Tumor response to pre-operative chemotherapy (CT) with FOLFOX-4 for resectable colorectal cancer liv...
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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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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,

  • 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

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

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

Main Eligibility Criteria

  • Potentially resectable liver metastases of

    CRC (metachronous or synchronous)

  • No extra-hepatic disease

  • No previous chemotherapy with

    oxaliplatin

  • Informed consent


Study design

Study Design


T gruenberger h sorbye m debois u bethe j primrose

Chemotherapy Regimen

LV5FU2 + Oxaliplatin 1 Cycle: 15 Days


Patient population

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%


Chemotherapy

Chemotherapy


T gruenberger h sorbye m debois u bethe j primrose

Largest diameter of the largest lesion

on imaging


T gruenberger h sorbye m debois u bethe j primrose

Change in the largest diameter of the largest lesion


T gruenberger h sorbye m debois u bethe j primrose

Change in the SUM of the largest diameter of the lesions

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


T gruenberger h sorbye m debois u bethe j primrose

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


T gruenberger h sorbye m debois u bethe j primrose

Surgery


T gruenberger h sorbye m debois u bethe j primrose

Pathology


Conclusions

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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