Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial
Background: Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil–leucovorin (5-FU/LV) as first-line treatment for patients with metastatic colorectal cancer. We report here the results of a large phase III trial investigating adjuvant...
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| Veröffentlicht in: | Annals of oncology 2003-12, Vol.14 (12), p.1735-1743 |
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| creator | Scheithauer, W. McKendrick, J. Begbie, S. Borner, M. Burns, W. I. Burris, H. A. Cassidy, J. Jodrell, D. Koralewski, P. Levine, E. L. Marschner, N. Maroun, J. Garcia-Alfonso, P. Tujakowski, J. Van Hazel, G. Wong, A. Zaluski, J. Twelves, C. |
| description | Background: Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil–leucovorin (5-FU/LV) as first-line treatment for patients with metastatic colorectal cancer. We report here the results of a large phase III trial investigating adjuvant oral capecitabine compared with 5-FU/LV (Mayo Clinic regimen) in Dukes’ C colon cancer. Patients and methods: Patients aged 18–75 years with resected Dukes’ C colon carcinoma were randomized to receive 24 weeks of treatment with either oral capecitabine 1250 mg/m2 twice daily, days 1–14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m2 with i.v. leucovorin 20 mg/m2 on days 1–5, repeated every 28 days (n = 974). Results: Patients receiving capecitabine experienced significantly (P |
| doi_str_mv | 10.1093/annonc/mdg500 |
| format | Article |
| fullrecord | <record><control><sourceid>istex_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1093_annonc_mdg500</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>ark_67375_HXZ_THLC03K7_4</sourcerecordid><originalsourceid>FETCH-LOGICAL-c462t-dc0155d40667a268acb7f8e46aed881ed2e22c0e23e1f7a29f12cfb75fa0e82e3</originalsourceid><addsrcrecordid>eNpFkE2P0zAQQC0EYrsLR67IF26k64_YSbihCrYVlfaySIhLNLHHrJfUrmynovwN_jBBrehpDvP0RvMIecPZkrNO3kIIMZjbnf2hGHtGFlzprmpZzZ-TBeuErBol6ytynfMTY0x3ontJrnitJdNNuyB_7hOM1MAejS8w-IAUMoVAYSyYAhR_QFoi9cvDkqrKjVNMcUpg_FgNkNFSsE_TAUKh5RET7I_UxURNHGOYtcFg-kAzOCxHmjBPY8k0Ogo0QbBx53-jfU_3j7OJbjYbWpKH8RV54WDM-Po8b8jXz58eVutqe3-3WX3cVqbWolTWMK6UrZnWDQjdghka12KtAW3bcrQChTAMhUTuZqJzXBg3NMoBw1agvCHVyWtSzDmh6_fJ7yAde876f3H7U9z-FHfm3574_TTs0F7oc80ZeHcGIBsY3fyj8fnCKSmkqvnlsM8Ff_3fQ_rZ60Y2ql9_-94_rLcrJr80fS3_AoYolgw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>Scheithauer, W. ; McKendrick, J. ; Begbie, S. ; Borner, M. ; Burns, W. I. ; Burris, H. A. ; Cassidy, J. ; Jodrell, D. ; Koralewski, P. ; Levine, E. L. ; Marschner, N. ; Maroun, J. ; Garcia-Alfonso, P. ; Tujakowski, J. ; Van Hazel, G. ; Wong, A. ; Zaluski, J. ; Twelves, C.</creator><creatorcontrib>Scheithauer, W. ; McKendrick, J. ; Begbie, S. ; Borner, M. ; Burns, W. I. ; Burris, H. A. ; Cassidy, J. ; Jodrell, D. ; Koralewski, P. ; Levine, E. L. ; Marschner, N. ; Maroun, J. ; Garcia-Alfonso, P. ; Tujakowski, J. ; Van Hazel, G. ; Wong, A. ; Zaluski, J. ; Twelves, C. ; X-ACT Study Group</creatorcontrib><description>Background: Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil–leucovorin (5-FU/LV) as first-line treatment for patients with metastatic colorectal cancer. We report here the results of a large phase III trial investigating adjuvant oral capecitabine compared with 5-FU/LV (Mayo Clinic regimen) in Dukes’ C colon cancer. Patients and methods: Patients aged 18–75 years with resected Dukes’ C colon carcinoma were randomized to receive 24 weeks of treatment with either oral capecitabine 1250 mg/m2 twice daily, days 1–14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m2 with i.v. leucovorin 20 mg/m2 on days 1–5, repeated every 28 days (n = 974). Results: Patients receiving capecitabine experienced significantly (P <0.001) less diarrhea, stomatitis, nausea/vomiting, alopecia and neutropenia, but more hand–foot syndrome than those receiving 5-FU/LV. Fewer patients receiving capecitabine experienced grade 3 or 4 neutropenia, febrile neutropenia/sepsis and stomatitis (P <0.001), although more experienced grade 3 hand–foot syndrome than those treated with 5-FU/LV (P <0.001). Capecitabine demonstrates a similar, favorable safety profile in patients aged <65 years or ≥65 years old. Conclusions: Based on its improved safety profile, capecitabine has the potential to replace 5-FU/LV as standard adjuvant treatment for patients with colon cancer. Efficacy results are expected to be available in 2004. Keywords: Adjuvant treatment, capecitabine, chemotherapy, colorectal cancer</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdg500</identifier><identifier>PMID: 14630678</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Administration, Oral ; Adult ; Age Factors ; Aged ; Aged, 80 and over ; Antimetabolites, Antineoplastic - administration & dosage ; Antimetabolites, Antineoplastic - adverse effects ; Antimetabolites, Antineoplastic - therapeutic use ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Capecitabine ; Chemotherapy ; Colonic Neoplasms - drug therapy ; Colonic Neoplasms - pathology ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - therapeutic use ; Diarrhea - chemically induced ; Female ; Fluorouracil - administration & dosage ; Humans ; Leucovorin - administration & dosage ; Male ; Medical sciences ; Middle Aged ; Neoplasm Metastasis ; Neutropenia - chemically induced ; Peripheral Nervous System Diseases - chemically induced ; Pharmacology. Drug treatments ; Safety</subject><ispartof>Annals of oncology, 2003-12, Vol.14 (12), p.1735-1743</ispartof><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c462t-dc0155d40667a268acb7f8e46aed881ed2e22c0e23e1f7a29f12cfb75fa0e82e3</citedby><cites>FETCH-LOGICAL-c462t-dc0155d40667a268acb7f8e46aed881ed2e22c0e23e1f7a29f12cfb75fa0e82e3</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=15323541$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14630678$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Scheithauer, W.</creatorcontrib><creatorcontrib>McKendrick, J.</creatorcontrib><creatorcontrib>Begbie, S.</creatorcontrib><creatorcontrib>Borner, M.</creatorcontrib><creatorcontrib>Burns, W. I.</creatorcontrib><creatorcontrib>Burris, H. A.</creatorcontrib><creatorcontrib>Cassidy, J.</creatorcontrib><creatorcontrib>Jodrell, D.</creatorcontrib><creatorcontrib>Koralewski, P.</creatorcontrib><creatorcontrib>Levine, E. L.</creatorcontrib><creatorcontrib>Marschner, N.</creatorcontrib><creatorcontrib>Maroun, J.</creatorcontrib><creatorcontrib>Garcia-Alfonso, P.</creatorcontrib><creatorcontrib>Tujakowski, J.</creatorcontrib><creatorcontrib>Van Hazel, G.</creatorcontrib><creatorcontrib>Wong, A.</creatorcontrib><creatorcontrib>Zaluski, J.</creatorcontrib><creatorcontrib>Twelves, C.</creatorcontrib><creatorcontrib>X-ACT Study Group</creatorcontrib><title>Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Background: Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil–leucovorin (5-FU/LV) as first-line treatment for patients with metastatic colorectal cancer. We report here the results of a large phase III trial investigating adjuvant oral capecitabine compared with 5-FU/LV (Mayo Clinic regimen) in Dukes’ C colon cancer. Patients and methods: Patients aged 18–75 years with resected Dukes’ C colon carcinoma were randomized to receive 24 weeks of treatment with either oral capecitabine 1250 mg/m2 twice daily, days 