Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC
Crizotinib is approved to treat advanced ALK-positive non-small-cell lung cancer (NSCLC), but most patients ultimately develop progressive disease (PD). We investigated whether continuing ALK inhibition with crizotinib beyond PD (CBPD) is clinically beneficial and attempted to identify clinicopathol...
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| Veröffentlicht in: | Annals of oncology 2014-02, Vol.25 (2), p.415-422 |
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| creator | Ou, S.-H. I. Jänne, P.A. Bartlett, C.H. Tang, Y. Kim, D.-W. Otterson, G.A. Crinò, L. Selaru, P. Cohen, D.P. Clark, J.W. Riely, G.J. |
| description | Crizotinib is approved to treat advanced ALK-positive non-small-cell lung cancer (NSCLC), but most patients ultimately develop progressive disease (PD). We investigated whether continuing ALK inhibition with crizotinib beyond PD (CBPD) is clinically beneficial and attempted to identify clinicopathologic characteristics associated with patients who experience clinical benefit.
Patients with advanced ALK-positive NSCLC enrolled in two ongoing multicenter, single-arm trials who developed RECIST-defined PD were allowed to continue crizotinib if they were deriving ongoing clinical benefit. In the present retrospective analysis, continuation of CBPD was defined as >3 weeks of crizotinib treatment after PD documentation. Patients who had PD as best response to initial crizotinib treatment were excluded. Baseline and post-progression characteristics, sites of PD, and overall survival (OS) were compared in patients who continued CBPD versus those who did not. The impact of continuing CBPD on OS after adjusting for potential confounding factors was assessed.
Among 194 crizotinib-treated patients with RECIST-defined PD, 120 (62%) continued CBPD. A significantly higher proportion of patients who continued CBPD than patients who did not had an ECOG performance status (PS) of 0/1 at PD (96% versus 82%; P = 0.02). CBPD patients had significantly longer OS from the time of PD [median 16.4 versus 3.9 months; hazards ratio (HR) 0.27, 95% confidence interval (CI): 0.17–0.42; P < 0.0001] and from the time of initial crizotinib treatment (median 29.6 versus 10.8 months; HR 0.30, 95% CI: 0.19–0.46; P < 0.0001). The multiple-covariate Cox regression analysis revealed that CBPD remained significantly associated with improved OS after adjusting for relevant factors.
Patients who continued CBPD were more likely to have good ECOG PS (0/1) at the time of PD. Continuing ALK inhibition with crizotinib after PD may provide survival benefit to patients with advanced ALK-positive NSCLC. |
| doi_str_mv | 10.1093/annonc/mdt572 |
| format | Article |
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Patients with advanced ALK-positive NSCLC enrolled in two ongoing multicenter, single-arm trials who developed RECIST-defined PD were allowed to continue crizotinib if they were deriving ongoing clinical benefit. In the present retrospective analysis, continuation of CBPD was defined as >3 weeks of crizotinib treatment after PD documentation. Patients who had PD as best response to initial crizotinib treatment were excluded. Baseline and post-progression characteristics, sites of PD, and overall survival (OS) were compared in patients who continued CBPD versus those who did not. The impact of continuing CBPD on OS after adjusting for potential confounding factors was assessed.
Among 194 crizotinib-treated patients with RECIST-defined PD, 120 (62%) continued CBPD. A significantly higher proportion of patients who continued CBPD than patients who did not had an ECOG performance status (PS) of 0/1 at PD (96% versus 82%; P = 0.02). CBPD patients had significantly longer OS from the time of PD [median 16.4 versus 3.9 months; hazards ratio (HR) 0.27, 95% confidence interval (CI): 0.17–0.42; P < 0.0001] and from the time of initial crizotinib treatment (median 29.6 versus 10.8 months; HR 0.30, 95% CI: 0.19–0.46; P < 0.0001). The multiple-covariate Cox regression analysis revealed that CBPD remained significantly associated with improved OS after adjusting for relevant factors.
