Radiofrequency Ablation Combined with Hepatic Arterial Chemoembolization Using Degradable Starch Microsphere Mixed with Mitomycin C for the Treatment of Liver Metastasis from Colorectal Cancer: A Prospective Multicenter Study
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This phase II prospective study investigates possible benefits of radiofrequency ablation (RFA) combined with hepatic arterial chemoembolization using degradable starch microsphere (DSM) mixed with mitomycin C (MMC) in non-surgical candidates with colorectal liver metastases.
Materials and Methods
This study, approved by the respective institutional review board, included non-surgical candidates with 3 or fewer liver tumors of 3 cm or smaller, or a single lesion 5 cm or smaller. Percutaneous RFA was performed immediately after chemoembolization using DSM-MMC. Primary and secondary endpoints were the local tumor control rate, safety, and 2-year recurrence-free and overall survival rates.
This study examined 25 patients (22 males, 3 females) with 38 tumors of mean maximum diameter of 2.2 ± 0.9 cm (standard deviation) (range 1.0–4.2 cm). Their mean age was 70.2 ± 8.2 years (range 55–82 years). Local tumor progression developed in 3 tumors (7.9%, 3/38) of 3 patients (12%, 3/25) during the mean follow-up of 34.9 ± 9.2 months (range 18.3–50.1 months). The 2-year local tumor control rates were 92.0% [95% confidence interval (CI), 81.4–100%] on a patient basis and 94.6% (95% CI, 87.3–100%) on a tumor basis. The respective 2-year overall and recurrence-free survival rates were 88.0% (95% CI, 75.3–98.5%) and 63.3% (95% CI, 44.2–82.5%), with median survival time of 48.4 months. Fever was the only adverse event requiring treatments in 2 patients (8%).
This combination therapy is safe, exhibiting strong anticancer effects on colorectal liver metastasis, which might contribute to patient survival.
KeywordsColorectal cancer Liver metastasis Radiofrequency ablation Chemoembolization Local recurrence
Funding was provided by Japan Society for the Promotion of Science (Grant No. 25461876).
Compliance with Ethical Standards
Conflict of interest
This study has been approved by the institutional review board of each institution where patients were enrolled in this clinical trial.
Informed consent was obtained from all individual participants included in the study.
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