Effectiveness, Toxicity, and Survival Predictors of Regorafenib in Metastatic Colorectal Cancer: A Multicenter Study of Routinely Collected Data
To assess the effectiveness and toxicity of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice, as well as predictive factors of effectiveness. This was a retrospective multicenter study in patients with mCRC who received regorafenib from November 2013 to M...
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| Veröffentlicht in: | Oncology (Williston Park, N.Y.) N.Y.), 2022-12, Vol.36 (12), p.732-738 |
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| creator | Calvo-García, Alberto Abánades, María Pérez Ruíz-García, Silvia Román, Ana Beatriz Fernández Fernández, Javier Letellez García, Beatriz Candel Terciado, Carlos Hernández Álvarez, Raquel De Santiago Solis, Rebeca Mondéjar Marin, Berta Hernández Diez, Patricia Toquero Baladrón, Alberto Morell Bosch, Ramón Colomer |
| description | To assess the effectiveness and toxicity of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice, as well as predictive factors of effectiveness.
This was a retrospective multicenter study in patients with mCRC who received regorafenib from November 2013 to May 2020. Effectiveness was evaluated by overall survival (OS) and progression-free survival (PFS) using the Kaplan-Meier method. Cox regression was performed to determine survival predictors.
Ninety patients were enrolled (median age, 64.3 years). Fifty-two patients (57.8%) were male, and 57 (63.3%) had an ECOG performance status (PS) of 0 to 1. Median follow-up was 2.80 months. Median OS was 8.03 months (95% CI, 5.90-10.17), and median PFS was 2.90 months (95% CI, 2.59-3.21). Eighty-eight patients (97.8%) experienced drug-related adverse events. The most frequent were fatigue in 66 patients (73.3%), followed by palmar-plantar erythrodysesthesia in 40 (44.4%). Low liver tumor burden score (LTBS) and good ECOG PS were independent OS predictive factors.
Patients taking regorafenib had OS and PFS rates similar to those reported in previous randomized trials; the agent had a poor toxicity profile. We identified low LTBS and good ECOG PS as possible predictive factors of better OS, useful in selecting patients with mCRC who might benefit from regorafenib. |
| doi_str_mv | 10.46883/2022.25920981 |
| format | Article |
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This was a retrospective multicenter study in patients with mCRC who received regorafenib from November 2013 to May 2020. Effectiveness was evaluated by overall survival (OS) and progression-free survival (PFS) using the Kaplan-Meier method. Cox regression was performed to determine survival predictors.
Ninety patients were enrolled (median age, 64.3 years). Fifty-two patients (57.8%) were male, and 57 (63.3%) had an ECOG performance status (PS) of 0 to 1. Median follow-up was 2.80 months. Median OS was 8.03 months (95% CI, 5.90-10.17), and median PFS was 2.90 months (95% CI, 2.59-3.21). Eighty-eight patients (97.8%) experienced drug-related adverse events. The most frequent were fatigue in 66 patients (73.3%), followed by palmar-plantar erythrodysesthesia in 40 (44.4%). Low liver tumor burden score (LTBS) and good ECOG PS were independent OS predictive factors.
