A randomized, double-blind, placebo-controlled, phase III study in patients (Pts) with metastatic adenocarcinoma of the colon or rectum receiving first-line chemotherapy with oxaliplatin/5-fluorouracil/leucovorin and PTK787/ZK 222584 or placebo (CONFIRM-1)

Simplified Prognostic Model in Patients with Oxaliplatin-Based or Irinotecan-Based First-Line Chemotherapy for Metastatic Colorectal Cancer: A GERCOR Study

“…LDH has been previously identified as a prognostic factor in colorectal cancer [4,5,9,11,25] and other tumor localizations [26 -30]. Of note, LDH has also been identified as a potential predictive factor for a vascular endothelial growth factor inhibitor and chemotherapy combination in patients with metastatic colorectal cancer [31].…”

“…Intermediate-risk 223 (42) 19.5 months [16.5-21.1] 3-4 points High-risk 128 (24) 13.9 months [11.1-14.8] 0 point Low-risk 184 (34) 29.8 months [26.4-34.7] Learning sample (n = 535) Validation sample (n = 268) 112 (42) 21.2 months [18.1-24.3] 72 (27) 14.0 months [11.4-16.5] 84 (31) 26.9 months [22.0-36. www.TheOncologist.com…”

DCE-MRI biomarkers in the clinical evaluation of antiangiogenic and vascular disrupting agents

“…Oral PTK/ZK (1250 mg q.d.s) or placebo were administered with oxaloplatin/ 5-flurouracil/leucovorin (FOLFOX4) as first-line (CONFIRM-1) (Hecht et al, 2005) or second-line therapy (CONFIRM-2) (Koehne et al, 2006). Analysis of PFS in CONFIRM-1 did not achieve statistical significance.…”

The Role of VEGF and EGFR Inhibition: Implications for Combining Anti–VEGF and Anti–EGFR Agents

“…Despite encouraging results in combination with chemotherapy in phase I/II studies as firstline therapy for advanced or metastatic colorectal cancer (74,75), a central review of data from the phase III CONFIRM-1 trial and survival data from CONFIRM-2 was less positive (76)(77)(78). The central radiology review found no statistically significant response or progression-free survival benefit with the addition of vatalanib to FOLFOX4 (infusional 5-FU/leucovorin/oxaliplatin) versus FOLFOX4 alone in previously untreated metastatic colorectal cancer (77). Additionally, planned interim analysis of CONFIRM-2 data indicates a low probability of showing overall survival benefit with vatalanib in the second-line treatment of metastatic colorectal cancer (78).…”

“…In a phase I/II trial of vatalanib plus FOLFOX4, of the 35 patients evaluable for toxicity, 11% (n = 4) experienced grade 3 fatigue, 26% (n = 9) presented with grade 3 neutropenia, and 17% (n = 6) reported grade 3 dizziness (75). In the CONFIRM-1 study, the addition of vatalanib to the FOLFOX regimen increased the incidence of grade 4 pulmonary embolism by 4.6% (n = 29) versus placebo (77).…”