Adjuvant Hepatic Intra-arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Trial
Background The purpose of the present study was to determine whether intrahepatic injection of 131 I-lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC). Methods From June 2001 through March 2007, this nationwide multi-center prospective randomiz...
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| Published in: | World journal of surgery Vol. 37; no. 6; pp. 1356 - 1361 |
|---|---|
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
New York
Springer-Verlag
01-06-2013
Springer‐Verlag Springer Nature B.V |
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| Abstract | Background
The purpose of the present study was to determine whether intrahepatic injection of
131
I-lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC).
Methods
From June 2001 through March 2007, this nationwide multi-center prospective randomized controlled trial enrolled 103 patients 4–6 weeks after curative resection of HCC with complete recovery (52: Lipiodol, 51: Control). Follow-up was every 3 months for 1 year, then every 6 months. Primary and secondary endpoints were recurrence-free survival (RFS) and overall survival (OS), respectively, both of which were evaluated by the Kaplan–Meier technique and summarized by the hazard ratio (HR). The design was based on information obtained from a similar trial that had been conducted in Hong Kong.
Results
The Lipiodol group showed a small, and nonsignificant, improvement over control in RFS (HR = 0.75; 95 % confidence interval [95 % CI] 0.46–1.23;
p
= 0.25) and OS (HR = 0.88; 95 % CI 0.51–1.51;
p
= 0.64). Only two serious adverse events were reported, both with hypothyroidism caused by
131
I-lipiodol and hepatic artery dissection during angiography.
Conclusions
The randomized trial provides insufficient evidence to recommend the routine use of
131
I-lipiodol in these patients. |
|---|---|
| AbstractList | Background
The purpose of the present study was to determine whether intrahepatic injection of 131I‐lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC).
Methods
From June 2001 through March 2007, this nationwide multi‐center prospective randomized controlled trial enrolled 103 patients 4–6 weeks after curative resection of HCC with complete recovery (52: Lipiodol, 51: Control). Follow‐up was every 3 months for 1 year, then every 6 months. Primary and secondary endpoints were recurrence‐free survival (RFS) and overall survival (OS), respectively, both of which were evaluated by the Kaplan–Meier technique and summarized by the hazard ratio (HR). The design was based on information obtained from a similar trial that had been conducted in Hong Kong.
Results
The Lipiodol group showed a small, and nonsignificant, improvement over control in RFS (HR = 0.75; 95 % confidence interval [95 % CI] 0.46–1.23; p = 0.25) and OS (HR = 0.88; 95 % CI 0.51–1.51; p = 0.64). Only two serious adverse events were reported, both with hypothyroidism caused by 131I‐lipiodol and hepatic artery dissection during angiography.
Conclusions
The randomized trial provides insufficient evidence to recommend the routine use of 131I‐lipiodol in these patients. The purpose of the present study was to determine whether intrahepatic injection of ^sup 131^I-lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC). From June 2001 through March 2007, this nationwide multi-center prospective randomized controlled trial enrolled 103 patients 4-6 weeks after curative resection of HCC with complete recovery (52: Lipiodol, 51: Control). Follow-up was every 3 months for 1 year, then every 6 months. Primary and secondary endpoints were recurrence-free survival (RFS) and overall survival (OS), respectively, both of which were evaluated by the Kaplan-Meier technique and summarized by the hazard ratio (HR). The design was based on information obtained from a similar trial that had been conducted in Hong Kong. The Lipiodol group showed a small, and nonsignificant, improvement over control in RFS (HR = 0.75; 95 % confidence interval [95 % CI] 0.46-1.23; p = 0.25) and OS (HR = 0.88; 95 % CI 0.51-1.51; p = 0.64). Only two serious adverse events were reported, both with hypothyroidism caused by ^sup 131^I-lipiodol and hepatic artery dissection during angiography. The randomized trial provides insufficient evidence to recommend the routine use of ^sup 131^I-lipiodol in these patients.