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Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): Long-term survival results of a randomized phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC).
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2015
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Surgical OncologySurgeryCt ArmRadiation MedicineOncologyRadiofrequency AblationGastrointestinal OncologyHepatobiliary TumorClinical Radiation OncologyCrc LmRadiation OncologyCancer ResearchMolecular OncologyRadiologyHealth SciencesRadiation TherapyLong-term Survival ResultsRfa+ct ArmCancer TreatmentLocal Tumor DestructionHepatologyLiver CancerMedicine
3501 Background: This study evaluates the benefit of combining systemic chemotherapy (CT) with local tumor destruction by RFA in patients with unresectable CRC LM up to 9 lesions and without extrahepatic disease. Overall survival (OS) at 30 months and progression free survival (PFS) results were reported (Ann Oncol. 23(10): 2619-26, 2012). We now report on OS results, after a long term median follow-up of 9.7 years. Methods: Between 2002 and 2007, 119 pts were randomized between CT alone (59) or RFA+CT (60). In both arms, CT consisted of 6 months FOLFOX (oxaliplatin 85mg/m2 and LV5FU2) plus, since October 2005, bevacizumab. In the CT arm resection was allowed when unresectable disease was converted by CT to resectable disease. Primary objective was a 30-months OS rate > 38% for the combined treatment group. OS and PFS were secondary endpoints. Results: In the RFA+CT arm, 56 pts (93.3%) received RFA which was combined with resection in 27 pts (45%), 1 pt had all metastases resected (ineligible), 2 pts were not treated at all, in 1 pt no local treatment data were available. 51 patients (85%) in the RFA+CT arm received CT compared to all 59 in the CT arm. 6 pts in the CT arm eventually underwent hepatic resection. The primary endpoint was met, 30-months OS rate was 61.7% (95% CI: 48.2-73.9) for combined treatment. However, 30-month OS for systemic treatment only was 57.6% (95% CI: 44.1-70.4), higher than anticipated. At a median follow-up of 9.7 years, 92 deaths were reported, 53 in the CT arm and 39 in the RFA+CT arm. Causes of death in the CT arm were progressive disease (49 pts), and unknown for 4 pts, and in the RFA+CT arm, progressive disease (35 pts), other causes (2 pts) and unknown (2 pts). There was a significant difference in OS in favor of the RFA+CT arm (HR = 0.58, 95% CI: 0.38-0.88, p = 0.01). Observed median OS was 45.6 months (95% CI: 30.3 – 67.8) in the RFA+CT arm vs. 40.5 months (95% CI: 27.5 - 47.7) in the CT arm. Conclusions: This is the first study that prospectively investigated the efficacy of RFA +CT in pts with unresectable CRC LM. In this phase II trial, RFA+CT was associated with improved long-term OS compared to CT alone. Clinical trial information: NCT00043004.