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Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group

Summary Background The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown. The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus obser... Full description

Journal Title: The Lancet (British edition) 2015, Vol.385 (9980), p.1843-1852
Main Author: Simkens, Lieke H J, MD
Other Authors: van Tinteren, Harm, PhD , May, Anne, PhD , ten Tije, Albert J, MD , Creemers, Geert-Jan M, MD , Loosveld, Olaf J L, MD , de Jongh, Felix E, MD , Erdkamp, Frans L G, MD , Erjavec, Zoran, MD , van der Torren, Adelheid M E, MD , Tol, Jolien, MD , Braun, Hans J J, MD , Nieboer, Peter, MD , van der Hoeven, Jacobus J M, Prof , Haasjes, Janny G, MD , Jansen, Rob L H, MD , Wals, Jaap, MD , Cats, Annemieke, MD , Derleyn, Veerle A, MD , Honkoop, Aafke H, MD , Mol, Linda, MSc , Punt, Cornelis J A, Prof , Koopman, Miriam, Dr
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/25862517
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title: Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group
format: Article
creator:
  • Simkens, Lieke H J, MD
  • van Tinteren, Harm, PhD
  • May, Anne, PhD
  • ten Tije, Albert J, MD
  • Creemers, Geert-Jan M, MD
  • Loosveld, Olaf J L, MD
  • de Jongh, Felix E, MD
  • Erdkamp, Frans L G, MD
  • Erjavec, Zoran, MD
  • van der Torren, Adelheid M E, MD
  • Tol, Jolien, MD
  • Braun, Hans J J, MD
  • Nieboer, Peter, MD
  • van der Hoeven, Jacobus J M, Prof
  • Haasjes, Janny G, MD
  • Jansen, Rob L H, MD
  • Wals, Jaap, MD
  • Cats, Annemieke, MD
  • Derleyn, Veerle A, MD
  • Honkoop, Aafke H, MD
  • Mol, Linda, MSc
  • Punt, Cornelis J A, Prof
  • Koopman, Miriam, Dr
subjects:
  • Abridged Index Medicus
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal, Humanized - administration & dosage
  • Antibodies, Monoclonal, Humanized - adverse effects
  • Antimitotic agents
  • Antineoplastic agents
  • Antineoplastic Combined Chemotherapy Protocols - adverse effects
  • Antineoplastic Combined Chemotherapy Protocols - therapeutic use
  • Bevacizumab
  • Cancer
  • Cancer therapies
  • Capecitabine
  • Chemotherapy
  • Clinical trials
  • Colorectal cancer
  • Colorectal Neoplasms - drug therapy
  • Colorectal Neoplasms - pathology
  • Deoxycytidine - administration & dosage
  • Deoxycytidine - adverse effects
  • Deoxycytidine - analogs & derivatives
  • Drug dosages
  • Female
  • Fluorouracil - administration & dosage
  • Fluorouracil - adverse effects
  • Fluorouracil - analogs & derivatives
  • Humans
  • Internal Medicine
  • Kaplan-Meier Estimate
  • Male
  • Medical prognosis
  • Medical treatment
  • Metastasis
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Staging
  • Organoplatinum Compounds - administration & dosage
  • Organoplatinum Compounds - adverse effects
  • Product development
  • Quality of life
  • Treatment Outcome
ispartof: The Lancet (British edition), 2015, Vol.385 (9980), p.1843-1852
description: Summary Background The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown. The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation. Methods In this open-label, phase 3, randomised controlled trial, we recruited patients in 64 hospitals in the Netherlands. We included patients older than 18 years with previously untreated metastatic colorectal cancer, with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine, oxaliplatin, and bevacizumab (CAPOX-B), WHO performance status of 0 or 1, and adequate bone marrow, liver, and renal function. Patients were randomly assigned (1:1) to either maintenance treatment with capecitabine and bevacizumab (maintenance group) or observation (observation group). Randomisation was done centrally by minimisation, with stratification according to previous adjuvant chemotherapy, response to induction treatment, WHO performance status, serum lactate dehydrogenase concentration, and treatment centre. Both patients and investigators were aware of treatment assignment. We assessed disease status every 9 weeks. On first progression (defined as PFS1), patients in both groups were to receive the induction regimen of CAPOX-B until second progression (PFS2), which was the study's primary endpoint. All endpoints were calculated from the time of randomisation. