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Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: the AFFIRM study

Folprecht, G. ; Pericay, C. ; Saunders, M.P. ; Thomas, A. ; Lopez Lopez, R. ; Roh, J.K. ; Chistyakov, V. ; Höhler, T. ; Kim, J.-S. ; Hofheinz, R.-D. ; Ackland, S.P. ; Swinson, D. ; Kopp, M. ; Udovitsa, D. ; Hall, M. ; Iveson, T. ; Vogel, A. ; Zalcberg, J.R.

Annals of oncology, 2016-07, Vol.27 (7), p.1273-1279 [Revista revisada por pares]

England: Elsevier Ltd

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Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: the AFFIRM study
Autor: Folprecht, G. ; Pericay, C. ; Saunders, M.P. ; Thomas, A. ; Lopez Lopez, R. ; Roh, J.K. ; Chistyakov, V. ; Höhler, T. ; Kim, J.-S. ; Hofheinz, R.-D. ; Ackland, S.P. ; Swinson, D. ; Kopp, M. ; Udovitsa, D. ; Hall, M. ; Iveson, T. ; Vogel, A. ; Zalcberg, J.R.
Materias: Adult ; aflibercept ; Aged ; angiogenesis ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; colorectal cancer ; Colorectal Neoplasms - drug therapy ; Colorectal Neoplasms - pathology ; Disease-Free Survival ; Drug-Related Side Effects and Adverse Reactions - pathology ; Female ; Fluorouracil - administration & dosage ; Fluorouracil - adverse effects ; Humans ; Leucovorin - administration & dosage ; Leucovorin - adverse effects ; Male ; mFOLFOX6 ; Middle Aged ; Neoplasm Metastasis ; Organoplatinum Compounds - administration & dosage ; Organoplatinum Compounds - adverse effects ; Oxaliplatin ; Receptors, Vascular Endothelial Growth Factor - administration & dosage ; Recombinant Fusion Proteins - administration & dosage
Es parte de: Annals of oncology, 2016-07, Vol.27 (7), p.1273-1279
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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Descripción: The combination of aflibercept with FOLFIRI has been shown to significantly prolong overall survival in patients with metastatic colorectal cancer (mCRC) after progression on oxaliplatin-based therapy. This trial evaluated the addition of aflibercept to oxaliplatin-based first-line treatment of patients with mCRC. Patients with mCRC were randomized to receive first-line therapy with mFOLFOX6 plus aflibercept (4 mg/kg) or mFOLFOX6 alone. The primary end point of this phase II study was the progression-free survival (PFS) rate at 12 months in each arm. The analysis of efficacy between the arms was a pre-planned secondary analysis. Of 236 randomized patients, 227 and 235 patients were evaluable for the primary efficacy analysis and safety, respectively. The probabilities of being progression-free at 12 months were 25.8% [95% confidence interval (CI) 17.2–34.4] for the aflibercept/mFOLFOX6 arm and 21.2% (95% CI 12.2–30.3) for the mFOLFOX6 arm. The median PFS was 8.48 months (95% CI 7.89–9.92) for the aflibercept/mFOLFOX6 arm and 8.77 months (95% CI 7.62–9.27) for the mFOLFOX6 arm; the hazard ratio of aflibercept/mFOLFOX6 versus mFOLFOX6 was 1.00 (95% CI 0.74–1.36). The response rates were 49.1% (95% CI 39.7–58.6) and 45.9% (95% CI 36.4–55.7) for patients treated with and without aflibercept, respectively. The most frequent treatment-emergent grade 3/4 adverse events (AEs) excluding laboratory abnormalities reported for aflibercept/mFOLFOX6 versus mFOLFOX6 were neuropathy (16.8% versus 17.2%) and diarrhea (13.4% versus 5.2%). Neutropenia grade 3/4 occurred in 36.1% versus 29.3%. The most common vascular endothelial growth factor inhibition class-effect grade 3/4 AEs for aflibercept/mFOLFOX6 versus mFOLFOX6 were hypertension (35.3% versus 1.7%), proteinuria (9.2% versus 0%), deep vein thrombosis (5.9% versus 0.9%) and pulmonary embolism (5.9% versus 5.2%). No difference in PFS rate was observed between treatment groups. Adding aflibercept to first-line mFOLFOX6 did not increase efficacy but was associated with higher toxicity. NCT00851084, www.clinicaltrials.gov, EudraCT 2008-004178-41.
Editor: England: Elsevier Ltd
Idioma: Inglés

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Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: the AFFIRM study

Folprecht, G. ; Pericay, C. ; Saunders, M.P. ; Thomas, A. ; Lopez Lopez, R. ; Roh, J.K. ; Chistyakov, V. ; Höhler, T. ; Kim, J.-S. ; Hofheinz, R.-D. ; Ackland, S.P. ; Swinson, D. ; Kopp, M. ; Udovitsa, D. ; Hall, M. ; Iveson, T. ; Vogel, A. ; Zalcberg, J.R.

England: Elsevier Ltd

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