Addition of Aflibercept to Fluorouracil, Leucovorin, and
Irinotecan Improves Survival in a Phase III Randomized Trial in
Patients With Metastatic Colorectal Cancer Previously Treated
With an Oxaliplatin-Based Regimen

J 2012

Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

VAN CUTSEM, Eric; Josep TABERNERO; Radek LAKOMÝ; Hans PRENEN; Jana PRAUSOVÁ et al.

Základní údaje

Originální název

Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

Autoři

Vydání

Journal of clinical oncology, United States, American Society of Clinical Oncology, 2012, 0732-183X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30200 3.2 Clinical medicine

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 18.038

Označené pro přenos do RIV

Organizační jednotka

Lékařská fakulta

DOI

https://doi.org/10.1200/JCO.2012.42.8201

UT WoS

000309517700015

Klíčová slova anglicky

ENDOTHELIAL GROWTH-FACTOR; ADVANCED SOLID TUMORS; VEGF-TRAP; ANGIOGENESIS; BEVACIZUMAB; CONSORTIUM; RECURRENT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 23. 4. 2014 15:28, Ing. Mgr. Věra Pospíšilíková

Anotace

V originále

Purpose Treatment for metastatic colorectal cancer (mCRC) commonly involves a fluoropyrimidine-based chemotherapy regimen such as infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) or fluorouracil, leucovorin, and oxaliplatin, often combined with bevacizumab or an epidermal growth factor receptor monoclonal antibody. We studied the effect of adding the novel antiangiogenic agent aflibercept (also known as ziv-aflibercept in the United States) to FOLFIRI in patients with mCRC previously treated with oxaliplatin, including patients who received prior bevacizumab. Results Adding aflibercept to FOLFIRI significantly improved overall survival relative to placebo plus FOLFIRI (hazard ratio [HR], 0.817; 95.34% CI, 0.713 to 0.937; P = .0032) with median survival times of 13.50 versus 12.06 months, respectively. Aflibercept also significantly improved progression-free survival (PFS; HR, 0.758; 95% CI, 0.661 to 0.869; P < .0001), with median PFS times of 6.90 versus 4.67 months, respectively. The effects on overall survival and PFS exhibited a consistent trend across prespecified subgroup analyses, including bevacizumab pretreated patients. Response rate was 19.8% (95% CI, 16.4% to 23.2%) with aflibercept plus FOLFIRI compared with 11.1% (95% CI, 8.5% to 13.8%) with placebo plus FOLFIRI (P = .0001). Adverse effects reported with aflibercept combined with FOLFIRI included the characteristic anti-vascular endothelial growth factor effects and also reflected an increased incidence of some chemotherapy-related toxicities. Conclusion Aflibercept in combination with FOLFIRI conferred a statistically significant survival benefit over FOLFIRI combined with placebo in patients with mCRC previously treated with oxaliplatin. J Clin Oncol 30:3499-3506. (C) 2012 by American Society of Clinical Oncology

Citovat

VAN CUTSEM, Eric; Josep TABERNERO; Radek LAKOMÝ; Hans PRENEN; Jana PRAUSOVÁ; Teresa MACARULLA; Paul RUFF; Guy A. VAN HAZEL; Vladimir MOISEYENKO; David FERRY; Joe MCKENDRICK; Jonathan POLIKOFF; Alexia TELLIER; Remi CASTAN a Carmen ALLEGRA. Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen. Journal of clinical oncology. United States: American Society of Clinical Oncology, 2012, roč. 30, č. 28, s. 3499-3506. ISSN 0732-183X. Dostupné z: https://doi.org/10.1200/JCO.2012.42.8201.

