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A decoy receptor that mops up the signals feeding tumour blood vessels added about six weeks of life in second-line treatment. England decided that was not worth the price.
VELOUR randomised 1,226 patients whose metastatic colorectal cancer had progressed after an oxaliplatin-based regimen, including patients who had already had bevacizumab, to FOLFIRI with ziv-aflibercept 4 mg/kg or placebo every two weeks. Median overall survival was 13.50 against 12.06 months (hazard ratio 0.817, 95.34% CI 0.713 to 0.937, p=0.0032) and progression-free survival also improved (hazard ratio 0.758, 0.661 to 0.869). The FDA approved ziv-aflibercept in August 2012 and the EU marketing authorisation for Zaltrap followed on 1 February 2013, but NICE TA307 in March 2014 did not recommend it, so it is not routinely funded in England. It remains an option in guidelines where the modest absolute gain is judged worthwhile.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,226 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | FOLFIRI plus ziv-aflibercept | 612 | 13.5 months | 0.817 (0.713 to 0.937) | 0.0032 | link |
| FOLFIRI plus placebo | 614 | 12.06 months |
Shares Ziv-aflibercept, Sanofi, Irinotecan (and liposomal irinotecan), Fluorouracil (5-FU).
Shares Irinotecan (and liposomal irinotecan), FOLFIRI (5-FU, leucovorin, irinotecan), VEGF / VEGFR, Fluorouracil (5-FU).
Shares Irinotecan (and liposomal irinotecan), VEGF / VEGFR, Fluorouracil (5-FU), Anti-angiogenic therapy.
Shares Irinotecan (and liposomal irinotecan), FOLFIRI (5-FU, leucovorin, irinotecan), VEGF / VEGFR, Fluorouracil (5-FU).
Shares FOLFIRI (5-FU, leucovorin, irinotecan), VEGF / VEGFR, Anti-angiogenic therapy, Cytotoxic chemotherapy.
Shares FOLFIRI (5-FU, leucovorin, irinotecan), Fluorouracil (5-FU), Anti-angiogenic therapy, Cytotoxic chemotherapy.
Shares Irinotecan (and liposomal irinotecan), FOLFIRI (5-FU, leucovorin, irinotecan), Fluorouracil (5-FU), Cytotoxic chemotherapy.
Shares VEGF / VEGFR, Anti-angiogenic therapy, Cytotoxic chemotherapy, Colorectal cancer.