1–14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m2 with i.v. leucovorin 20 mg/m2 on days 1–5, repeated every 28 days (n = 974). Results: Patients receiving capecitabine experienced significantly (P <0.001) less diarrhea, stomatitis, nausea/vomiting, alopecia and neutropenia, but more hand–foot syndrome than those receiving 5-FU/LV. Fewer patients receiving capecitabine experienced grade 3 or 4 neutropenia, febrile neutropenia/sepsis and stomatitis (P <0.001), although more experienced grade 3 hand–foot syndrome than those treated with 5-FU/LV (P <0.001). Capecitabine demonstrates a similar, favorable safety profile in patients aged <65 years or ≥65 years old. Conclusions: Based on its improved safety profile, capecitabine has the potential to replace 5-FU/LV as standard adjuvant treatment for patients with colon cancer. Efficacy results are expected to be available in 2004. Keywords: Adjuvant treatment, capecitabine, chemotherapy, colorectal cancer</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Age Factors</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antimetabolites, Antineoplastic - administration & dosage</subject><subject>Antimetabolites, Antineoplastic - adverse effects</subject><subject>Antimetabolites, Antineoplastic - therapeutic use</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Capecitabine</subject><subject>Chemotherapy</subject><subject>Colonic Neoplasms - drug therapy</subject><subject>Colonic Neoplasms - pathology</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - therapeutic use</subject><subject>Diarrhea - chemically induced</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Humans</subject><subject>Leucovorin - administration & dosage</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis</subject><subject>Neutropenia - chemically induced</subject><subject>Peripheral Nervous System Diseases - chemically induced</subject><subject>Pharmacology. Drug treatments</subject><subject>Safety</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkE2P0zAQQC0EYrsLR67IF26k64_YSbihCrYVlfaySIhLNLHHrJfUrmynovwN_jBBrehpDvP0RvMIecPZkrNO3kIIMZjbnf2hGHtGFlzprmpZzZ-TBeuErBol6ytynfMTY0x3ontJrnitJdNNuyB_7hOM1MAejS8w-IAUMoVAYSyYAhR_QFoi9cvDkqrKjVNMcUpg_FgNkNFSsE_TAUKh5RET7I_UxURNHGOYtcFg-kAzOCxHmjBPY8k0Ogo0QbBx53-jfU_3j7OJbjYbWpKH8RV54WDM-Po8b8jXz58eVutqe3-3WX3cVqbWolTWMK6UrZnWDQjdghka12KtAW3bcrQChTAMhUTuZqJzXBg3NMoBw1agvCHVyWtSzDmh6_fJ7yAde876f3H7U9z-FHfm3574_TTs0F7oc80ZeHcGIBsY3fyj8fnCKSmkqvnlsM8Ff_3fQ_rZ60Y2ql9_-94_rLcrJr80fS3_AoYolgw</recordid><startdate>20031201</startdate><enddate>20031201</enddate><creator>Scheithauer, W.</creator><creator>McKendrick, J.</creator><creator>Begbie, S.</creator><creator>Borner, M.</creator><creator>Burns, W. I.</creator><creator>Burris, H. A.</creator><creator>Cassidy, J.</creator><creator>Jodrell, D.</creator><creator>Koralewski, P.</creator><creator>Levine, E. L.</creator><creator>Marschner, N.</creator><creator>Maroun, J.</creator><creator>Garcia-Alfonso, P.</creator><creator>Tujakowski, J.</creator><creator>Van Hazel, G.</creator><creator>Wong, A.</creator><creator>Zaluski, J.</creator><creator>Twelves, C.</creator><general>Oxford University Press</general><scope>BSCLL</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></search><sort><creationdate>20031201</creationdate><title>Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial</title><author>Scheithauer, W. ; McKendrick, J. ; Begbie, S. ; Borner, M. ; Burns, W. I. ; Burris, H. A. ; Cassidy, J. ; Jodrell, D. ; Koralewski, P. ; Levine, E. 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L.</creatorcontrib><creatorcontrib>Marschner, N.</creatorcontrib><creatorcontrib>Maroun, J.</creatorcontrib><creatorcontrib>Garcia-Alfonso, P.