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

Annals of Oncology

Volumn 27, Issue 7, 2016, Pages 1273-1279

  Folprecht, G ^a   Pericay, C ^b   Saunders, M P ^c   Thomas, A ^d   Lopez Lopez, R ^e   Roh, J K ^f   Chistyakov, V ^g   Hohler T ^h   Kim, J S ⁱ   Hofheinz, R D ^j   Ackland, S P ^k,l   Swinson, D ^m   Kopp, M ⁿ   Udovitsa, D ^o   Hall, M ^p   Iveson, T ^q   Vogel, A ^r   Zalcberg, J R ^s  

^a UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^b HOSPITAL DE SABADELL   (Spain)

^c CHRISTIE HOSPITAL   (United Kingdom)

^d UNIVERSITY OF LEICESTER   (United Kingdom)

^e Instituto de Salud Carlos III   (Spain)

^f Yonsei University College of Medicine   (South Korea)

^g Pyatigorsk Cancer Dispensary   (Russian Federation)

^h PROSPER HOSPITAL   (Germany)

ⁱ Korea University College of Medicine   (South Korea)

^j UNIVERSITY OF HEIDELBERG   (Germany)

^k CALVARY MATER NEWCASTLE HOSPITAL   (Australia)

^l UNIVERSITY OF NEWCASTLE   (Australia)

^m ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

ⁿ Samara Regional Oncology Center   (Russian Federation)

^o Oncological Dispensary No 2   (Russian Federation)

^p MOUNT VERNON CANCER CENTRE   (United Kingdom)

^q UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

^r HANNOVER MEDICAL SCHOOL   (Germany)

^s MONASH UNIVERSITY   (Australia)

more..

Author keywords

Aflibercept; Angiogenesis; Colorectal cancer; mFOLFOX6; Oxaliplatin

Indexed keywords

AFLIBERCEPT; FLUOROURACIL; FOLINIC ACID; OXALIPLATIN; VASCULOTROPIN; ANTINEOPLASTIC AGENT; HYBRID PROTEIN; PLATINUM COMPLEX; VASCULOTROPIN RECEPTOR;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ADULT; ADVERSE OUTCOME; AGED; ANEMIA; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER GRADING; COMPARATIVE STUDY; CONSTIPATION; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG EXPOSURE; DRUG HYPERSENSITIVITY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPHONIA; DYSPNEA; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; LEUKOPENIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MEDIAN SURVIVAL TIME; METASTATIC COLORECTAL CANCER; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; RECTUM HEMORRHAGE; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT OUTCOME; VOMITING; ADVERSE DRUG REACTION; CLINICAL TRIAL; COLORECTAL TUMOR; DISEASE FREE SURVIVAL; METASTASIS; MIDDLE AGED; PATHOLOGY;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; RECOMBINANT FUSION PROTEINS;

EID: 84977138848     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdw176     Document Type: Article

References (22)

1. Van Cutsem E, Cervantes A, Nordlinger B et al. Metastatic colorectal cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2014; 25(Suppl 3): iii1-iii9.
2. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350: 2335-2342.
3. Kabbinavar FF, Hambleton J, Mass RD et al. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol 2005; 23: 3706-3712.
4. Saltz LB, Clarke S, Diaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol 2008; 26: 2013-2019.
5. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007; 25: 1539-1544.
6. Bennouna J, Sastre J, Arnold D et al. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol 2013; 14: 29-37.
7. Papadopoulos N, Martin J, Ruan Q et al. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis 2012; 15: 171-185.
8. Van Cutsem E, Tabernero J, Lakomy R et al. 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 oxaliplatinbased regimen. J Clin Oncol 2012; 30: 3499-3506.
9. Tabernero J, Van Cutsem E, Lakomy R et al. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer 2014; 50: 320-331.
10. Lambrechts D, Thienpont B, Thuillier V et al. Evaluation of efficacy and safety markers in a phase II study of metastatic colorectal cancer treated with aflibercept in the first-line setting. Br J Cancer 2015; 113: 1027-1034.
11. Grothey A, Van Cutsem E, Sobrero A et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381: 303-312.
12. Tabernero J, Yoshino T, Cohn AL et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol 2015; 16: 499-508.
13. Berry SR, Cosby R, Asmis T et al. Continuous versus intermittent chemotherapy strategies in metastatic colorectal cancer: a systematic review and meta-analysis. Ann Oncol 2014; 26: 477-485.
14. Heinemann V, von Weikersthal LF, Decker T et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol 2014; 15: 1065-1075.
15. Simkens LH, van Tinteren H, May A et al. Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group. Lancet 2015; 385: 1843-1852.
16. Hegewisch-Becker S, Graeven U, Lerchenmuller CA et al. Maintenance strategies after first-line oxaliplatin plus fluoropyrimidine plus bevacizumab for patients with metastatic colorectal cancer (AIO 0207): a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol 2015; 16: 1355-1369.
17. Schwartzberg LS, Rivera F, Karthaus M et al. PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. J Clin Oncol 2014; 32: 2240-2247.
18. Hecht JR, Trarbach T, Hainsworth JD et al. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol 2011; 29: 1997-2003.
19. Hecht JR, Trarbach T, Jaeger E et al. A randomized, double-blind, placebocontrolled, phase III study in patients (Pts) with metastatic adenocarcinoma of the colon or recturm receiving first-line chemotherapy with oxaliplatin/5-fluorouracil/ leucovorin and PTK787/ZK 222584 or placebo (CONFIRM-1). J Clin Oncol 2005; 23(16S): Abstr LBA3.
20. Van Cutsem E, Prenen H, D'Haens G et al. A phase I/II, open-label, randomised study of nintedanib plus mFOLFOX6 versus bevacizumab plus mFOLFOX6 in firstline metastatic colorectal cancer patients. Ann Oncol 2015; 26(10): 2085-2091.
21. Hoff PM, Hochhaus A, Pestalozzi BC et al. Cediranib plus FOLFOX/CAPOX versus placebo plus FOLFOX/CAPOX in patients with previously untreated metastatic colorectal cancer: a randomized, double-blind, phase III study (HORIZON II). J Clin Oncol 2012; 30: 3596-3603.
22. Schmoll HJ, Cunningham D, Sobrero A et al. Cediranib with mFOLFOX6 versus bevacizumab with mFOLFOX6 as first-line treatment for patients with advanced colorectal cancer: a double-blind, randomized phase III study (HORIZON III). J Clin Oncol 2012; 30: 3588-3595.