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Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial

Summary Background The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined. Our aim was to investigate whether combination treatment is better than sequential administration of the same drugs in patients with advanced colorectal cancer. Methods We randomly assigned 820... Full description

Journal Title: The Lancet (British edition) 2007, Vol.370 (9582), p.135-142
Main Author: Koopman, Miriam, MD
Other Authors: Antonini, Ninja F, MSc , Douma, Joep, MD , Wals, Jaap, MD , Honkoop, Aafke H, MD , Erdkamp, Frans LG, MD , de Jong, Robert S, MD , Rodenburg, Cees J, MD , Vreugdenhil, Gerard, MD , Loosveld, Olaf JL, MD , van Bochove, Aart, MD , Sinnige, Harm AM, MD , Creemers, Geert-Jan M, MD , Tesselaar, Margot ET, MD , Slee, Peter H Th J, MD , Werter, Marjon JBP, MD , Mol, Linda, Msc , Dalesio, Otilia, MSc , Punt, Cornelis JA, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/17630036
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recordid: cdi_proquest_journals_2067059698
title: Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial
format: Article
creator:
  • Koopman, Miriam, MD
  • Antonini, Ninja F, MSc
  • Douma, Joep, MD
  • Wals, Jaap, MD
  • Honkoop, Aafke H, MD
  • Erdkamp, Frans LG, MD
  • de Jong, Robert S, MD
  • Rodenburg, Cees J, MD
  • Vreugdenhil, Gerard, MD
  • Loosveld, Olaf JL, MD
  • van Bochove, Aart, MD
  • Sinnige, Harm AM, MD
  • Creemers, Geert-Jan M, MD
  • Tesselaar, Margot ET, MD
  • Slee, Peter H Th J, MD
  • Werter, Marjon JBP, MD
  • Mol, Linda, Msc
  • Dalesio, Otilia, MSc
  • Punt, Cornelis JA, Prof
subjects:
  • Adult
  • Aged
  • Aged, 80 and over
  • Analysis
  • Anemia
  • Antimitotic agents
  • Antineoplastic agents
  • Antineoplastic Combined Chemotherapy Protocols - adverse effects
  • Antineoplastic Combined Chemotherapy Protocols - therapeutic use
  • Camptothecin - administration & dosage
  • Camptothecin - analogs & derivatives
  • Cancer
  • Cancer therapies
  • Capecitabine
  • Chemotherapy
  • Colorectal cancer
  • Colorectal carcinoma
  • Colorectal Neoplasms - drug therapy
  • Colorectal Neoplasms - mortality
  • Cytotoxicity
  • Data analysis
  • Data collection
  • Deoxycytidine - administration & dosage
  • Deoxycytidine - analogs & derivatives
  • Diarrhea
  • Disease
  • Drug dosages
  • Drug therapy
  • Drug therapy, Combination
  • Drugs
  • Embolisms
  • Evidence-based medicine
  • Female
  • Fluorouracil - administration & dosage
  • Fluorouracil - analogs & derivatives
  • Hematology
  • Humans
  • Inflammatory bowel disease
  • Internal Medicine
  • Irinotecan
  • Male
  • Medical research
  • Medicine, Experimental
  • Metastasis
  • Middle Aged
  • Motivation
  • Nervous system
  • Neutropenia
  • Organoplatinum Compounds - administration & dosage
  • Oxaliplatin
  • Patients
  • Physical examinations
  • Product development
  • Studies
  • Survival
  • Survival Rate
  • Task forces
  • Thrombosis
  • Toxicity
ispartof: The Lancet (British edition), 2007, Vol.370 (9582), p.135-142
description: Summary Background The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined. Our aim was to investigate whether combination treatment is better than sequential administration of the same drugs in patients with advanced colorectal cancer. Methods We randomly assigned 820 patients with advanced colorectal cancer to receive either first-line treatment with capecitabine, second-line irinotecan, and third-line capecitabine plus oxaliplatin (sequential treatment; n=410) or first-line treatment capecitabine plus irinotecan and second-line capecitabine plus oxaliplatin (combination treatment; n=410). The primary endpoint was overall survival. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov with the number NCT00312000. Findings 17 patients (nine in the sequential treatment group, eight in the combination group) were found to be ineligible and were excluded from the analysis. 675 (84%) patients died during the study: 336 in the sequential group and 339 in the combination group. Median overall survival was 16·3 (95% CI 14·3–18·1) months for sequential treatment and 17·4 (15·2–19·2) months for combination treatment (p=0·3281). The hazard ratio for combination versus sequential treatment was 0·92 (95% CI 0·79–1·08; p=0·3281). The frequency of grade 3–4 toxicity over all lines of treatment did not differ significantly between the two groups, except for grade 3 hand-foot syndrome, which occurred more often with sequential treatment than with combination treatment (13% vs 7%; p=0·004). Interpretation Combination treatment does not significantly improve overall survival compared with the sequential use of cytotoxic drugs in advanced colorectal cancer. Thus sequential treatment remains a valid option for patients with advanced colorectal cancer.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleSequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial
