Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial.

2.50
Hdl Handle:
http://hdl.handle.net/10541/79056
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.
Authors:
Scheithauer, W; McKendrik, J; Begbie, S; Borner, M; Burns, W I; Burris, H A; Cassidy, J; Jodrell, D; Koralewski, P; Levine, Edward; Marschner, N; Maroun, J; Garcia-Alfonso, P; Tujakowski, J; Van Hazel, G; Wong, A; Zaluski, J; Twelves, C
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/m(2) twice daily, days 1-14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m(2) with i.v. leucovorin 20 mg/m(2) 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 > 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 Keywords: Adjuvant treatment, capecitabine, chemotherapy, colorectal cancer
Affiliation:
Klinik für Innere Medizin I, Vienna University Medical School, Vienna, Austria. Werner.Scheithauer@akh-wien.ac.at
Citation:
Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial. 2003, 14 (12):1735-43 Ann. Oncol.
Journal:
Annals of Oncology
Issue Date:
Dec-2003
URI:
http://hdl.handle.net/10541/79056
DOI:
10.1093/annoc/mdg500
PubMed ID:
14630678
Type:
Article
Language:
en
ISSN:
0923-7534
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorScheithauer, W-
dc.contributor.authorMcKendrik, J-
dc.contributor.authorBegbie, S-
dc.contributor.authorBorner, M-
dc.contributor.authorBurns, W I-
dc.contributor.authorBurris, H A-
dc.contributor.authorCassidy, J-
dc.contributor.authorJodrell, D-
dc.contributor.authorKoralewski, P-
dc.contributor.authorLevine, Edward-
dc.contributor.authorMarschner, N-
dc.contributor.authorMaroun, J-
dc.contributor.authorGarcia-Alfonso, P-
dc.contributor.authorTujakowski, J-
dc.contributor.authorVan Hazel, G-
dc.contributor.authorWong, A-
dc.contributor.authorZaluski, J-
dc.contributor.authorTwelves, C-
dc.date.accessioned2009-08-28T08:43:35Z-
dc.date.available2009-08-28T08:43:35Z-
dc.date.issued2003-12-
dc.identifier.citationOral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial. 2003, 14 (12):1735-43 Ann. Oncol.en
dc.identifier.issn0923-7534-
dc.identifier.pmid14630678-
dc.identifier.doi10.1093/annoc/mdg500-
dc.identifier.urihttp://hdl.handle.net/10541/79056-
dc.description.abstractBACKGROUND: 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/m(2) twice daily, days 1-14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m(2) with i.v. leucovorin 20 mg/m(2) 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 > 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 Keywords: Adjuvant treatment, capecitabine, chemotherapy, colorectal canceren
dc.language.isoenen
dc.subjectColonic Canceren
dc.subjectCancer Metastasisen
dc.subject.meshAdministration, Oral-
dc.subject.meshAdult-
dc.subject.meshAge Factors-
dc.subject.meshAged-
dc.subject.meshAged, 80 and over-
dc.subject.meshAntimetabolites, Antineoplastic-
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshColonic Neoplasms-
dc.subject.meshDeoxycytidine-
dc.subject.meshDiarrhea-
dc.subject.meshFemale-
dc.subject.meshFluorouracil-
dc.subject.meshHumans-
dc.subject.meshLeucovorin-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasm Metastasis-
dc.subject.meshNeutropenia-
dc.subject.meshPeripheral Nervous System Diseases-
dc.subject.meshSafety-
dc.titleOral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial.en
dc.typeArticleen
dc.contributor.departmentKlinik für Innere Medizin I, Vienna University Medical School, Vienna, Austria. Werner.Scheithauer@akh-wien.ac.aten
dc.identifier.journalAnnals of Oncologyen

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