Phase II study of a combination of radiofrequency ablation (RFA) and systemic chemotherapy for patients with colorectal liver metastases.

3716 Background: More than 25% of patients (pts) with colorectal cancer (CRC) develop metastases confined to the liver (LM) without extra hepatic spread. In these pts surgery is the mainstay of treatment; however, not all pts are suitable for a surgical approach. This study has investigated the toxicity and efficacy of percutaneous RFA in combination with FOLFOX-4 chemotherapy in pts with inoperable LM of CRC.,Pts with a maximum of 5 non-resectable LM up to a maximal size < 5 cm without extra hepatic spread were allocated to 12 cycles of systemic chemotherapy with FOLFOX-4 (every 2 wks: oxaliplatin 85 mg/sqm IV, D 1; folinic acid 200 mg/sqm IV over 2h and 5-FU 400 mg/sqm IV bolus followed by 600 mg/sqm IV 22h-infusion, D 1 and 2). Percutaneous RFA with internally cooled electrodes (Cool Tip, Valleylab, Boulder, Co) controlled by simultaneous CT or MRI guidance was performed after completion of 4 cycles and repeated if required. Follow-up investigations including dynamic MRI have been done after every 4 cycles of FOLFOX-4, and every three month after stop of treatment.,Thirteen pts have prospectively entered the study. Pts' characteristics: m/f 9/4; median age 63 yrs (range, 44 - 78); primary tumor colon 9, rectum 4. Five pts were diagnosed with synchronous and 7 pts with metachronous LM with a median interval of 8 mos. AJCC classification at initial diagnosis: stage II/III/IV 4/4/5. Median no. of LM: 3 (range, 1 - 5), size range 7 - 48 mm. The median follow-up was 14.5 mos (range, 2 - 36). WHO Grade 4 leucocytopenia occurred in 1 pt; Grade 3 toxicity: diarrhoea 2 pts, infection 2 pts, peripheral NP 1 pt, pain 1 pt. Of the 12 pts, who have completed the protocol 8 pts achieved a complete remission (CR) lasting 9.5 mos (range, 2 - 32). 2 pts attained a partial remission and 1 pt had intrahepatic progressive disease.,In a well defined subgroup of pts with LM of CRC origin the combination of RFA and systemic chemotherapy is a feasible approach with a low toxicity and complication rate. This combination therapy can achieve complete responses without an operative approach. Median duration of remissions warrants further investigation of a combined treatment approach in controlled clinical trials. No significant financial relationships to disclose.