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creatorKoopman, Miriam, MD ; Antonini, Ninja F, MSc ; Douma, Joep, MD ; Wals, Jaap, MD ; Honkoop, Aafke H, MD ; Erdkamp, Frans LG, MD ; de Jong, Robert S, MD ; Rodenburg, Cees J, MD ; Vreugdenhil, Gerard, MD ; Loosveld, Olaf JL, MD ; van Bochove, Aart, MD ; Sinnige, Harm AM, MD ; Creemers, Geert-Jan M, MD ; Tesselaar, Margot ET, MD ; Slee, Peter H Th J, MD ; Werter, Marjon JBP, MD ; Mol, Linda, Msc ; Dalesio, Otilia, MSc ; Punt, Cornelis JA, Prof
creatorcontribKoopman, Miriam, MD ; Antonini, Ninja F, MSc ; Douma, Joep, MD ; Wals, Jaap, MD ; Honkoop, Aafke H, MD ; Erdkamp, Frans LG, MD ; de Jong, Robert S, MD ; Rodenburg, Cees J, MD ; Vreugdenhil, Gerard, MD ; Loosveld, Olaf JL, MD ; van Bochove, Aart, MD ; Sinnige, Harm AM, MD ; Creemers, Geert-Jan M, MD ; Tesselaar, Margot ET, MD ; Slee, Peter H Th J, MD ; Werter, Marjon JBP, MD ; Mol, Linda, Msc ; Dalesio, Otilia, MSc ; Punt, Cornelis JA, Prof
descriptionSummary Background The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined. Our aim was to investigate whether combination treatment is better than sequential administration of the same drugs in patients with advanced colorectal cancer. Methods We randomly assigned 820 patients with advanced colorectal cancer to receive either first-line treatment with capecitabine, second-line irinotecan, and third-line capecitabine plus oxaliplatin (sequential treatment; n=410) or first-line treatment capecitabine plus irinotecan and second-line capecitabine plus oxaliplatin (combination treatment; n=410). The primary endpoint was overall survival. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov with the number NCT00312000. Findings 17 patients (nine in the sequential treatment group, eight in the combination group) were found to be ineligible and were excluded from the analysis. 675 (84%) patients died during the study: 336 in the sequential group and 339 in the combination group. Median overall survival was 16·3 (95% CI 14·3–18·1) months for sequential treatment and 17·4 (15·2–19·2) months for combination treatment (p=0·3281). The hazard ratio for combination versus sequential treatment was 0·92 (95% CI 0·79–1·08; p=0·3281). The frequency of grade 3–4 toxicity over all lines of treatment did not differ significantly between the two groups, except for grade 3 hand-foot syndrome, which occurred more often with sequential treatment than with combination treatment (13% vs 7%; p=0·004). Interpretation Combination treatment does not significantly improve overall survival compared with the sequential use of cytotoxic drugs in advanced colorectal cancer. Thus sequential treatment remains a valid option for patients with advanced colorectal cancer.
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1Antonini, Ninja F, MSc
2Douma, Joep, MD
3Wals, Jaap, MD
4Honkoop, Aafke H, MD
5Erdkamp, Frans LG, MD
6de Jong, Robert S, MD
7Rodenburg, Cees J, MD
8Vreugdenhil, Gerard, MD
9Loosveld, Olaf JL, MD
10van Bochove, Aart, MD
11Sinnige, Harm AM, MD
12Creemers, Geert-Jan M, MD
13Tesselaar, Margot ET, MD
14Slee, Peter H Th J, MD
15Werter, Marjon JBP, MD
16Mol, Linda, Msc
17Dalesio, Otilia, MSc
18Punt, Cornelis JA, Prof
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0Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial
1The Lancet (British edition)
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descriptionSummary Background The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined. Our aim was to investigate whether combination treatment is better than sequential administration of the same drugs in patients with advanced colorectal cancer. Methods We randomly assigned 820 patients with advanced colorectal cancer to receive either first-line treatment with capecitabine, second-line irinotecan, and third-line capecitabine plus oxaliplatin (sequential treatment; n=410) or first-line treatment capecitabine plus irinotecan and second-line capecitabine plus oxaliplatin (combination treatment; n=410). The primary endpoint was overall survival. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov with the number NCT00312000. Findings 17 patients (nine in the sequential treatment group, eight in the combination group) were found to be ineligible and were excluded from the analysis. 675 (84%) patients died during the study: 336 in the sequential group and 339 in the combination group. Median overall survival was 16·3 (95% CI 14·3–18·1) months for sequential treatment and 17·4 (15·2–19·2) months for combination treatment (p=0·3281). The hazard ratio for combination versus sequential treatment was 0·92 (95% CI 0·79–1·08; p=0·3281). The frequency of grade 3–4 toxicity over all lines of treatment did not differ significantly between the two groups, except for grade 3 hand-foot syndrome, which occurred more often with sequential treatment than with combination treatment (13% vs 7%; p=0·004). Interpretation Combination treatment does not significantly improve overall survival compared with the sequential use of cytotoxic drugs in advanced colorectal cancer. Thus sequential treatment remains a valid option for patients with advanced colorectal cancer.