[PUBLICATION ABSTRACT] BACKGROUNDThe purpose of the present study was to determine whether intrahepatic injection of (131)I-lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC). METHODSFrom June 2001 through March 2007, this nationwide multi-center prospective randomized controlled trial enrolled 103 patients 4-6 weeks after curative resection of HCC with complete recovery (52: Lipiodol, 51: Control). Follow-up was every 3 months for 1 year, then every 6 months. Primary and secondary endpoints were recurrence-free survival (RFS) and overall survival (OS), respectively, both of which were evaluated by the Kaplan-Meier technique and summarized by the hazard ratio (HR). The design was based on information obtained from a similar trial that had been conducted in Hong Kong. RESULTSThe Lipiodol group showed a small, and nonsignificant, improvement over control in RFS (HR = 0.75; 95 % confidence interval [95 % CI] 0.46-1.23; p = 0.25) and OS (HR = 0.88; 95 % CI 0.51-1.51; p = 0.64). Only two serious adverse events were reported, both with hypothyroidism caused by (131)I-lipiodol and hepatic artery dissection during angiography. CONCLUSIONSThe randomized trial provides insufficient evidence to recommend the routine use of (131)I-lipiodol in these patients. Abstract Background The purpose of the present study was to determine whether intrahepatic injection of 131 I‐lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC). Methods From June 2001 through March 2007, this nationwide multi‐center prospective randomized controlled trial enrolled 103 patients 4–6 weeks after curative resection of HCC with complete recovery (52: Lipiodol, 51: Control). Follow‐up was every 3 months for 1 year, then every 6 months. Primary and secondary endpoints were recurrence‐free survival (RFS) and overall survival (OS), respectively, both of which were evaluated by the Kaplan–Meier technique and summarized by the hazard ratio (HR). The design was based on information obtained from a similar trial that had been conducted in Hong Kong. Results The Lipiodol group showed a small, and nonsignificant, improvement over control in RFS (HR = 0.75; 95 % confidence interval [95 % CI] 0.46–1.23; p = 0.25) and OS (HR = 0.88; 95 % CI 0.51–1.51; p = 0.64). Only two serious adverse events were reported, both with hypothyroidism caused by 131 I‐lipiodol and hepatic artery dissection during angiography. Conclusions The randomized trial provides insufficient evidence to recommend the routine use of 131 I‐lipiodol in these patients. The purpose of the present study was to determine whether intrahepatic injection of (131)I-lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC). From June 2001 through March 2007, this nationwide multi-center prospective randomized controlled trial enrolled 103 patients 4-6 weeks after curative resection of HCC with complete recovery (52: Lipiodol, 51: Control). Follow-up was every 3 months for 1 year, then every 6 months. Primary and secondary endpoints were recurrence-free survival (RFS) and overall survival (OS), respectively, both of which were evaluated by the Kaplan-Meier technique and summarized by the hazard ratio (HR). The design was based on information obtained from a similar trial that had been conducted in Hong Kong. The Lipiodol group showed a small, and nonsignificant, improvement over control in RFS (HR = 0.75; 95 % confidence interval [95 % CI] 0.46-1.23; p = 0.25) and OS (HR = 0.88; 95 % CI 0.51-1.51; p = 0.64). Only two serious adverse events were reported, both with hypothyroidism caused by (131)I-lipiodol and hepatic artery dissection during angiography. The randomized trial provides insufficient evidence to recommend the routine use of (131)I-lipiodol in these patients. Background The purpose of the present study was to determine whether intrahepatic injection of 131 I-lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC). Methods From June 2001 through March 2007, this nationwide multi-center prospective randomized controlled trial enrolled 103 patients 4–6 weeks after curative resection of HCC with complete recovery (52: Lipiodol, 51: Control). Follow-up