@article{1089664,
   author = {Van Cutsem, Eric and Tabernero, Josep and Lakomý, Radek and Prenen, Hans and Prausová, Jana and Macarulla, Teresa and Ruff, Paul and van Hazel, Guy A. and Moiseyenko, Vladimir and Ferry, David and McKendrick, Joe and Polikoff, Jonathan and Tellier, Alexia and Castan, Remi and Allegra, Carmen},
   article_location = {United States},
   article_number = {28},
   doi = {https://doi.org/10.1200/JCO.2012.42.8201},
   keywords = {ENDOTHELIAL GROWTH-FACTOR; ADVANCED SOLID TUMORS; VEGF-TRAP; ANGIOGENESIS; BEVACIZUMAB; CONSORTIUM; RECURRENT},
   language = {eng},
   issn = {0732-183X},
   journal = {Journal of clinical oncology},
   title = {Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen},
   volume = {30},
   year = {2012}
}

TY  - JOUR
ID  - 1089664
AU  - Van Cutsem, Eric - Tabernero, Josep - Lakomý, Radek - Prenen, Hans - Prausová, Jana - Macarulla, Teresa - Ruff, Paul - van Hazel, Guy A. - Moiseyenko, Vladimir - Ferry, David - McKendrick, Joe - Polikoff, Jonathan - Tellier, Alexia - Castan, Remi - Allegra, Carmen
PY  - 2012
TI  - Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen
JF  - Journal of clinical oncology
VL  - 30
IS  - 28
SP  - 3499-3506
EP  - 3499-3506
PB  - American Society of Clinical Oncology
SN  - 0732183X
KW  - ENDOTHELIAL GROWTH-FACTOR
KW  - ADVANCED SOLID TUMORS
KW  - VEGF-TRAP
KW  - ANGIOGENESIS
KW  - BEVACIZUMAB
KW  - CONSORTIUM
KW  - RECURRENT
N2  - Purpose Treatment for metastatic colorectal cancer (mCRC) commonly involves a fluoropyrimidine-based chemotherapy regimen such as infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) or fluorouracil, leucovorin, and oxaliplatin, often combined with bevacizumab or an epidermal growth factor receptor monoclonal antibody. We studied the effect of adding the novel antiangiogenic agent aflibercept (also known as ziv-aflibercept in the United States) to FOLFIRI in patients with mCRC previously treated with oxaliplatin, including patients who received prior bevacizumab. Results Adding aflibercept to FOLFIRI significantly improved overall survival relative to placebo plus FOLFIRI (hazard ratio [HR], 0.817; 95.34% CI, 0.713 to 0.937; P = .0032) with median survival times of 13.50 versus 12.06 months, respectively. Aflibercept also significantly improved progression-free survival (PFS; HR, 0.758; 95% CI, 0.661 to 0.869; P < .0001), with median PFS times of 6.90 versus 4.67 months, respectively. The effects on overall survival and PFS exhibited a consistent trend across prespecified subgroup analyses, including bevacizumab pretreated patients. Response rate was 19.8% (95% CI, 16.4% to 23.2%) with aflibercept plus FOLFIRI compared with 11.1% (95% CI, 8.5% to 13.8%) with placebo plus FOLFIRI (P = .0001). Adverse effects reported with aflibercept combined with FOLFIRI included the characteristic anti-vascular endothelial growth factor effects and also reflected an increased incidence of some chemotherapy-related toxicities. Conclusion Aflibercept in combination with FOLFIRI conferred a statistically significant survival benefit over FOLFIRI combined with placebo in patients with mCRC previously treated with oxaliplatin. J Clin Oncol 30:3499-3506. (C) 2012 by American Society of Clinical Oncology
ER  -

VAN CUTSEM, Eric; Josep TABERNERO; Radek LAKOMÝ; Hans PRENEN; Jana PRAUSOVÁ; Teresa MACARULLA; Paul RUFF; Guy A. VAN HAZEL; Vladimir MOISEYENKO; David FERRY; Joe MCKENDRICK; Jonathan POLIKOFF; Alexia TELLIER; Remi CASTAN a Carmen ALLEGRA. Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen. \textit{Journal of clinical oncology}. United States: American Society of Clinical Oncology, 2012, roč.~30, č.~28, s.~3499-3506. ISSN~0732-183X. Dostupné z: https://doi.org/10.1200/JCO.2012.42.8201.

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