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1Aged
2Aged, 80 and over
3Analysis
4Anemia
5Antimitotic agents
6Antineoplastic agents
7Antineoplastic Combined Chemotherapy Protocols - adverse effects
8Antineoplastic Combined Chemotherapy Protocols - therapeutic use
9Camptothecin - administration & dosage
10Camptothecin - analogs & derivatives
11Cancer
12Cancer therapies
13Capecitabine
14Chemotherapy
15Colorectal cancer
16Colorectal carcinoma
17Colorectal Neoplasms - drug therapy
18Colorectal Neoplasms - mortality
19Cytotoxicity
20Data analysis
21Data collection
22Deoxycytidine - administration & dosage
23Deoxycytidine - analogs & derivatives
24Diarrhea
25Disease
26Drug dosages
27Drug therapy
28Drug therapy, Combination
29Drugs
30Embolisms
31Evidence-based medicine
32Female
33Fluorouracil - administration & dosage
34Fluorouracil - analogs & derivatives
35Hematology
36Humans
37Inflammatory bowel disease
38Internal Medicine
39Irinotecan
40Male
41Medical research
42Medicine, Experimental
43Metastasis
44Middle Aged
45Motivation
46Nervous system
47Neutropenia
48Organoplatinum Compounds - administration & dosage
49Oxaliplatin
50Patients
51Physical examinations
52Product development
53Studies
54Survival
55Survival Rate
56Task forces
57Thrombosis
58Toxicity
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8Vreugdenhil, Gerard, MD
9Loosveld, Olaf JL, MD
10van Bochove, Aart, MD
11Sinnige, Harm AM, MD
12Creemers, Geert-Jan M, MD
13Tesselaar, Margot ET, MD
14Slee, Peter H Th J, MD
15Werter, Marjon JBP, MD
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titleSequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial
authorKoopman, Miriam, MD ; Antonini, Ninja F, MSc ; Douma, Joep, MD ; Wals, Jaap, MD ; Honkoop, Aafke H, MD ; Erdkamp, Frans LG, MD ; de Jong, Robert S, MD ; Rodenburg, Cees J, MD ; Vreugdenhil, Gerard, MD ; Loosveld, Olaf JL, MD ; van Bochove, Aart, MD ; Sinnige, Harm AM, MD ; Creemers, Geert-Jan M, MD ; Tesselaar, Margot ET, MD ; Slee, Peter H Th J, MD ; Werter, Marjon JBP, MD ; Mol, Linda, Msc ; Dalesio, Otilia, MSc ; Punt, Cornelis JA, Prof
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8Antineoplastic Combined Chemotherapy Protocols - therapeutic use
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30Embolisms
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37Inflammatory bowel disease
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39Irinotecan
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41Medical research
42Medicine, Experimental
43Metastasis
44Middle Aged
45Motivation
46Nervous system
47Neutropenia
48Organoplatinum Compounds - administration & dosage
49Oxaliplatin
50Patients
51Physical examinations
52Product development
53Studies
54Survival
55Survival Rate
56Task forces
57Thrombosis
58Toxicity
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eissn1474-547X
codenLANCAO
abstractSummary Background The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined. Our aim was to investigate whether combination treatment is better than sequential administration of the same drugs in patients with advanced colorectal cancer. Methods We randomly assigned 820 patients with advanced colorectal cancer to receive either first-line treatment with capecitabine, second-line irinotecan, and third-line capecitabine plus oxaliplatin (sequential treatment; n=410) or first-line treatment capecitabine plus irinotecan and second-line capecitabine plus oxaliplatin (combination treatment; n=410). The primary endpoint was overall survival. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov with the number NCT00312000. Findings 17 patients (nine in the sequential treatment group, eight in the combination group) were found to be ineligible and were excluded from the analysis. 675 (84%) patients died during the study: 336 in the sequential group and 339 in the combination group. Median overall survival was 16·3 (95% CI 14·3–18·1) months for sequential treatment and 17·4 (15·2–19·2) months for combination treatment (p=0·3281). The hazard ratio for combination versus sequential treatment was 0·92 (95% CI 0·79–1·08; p=0·3281). The frequency of grade 3–4 toxicity over all lines of treatment did not differ significantly between the two groups, except for grade 3 hand-foot syndrome, which occurred more often with sequential treatment than with combination treatment (13% vs 7%; p=0·004). Interpretation Combination treatment does not significantly improve overall survival compared with the sequential use of cytotoxic drugs in advanced colorectal cancer. Thus sequential treatment remains a valid option for patients with advanced colorectal cancer.
copEngland
pubElsevier Ltd
pmid17630036
doi10.1016/S0140-6736(07)61086-1