Patients taking regorafenib had OS and PFS rates similar to those reported in previous randomized trials; the agent had a poor toxicity profile. We identified low LTBS and good ECOG PS as possible predictive factors of better OS, useful in selecting patients with mCRC who might benefit from regorafenib.</description><identifier>ISSN: 0890-9091</identifier><identifier>DOI: 10.46883/2022.25920981</identifier><identifier>PMID: 36548097</identifier><language>eng</language><publisher>United States: Intellisphere, LLC</publisher><subject>Cancer ; Cancer patients ; Cancer therapies ; Chemotherapy ; Clinical medicine ; Colonic Neoplasms ; Colorectal cancer ; Colorectal Neoplasms - pathology ; Drug dosages ; FDA approval ; Female ; Humans ; Inhibitor drugs ; Liver ; Liver cancer ; Liver Neoplasms - secondary ; Male ; Medical prognosis ; Metastasis ; Middle Aged ; Multivariate analysis ; Oncology, Experimental ; Patients ; Performance evaluation ; Phenylurea Compounds - adverse effects ; Rectal Neoplasms ; Routinely Collected Health Data ; Sociodemographics ; Survival analysis ; Targeted cancer therapy ; Variables</subject><ispartof>Oncology (Williston Park, N.Y.), 2022-12, Vol.36 (12), p.732-738</ispartof><rights>COPYRIGHT 2022 Intellisphere, LLC</rights><rights>Copyright MultiMedia Healthcare Inc. 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c499t-c0c5541900f1c26ccd96409fc71ad7b2edc21f751aeba6b8005594efe1780243</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36548097$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Calvo-García, Alberto</creatorcontrib><creatorcontrib>Abánades, María Pérez</creatorcontrib><creatorcontrib>Ruíz-García, Silvia</creatorcontrib><creatorcontrib>Román, Ana Beatriz Fernández</creatorcontrib><creatorcontrib>Fernández, Javier Letellez</creatorcontrib><creatorcontrib>García, Beatriz Candel</creatorcontrib><creatorcontrib>Terciado, Carlos Hernández</creatorcontrib><creatorcontrib>Álvarez, Raquel De Santiago</creatorcontrib><creatorcontrib>Solis, Rebeca Mondéjar</creatorcontrib><creatorcontrib>Marin, Berta Hernández</creatorcontrib><creatorcontrib>Diez, Patricia Toquero</creatorcontrib><creatorcontrib>Baladrón, Alberto Morell</creatorcontrib><creatorcontrib>Bosch, Ramón Colomer</creatorcontrib><title>Effectiveness, Toxicity, and Survival Predictors of Regorafenib in Metastatic Colorectal Cancer: A Multicenter Study of Routinely Collected Data</title><title>Oncology (Williston Park, N.Y.)</title><addtitle>Oncology (Williston Park)</addtitle><description>To assess the effectiveness and toxicity of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice, as well as predictive factors of effectiveness.
This was a retrospective multicenter study in patients with mCRC who received regorafenib from November 2013 to May 2020. Effectiveness was evaluated by overall survival (OS) and progression-free survival (PFS) using the Kaplan-Meier method. Cox regression was performed to determine survival predictors.
Ninety patients were enrolled (median age, 64.3 years). Fifty-two patients (57.8%) were male, and 57 (63.3%) had an ECOG performance status (PS) of 0 to 1. Median follow-up was 2.80 months. Median OS was 8.03 months (95% CI, 5.90-10.17), and median PFS was 2.90 months (95% CI, 2.59-3.21). Eighty-eight patients (97.8%) experienced drug-related adverse events. The most frequent were fatigue in 66 patients (73.3%), followed by palmar-plantar erythrodysesthesia in 40 (44.4%). Low liver tumor burden score (LTBS) and good ECOG PS were independent OS predictive factors.