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00442637. Findings Between May 30, 2007, and Oct 15, 2012, we randomly assigned 558 patients to either the maintenance group (n=279) or the observation group (n=279). Median follow-up was 48 months (IQR 36–57). The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment, and was 8·5 months in the observation group and 11·7 months in the maintenance group (HR 0·67, 95% CI 0·56–0·81, p
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleMaintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group
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creatorSimkens, Lieke H J, MD ; van Tinteren, Harm, PhD ; May, Anne, PhD ; ten Tije, Albert J, MD ; Creemers, Geert-Jan M, MD ; Loosveld, Olaf J L, MD ; de Jongh, Felix E, MD ; Erdkamp, Frans L G, MD ; Erjavec, Zoran, MD ; van der Torren, Adelheid M E, MD ; Tol, Jolien, MD ; Braun, Hans J J, MD ; Nieboer, Peter, MD ; van der Hoeven, Jacobus J M, Prof ; Haasjes, Janny G, MD ; Jansen, Rob L H, MD ; Wals, Jaap, MD ; Cats, Annemieke, MD ; Derleyn, Veerle A, MD ; Honkoop, Aafke H, MD ; Mol, Linda, MSc ; Punt, Cornelis J A, Prof ; Koopman, Miriam, Dr
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descriptionSummary Background The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown. The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation. Methods In this open-label, phase 3, randomised controlled trial, we recruited patients in 64 hospitals in the Netherlands. We included patients older than 18 years with previously untreated metastatic colorectal cancer, with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine, oxaliplatin, and bevacizumab (CAPOX-B), WHO performance status of 0 or 1, and adequate bone marrow, liver, and renal function. Patients were randomly assigned (1:1) to either maintenance treatment with capecitabine and bevacizumab (maintenance group) or observation (observation group). Randomisation was done centrally by minimisation, with stratification according to previous adjuvant chemotherapy, response to induction treatment, WHO performance status, serum lactate dehydrogenase concentration, and treatment centre. Both patients and investigators were aware of treatment assignment. We assessed disease status every 9 weeks. On first progression (defined as PFS1), patients in both groups were to receive the induction regimen of CAPOX-B until second progression (PFS2), which was the study's primary endpoint. All endpoints were calculated from the time of randomisation. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00442637. Findings Between May 30, 2007, and Oct 15, 2012, we randomly assigned 558 patients to either the maintenance group (n=279) or the observation group (n=279). Median follow-up was 48 months (IQR 36–57). The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment, and was 8·5 months in the observation group and 11·7 months in the maintenance group (HR 0·67, 95% CI 0·56–0·81, p<0·0001). This difference remained significant when any treatment after PFS1 was considered. Maintenance treatment was well tolerated, although the incidence of hand-foot syndrome was increased (64 [23%] patients with hand-foot skin reaction during maintenance). The global quality of life did not deteriorate during maintenance treatment and was clinically not different between treatment groups. Interpretation Maintenance treatment with capecitabine plus bevacizumab after six cycles of CAPOX-B in patients with metastatic colorectal cancer is effective and does not compromise quality of life. Funding Dutch Colorectal Cancer Group (DCCG). The DCCG received financial support for the study from the Commissie Klinische Studies (CKS) of the Dutch Cancer Foundation (KWF), Roche, and Sanofi-Aventis.