Patients who continued CBPD were more likely to have good ECOG PS (0/1) at the time of PD. Continuing ALK inhibition with crizotinib after PD may provide survival benefit to patients with advanced ALK-positive NSCLC.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdt572</identifier><identifier>PMID: 24478318</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adenocarcinoma - drug therapy ; Adenocarcinoma - enzymology ; Adenocarcinoma - mortality ; Adenocarcinoma - pathology ; Adult ; Aged ; ALK-positive NSCLC ; Anaplastic Lymphoma Kinase ; Antineoplastic agents ; Antineoplastic Agents - pharmacology ; Antineoplastic Agents - therapeutic use ; Biological and medical sciences ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - enzymology ; Carcinoma, Non-Small-Cell Lung - mortality ; Carcinoma, Non-Small-Cell Lung - pathology ; Crizotinib ; Disease Progression ; Female ; Humans ; Kaplan-Meier Estimate ; Lung Neoplasms - drug therapy ; Lung Neoplasms - enzymology ; Lung Neoplasms - mortality ; Lung Neoplasms - pathology ; Male ; Medical sciences ; Middle Aged ; Molecular Targeted Therapy ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; oncogene addiction ; Pharmacology. Drug treatments ; Pneumology ; Proportional Hazards Models ; Pyrazoles - pharmacology ; Pyrazoles - therapeutic use ; Pyridines - pharmacology ; Pyridines - therapeutic use ; Receptor Protein-Tyrosine Kinases - antagonists & inhibitors ; Receptor Protein-Tyrosine Kinases - metabolism ; RECIST ; Retrospective Studies ; TKI ; treatment beyond disease progression ; Treatment Outcome ; Tumors ; Tumors of the respiratory system and mediastinum ; Young Adult</subject><ispartof>Annals of oncology, 2014-02, Vol.25 (2), p.415-422</ispartof><rights>2014 European Society for Medical Oncology</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-1e453137c2abf91134f8fc9a942a7618577c788332ef9e490e229fd89924d7f53</citedby><cites>FETCH-LOGICAL-c410t-1e453137c2abf91134f8fc9a942a7618577c788332ef9e490e229fd89924d7f53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28168506$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24478318$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ou, S.-H. I.</creatorcontrib><creatorcontrib>Jänne, P.A.</creatorcontrib><creatorcontrib>Bartlett, C.H.</creatorcontrib><creatorcontrib>Tang, Y.</creatorcontrib><creatorcontrib>Kim, D.-W.</creatorcontrib><creatorcontrib>Otterson, G.A.</creatorcontrib><creatorcontrib>Crinò, L.</creatorcontrib><creatorcontrib>Selaru, P.</creatorcontrib><creatorcontrib>Cohen, D.P.</creatorcontrib><creatorcontrib>Clark, J.W.</creatorcontrib><creatorcontrib>Riely, G.J.</creatorcontrib><title>Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Crizotinib is approved to treat advanced ALK-positive non-small-cell lung cancer (NSCLC), but most patients ultimately develop progressive disease (PD). We investigated whether continuing ALK inhibition with crizotinib beyond PD (CBPD) is clinically beneficial and attempted to identify clinicopathologic characteristics associated with patients who experience clinical benefit.
Patients with advanced ALK-positive NSCLC enrolled in two ongoing multicenter, single-arm trials who developed RECIST-defined PD were allowed to continue crizotinib if they were deriving ongoing clinical benefit. In the present retrospective analysis, continuation of CBPD was defined as >3 weeks of crizotinib treatment after PD documentation. Patients who had PD as best response to initial crizotinib treatment were excluded. Baseline and post-progression characteristics, sites of PD, and overall survival (OS) were compared in patients who continued CBPD versus those who did not. The impact of continuing CBPD on OS after adjusting for potential confounding factors was assessed.
Among 194 crizotinib-treated patients with RECIST-defined PD, 120 (62%) continued CBPD. A significantly higher proportion of patients who continued CBPD than patients who did not had an ECOG performance status (PS) of 0/1 at PD (96% versus 82%; P = 0.02). CBPD patients had significantly longer OS from the time of PD [median 16.4 versus 3.9 months; hazards ratio (HR) 0.27, 95% confidence interval (CI): 0.17–0.42; P < 0.0001] and from the time of initial crizotinib treatment (median 29.6 versus 10.8 months; HR 0.30, 95% CI: 0.19–0.46; P < 0.0001). The multiple-covariate Cox regression analysis revealed that CBPD remained significantly associated with improved OS after adjusting for relevant factors.
