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
DC Field | Value | Language |
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dc.contributor.author | Folprecht, G. | - |
dc.contributor.author | Pericay, C. | - |
dc.contributor.author | Saunders, M. P. | - |
dc.contributor.author | Thomas, A. | - |
dc.contributor.author | Lopez Lopez, R. | - |
dc.contributor.author | Roh, J. K. | - |
dc.contributor.author | Chistyakov, V. | - |
dc.contributor.author | Hoehler, T. | - |
dc.contributor.author | Kim, J. -S. | - |
dc.contributor.author | Hofheinz, R. -D. | - |
dc.contributor.author | Ackland, S. P. | - |
dc.contributor.author | Swinson, D. | - |
dc.contributor.author | Kopp, M. | - |
dc.contributor.author | Udovitsa, D. | - |
dc.contributor.author | Hall, M. | - |
dc.contributor.author | Iveson, T. | - |
dc.contributor.author | Vogel, A. | - |
dc.contributor.author | Zalcberg, J. R. | - |
dc.date.accessioned | 2021-09-03T22:35:19Z | - |
dc.date.available | 2021-09-03T22:35:19Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2016-07 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/88285 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | OXFORD UNIV PRESS | - |
dc.subject | BEVACIZUMAB PLUS MFOLFOX6 | - |
dc.subject | RANDOMIZED PHASE-III | - |
dc.subject | DOUBLE-BLIND | - |
dc.subject | OPEN-LABEL | - |
dc.subject | IMPROVES SURVIVAL | - |
dc.subject | TRIAL | - |
dc.subject | FLUOROURACIL | - |
dc.subject | LEUCOVORIN | - |
dc.subject | PLACEBO | - |
dc.subject | COMBINATION | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, J. -S. | - |
dc.identifier.doi | 10.1093/annonc/mdw176 | - |
dc.identifier.scopusid | 2-s2.0-84977138848 | - |
dc.identifier.wosid | 000379760700012 | - |
dc.identifier.bibliographicCitation | ANNALS OF ONCOLOGY, v.27, no.7, pp.1273 - 1279 | - |
dc.relation.isPartOf | ANNALS OF ONCOLOGY | - |
dc.citation.title | ANNALS OF ONCOLOGY | - |
dc.citation.volume | 27 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 1273 | - |
dc.citation.endPage | 1279 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | BEVACIZUMAB PLUS MFOLFOX6 | - |
dc.subject.keywordPlus | RANDOMIZED PHASE-III | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | IMPROVES SURVIVAL | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | FLUOROURACIL | - |
dc.subject.keywordPlus | LEUCOVORIN | - |
dc.subject.keywordPlus | PLACEBO | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordAuthor | aflibercept | - |
dc.subject.keywordAuthor | mFOLFOX6 | - |
dc.subject.keywordAuthor | angiogenesis | - |
dc.subject.keywordAuthor | oxaliplatin | - |
dc.subject.keywordAuthor | colorectal cancer | - |
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