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0Simkens, Lieke H J, MD
1van Tinteren, Harm, PhD
2May, Anne, PhD
3ten Tije, Albert J, MD
4Creemers, Geert-Jan M, MD
5Loosveld, Olaf J L, MD
6de Jongh, Felix E, MD
7Erdkamp, Frans L G, MD
8Erjavec, Zoran, MD
9van der Torren, Adelheid M E, MD
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11Braun, Hans J J, MD
12Nieboer, Peter, MD
13van der Hoeven, Jacobus J M, Prof
14Haasjes, Janny G, MD
15Jansen, Rob L H, MD
16Wals, Jaap, MD
17Cats, Annemieke, MD
18Derleyn, Veerle A, MD
19Honkoop, Aafke H, MD
20Mol, Linda, MSc
21Punt, Cornelis J A, Prof
22Koopman, Miriam, Dr
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0Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group
1The Lancet (British edition)
addtitleLancet
descriptionSummary Background The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown. The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation. Methods In this open-label, phase 3, randomised controlled trial, we recruited patients in 64 hospitals in the Netherlands. We included patients older than 18 years with previously untreated metastatic colorectal cancer, with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine, oxaliplatin, and bevacizumab (CAPOX-B), WHO performance status of 0 or 1, and adequate bone marrow, liver, and renal function. Patients were randomly assigned (1:1) to either maintenance treatment with capecitabine and bevacizumab (maintenance group) or observation (observation group). Randomisation was done centrally by minimisation, with stratification according to previous adjuvant chemotherapy, response to induction treatment, WHO performance status, serum lactate dehydrogenase concentration, and treatment centre. Both patients and investigators were aware of treatment assignment. We assessed disease status every 9 weeks. On first progression (defined as PFS1), patients in both groups were to receive the induction regimen of CAPOX-B until second progression (PFS2), which was the study's primary endpoint. All endpoints were calculated from the time of randomisation. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00442637. Findings Between May 30, 2007, and Oct 15, 2012, we randomly assigned 558 patients to either the maintenance group (n=279) or the observation group (n=279). Median follow-up was 48 months (IQR 36–57). The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment, and was 8·5 months in the observation group and 11·7 months in the maintenance group (HR 0·67, 95% CI 0·56–0·81, p<0·0001). This difference remained significant when any treatment after PFS1 was considered. Maintenance treatment was well tolerated, although the incidence of hand-foot syndrome was increased (64 [23%] patients with hand-foot skin reaction during maintenance). The global quality of life did not deteriorate during maintenance treatment and was clinically not different between treatment groups. Interpretation Maintenance treatment with capecitabine plus bevacizumab after six cycles of CAPOX-B in patients with metastatic colorectal cancer is effective and does not compromise quality of life. Funding Dutch Colorectal Cancer Group (DCCG). The DCCG received financial support for the study from the Commissie Klinische Studies (CKS) of the Dutch Cancer Foundation (KWF), Roche, and Sanofi-Aventis.
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3Aged, 80 and over
4Antibodies, Monoclonal, Humanized - administration & dosage
5Antibodies, Monoclonal, Humanized - adverse effects
6Antimitotic agents
7Antineoplastic agents
8Antineoplastic Combined Chemotherapy Protocols - adverse effects
9Antineoplastic Combined Chemotherapy Protocols - therapeutic use
10Bevacizumab
11Cancer
12Cancer therapies
13Capecitabine
14Chemotherapy
15Clinical trials
16Colorectal cancer
17Colorectal Neoplasms - drug therapy
18Colorectal Neoplasms - pathology
19Deoxycytidine - administration & dosage
20Deoxycytidine - adverse effects
21Deoxycytidine - analogs & derivatives
22Drug dosages
23Female
24Fluorouracil - administration & dosage
25Fluorouracil - adverse effects
26Fluorouracil - analogs & derivatives
27Humans
28Internal Medicine
29Kaplan-Meier Estimate
30Male
31Medical prognosis
32Medical treatment
33Metastasis
34Middle Aged
35Neoplasm Metastasis
36Neoplasm Staging
37Organoplatinum Compounds - administration & dosage
38Organoplatinum Compounds - adverse effects
39Product development
40Quality of life
41Treatment Outcome
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titleMaintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group
