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Tumor response to pre-operative chemotherapy (CT) with FOLFOX-4 for resectable colorectal cancer liver metastases (LM) Interim results of the EORTC Intergroup randomized phase III study 40983. T. Gruenberger*, H. Sorbye, M. Debois, U. Bethe, J. Primrose,
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Tumor response to pre-operative chemotherapy (CT) with FOLFOX-4 for resectable colorectal cancer liver metastases (LM)Interim results of the EORTC Intergroup randomized phase III study 40983 • T. Gruenberger*, H. Sorbye, M. Debois, U. Bethe, J. Primrose, • Ph.Rougier, D. Jaeck, M. Finch-Jones, E. Van Cutsem, • B.Nordlinger, • For the EORTC GI, CRC, ALMCAO, AGITG and FFCD • *University Hospital, Dept. General Surgery, HPB Service,Vienna, Austria
Background • After resection of liver metastases 5 year- survival is 30% • Recurrence of disease occurs in about 70% • The benefit of combining surgery and chemotherapy is not yet formally proven
Objectives • Objective of the study Improve progression-free survival with peri-operative CT with Oxaliplatin and LV5FU2 as compared to surgery alone • Objective of this analysis To evaluate tumor response to pre-operative CT and to determine if CT induces a tumor size reduction The safety and feasibility of the regimen were already reported (ASCO ’05)
Main Eligibility Criteria • Potentially resectable liver metastases of CRC (metachronous or synchronous) • No extra-hepatic disease • No previous chemotherapy with oxaliplatin • Informed consent
Chemotherapy Regimen LV5FU2 + Oxaliplatin 1 Cycle: 15 Days
Patient Population • Age: median 62.5 y (range: 25-79) • 1-3 liver metastases on CT-scan: 92.3% • < 2yrs between diagnosis of primary cancer and diagnosis of liver mets: 74.7% • T0-2: 17.6%, T3-4: 80.8%, Tx: 1.6% • N0: 42%, N1: 37.4%, N2: 18.4%, Nx: 2.2%
Largest diameter of the largest lesion on imaging
Change in the SUM of the largest diameter of the lesions * Change in the SUM of largest of lesions (mm)
Response to Chemotherapy (RECIST) • Complete response: 6 (3.3%) • Partial response: 64 (35.2%) • Stable disease: 61 (33.5%) • Progressive disease: 14 (7.7%) • Not available: 37 (20.3%) 182
Conclusions 1. CT-scan measurements were consistent with the measurements performed at pathological examination 2. Pre-op CT with 6 cycles of FOLFOX4 decreased the diameter of lesions 3. Since size of metastases at the time of surgery is a known prognostic factor for survival, there is hope that pre-op FOLFOX4 may improve survival 4. The trial results regarding progression-free and overall survival will become available at the end of 2006