Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 3524
© 2006 American Society of Clinical Oncology

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Abstract

Adjuvant chemotherapy after potentially curative resection of metastases from colorectal cancer. A meta-analysis of two randomized trials

University Hospital Ambroise Pare, Boulogne, France; Cross Cancer Institute, Edmonton, AB, Canada; Institut Jules Bordet, Brussels, Belgium; Ospedali Riuniti, Bergamo, Italy; University Hospital Purpan, Toulouse, France; National Cancer Institute Canada Clinical Trials Group— Queen’s University, Kingston, ON, Canada; Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy; University Hospital Gasthuisberg, Leuven, Belgium

3524

Background: Adjuvant systemic chemotherapy (CT) administered after resection of colorectal cancer (CRC) metastases (M) may reduce the risk of recurrence and improved survival but its benefit has never been demonstrated. Two phase III trials (FFCD 9002 and EORTC/NCIC CTG/GIVIO (ENG) trials) with a very similar design showed a trend for improvement in survival after adjuvant CT but had to close prematurely because of slow accrual, lacking the statistical power to demonstrate any significant difference in survival. We report here a pooled analysis based on individual data from these trials. Methods: Patients were required to have a WHO performance status 2 and a histologically proven CRC with a complete (R0) surgical resection of the primary tumour and of 4 liver or lung metastases. They were randomized between chemotherapy (CT arm) [5FU 400 mg/m² (FFCD) or 370 mg/m² (ENG) IV q.d. x 5 days plus dl-leucovorin 200 mg/m² (FFCD) or l-leucovorin 100 mg/m² (ENG) IV q.d. x 5 days, 6 cycles at 28 days intervals] or surgery alone (S arm). Results: 129 pts were included in the ENG trial between 1994 and 1998, 173 in the FFCD trial between 1991 and 2001. 24 pts (ENG: 22, FFCD: 2) were excluded from analysis for missing post-baseline data: 278 pts were included in the present analysis (CT: 138, S: 140). Patients’ characteristics by treatment arm (% CT/S): males 58.0/63.6, age <70 years: 79.7/79.3, stage IV primary tumor: 29.0/47.1 (p=0.02), liver M 94.2/93.6, 2 M resected: 33.3/31.4. Conclusion: Adjuvant CT with a 5FU bolus based regimen tends to improve survival after complete resection of CRC metastases. The observed improvement in median PFS was almost statistically significant whereas the improvement in median OS (more than 1 year) was not (lack of statistical power?). This pooled analysis supports the use of adjuvant CT, with a more effective regimen, after potentially curative resection of CRC metastases. Updated results will be presented. (Supported by AROLD)

Abstract presentation from the 2006 ASCO Annual Meeting