Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): Interim results of a randomised phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC)

Abstract

4012 Background: In patients with a limited number of unresectable CRC LM there is an increasing tendency to combine systemic chemotherapy (CT) with local tumour destruction by RFA. However, the benefit of this combined treatment has not been proven. Methods: This study evaluated the addition of RFA to systemic CT in patients with unresectable CRC LM up to 9 lesions and without extrahepatic disease. Between April 2002 and June 2007, 119 pts were randomised between CT alone or CT plus RFA (alone or combined with surgical resection). In both arms, CT consisted of 6 months FOLFOX (oxaliplatin 85mg/m2 and LV5FU2) plus, since October 2005, bevacizumab. Primary endpoint was overall survival at 30 months. Safety and feasibility were secondary endpoints. Results: Treatment data are available for 101 of 113 patients recruited before 2007. Two of 56 allocated to CT never started treatment due to progression, while 7 of 57 allocated to RFA never started CT, three due to postoperative complications; toxicity data are available for 92 patients (45 RFA, 47 CT arm) having received at least one cycle of CT. Baseline characteristics were similar between arms: 60% had ≥ 4 LM. Twenty-four in each arm completed the full CT (53.3% RFA, 51.0% CT arm). CT was discontinued for toxicity and progression in 23% and 7.5% of patients in the RFA arm versus 16% and 17% in the CT arm. Toxicity profiles were identical between arms. Grade ≥ 3 haematological toxicity (ANC) was 24% in the RFA arm and 23% in the CT arm. Grade ≥ 3 diarrhoea, nausea, neurotoxicity and fatigue were reported in 18%, 13%, 20% and 11% of patients in the RFA arm and 15%, 11%, 11% and 0% in the CT arm, respectively. Complications after RFA were observed in 22% of patients: fever 11%, fatigue 6.6% and wound infection 4.4%. There was one post-operative death (2.2%). Conclusion: This is the first study that prospectively investigates the efficacy of RFA in combination with CT. Combined treatment of RFA plus CT was safely performed. Data on time to progression will become available in Spring 2008. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Boston Scientific, sanofi-aventis