RF IMPROVES PFS IN COLORECTAL CANCER PATIENTS

Radiofrequency ablation with chemotherapy is safe and improves progression free survival in patients with unresectable colorectal cancer liver metastases

03.07.09

Category: Scientific News

Highlights of the ESMO Conference: 11th World Gastrointestinal Cancer Congress

The addition of radiofrequency ablation (RFA) to chemotherapy prolongs progression-free survival (PFS) and decreases local disease recurrence according to study results presented by Theo J. Ruers MD, of the Netherlands Cancer Institute in Amsterdam, The Netherlands, who headed an European Organization for Research and Treatment of Cancer (EORTC) study team that demonstrated the benefit of adding to chemotherapy in patients with unresectable colorectal cancer (CRC) liver metastases. Unresectable tumors were defined as those having no surrounding disease-free margin.
The primary endpoint was overall survival (OS) at 30 months and secondary endpoints included safety, OS and PFS.

Patients (n=119) with CRC liver metastasis and a maximum of 9 lesions and without extrahepatic disease were randomized to receive 6 months of FOLFOX plus, since October 2005, bevacizumab (n=59) or RFA plus the same chemotherapy regimen (n=60).

Baseline characteristics of the patients were similar in both groups; 60% of the patients had 4 liver metastases. In the RFA+chemotherapy arm, 30 patients (52.6%) received only RFA and in 27 patients (47.4%) RFA was combined with resection. Chemotherapy was administered to 51 patients (85%) in the RFA+chemotherapy arm. All 59 patients in the chemotherapy arm received a median number of 10 cycles of FOLFOX. The authors clarified that patients could be considered unresectable after undergoing surgical resection when there were remaining tumors that were unresectable.

The chemotherapy toxicity profiles were comparable between both arms and consistent with that seen in previous trials. Post-operative complications were observed in 10 patients who received RFA (33%) and in 9 patients (33%) who underwent RFA plus resection. Complications observed in patients were cardiac arrest (3) hemorrhage (2) and infection (6); 3 patients required re-operation. One patient died after surgery

At one year the PFS in the chemotherapy group was 39.35% compared to 60.06% in the RFA+chemotherapy arm (P=0.0267). At the interim analysis, the median PFS duration was 10 moths and 16.8 months in the chemotherapy and RFA+chemotherapy arms, respectively. Five patients had local recurrence at the RFA site and 10% of the tumors converted to being resectable. The 30 month time point has not yet been reached and the final analysis will be completed at that time.

The investigators concluded that this study demonstrates that a regimen of RFA combined with chemotherapy is safe, improves PFS and has a superior clinical benefit over FOLFOX treatment in patients with unresectable CRC liver metastases.