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
- Authors
- Folprecht, G.; Pericay, C.; Saunders, M. P.; Thomas, A.; Lopez Lopez, R.; Roh, J. K.; Chistyakov, V.; Hoehler, 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.
- Issue Date
- 7월-2016
- Publisher
- OXFORD UNIV PRESS
- Keywords
- aflibercept; mFOLFOX6; angiogenesis; oxaliplatin; colorectal cancer
- Citation
- ANNALS OF ONCOLOGY, v.27, no.7, pp.1273 - 1279
- Indexed
- SCIE
SCOPUS
- Journal Title
- ANNALS OF ONCOLOGY
- Volume
- 27
- Number
- 7
- Start Page
- 1273
- End Page
- 1279
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/88285
- DOI
- 10.1093/annonc/mdw176
- ISSN
- 0923-7534
- Abstract
- Background: 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, , EudraCT 2008-004178-41.
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