Patients who continued CBPD were more likely to have good ECOG PS (0/1) at the time of PD. Continuing ALK inhibition with crizotinib after PD may provide survival benefit to patients with advanced ALK-positive NSCLC.</description><subject>Adenocarcinoma - drug therapy</subject><subject>Adenocarcinoma - enzymology</subject><subject>Adenocarcinoma - mortality</subject><subject>Adenocarcinoma - pathology</subject><subject>Adult</subject><subject>Aged</subject><subject>ALK-positive NSCLC</subject><subject>Anaplastic Lymphoma Kinase</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - pharmacology</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - enzymology</subject><subject>Carcinoma, Non-Small-Cell Lung - mortality</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Crizotinib</subject><subject>Disease Progression</subject><subject>Female</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - enzymology</subject><subject>Lung Neoplasms - mortality</subject><subject>Lung Neoplasms - pathology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Molecular Targeted Therapy</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>oncogene addiction</subject><subject>Pharmacology. Drug treatments</subject><subject>Pneumology</subject><subject>Proportional Hazards Models</subject><subject>Pyrazoles - pharmacology</subject><subject>Pyrazoles - therapeutic use</subject><subject>Pyridines - pharmacology</subject><subject>Pyridines - therapeutic use</subject><subject>Receptor Protein-Tyrosine Kinases - antagonists & inhibitors</subject><subject>Receptor Protein-Tyrosine Kinases - metabolism</subject><subject>RECIST</subject><subject>Retrospective Studies</subject><subject>TKI</subject><subject>treatment beyond disease progression</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Tumors of the respiratory system and mediastinum</subject><subject>Young Adult</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kTuP1DAUhSMEYoeFkha5QaIJ61diu1xFy0OMoADqyHGudy_K2IPtGbT8B_4zHmWAisqFv3N09Z2mec7oa0aNuLIhxOCudnPpFH_QbFjXm1ZTyR42G2q4aFUn5EXzJOdvlNLecPO4ueBSKi2Y3jS_hgUDOruQCQJ4LCR64mIoGA4Ybsn19gPBcIcTFoyB_MByR1zCn7ECONXQfQxzJep37Zgxg81A9ineJsj5FMFA9rYghJLXuJ2PNjiYT93tPuYaPQL5-HnYDk-bR94uGZ6d38vm65ubL8O7dvvp7fvhets6yWhpGchOMKEct5M3jAnptXfGGsmt6pnulHJKayE4eAPSUODc-Fkbw-WsfCcum1drbz30-wFyGXeYHSyLDRAPeWTSCGU6TkVF2xV1KeacwI_7hDub7kdGx9MC47rAuC5Q-Rfn6sO0g_kv_Ud5BV6eAZurd5-qDMz_OM163dG-cmrloIo4IqQxu2qxisMEroxzxP-c8BuesqYV</recordid><startdate>20140201</startdate><enddate>20140201</enddate><creator>Ou, S.-H. I.</creator><creator>Jänne, P.A.</creator><creator>Bartlett, C.H.</creator><creator>Tang, Y.</creator><creator>Kim, D.-W.</creator><creator>Otterson, G.A.</creator><creator>Crinò, L.</creator><creator>Selaru, P.</creator><creator>Cohen, D.P.</creator><creator>Clark, J.W.</creator><creator>Riely, G.J.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><scope>6I.</scope><scope>AAFTH</scope><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>7X8</scope></search><sort><creationdate>20140201</creationdate><title>Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC</title><author>Ou, S.-H. I. ; Jänne, P.A. ; Bartlett, C.H. ; Tang, Y. ; Kim, D.-W. ; Otterson, G.A. ; Crinò, L. ; Selaru, P. ; Cohen, D.P. ; Clark, J.W. ; Riely, G.J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-1e453137c2abf91134f8fc9a942a7618577c788332ef9e490e229fd89924d7f53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Adenocarcinoma - enzymology</topic><topic>Adenocarcinoma - mortality</topic><topic>Adenocarcinoma - pathology</topic><topic>Adult</topic><topic>Aged</topic><topic>ALK-positive NSCLC</topic><topic>Anaplastic Lymphoma Kinase</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - pharmacology</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - enzymology</topic><topic>Carcinoma, Non-Small-Cell Lung - mortality</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Crizotinib</topic><topic>Disease Progression</topic><topic>Female</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - enzymology</topic><topic>Lung Neoplasms - mortality</topic><topic>Lung Neoplasms - pathology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Molecular Targeted Therapy</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>oncogene addiction</topic><topic>Pharmacology. Drug treatments</topic><topic>Pneumology</topic><topic>Proportional Hazards Models</topic><topic>Pyrazoles - pharmacology</topic><topic>Pyrazoles - therapeutic use</topic><topic>Pyridines - pharmacology</topic><topic>Pyridines - therapeutic use</topic><topic>Receptor Protein-Tyrosine Kinases - antagonists & inhibitors</topic><topic>Receptor Protein-Tyrosine Kinases - metabolism</topic><topic>RECIST</topic><topic>Retrospective Studies</topic><topic>TKI</topic><topic>treatment beyond disease progression</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Tumors of the respiratory system and mediastinum</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ou, S.