Abstract | BACKGROUND: METHODS: Patients had adenocarcinoma of the colon or rectum with progression within 6 months of receiving only one prior fluoropyrimidine/ oxaliplatin-based chemotherapy regimen for metastatic disease. All patients received FOLFIRI and were randomised 2:1 to also receive intravenous trebananib 10 mg kg(-1) once weekly (QW) (Arm A) or placebo QW (Arm B). The primary end point was investigator-assessed progression-free survival (PFS). RESULTS: One hundred and forty-four patients were randomised (Arms A/B, n=95/49). Median PFS in Arms A and B was 3.5 and 5.2 months (hazard ratio (HR) 1.23; 95% CI, 0.81-1.86; P=0.33) and median overall survival (OS) was 11.9 and 8.8 months, respectively (HR 0.90; 95% CI; 0.53-1.54; P=0.70). Objective response rate (ORR) was 14% and 0% in Arms A and B, respectively. Incidence of grade ≥3 adverse events was similar between treatment arms (Arm A, 61%; Arm B, 65%) and included pulmonary embolism (1%/4%), deep vein thrombosis (5%/2%), and hypertension (1%/0%). CONCLUSION: Administration of trebananib plus FOLFIRI did not prolong PFS compared with placebo plus FOLFIRI. Toxicities were manageable and consistent with those known for FOLFIRI and trebananib.
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Authors | M Peeters, A H Strickland, M Lichinitser, A V S Suresh, G Manikhas, J Shapiro, W Rogowski, X Huang, B Wu, D Warner, R Jain, N C Tebbutt |
Journal | British journal of cancer
(Br J Cancer)
Vol. 108
Issue 3
Pg. 503-11
(Feb 19 2013)
ISSN: 1532-1827 [Electronic] England |
PMID | 23361051
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biomarkers, Tumor
- Recombinant Fusion Proteins
- Leucovorin
- Fluorouracil
- trebananib
- Camptothecin
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Topics |
- Adenocarcinoma
(drug therapy, mortality, secondary)
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Biomarkers, Tumor
(analysis)
- Camptothecin
(administration & dosage)
- Colorectal Neoplasms
(drug therapy, mortality, pathology)
- Double-Blind Method
- Female
- Fluorouracil
(administration & dosage)
- Humans
- International Agencies
- Leucovorin
(administration & dosage)
- Liver Neoplasms
(drug therapy, mortality, secondary)
- Male
- Middle Aged
- Prognosis
- Recombinant Fusion Proteins
(administration & dosage)
- Salvage Therapy
- Survival Rate
- Young Adult
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