Abstract | OBJECTIVE: In this prospective randomized trial, we attempted to find out if 1 dose of postoperative adjuvant intra-arterial iodine-131-labeled lipiodol could reduce the rate of local recurrence, and increase disease-free and overall survival for patients with hepatocellular carcinoma (HCC). This study evaluated the long-term outcome. BACKGROUND: Resection of HCC is potentially curative, but local recurrence is common. However, there is currently no effective adjuvant therapy. Early results after closing the trial (Lau et al. Lancet 1999;353:797-801) showed that 1 dose of intra-arterial I- lipiodol given after curative resection significantly decreased the rate of recurrence, and increased disease-free and overall survival. METHODS: Patients who underwent curative resection for HCC and recovered within 6 weeks were randomly assigned one 1850 MBq dose of I- lipiodol or no further treatment (controls). We compared rates of recurrence, and long-term disease-free and overall survival (the primary endpoints) between the 2 groups by intention-to-treat. RESULTS: Between April 1992 and August 1997, we recruited 43 patients: 21 were randomized to receive intra-arterial I- lipiodol and 22 to receive no adjuvant treatment. I- lipiodol had no significant toxic effects. During a median follow-up of 66 (range, 3-198) months, there were 10 (47.6%) recurrences among the 21 patients in the adjuvant treatment group, compared with 14 (63.6%) in the control group (P = 0.29). The actuarial 5-year disease-free survival in the treatment and control groups was 61.9% and 31.8%, respectively (P = 0.0397). The actuarial 5-year overall survival in the treatment and control groups was 66.7% and 36.4%, respectively (P = 0.0433). The actuarial 7-year disease-free survival in the treatment and control groups was 52.4% and 31.8%, respectively (P = 0.0224). The actuarial 7-year overall survival in the treatment and control groups was 66.7% and 31.8%, respectively (P = 0.0243). The actuarial 10-year disease-free survival in the treatment and control groups was 47.6% and 27.3%, respectively (P = 0.0892). The actuarial 10-year overall survival in the treatment and control groups was 52.4% and 27.3%, respectively (P = 0.0905). CONCLUSIONS: In patients with HCC, adjuvant intra-arterial I- lipiodol after curative liver resection provided survival benefit on the disease-free survival and overall survival, although the difference became statistically insignificant at 8 years after randomization.
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Authors | Wan Yee Lau, Eric C H Lai, Thomas W T Leung, Simon C H Yu |
Journal | Annals of surgery
(Ann Surg)
Vol. 247
Issue 1
Pg. 43-8
(Jan 2008)
ISSN: 0003-4932 [Print] United States |
PMID | 18156922
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Iodine Radioisotopes
- Iodized Oil
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Topics |
- Adult
- Aged
- Carcinoma, Hepatocellular
(radiotherapy, surgery)
- Chi-Square Distribution
- Combined Modality Therapy
- Disease-Free Survival
- Female
- Follow-Up Studies
- Humans
- Injections, Intra-Arterial
- Iodine Radioisotopes
(administration & dosage, therapeutic use)
- Iodized Oil
(administration & dosage, therapeutic use)
- Liver Neoplasms
- Male
- Middle Aged
- Neoplasm Recurrence, Local
- Prospective Studies
- Radiotherapy, Adjuvant
- Statistics, Nonparametric
- Survival Analysis
- Treatment Outcome
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