authorSimkens, Lieke H J, MD ; van Tinteren, Harm, PhD ; May, Anne, PhD ; ten Tije, Albert J, MD ; Creemers, Geert-Jan M, MD ; Loosveld, Olaf J L, MD ; de Jongh, Felix E, MD ; Erdkamp, Frans L G, MD ; Erjavec, Zoran, MD ; van der Torren, Adelheid M E, MD ; Tol, Jolien, MD ; Braun, Hans J J, MD ; Nieboer, Peter, MD ; van der Hoeven, Jacobus J M, Prof ; Haasjes, Janny G, MD ; Jansen, Rob L H, MD ; Wals, Jaap, MD ; Cats, Annemieke, MD ; Derleyn, Veerle A, MD ; Honkoop, Aafke H, MD ; Mol, Linda, MSc ; Punt, Cornelis J A, Prof ; Koopman, Miriam, Dr
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26Fluorouracil - analogs & derivatives
27Humans
28Internal Medicine
29Kaplan-Meier Estimate
30Male
31Medical prognosis
32Medical treatment
33Metastasis
34Middle Aged
35Neoplasm Metastasis
36Neoplasm Staging
37Organoplatinum Compounds - administration & dosage
38Organoplatinum Compounds - adverse effects
39Product development
40Quality of life
41Treatment Outcome
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77SIRS Editorial
78MEDLINE - Academic
jtitleThe Lancet (British edition)
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delcategoryRemote Search Resource
fulltextfulltext
addata
au
0Simkens, Lieke H J, MD
1van Tinteren, Harm, PhD
2May, Anne, PhD
3ten Tije, Albert J, MD
4Creemers, Geert-Jan M, MD
5Loosveld, Olaf J L, MD
6de Jongh, Felix E, MD
7Erdkamp, Frans L G, MD
8Erjavec, Zoran, MD
9van der Torren, Adelheid M E, MD
10Tol, Jolien, MD
11Braun, Hans J J, MD
12Nieboer, Peter, MD
13van der Hoeven, Jacobus J M, Prof
14Haasjes, Janny G, MD
15Jansen, Rob L H, MD
16Wals, Jaap, MD
17Cats, Annemieke, MD
18Derleyn, Veerle A, MD
19Honkoop, Aafke H, MD
20Mol, Linda, MSc
21Punt, Cornelis J A, Prof
22Koopman, Miriam, Dr
formatjournal
genrearticle
ristypeJOUR
atitleMaintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group
jtitleThe Lancet (British edition)
addtitleLancet
date2015
risdate2015
volume385
issue9980
spage1843
epage1852
pages1843-1852
issn0140-6736
eissn1474-547X
codenLANCAO
abstractSummary Background The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown. The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation. Methods In this open-label, phase 3, randomised controlled trial, we recruited patients in 64 hospitals in the Netherlands. We included patients older than 18 years with previously untreated metastatic colorectal cancer, with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine, oxaliplatin, and bevacizumab (CAPOX-B), WHO performance status of 0 or 1, and adequate bone marrow, liver, and renal function. Patients were randomly assigned (1:1) to either maintenance treatment with capecitabine and bevacizumab (maintenance group) or observation (observation group). Randomisation was done centrally by minimisation, with stratification according to previous adjuvant chemotherapy, response to induction treatment, WHO performance status, serum lactate dehydrogenase concentration, and treatment centre. Both patients and investigators were aware of treatment assignment. We assessed disease status every 9 weeks. On first progression (defined as PFS1), patients in both groups were to receive the induction regimen of CAPOX-B until second progression (PFS2), which was the study's primary endpoint. All endpoints were calculated from the time of randomisation. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00442637. Findings Between May 30, 2007, and Oct 15, 2012, we randomly assigned 558 patients to either the maintenance group (n=279) or the observation group (n=279). Median follow-up was 48 months (IQR 36–57). The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment, and was 8·5 months in the observation group and 11·7 months in the maintenance group (HR 0·67, 95% CI 0·56–0·81, p<0·0001). This difference remained significant when any treatment after PFS1 was considered. Maintenance treatment was well tolerated, although the incidence of hand-foot syndrome was increased (64 [23%] patients with hand-foot skin reaction during maintenance). The global quality of life did not deteriorate during maintenance treatment and was clinically not different between treatment groups. Interpretation Maintenance treatment with capecitabine plus bevacizumab after six cycles of CAPOX-B in patients with metastatic colorectal cancer is effective and does not compromise quality of life. Funding Dutch Colorectal Cancer Group (DCCG). The DCCG received financial support for the study from the Commissie Klinische Studies (CKS) of the Dutch Cancer Foundation (KWF), Roche, and Sanofi-Aventis.
copEngland
pubElsevier Ltd
pmid25862517
doi10.1016/S0140-6736(14)62004-3