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, Gunnar; Pericay, Carles; Saunders, Mark; Thomas, Anne; López, Ricardo Calvo; Roh, Jae Hoon; Chistyakov, V. V.; Hawranek, Thomas; Kim, J. S.; Hofheinz, Ralf; Ackland, Stephen P.; Swinson, Daniel; Kopp, Mikhail V.; Udovitsa, Dmitry; Hall, Marcia; Iveson, Tim; Vogel, Arndt; Zalcberg, John

doi:10.1093/annonc/mdw176

Cited by 71 publications

(69 citation statements)

References 21 publications

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“…Furthermore, the addition of ziv-aflibercept to FOL-FIRI in first-line therapy of patients with metastatic CRC in the phase II AFFIRM study had no benefit and increased toxicity. 215 Thus, the panel added ziv-aflibercept as a second-line treatment option in combination with FOLFIRI or irinotecan only after progression on therapy not containing irinotecan. However, the panel prefers bevacizumab over zivaflibercept and ramucirumab in this setting, based on toxicity and/or cost.…”

mentioning

confidence: 99%

Colon Cancer, Version 1.2017, NCCN Clinical Practice Guidelines in Oncology

Benson¹,

Venook²,

Cederquist³

et al. 2017

J Natl Compr Canc Netw

741

515

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OverviewColorectal cancer (CRC) is the fourth most frequently diagnosed cancer and the second leading cause of cancer death in the United States. In 2016, an estimated 95,270 new cases of colon cancer and approximately 39,220 cases of rectal cancer will occur. During the same year, an estimated 49,190 people will die of colon and rectal cancer combined. AbstractThis portion of the NCCN Guidelines for Colon Cancer focuses on the use of systemic therapy in metastatic disease. Considerations for treatment selection among 32 different monotherapies and combination regimens in up to 7 lines of therapy have included treatment history, extent of disease, goals of treatment, the efficacy and toxicity profiles of the regimens, KRAS/NRAS mutational status, and patient comorbidities and preferences. Location of the primary tumor, the BRAF mutation status, and tumor microsatellite stability should also be considered in treatment decisions. J Natl Compr Canc Netw 2017;15(3): 370-398 NCCN Categories of Evidence and ConsensusCategory 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate. Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate. These guidelines are also available on the Internet. For the latest update, visit NCCN.org.

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mentioning

confidence: 99%

Colon Cancer, Version 1.2017, NCCN Clinical Practice Guidelines in Oncology

Benson¹,

Venook²,

Cederquist³

et al. 2017

J Natl Compr Canc Netw

741

515

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“…По результатам рандомизированных исследований III фазы оба препа-рата зарегистрированы только в сочетании с режимом FOLFIRI во второй линии терапии [19,20]. Эффектив-ность данных моноклональных антител в первой линии или в комбинациях с оксалиплатин-содержащими режи-мами не доказана [21][22][23][24].…”

Section: какой режим химиотерапии лучше комбинировать с таргетным преunclassified

Optimal Sequences and Combination of Chemotherapy and Monoclonal Antibodies in the Treatment of Patients With Metastatic Colorectal Cancer

Федянин¹,

Тюляндин²

2018

Zlokač. opuholi

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In this review we analyzed results of studies concerning the choice of first and subsequent lines of therapy in patients with metastatic colon cancer. We discussed data of various combinations of monoclonal antibodies with different chemotherapeutic regimens. Also we discussed modern preclinical and clinical trials concerning strategy of choice of targeted therapy sequence in patients with metastatic disease. We considered the impact of various molecular and clinical factors on the effectiveness of drugs and determined their application for therapy choice for colon cancer.

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“…Hypothesis generating data was produced initially in the phase II AFFIRM study (FOLFOX6 with or without aflibercept in first-line treatment of mCRC). 16 The programme was expanded to include samples from the pivotal VELOUR study and another phase III study of aflibercept in Asian patients (with a similar design to the VELOUR study). The full results of the biomarker programme are expected to be submitted in December 2016.…”

Section: Benefit-risk Assessmentmentioning

confidence: 99%

European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer

Stanel¹,

Sjøberg

Salmonson

et al. 2017

ESMO Open

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On 1 February 2013, a marketing authorisation valid throughout the European Union was issued for aflibercept (Zaltrap) in combination with irinotecan/5-fluorouracil/folinic acid chemotherapy for the treatment of adults with metastatic colorectal cancer resistant to or progressive after an oxaliplatin-containing regimen. Aflibercept is a recombinant fusion protein which blocks the activation of vascular endothelial growth factor (VEGF) receptors and the proliferation of endothelial cells, acting as a soluble decoy receptor that binds to VEGF-A with higher affinity than its native receptors, as well as placental growth factor and VEGF-B. The use of aflibercept was studied in a randomised, double-blind, placebo-controlled phase III study, in patients with metastatic colorectal cancer (mCRC) who had previously been treated with an oxaliplatin-based treatment with or without prior bevacizumab. Aflibercept (n=612) was compared with placebo (n=614), both in combination with FOLFIRI (infusional fluorouracil, leucovorin and irinotecan). The primary endpoint of the study was overall survival (OS). The median OS in the intent-to-treat population was 13.5 months in subjects treated with aflibercept compared with 12.1 months for subjects in the control arm (stratified HR=0.817, 95% CI 0.714 to 0.935, stratified pvalue=0.0032). The frequency of adverse events was higher in the aflibercept arm compared with the placebo arm, reflecting the toxicity profile of anti-VEGF agents in combination with chemotherapy. This paper is based on the scientific review of the application leading to approval of aflibercept in the EU. The detailed scientific assessment report and product information for this product are available on the European Medicines Agency website (http://www.ema.europa.eu). Trial registration number NCT00561470, Results.

show abstract

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

Abstract: NCT00851084, www.clinicaltrials.gov, EudraCT 2008-004178-41.

Cited by 71 publications

References 21 publications

Colon Cancer, Version 1.2017, NCCN Clinical Practice Guidelines in Oncology

Colon Cancer, Version 1.2017, NCCN Clinical Practice Guidelines in Oncology

Optimal Sequences and Combination of Chemotherapy and Monoclonal Antibodies in the Treatment of Patients With Metastatic Colorectal Cancer

European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer

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