Aflibercept Plus Folfiri in Asian Patients with Pretreated Metastatic Colorectal Cancer: A Randomized Phase III Study
Author(s) -
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,
KunHuei Yeh,
Brigette Ma,
Vivian Wei,
Dongmei Shi,
E. Magherini,
Lin Shen
Publication year - 2018
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2017-0669
Subject(s) - folfiri , medicine , aflibercept , folinic acid , irinotecan , oxaliplatin , colorectal cancer , oncology , clinical endpoint , hazard ratio , adverse effect , bevacizumab , randomized controlled trial , chemotherapy , cancer , confidence interval
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.
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