Feasibility and risks of pre-operative chemotherapy (CT) with Folfox 4 and surgery for resectable colorectal cancer liver metastases (LM). Interim results of the EORTC Intergroup randomized phase III study 40983

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Abstract
3528 Background: After resection of LM, 5y survival is 30%, but cancer recurrence is frequent. The benefit of combining surgery and CT is not yet formally proven. Methods: This study evaluates pre- and postoperative CT. Between September 2000 and July 2004, 364 patients with potentially resectable liver metastases from colorectal cancer were randomized between peri-operative FOLFOX4 (oxaliplatin 85mg/m2 and LV5FU2), 6 cycles before and 6 cycles after surgery, and surgery alone. The primary endpoint was disease-free survival. Safety was a secondary end point. Results: We report the interim safety results of the first 346 patients with at least 3 months follow-up post surgery (174 patients in the CT arm and 172 in the surgery arm). Median follow up is 17 months. Baseline characteristics were similar in both arms. In the CT arm, 84.8% of the patients were documented to have completed CT (6 preoperative cycles). 28.2% of the patients who started CT required a dose reduction. Grade ≥3 diarrhea was reported in 6.7%, vomiting in 2.0% febrile neutropenia in 1.3% and grade 3 neurotoxicity in 4.7% of the patients. There was no toxic death. Surgery was performed within the timelines foreseen (median 114 days) in the CT arm. 92.5% and 96.7% of evaluated patients underwent surgery in the CT and surgery arm respectively. Surgical procedures were similar in both arms. Complete resection was achieved in 96.7% and 88.5% of operated patients in CT and surgery arms, respectively. Surgical complications (within 30 days of surgery) were observed in 24.5% and 13.3%, with 4.5% and 2.3% requiring reoperation, and deaths in 0.9% and 1.6% in the CT and surgery arms respectively. Most frequent surgical complications were: transient liver failure (6.4% and 1.6%), biliary fistula (5.5% and 1.6%), bleeding (2.7% and 2.3%), wound infection (2.7 and 3.1%), intra-abdominal infection (4.5% and 0.8%), and cardio-pulmonary failure (2.7% and 1.6%). Conclusions: Preoperative chemotherapy with FOLFOX4 was safely administered. Timing of surgery was respected. Surgical mortality and morbidity rates were low. Results on survival should be available in 2006.

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