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T. Gruenberger*, H. Sorbye, M. Debois, U. Bethe, J. Primrose,

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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T. Gruenberger*, H. Sorbye, M. Debois, U. Bethe, J. Primrose,

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  1. 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

  2. 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

  3. 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)

  4. Main Eligibility Criteria • Potentially resectable liver metastases of CRC (metachronous or synchronous) • No extra-hepatic disease • No previous chemotherapy with oxaliplatin • Informed consent

  5. Study Design

  6. Chemotherapy Regimen LV5FU2 + Oxaliplatin 1 Cycle: 15 Days

  7. 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%

  8. Chemotherapy

  9. Largest diameter of the largest lesion on imaging

  10. Change in the largest diameter of the largest lesion

  11. Change in the SUM of the largest diameter of the lesions * Change in the SUM of largest  of lesions (mm)

  12. 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

  13. Surgery

  14. Pathology

  15. 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

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