Capecitabine as Adjuvant Treatment for Stage III Colon Cancer

The standard combination of intravenous fluorouracil plus leucovorin for adjuvant treatment of colon cancer was compared with the oral fluoropyrimidine capecitabine in almost 2000 patients with resected colon cancer. With disease-free survival as the primary end point, capecitabine was at least as e...

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Published in	The New England journal of medicine Vol. 352; no. 26; pp. 2696 - 2704
Main Authors	Twelves, Chris, Wong, Alfred, Nowacki, Marek P, Abt, Markus, Burris, Howard, Carrato, Alfredo, Cassidy, Jim, Cervantes, Andrés, Fagerberg, Jan, Georgoulias, Vassilis, Husseini, Fares, Jodrell, Duncan, Koralewski, Piotr, Kröning, Hendrik, Maroun, Jean, Marschner, Norbert, McKendrick, Joseph, Pawlicki, Marek, Rosso, Riccardo, Schüller, Johannes, Seitz, Jean-François, Stabuc, Borut, Tujakowski, Jerzy, Van Hazel, Guy, Zaluski, Jerzy, Scheithauer, Werner
Format	Journal Article
Language	English
Published	Boston, MA Massachusetts Medical Society 30.06.2005
Subjects	Adult Aged Aged, 80 and over Antimetabolites, Antineoplastic - adverse effects Antimetabolites, Antineoplastic - therapeutic use Biological and medical sciences Capecitabine Chemotherapy, Adjuvant Colonic Neoplasms - drug therapy Colonic Neoplasms - mortality Colonic Neoplasms - surgery Colorectal cancer Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Disease-Free Survival Drug therapy Effectiveness Female Fluorouracil - analogs & derivatives Gastroenterology. Liver. Pancreas. Abdomen General aspects Humans Male Medical sciences Middle Aged Multivariate Analysis Neoplasm Staging Patients Prescription drugs Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Survival Analysis Tumors Antineoplastic agent Medicine Colon cancer Capecitabine Fluoropyrimidine derivatives Adjuvant treatment Digestive diseases Intestinal disease Malignant tumor Pyrimidine nucleoside
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Abstract	The standard combination of intravenous fluorouracil plus leucovorin for adjuvant treatment of colon cancer was compared with the oral fluoropyrimidine capecitabine in almost 2000 patients with resected colon cancer. With disease-free survival as the primary end point, capecitabine was at least as effective as fluorouracil plus leucovorin. The oral drug had fewer side effects than the intravenous combination. With disease-free survival as the primary end point, capecitabine was at least as effective as fluorouracil plus leucovorin. The oral drug had fewer side effects than the intravenous combination. Almost 1 million patients receive a diagnosis of colorectal cancer yearly, and half a million deaths from this neoplasm occur annually worldwide. 1 Each year, approximately 230,000 patients with colon cancer are eligible for adjuvant chemotherapy. 1 – 3 The benefits of fluorouracil-based adjuvant chemotherapy in reducing the risk of relapse and prolonging survival in patients with resected colon cancer are well established, particularly in stage III disease. 4 – 6 Survival advantages were demonstrated with bolus intravenous fluorouracil plus leucovorin administered according to the Mayo Clinic regimen (five days, monthly, for six months) or the Roswell Park regimen (weekly bolus, six of every eight . . .
