Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: LBA5
© 2007 American Society of Clinical Oncology

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Abstract

Final results of the EORTC Intergroup randomized phase III study 40983 [EPOC] evaluating the benefit of peri-operative FOLFOX4 chemotherapy for patients with potentially resectable colorectal cancer liver metastases

Hopital Ambroise Pare, Boulogne Cedex, France; Haukeland Hospital - University of Bergen, Bergen, Norway; EORTC Data Center, Brussels, Belgium; Akademiska Sjukhuset, Uppsala, Sweden; Royal Liverpool University Hospital, Liverpool, United Kingdom; Robert- Roessle-Klinik, Humboldt Universitaet, Berlin, Germany; Centre Hospitalier Universitaire Ambroise Paré, Boulogne-Billancourt, France; Klinikum der J.W. Goethe Universitaet, Frankfurt am Main, Germany; Princess Alexandra Hospital - University Of Queens, Woolloongabba, Brisbane, Australia; Allgemeines Krankenhaus der Stadt Wien, Vienna, Austria

LBA5

Background: The 5-year survival after resection of colorectal cancer liver metastases is 30% but recurrence is common. This study evaluates the benefit of combining peri-operative chemotherapy and surgery for patients with initially resectable liver only metastases from colorectal cancer (LM). Methods: Between September 2000 and July 2004, 364 pts with up to 4 LM were randomized between peri-operative FOLFOX4 (oxaliplatin 85mg/m² and LV5FU2), 6 cycles before and 6 cycles after surgery, (CT), and surgery alone (S). The primary endpoint was progression free survival (PFS) with the goal to increase median PFS by 40% (HR=0.71). Safety was a secondary endpoint (already reported at ASCO 2005). PFS results are reported at the 2-sided 0.0434 significance level (adjusting for one interim analysis). Results: Baseline characteristics were similar in both arms. Eleven of 182 pts were ineligible in each arm, mostly for more advanced disease. In the CT arm, a median of 6 pre-op cycles were delivered and 151 patients were resected. 115 pts (63%) received post-op CT, with a median number of 6 cycles and a relative dose intensity of 79% to 86%. In the S arm, 152 pts were resected. Due to the nature of the trial, evaluation of resectability (relevant for eligibility) was based on pre-op imaging, but 31/182 pts (CT arm) and 30/182 pt (S arm) could not undergo resection. There were 2 (S arm) and 1 (CT arm) deaths after surgery. At a median follow-up of 3.9 years, 254 PFS events were reported (240 in eligible pts) and the results are as shown in the table. Conclusions: Peri-operative FOLFOX4 chemotherapy improved PFS over surgery alone in patients whose metastases were actually resected. The benefit was slightly diluted when also pts considered resectable on imaging but eventually not resected were taken into account. FOLFOX4 given peri-operatively is safe and does not prevent the pts from undergoing surgery.

Abstract presentation from the 2007 ASCO Annual Meeting