-H. I.</creatorcontrib><creatorcontrib>Jänne, P.A.</creatorcontrib><creatorcontrib>Bartlett, C.H.</creatorcontrib><creatorcontrib>Tang, Y.</creatorcontrib><creatorcontrib>Kim, D.-W.</creatorcontrib><creatorcontrib>Otterson, G.A.</creatorcontrib><creatorcontrib>Crinò, L.</creatorcontrib><creatorcontrib>Selaru, P.</creatorcontrib><creatorcontrib>Cohen, D.P.</creatorcontrib><creatorcontrib>Clark, J.W.</creatorcontrib><creatorcontrib>Riely, G.J.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</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>MEDLINE - Academic</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ou, S.-H. I.</au><au>Jänne, P.A.</au><au>Bartlett, C.H.</au><au>Tang, Y.</au><au>Kim, D.-W.</au><au>Otterson, G.A.</au><au>Crinò, L.</au><au>Selaru, P.</au><au>Cohen, D.P.</au><au>Clark, J.W.</au><au>Riely, G.J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2014-02-01</date><risdate>2014</risdate><volume>25</volume><issue>2</issue><spage>415</spage><epage>422</epage><pages>415-422</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Crizotinib is approved to treat advanced ALK-positive non-small-cell lung cancer (NSCLC), but most patients ultimately develop progressive disease (PD). We investigated whether continuing ALK inhibition with crizotinib beyond PD (CBPD) is clinically beneficial and attempted to identify clinicopathologic characteristics associated with patients who experience clinical benefit.
Patients with advanced ALK-positive NSCLC enrolled in two ongoing multicenter, single-arm trials who developed RECIST-defined PD were allowed to continue crizotinib if they were deriving ongoing clinical benefit. In the present retrospective analysis, continuation of CBPD was defined as >3 weeks of crizotinib treatment after PD documentation. Patients who had PD as best response to initial crizotinib treatment were excluded. Baseline and post-progression characteristics, sites of PD, and overall survival (OS) were compared in patients who continued CBPD versus those who did not. The impact of continuing CBPD on OS after adjusting for potential confounding factors was assessed.
Among 194 crizotinib-treated patients with RECIST-defined PD, 120 (62%) continued CBPD. A significantly higher proportion of patients who continued CBPD than patients who did not had an ECOG performance status (PS) of 0/1 at PD (96% versus 82%; P = 0.02). CBPD patients had significantly longer OS from the time of PD [median 16.4 versus 3.9 months; hazards ratio (HR) 0.27, 95% confidence interval (CI): 0.17–0.42; P < 0.0001] and from the time of initial crizotinib treatment (median 29.6 versus 10.8 months; HR 0.30, 95% CI: 0.19–0.46; P < 0.0001). The multiple-covariate Cox regression analysis revealed that CBPD remained significantly associated with improved OS after adjusting for relevant factors.
Patients who continued CBPD were more likely to have good ECOG PS (0/1) at the time of PD. Continuing ALK inhibition with crizotinib after PD may provide survival benefit to patients with advanced ALK-positive NSCLC.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>24478318</pmid><doi>10.1093/annonc/mdt572</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Annals of oncology, 2014-02, Vol.25 (2), p.415-422 |
| issn | 0923-7534 1569-8041 |
| language | eng |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Adenocarcinoma - drug therapy Adenocarcinoma - enzymology Adenocarcinoma - mortality Adenocarcinoma - pathology Adult Aged ALK-positive NSCLC Anaplastic Lymphoma Kinase Antineoplastic agents Antineoplastic Agents - pharmacology Antineoplastic Agents - therapeutic use Biological and medical sciences Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - enzymology Carcinoma, Non-Small-Cell Lung - mortality Carcinoma, Non-Small-Cell Lung - pathology Crizotinib Disease Progression Female Humans Kaplan-Meier Estimate Lung Neoplasms - drug therapy Lung Neoplasms - enzymology Lung Neoplasms - mortality Lung Neoplasms - pathology Male Medical sciences Middle Aged Molecular Targeted Therapy Multiple tumors. Solid tumors. Tumors in childhood (general aspects) oncogene addiction Pharmacology. Drug treatments Pneumology Proportional Hazards Models Pyrazoles - pharmacology Pyrazoles - therapeutic use Pyridines - pharmacology Pyridines - therapeutic use Receptor Protein-Tyrosine Kinases - antagonists & inhibitors Receptor Protein-Tyrosine Kinases - metabolism RECIST Retrospective Studies TKI treatment beyond disease progression Treatment Outcome Tumors Tumors of the respiratory system and mediastinum Young Adult |
| title | Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC |
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