Aflibercept plus FOLFIRI in Asian patients with pretreated metastatic colorectal cancer: a randomized Phase III study.

Abstract

AIM:

To investigate whether the benefit of combining aflibercept with 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) chemotherapy could be confirmed in patients from the Asia-Pacific region (ClinicalTrials.gov: NCT01661270). Patients & methods: Asian patients with oxaliplatin-pretreated metastatic colorectal cancer were randomized to receive aflibercept or placebo, followed by FOLFIRI. The primary end point was progression-free survival.

RESULTS:

The intention-to-treat population comprised 332 patients. A clinical supply misallocation resulted in 198/332 (60%) patients receiving at least one cycle of misallocated treatment. Nevertheless, the addition of aflibercept to FOLFIRI was shown to improve progression-free survival (hazard ratio: 0.629; 95% CI: 0.488-0.812). Adverse events were in line with expectations.

CONCLUSION:

The beneficial treatment effect associated with the addition of aflibercept to FOLFIRI was confirmed in Asian patients with pretreated metastatic colorectal cancer.

• Authors: Jin Li, Ruihua Xu, Shukui Qin, Tianshu Liu, Hongming Pan, Jianming Xu, Feng Bi, Robert Lim, Suzhan Zhang, Yi Ba, Yuxian Bai, Nanfeng Fan, Akihito Tsuji, Kun-Huei Yeh, Brigette Ma, Vivian Wei, Dongmei Shi, Emmanuelle Magherini, Lin Shen
• Journal: Future oncology (London, England) (Future Oncol) Vol. 14 Issue 20 Pg. 2031-2044 (Aug 2018) ISSN: 1744-8301 [Electronic] England
• PMID: 30117334 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Recombinant Fusion Proteins
• aflibercept
• Receptors, Vascular Endothelial Growth Factor
• Leucovorin
• Fluorouracil
• Camptothecin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Asian People
• Camptothecin (adverse effects, analogs & derivatives, therapeutic use)
• Colorectal Neoplasms (drug therapy, pathology)
• Female
• Fluorouracil (adverse effects, therapeutic use)
• Humans
• Kaplan-Meier Estimate
• Leucovorin (adverse effects, therapeutic use)
• Male
• Middle Aged
• Neoplasm Metastasis
• Neoplasm Staging
• Receptors, Vascular Endothelial Growth Factor (administration & dosage)
• Recombinant Fusion Proteins (administration & dosage)
• Retreatment
• Treatment Outcome