB Receptors - antagonists & inhibitors</subject><subject>ErbB Receptors - genetics</subject><subject>Female</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Middle Aged</subject><subject>necitumumab</subject><subject>Neoplasm Staging</subject><subject>Original</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>squamous NSCLC</subject><subject>SQUIRE</subject><subject>Treatment Outcome</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1ksFuEzEQhhcEoqFw5Ir8ADH1rjdxzAGpitISqRKiUK6riXecGHntxfamhBPvwBvyJHiVUsGhJ1uez_P_M_qL4lXJ3pRM8jNwzjt11rW3VVk_LiblbC7pgtXlk2LCZMWpmPH6pHge41fG2FxW8llxUomKiZKJySO69CGghWS8I16T1eXFNcXvfcAYx6dbk3YkgsZ0IOBaglobBepA_JCU7zAS48injzfr69VbAiRkxnfmB7ZT0g02GYUuYZgS36OjFjZop6TfQUSyXq9JTEN7GGW32CmTYGMc_v75S5nYj5Yc6e0QicNcG7qhgw3ZY4j56SEerHc4Wko7JNqEmKjNDEkBIXXZyyjWZzRf491wCbbZzRcSvw3Q-VHPOxo7sJYqtJbYwW2JAqcwvCiearARX96dp8XNxerz8j29-nC5Xp5fUVXzWaLIAFAsBG8lVFwqrSou2rqCxayeo67lnDGl2o3WotKKl3whOV-IUghR1iWX_LR4d-zbD5sO23GJAWzTB9NBODQeTPN_xZlds_X7ppYzKatFbkCPDVTwMQbU939L1oy5aY65aY65yfzrfwXv6b9ByYA4ApjH3hsMTVR5iQpbE1ClpvXmgdZ_AHXt36o</recordid><startdate>20160801</startdate><enddate>20160801</enddate><creator>Paz-Ares, L.</creator><creator>Socinski, M.A.</creator><creator>Shahidi, J.</creator><creator>Hozak, R.R.</creator><creator>Soldatenkova, V.</creator><creator>Kurek, R.</creator><creator>Varella-Garcia, M.</creator><creator>Thatcher, N.</creator><creator>Hirsch, F.R.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><scope>6I.</scope><scope>AAFTH</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>5PM</scope></search><sort><creationdate>20160801</creationdate><title>Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine–cisplatin plus necitumumab versus gemcitabine–cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer</title><author>Paz-Ares, L. ; Socinski, M.A. ; Shahidi, J. ; Hozak, R.R. ; Soldatenkova, V. ; Kurek, R. ; Varella-Garcia, M. ; Thatcher, N. ; Hirsch, F.R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c435t-e0aae7873d9a239cfc237d42a8546ef49600ccdbff72fc3138933871777141393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - genetics</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Carcinoma, Squamous Cell - drug therapy</topic><topic>Carcinoma, Squamous Cell - genetics</topic><topic>Carcinoma, Squamous Cell - pathology</topic><topic>Cisplatin - administration & dosage</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Disease-Free Survival</topic><topic>EGFR expressing</topic><topic>ErbB Receptors - antagonists & inhibitors</topic><topic>ErbB Receptors - genetics</topic><topic>Female</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Middle Aged</topic><topic>necitumumab</topic><topic>Neoplasm Staging</topic><topic>Original</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>squamous NSCLC</topic><topic>SQUIRE</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Paz-Ares, L.</creatorcontrib><creatorcontrib>Socinski, M.A.</creatorcontrib><creatorcontrib>Shahidi, J.</creatorcontrib><creatorcontrib>Hozak, R.R.</creatorcontrib><creatorcontrib>Soldatenkova, V.</creatorcontrib><creatorcontrib>Kurek, R.</creatorcontrib><creatorcontrib>Varella-Garcia, M.</creatorcontrib><creatorcontrib>Thatcher, N.</creatorcontrib><creatorcontrib>Hirsch, F.R.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Paz-Ares, L.</au><au>Socinski, M.A.</au><au>Shahidi, J.</au><au>Hozak, R.R.</au><au>Soldatenkova, V.</au><au>Kurek, R.</au><au>Varella-Garcia, M.</au><au>Thatcher, N.</au><au>Hirsch, F.R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine–cisplatin plus necitumumab versus gemcitabine–cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2016-08-01</date><risdate>2016</risdate><volume>27</volume><issue>8</issue><spage>1573</spage><epage>1579</epage><pages>1573-1579</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>SQUIRE demonstrated addition of necitumumab to gemcitabine and cisplatin significantly improved survival in patients with stage IV sq-NSCLC. Here, we report additional outcomes for the subpopulation of patients with tumor epidermal growth factor receptor (EGFR) protein expression.
Patients with pathologically confirmed stage IV sq-NSCLC were randomized 1:1 to receive a maximum of six 3-week cycles of gemcitabine (1250 mg/m2 i.v., days 1 and 8) and cisplatin (75 mg/m2 i.v., day 1) chemotherapy with or without necitumumab (800 mg i.v., days 1 and 8). Patients in the chemotherapy plus necitumumab group with no progression continued on necitumumab alone until disease progression or intolerable toxicity. SQUIRE included mandatory tissue collection. EGFR protein expression was detected by immunohistochemistry (IHC) in a central laboratory. Exploratory analyses were pre-specified for patients with EGFR protein expressing (EGFR > 0) and non-expressing (EGFR = 0) tumors.
A total of 982 patients [90% of intention-to-treat (ITT)] had evaluable IHC results. The large majority of these patients (95%) had tumor samples expressing EGFR protein; only 5% had tumors without detectable EGFR protein. Overall survival (OS) for EGFR > 0 patients was significantly longer in the necitumumab plus gemcitabine–cisplatin group than in the gemcitabine–cisplatin group {stratified hazard ratio (HR) 0.79 [95% confidence interval (CI) 0.69, 0.92; P = 0.002]; median 11.7 months (95% CI 10.7, 12.9) versus 10.0 months (8.9, 11.4)}. Additionally, an OS benefit was seen in all pre-specified subgroups in EGFR > 0 patients. However, OS HR for EGFR = 0 was 1.52. Adverse events of interest with the largest difference between treatment groups in EGFR > 0 patients (Grade ≥3) were hypomagnesemia (10% versus <1%) and skin rash (6% versus <1%).
In line with SQUIRE ITT, addition of necitumumab to gemcitabine–cisplatin significantly prolonged OS and was generally well tolerated in the subpopulation of patients with EGFR-expressing advanced sq-NSCLC. The benefit from addition of necitumumab to chemotherapy was not apparent in this analysis for the small subgroup of patients with non-EGFR-expressing tumors.
NCT00981058.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>27207107</pmid><doi>10.1093/annonc/mdw214</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Annals of oncology, 2016-08, Vol.27 (8), p.1573-1579 |
| issn | 0923-7534 1569-8041 |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols - administration & dosage Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - genetics Carcinoma, Non-Small-Cell Lung - pathology Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - genetics Carcinoma, Squamous Cell - pathology Cisplatin - administration & dosage Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Disease-Free Survival EGFR expressing ErbB Receptors - antagonists & inhibitors ErbB Receptors - genetics Female Humans Kaplan-Meier Estimate Male Middle Aged necitumumab Neoplasm Staging Original Protein Kinase Inhibitors - administration & dosage squamous NSCLC SQUIRE Treatment Outcome |
| title | Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine–cisplatin plus necitumumab versus gemcitabine–cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer |
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