Title: Fluorouracil, Leucovorin, and Irinotecan Plus Either Sunitinib or Placebo in Metastatic Colorectal Cancer: A Randomized, Phase III Trial
Authors: Carrato, Alfredo ×
Swieboda-Sadlej, Anna
Staszewska-Skurczynska, Marzanna
Lim, Robert
Roman, Laslo
Shparyk, Yaroslav
Bondarenko, Igor
Jonker, Derek J
Sun, Yan
De la Cruz, Jhony A
Williams, J Andrew
Korytowsky, Beata
Christensen, James G
Lin, Xun
Tursi, Jennifer M
Lechuga, Maria J
Van Cutsem, Eric #
Issue Date: Apr-2013
Publisher: Grune & Stratton
Series Title: Journal of Clinical Oncology vol:31 issue:10 pages:1341-1347
Abstract: PURPOSEThis double-blind, phase III study aimed to demonstrate that sunitinib plus FOLFIRI (fluorouracil, leucovorin, and irinotecan) was superior to placebo plus FOLFIRI in previously untreated metastatic colorectal cancer (mCRC). PATIENTS AND METHODSPatients were randomly assigned to receive FOLFIRI and either sunitinib (37.5 mg per day) or placebo (4 weeks on treatment, followed by 2 weeks off [schedule 4/2]) until disease progression. The primary end point was progression-free survival (PFS). Secondary end points included overall survival, safety, and patient-reported outcomes. The correlation between genotype and clinical outcomes was also analyzed.ResultsIn all, 768 patients were randomly assigned to sunitinib plus FOLFIRI (n = 386) or placebo plus FOLFIRI (n = 382). Following a second prespecified interim analysis, the study was stopped because of potential futility of sunitinib plus FOLFIRI. Final results are reported. The PFS hazard ratio was 1.095 (95% CI, 0.892 to 1.344; one-sided stratified log-rank P = .807), indicating a lack of superiority for sunitinib plus FOLFIRI. Median PFS for the sunitinib arm was 7.8 months (95% CI, 7.1 to 8.4 months) versus 8.4 months (95% CI, 7.6 to 9.2 months) for the placebo arm. Sunitinib plus FOLFIRI was associated with more grade ≥ 3 adverse events and laboratory abnormalities than placebo (especially diarrhea, stomatitis/oral syndromes, fatigue, hand-foot syndrome, neutropenia, thrombocytopenia, anemia, and febrile neutropenia). More deaths as a result of toxicity (12 v four) and significantly more dose delays, dose reductions, and treatment discontinuations occurred in the sunitinib arm. CONCLUSIONSunitinib 37.5 mg per day (schedule 4/2) plus FOLFIRI is not superior to FOLFIRI alone and has a poorer safety profile. This combination regimen is not recommended for previously untreated mCRC.
ISSN: 0732-183X
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Clinical Digestive Oncology (+)
× corresponding author
# (joint) last author

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