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.
RCT Entities:
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.
Authors: Celina Ang; Ali K Abu-Alfa; Khalid Abdullah; Maeve Lowery; Hassan Sibai; Hassan El Farran; Sally Tamraz; Ashwaq Al Olayan; Ali Shamseddine; Mohamed Naghy; Walid Faraj; Eileen M O'Reilly; Ghassan K Abou-Alfa Journal: Gastrointest Cancer Res Date: 2011-09