Patients taking regorafenib had OS and PFS rates similar to those reported in previous randomized trials; the agent had a poor toxicity profile. We identified low LTBS and good ECOG PS as possible predictive factors of better OS, useful in selecting patients with mCRC who might benefit from regorafenib.</description><subject>Cancer</subject><subject>Cancer patients</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Clinical medicine</subject><subject>Colonic Neoplasms</subject><subject>Colorectal cancer</subject><subject>Colorectal Neoplasms - pathology</subject><subject>Drug dosages</subject><subject>FDA approval</subject><subject>Female</subject><subject>Humans</subject><subject>Inhibitor drugs</subject><subject>Liver</subject><subject>Liver cancer</subject><subject>Liver Neoplasms - secondary</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Multivariate analysis</subject><subject>Oncology, Experimental</subject><subject>Patients</subject><subject>Performance evaluation</subject><subject>Phenylurea Compounds - adverse effects</subject><subject>Rectal Neoplasms</subject><subject>Routinely Collected Health Data</subject><subject>Sociodemographics</subject><subject>Survival analysis</subject><subject>Targeted cancer therapy</subject><subject>Variables</subject><issn>0890-9091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNptkk1rVDEUhu9CsbW6dSkBwVXveJKb-xF3w7R-QItiZ3_JTU6mKZmkJrmD8y_8yaa19QOGLALJ87wHDm9VvaKw4N0wNO8YMLZgrWAgBvqkOoZBQC1A0KPqeUo3AKzrYHhWHTVdywcQ_XH189wYVNnu0GNKp2Qdflhl8_6USK_J1Rx3dicd-RpRW5VDTCQY8g03IUqD3k7EenKJWaYss1VkFVyIJa8oK-kVxvdkSS5nV_7QZ4zkKs96f58R5mw9uv2d44qCmpzJLF9UT410CV8-3CfV-sP5evWpvvjy8fNqeVErLkSuFai25VQAGKpYp5QWHQdhVE-l7ieGWjFq-pZKnGQ3DQBtKzgapP0AjDcn1ZvfsbcxfJ8x5fEmzNGXiSMrgOAcOPtLbaTD0XoTcpRqa5Mal33T0A7aXhSqPkBtykajdMGjseX5P35xgC9H49aqg8Lbf4RrlC5fp-DKAoNPB5NVDClFNONttFsZ9yOF8b4j411HxseOFOH1wxrmaYv6D_5YkOYXNny3Lg</recordid><startdate>20221201</startdate><enddate>20221201</enddate><creator>Calvo-García, Alberto</creator><creator>Abánades, María Pérez</creator><creator>Ruíz-García, Silvia</creator><creator>Román, Ana Beatriz Fernández</creator><creator>Fernández, Javier Letellez</creator><creator>García, Beatriz Candel</creator><creator>Terciado, Carlos Hernández</creator><creator>Álvarez, Raquel De Santiago</creator><creator>Solis, Rebeca Mondéjar</creator><creator>Marin, Berta Hernández</creator><creator>Diez, Patricia Toquero</creator><creator>Baladrón, Alberto Morell</creator><creator>Bosch, Ramón Colomer</creator><general>Intellisphere, LLC</general><general>MultiMedia Healthcare Inc</general><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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20221201</creationdate><title>Effectiveness, Toxicity, and Survival Predictors of Regorafenib in Metastatic Colorectal Cancer: A Multicenter Study of Routinely Collected Data</title><author>Calvo-García, Alberto ; Abánades, María Pérez ; Ruíz-García, Silvia ; Román, Ana Beatriz Fernández ; Fernández, Javier Letellez ; García, Beatriz Candel ; Terciado, Carlos Hernández ; Álvarez, Raquel De Santiago ; Solis, Rebeca Mondéjar ; Marin, Berta Hernández ; Diez, Patricia Toquero ; Baladrón, Alberto Morell ; Bosch, Ramón Colomer</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c499t-c0c5541900f1c26ccd96409fc71ad7b2edc21f751aeba6b8005594efe1780243</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Cancer</topic><topic>Cancer patients</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Clinical medicine</topic><topic>Colonic Neoplasms</topic><topic>Colorectal cancer</topic><topic>Colorectal Neoplasms - pathology</topic><topic>Drug dosages</topic><topic>FDA approval</topic><topic>Female</topic><topic>Humans</topic><topic>Inhibitor drugs</topic><topic>Liver</topic><topic>Liver cancer</topic><topic>Liver Neoplasms - secondary</topic><topic>Male</topic><topic>Medical prognosis</topic><topic>Metastasis</topic><topic>Middle Aged</topic><topic>Multivariate analysis</topic><topic>Oncology, Experimental</topic><topic>Patients</topic><topic>Performance evaluation</topic><topic>Phenylurea Compounds - adverse effects</topic><topic>Rectal Neoplasms</topic><topic>Routinely Collected Health Data</topic><topic>Sociodemographics</topic><topic>Survival analysis</topic><topic>Targeted