AbstractList	Background Intravenous bolus fluorouracil plus leucovorin is the standard adjuvant treatment for colon cancer. The oral fluoropyrimidine capecitabine is an established alternative to bolus fluorouracil plus leucovorin as first-line treatment for metastatic colorectal cancer. We evaluated capecitabine in the adjuvant setting. Methods We randomly assigned a total of 1987 patients with resected stage III colon cancer to receive either oral capecitabine (1004 patients) or bolus fluorouracil plus leucovorin (Mayo Clinic regimen; 983 patients) over a period of 24 weeks. The primary efficacy end point was at least equivalence in disease-free survival; the primary safety end point was the incidence of grade 3 or 4 toxic effects due to fluoropyrimidines. Results Disease-free survival in the capecitabine group was at least equivalent to that in the fluorouracil-plus-leucovorin group (in the intention-to-treat analysis, P<0.001 for the comparison of the upper limit of the hazard ratio with the noninferiority margin of 1.20). Capecitabine improved relapse-free survival (hazard ratio, 0.86; 95 percent confidence interval, 0.74 to 0.99; P=0.04) and was associated with significantly fewer adverse events than fluorouracil plus leucovorin (P<0.001). Conclusions Oral capecitabine is an effective alternative to intravenous fluorouracil plus leucovorin in the adjuvant treatment of colon cancer. Intravenous bolus fluorouracil plus leucovorin is the standard adjuvant treatment for colon cancer. The oral fluoropyrimidine capecitabine is an established alternative to bolus fluorouracil plus leucovorin as first-line treatment for metastatic colorectal cancer. We evaluated capecitabine in the adjuvant setting. We randomly assigned a total of 1987 patients with resected stage III colon cancer to receive either oral capecitabine (1004 patients) or bolus fluorouracil plus leucovorin (Mayo Clinic regimen; 983 patients) over a period of 24 weeks. The primary efficacy end point was at least equivalence in disease-free survival; the primary safety end point was the incidence of grade 3 or 4 toxic effects due to fluoropyrimidines. Disease-free survival in the capecitabine group was at least equivalent to that in the fluorouracil-plus-leucovorin group (in the intention-to-treat analysis, P<0.001 for the comparison of the upper limit of the hazard ratio with the noninferiority margin of 1.20). Capecitabine improved relapse-free survival (hazard ratio, 0.86; 95 percent confidence interval, 0.74 to 0.99; P=0.04) and was associated with significantly fewer adverse events than fluorouracil plus leucovorin (P<0.001). Oral capecitabine is an effective alternative to intravenous fluorouracil plus leucovorin in the adjuvant treatment of colon cancer. The standard combination of intravenous fluorouracil plus leucovorin for adjuvant treatment of colon cancer was compared with the oral fluoropyrimidine capecitabine in almost 2000 patients with resected colon cancer. With disease-free survival as the primary end point, capecitabine was at least as effective as fluorouracil plus leucovorin. The oral drug had fewer side effects than the intravenous combination. With disease-free survival as the primary end point, capecitabine was at least as effective as fluorouracil plus leucovorin. The oral drug had fewer side effects than the intravenous combination. Almost 1 million patients receive a diagnosis of colorectal cancer yearly, and half a million deaths from this neoplasm occur annually worldwide. 1 Each year, approximately 230,000 patients with colon cancer are eligible for adjuvant chemotherapy. 1 – 3 The benefits of fluorouracil-based adjuvant chemotherapy in reducing the risk of relapse and prolonging survival in patients with resected colon cancer are well established, particularly in stage III disease. 4 – 6 Survival advantages were demonstrated with bolus intravenous fluorouracil plus leucovorin administered according to the Mayo Clinic regimen (five days, monthly, for six months) or the Roswell Park regimen (weekly bolus, six of every eight . . .
