Article
Combination of radiofrequency (RF) ablation and systemic chemotherapy for colorectal liver metastases: A prospective phase II study
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Published: | March 20, 2006 |
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Background: More than 25% of patients (pts) with colorectal cancer (CRC) develop liver metastases without extrahepatic spread. For these pts surgery is the mainstay of treatment; however, not every pt is 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 liver metastases of CRC origin.
Methods: Pts with a maximum of 5 inoperable liver metastases up to a maximal size of 5 cm without extrahepatic spread or not life threatening extrahepatic disease were prospectively included in this study. The treatment protocol consisted of 12 cycles of FOLFOX-4 (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, qd15). Percutaneous RFA with internally cooled electrodes (Cool Tip, Valleylab, Boulder, Co) controlled by simultaneous CT or MRI guidance of all accessible metastases was performed after completion of 4 cycles and repeated if required. Follow-up investigations including CT/MRI imaging were repeated after every 4th cycle, and every 3rd month after end of treatment.
Results: Eighteen pts have entered the trial. Pts´ characteristics: m/f, 13/5; median age, 63 yrs (range, 44 – 78); primary tumor, colon/rectum 9/9. Five pts were diagnosed with synchronous and 13 pts with metachronous metastases with a median interval of 12 mos (range, 3 – 41). AJCC classification at initial diagnosis: stage II/III/IV, 6/7/5. Median no. of metastases: 3 (range, 1 – 5), median size 15mm (range 6 - 46 mm). Only one pt died due to progressive disease. 17 of 18 pts are still alive after a median follow-up of 17.5+ mos (range, 4 – 48+). WHO Grade 4 leucocytopenia occurred in 1 pt; WHO grade 3 toxicity: diarrhoea 2 pts, infection 2 pts (one pts with a local infection of the RFA-region), peripheral NP 1 pt, pain 1 pt. In 15 of the 16 pts, who have completed the protocol, a complete remission (CR) was achieved lasting 11 + mos (range 3 – 44).
Conclusions: In a well defined subgroup of pts with isolated, inoperable, hepatic metastases of CRC the combination of RFA and systemic chemotherapy is a feasible approach associated with a low toxicity profile and complication rate. With the combined approach a high local and systemic control rate was achieved and it should be further evaluated compared to surgical resection.