cancer therapy</topic><topic>Variables</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Calvo-García, Alberto</creatorcontrib><creatorcontrib>Abánades, María Pérez</creatorcontrib><creatorcontrib>Ruíz-García, Silvia</creatorcontrib><creatorcontrib>Román, Ana Beatriz Fernández</creatorcontrib><creatorcontrib>Fernández, Javier Letellez</creatorcontrib><creatorcontrib>García, Beatriz Candel</creatorcontrib><creatorcontrib>Terciado, Carlos Hernández</creatorcontrib><creatorcontrib>Álvarez, Raquel De Santiago</creatorcontrib><creatorcontrib>Solis, Rebeca Mondéjar</creatorcontrib><creatorcontrib>Marin, Berta Hernández</creatorcontrib><creatorcontrib>Diez, Patricia Toquero</creatorcontrib><creatorcontrib>Baladrón, Alberto Morell</creatorcontrib><creatorcontrib>Bosch, Ramón Colomer</creatorcontrib><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>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</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 Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</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><jtitle>Oncology (Williston Park, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Calvo-García, Alberto</au><au>Abánades, María Pérez</au><au>Ruíz-García, Silvia</au><au>Román, Ana Beatriz Fernández</au><au>Fernández, Javier Letellez</au><au>García, Beatriz Candel</au><au>Terciado, Carlos Hernández</au><au>Álvarez, Raquel De Santiago</au><au>Solis, Rebeca Mondéjar</au><au>Marin, Berta Hernández</au><au>Diez, Patricia Toquero</au><au>Baladrón, Alberto Morell</au><au>Bosch, Ramón Colomer</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness, Toxicity, and Survival Predictors of Regorafenib in Metastatic Colorectal Cancer: A Multicenter Study of Routinely Collected Data</atitle><jtitle>Oncology (Williston Park, N.Y.)</jtitle><addtitle>Oncology (Williston Park)</addtitle><date>2022-12-01</date><risdate>2022</risdate><volume>36</volume><issue>12</issue><spage>732</spage><epage>738</epage><pages>732-738</pages><issn>0890-9091</issn><abstract>To assess the effectiveness and toxicity of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice, as well as predictive factors of effectiveness.
This was a retrospective multicenter study in patients with mCRC who received regorafenib from November 2013 to May 2020. Effectiveness was evaluated by overall survival (OS) and progression-free survival (PFS) using the Kaplan-Meier method. Cox regression was performed to determine survival predictors.
Ninety patients were enrolled (median age, 64.3 years). Fifty-two patients (57.8%) were male, and 57 (63.3%) had an ECOG performance status (PS) of 0 to 1. Median follow-up was 2.80 months. Median OS was 8.03 months (95% CI, 5.90-10.17), and median PFS was 2.90 months (95% CI, 2.59-3.21). Eighty-eight patients (97.8%) experienced drug-related adverse events. The most frequent were fatigue in 66 patients (73.3%), followed by palmar-plantar erythrodysesthesia in 40 (44.4%). Low liver tumor burden score (LTBS) and good ECOG PS were independent OS predictive factors.
Patients taking regorafenib had OS and PFS rates similar to those reported in previous randomized trials; the agent had a poor toxicity profile. We identified low LTBS and good ECOG PS as possible predictive factors of better OS, useful in selecting patients with mCRC who might benefit from regorafenib.</abstract><cop>United States</cop><pub>Intellisphere, LLC</pub><pmid>36548097</pmid><doi>10.46883/2022.25920981</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Cancer Cancer patients Cancer therapies Chemotherapy Clinical medicine Colonic Neoplasms Colorectal cancer Colorectal Neoplasms - pathology Drug dosages FDA approval Female Humans Inhibitor drugs Liver Liver cancer Liver Neoplasms - secondary Male Medical prognosis Metastasis Middle Aged Multivariate analysis Oncology, Experimental Patients Performance evaluation Phenylurea Compounds - adverse effects Rectal Neoplasms Routinely Collected Health Data Sociodemographics Survival analysis Targeted cancer therapy Variables |
| title | Effectiveness, Toxicity, and Survival Predictors of Regorafenib in Metastatic Colorectal Cancer: A Multicenter Study of Routinely Collected Data |
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