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Cited by 49Colorectal Cancer Treatments and StudiesColorectal Cancer Surgical TreatmentsIntraperitoneal and Appendiceal Malignancies

The DOI matches its Crossref record; 30 of the 30 references it cites were found in a registry or an index.

Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy

Van Cutsem, Eric, Joulain, Florence, Hoff, Paulo M., Mitchell, Edith, Ruff, Paul, Lakomý, Radek, Prausová, Jana, Moiseyenko, Vladimir M., van Hazel, Guy, Cunningham, David, Arnold, Dirk, Schmoll, Hans-Joachim, ten Tije, Albert J., McKendrick, Joseph, Kröning, Hendrik, Humblet, Yves, Grávalos, Cristina, Le-Guennec, Solenn, Andria, Michael, Dochy, Emmanuelle, Vishwanath, Raghu L., Macarulla, Teresa, Tabernero, Josep·2016·Targeted Oncology
DOI 10.1007/s11523-015-0402-9
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Abstract

The aim of this post hoc analysis of the VELOUR study (ClinicalTrials.gov NCT00561470) was to investigate the treatment effect of adding aflibercept to second-line infusional 5-fluorouracil (5-FU), leucovorin and irinotecan (FOLFIRI) in patients with metastatic colorectal cancer (mCRC) who had failed any prior oxaliplatin-containing regimen. Adjuvant rapid relapsers (ARR), who were enrolled directly following relapse during or within 6 months of completion of oxaliplatin-containing adjuvant chemotherapy (N = 124, including 17 patients who also received bevacizumab as part of their adjuvant therapy), were excluded from the original VELOUR intention-to-treat (ITT) population (N = 1226). After exclusion of the ARR, overall survival (OS) in the ITT minus ARR (ITT-ARR) population (N = 1102) was longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm [hazard ratio (HR) 0.78, 95 % confidence interval (CI) 0.68-0.90; median survival difference 1.87 months]. In the subgroup of patients assigned to the prior bevacizumab stratum at randomization, OS was numerically longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm (HR 0.81; 95 % CI 0.63-1.04; median survival difference 2.14 months). Comparison of the post hoc analysis results with the primary analysis from VELOUR suggests that the inclusion of the directly enrolled ARR may have understated the aflibercept treatment benefit for both bevacizumab-pretreated and bevacizumab-naïve patients in the strictly second-line setting although no definitive conclusion may be inferred. The benefit associated with the addition of aflibercept to second-line FOLFIRI in patients with mCRC was observed whatever the timing of first-line disease progression. There were no unexpected safety concerns.

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Metadata

Authors
Van Cutsem, E., Joulain, F., Hoff, P. M., Mitchell, E., Ruff, P., Lakomý, R., Prausová, J., Moiseyenko, V. M., van Hazel, G., Cunningham, D., Arnold, D., Schmoll, H.-J., ten Tije, A. J., McKendrick, J., Kröning, H., Humblet, Y., Grávalos, C., Le-Guennec, S., Andria, M., Dochy, E., Vishwanath, R. L., Macarulla, T., & Tabernero, J.
Affiliations
  • Sanofi (France) (FR)
  • Hospital Sírio-Libanês (BR)
  • Sidney Kimmel Cancer Center (US)
  • University of the Witwatersrand (ZA)
  • Masaryk Memorial Cancer Institute (CZ)
  • University Hospital in Motol (CZ)
  • Institute of Oncology NN Petrov (RU)
  • Royal Marsden Hospital (GB)
  • University of Freiburg (DE)
  • Martin Luther University Halle-Wittenberg (DE)
  • Monash University (AU)
  • Hospital Universitario 12 De Octubre (ES)
  • Regeneron (United States) (US)
  • Sanofi (Belgium) (BE)
  • Universitat Autònoma de Barcelona (ES)
ORCID
Venue
Targeted Oncology
Publisher
Springer Science and Business Media LLC
Published
2015-12-26
Volume
11
Issue
3
Pages
383-400
ISSN
  • 1776-2596 (ISSN-L)
  • 1776-260X
DOI
10.1007/s11523-015-0402-9
OpenAlex
W2197745343
Cited by
49
References
30
Citations by year
2025: 2 · 2024: 4 · 2023: 3 · 2021: 13 · 2020: 8 · 2019: 8 · 2018: 4 · 2017: 4 · 2016: 3
FWCI
1.60
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • Targeted Oncology (publishedVersion)
  • PubMed (publishedVersion)
  • UWA Profiles and Research Repository (UWA) (submittedVersion)
  • Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion)
Funders
Sanofi
Topics
  • Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
  • Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
  • Health Sciences › Medicine › Surgery › Intraperitoneal and Appendiceal Malignancies
Keywords
aflibercept, FOLFIRI, metastatic colorectal cancer, second-line therapy, overall survival, bevacizumab, anti-VEGF therapy, irinotecan, 5-fluorouracil, leucovorin
MeSH terms
Oxaliplatin, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Leucovorin, Double-Blind Method, Female, Fluorouracil, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Organoplatinum Compounds, Recombinant Fusion Proteins, Colorectal Neoplasms, Survival Analysis, Treatment Outcome, Receptors, Vascular Endothelial Growth Factor

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