Author	Seitz, Jean-François Jodrell, Duncan Kröning, Hendrik Nowacki, Marek P Husseini, Fares Tujakowski, Jerzy Abt, Markus Georgoulias, Vassilis Maroun, Jean Scheithauer, Werner Fagerberg, Jan Marschner, Norbert Carrato, Alfredo Van Hazel, Guy Zaluski, Jerzy Cervantes, Andrés Pawlicki, Marek Twelves, Chris Rosso, Riccardo Schüller, Johannes Wong, Alfred Burris, Howard Cassidy, Jim Koralewski, Piotr Stabuc, Borut McKendrick, Joseph
Author_xml	– sequence: 1 givenname: Chris surname: Twelves fullname: Twelves, Chris – sequence: 2 givenname: Alfred surname: Wong fullname: Wong, Alfred – sequence: 3 givenname: Marek P surname: Nowacki fullname: Nowacki, Marek P – sequence: 4 givenname: Markus surname: Abt fullname: Abt, Markus – sequence: 5 givenname: Howard surname: Burris fullname: Burris, Howard – sequence: 6 givenname: Alfredo surname: Carrato fullname: Carrato, Alfredo – sequence: 7 givenname: Jim surname: Cassidy fullname: Cassidy, Jim – sequence: 8 givenname: Andrés surname: Cervantes fullname: Cervantes, Andrés – sequence: 9 givenname: Jan surname: Fagerberg fullname: Fagerberg, Jan – sequence: 10 givenname: Vassilis surname: Georgoulias fullname: Georgoulias, Vassilis – sequence: 11 givenname: Fares surname: Husseini fullname: Husseini, Fares – sequence: 12 givenname: Duncan surname: Jodrell fullname: Jodrell, Duncan – sequence: 13 givenname: Piotr surname: Koralewski fullname: Koralewski, Piotr – sequence: 14 givenname: Hendrik surname: Kröning fullname: Kröning, Hendrik – sequence: 15 givenname: Jean surname: Maroun fullname: Maroun, Jean – sequence: 16 givenname: Norbert surname: Marschner fullname: Marschner, Norbert – sequence: 17 givenname: Joseph surname: McKendrick fullname: McKendrick, Joseph – sequence: 18 givenname: Marek surname: Pawlicki fullname: Pawlicki, Marek – sequence: 19 givenname: Riccardo surname: Rosso fullname: Rosso, Riccardo – sequence: 20 givenname: Johannes surname: Schüller fullname: Schüller, Johannes – sequence: 21 givenname: Jean-François surname: Seitz fullname: Seitz, Jean-François – sequence: 22 givenname: Borut surname: Stabuc fullname: Stabuc, Borut – sequence: 23 givenname: Jerzy surname: Tujakowski fullname: Tujakowski, Jerzy – sequence: 24 givenname: Guy surname: Van Hazel fullname: Van Hazel, Guy – sequence: 25 givenname: Jerzy surname: Zaluski fullname: Zaluski, Jerzy – sequence: 26 givenname: Werner surname: Scheithauer fullname: Scheithauer, Werner
BackLink	http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16893184$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/15987918$$D View this record in MEDLINE/PubMed
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Keywords	Antineoplastic agent Medicine Colon cancer Capecitabine Fluoropyrimidine derivatives Adjuvant treatment Digestive diseases Intestinal disease Malignant tumor Pyrimidine nucleoside
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Snippet	The standard combination of intravenous fluorouracil plus leucovorin for adjuvant treatment of colon cancer was compared with the oral fluoropyrimidine... Intravenous bolus fluorouracil plus leucovorin is the standard adjuvant treatment for colon cancer. The oral fluoropyrimidine capecitabine is an established... Background Intravenous bolus fluorouracil plus leucovorin is the standard adjuvant treatment for colon cancer. The oral fluoropyrimidine capecitabine is an...
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SubjectTerms	Adult Aged Aged, 80 and over Antimetabolites, Antineoplastic - adverse effects Antimetabolites, Antineoplastic - therapeutic use Biological and medical sciences Capecitabine Chemotherapy, Adjuvant Colonic Neoplasms - drug therapy Colonic Neoplasms - mortality Colonic Neoplasms - surgery Colorectal cancer Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Disease-Free Survival Drug therapy Effectiveness Female Fluorouracil - analogs & derivatives Gastroenterology. Liver. Pancreas. Abdomen General aspects Humans Male Medical sciences Middle Aged Multivariate Analysis Neoplasm Staging Patients Prescription drugs Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Survival Analysis Tumors
Title	Capecitabine as Adjuvant Treatment for Stage III Colon Cancer
URI	http://dx.doi.org/10.1056/NEJMoa043116 https://www.ncbi.nlm.nih.gov/pubmed/15987918 https://www.proquest.com/docview/223934600
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