</creatorcontrib><creatorcontrib>Tujakowski, J.</creatorcontrib><creatorcontrib>Van Hazel, G.</creatorcontrib><creatorcontrib>Wong, A.</creatorcontrib><creatorcontrib>Zaluski, J.</creatorcontrib><creatorcontrib>Twelves, C.</creatorcontrib><creatorcontrib>X-ACT Study Group</creatorcontrib><collection>Istex</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><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Scheithauer, W.</au><au>McKendrick, J.</au><au>Begbie, S.</au><au>Borner, M.</au><au>Burns, W. I.</au><au>Burris, H. A.</au><au>Cassidy, J.</au><au>Jodrell, D.</au><au>Koralewski, P.</au><au>Levine, E. L.</au><au>Marschner, N.</au><au>Maroun, J.</au><au>Garcia-Alfonso, P.</au><au>Tujakowski, J.</au><au>Van Hazel, G.</au><au>Wong, A.</au><au>Zaluski, J.</au><au>Twelves, C.</au><aucorp>X-ACT Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2003-12-01</date><risdate>2003</risdate><volume>14</volume><issue>12</issue><spage>1735</spage><epage>1743</epage><pages>1735-1743</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Background: Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil–leucovorin (5-FU/LV) as first-line treatment for patients with metastatic colorectal cancer. We report here the results of a large phase III trial investigating adjuvant oral capecitabine compared with 5-FU/LV (Mayo Clinic regimen) in Dukes’ C colon cancer. Patients and methods: Patients aged 18–75 years with resected Dukes’ C colon carcinoma were randomized to receive 24 weeks of treatment with either oral capecitabine 1250 mg/m2 twice daily, days 1–14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m2 with i.v. leucovorin 20 mg/m2 on days 1–5, repeated every 28 days (n = 974). Results: Patients receiving capecitabine experienced significantly (P <0.001) less diarrhea, stomatitis, nausea/vomiting, alopecia and neutropenia, but more hand–foot syndrome than those receiving 5-FU/LV. Fewer patients receiving capecitabine experienced grade 3 or 4 neutropenia, febrile neutropenia/sepsis and stomatitis (P <0.001), although more experienced grade 3 hand–foot syndrome than those treated with 5-FU/LV (P <0.001). Capecitabine demonstrates a similar, favorable safety profile in patients aged <65 years or ≥65 years old. Conclusions: Based on its improved safety profile, capecitabine has the potential to replace 5-FU/LV as standard adjuvant treatment for patients with colon cancer. Efficacy results are expected to be available in 2004. Keywords: Adjuvant treatment, capecitabine, chemotherapy, colorectal cancer</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>14630678</pmid><doi>10.1093/annonc/mdg500</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0923-7534 |
| ispartof | Annals of oncology, 2003-12, Vol.14 (12), p.1735-1743 |
| issn | 0923-7534 1569-8041 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Administration, Oral Adult Age Factors Aged Aged, 80 and over Antimetabolites, Antineoplastic - administration & dosage Antimetabolites, Antineoplastic - adverse effects Antimetabolites, Antineoplastic - therapeutic use Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Capecitabine Chemotherapy Colonic Neoplasms - drug therapy Colonic Neoplasms - pathology Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Diarrhea - chemically induced Female Fluorouracil - administration & dosage Humans Leucovorin - administration & dosage Male Medical sciences Middle Aged Neoplasm Metastasis Neutropenia - chemically induced Peripheral Nervous System Diseases - chemically induced Pharmacology. Drug treatments Safety |
| title | Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial |
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