was every 3 months for 1 year, then every 6 months. Primary and secondary endpoints were recurrence-free survival (RFS) and overall survival (OS), respectively, both of which were evaluated by the Kaplan–Meier technique and summarized by the hazard ratio (HR). The design was based on information obtained from a similar trial that had been conducted in Hong Kong. Results The Lipiodol group showed a small, and nonsignificant, improvement over control in RFS (HR = 0.75; 95 % confidence interval [95 % CI] 0.46–1.23; p = 0.25) and OS (HR = 0.88; 95 % CI 0.51–1.51; p = 0.64). Only two serious adverse events were reported, both with hypothyroidism caused by 131 I-lipiodol and hepatic artery dissection during angiography. Conclusions The randomized trial provides insufficient evidence to recommend the routine use of 131 I-lipiodol in these patients. |
| Author | Tan, S. B. Sundram, F. X. Soo, K. C. Liau, K. H. Ooi, L. L. P. J. Tan, Y. M. Yu, S. W. K. Chew, S. P. Ho, C. K. Goh, B. K. P. Machin, D. Chung, A. Y. F. Thng, C. H. Lo, R. H. G. Chen, Y. M. Li, P. C. N. Cheow, P. C. Wong, J. S. Chow, P. K. H. Gandhi, M. Tan, B. S. Htoo, A. M. M. Tay, K. H. Goh, A. S. W. |
| Author_xml | – sequence: 1 givenname: A. Y. F. surname: Chung fullname: Chung, A. Y. F. email: gsucyf@sgh.com.sg, alexander.chung.y.f@sgh.com.sg organization: General Surgery, Singapore General Hospital – sequence: 2 givenname: L. L. P. J. surname: Ooi fullname: Ooi, L. L. P. J. organization: Surgical Oncology, National Cancer Centre Singapore – sequence: 3 givenname: D. surname: Machin fullname: Machin, D. organization: Singapore Clinical Research Institute – sequence: 4 givenname: S. B. surname: Tan fullname: Tan, S. B. organization: Singapore Clinical Research Institute, Duke-NUS Graduate Medical School – sequence: 5 givenname: B. K. P. surname: Goh fullname: Goh, B. K. P. organization: General Surgery, Singapore General Hospital – sequence: 6 givenname: J. S. surname: Wong fullname: Wong, J. S. organization: General Surgery, Singapore General Hospital – sequence: 7 givenname: Y. M. surname: Chen fullname: Chen, Y. M. organization: Singapore Clinical Research Institute – sequence: 8 givenname: P. C. N. surname: Li fullname: Li, P. C. N. organization: Singapore Clinical Research Institute – sequence: 9 givenname: M. surname: Gandhi fullname: Gandhi, M. organization: Singapore Clinical Research Institute, Duke-NUS Graduate Medical School – sequence: 10 givenname: C. H. surname: Thng fullname: Thng, C. H. organization: Oncologic Imaging, National Cancer Centre Singapore – sequence: 11 givenname: S. W. K. surname: Yu fullname: Yu, S. W. K. organization: Nuclear Medicine, Singapore General Hospital – sequence: 12 givenname: B. S. surname: Tan fullname: Tan, B. S. organization: Diagnostic Radiology, Singapore General Hospital – sequence: 13 givenname: R. H. G. surname: Lo fullname: Lo, R. H. G. organization: Diagnostic Radiology, Singapore General Hospital – sequence: 14 givenname: A. M. M. surname: Htoo fullname: Htoo, A. M. M. organization: Diagnostic Radiology, Singapore General Hospital – sequence: 15 givenname: K. H. surname: Tay fullname: Tay, K. H. organization: Diagnostic Radiology, Singapore General Hospital – sequence: 16 givenname: F. X. surname: Sundram fullname: Sundram, F. X. organization: Nuclear Medicine, Singapore General Hospital – sequence: 17 givenname: A. S. W. surname: Goh fullname: Goh, A. S. W. organization: Nuclear Medicine, Singapore General Hospital – sequence: 18 givenname: S. P. surname: Chew fullname: Chew, S. P. organization: General Surgery, Tan Tock Seng Hospital – sequence: 19 givenname: K. H. surname: Liau fullname: Liau, K. H. organization: General Surgery, Tan Tock Seng Hospital – sequence: 20 givenname: P. K. H. surname: Chow fullname: Chow, P. K. H. organization: General Surgery, Singapore General Hospital – sequence: 21 givenname: K. H. surname: Tay fullname: Tay, K. H. organization: General Surgery, Changi General Hospital – sequence: 22 givenname: Y. M. surname: Tan fullname: Tan, Y. M. organization: Surgical Oncology, National Cancer Centre Singapore – sequence: 23 givenname: P. C. surname: Cheow fullname: Cheow, P. C. organization: General Surgery, Singapore General Hospital – sequence: 24 givenname: C. K. surname: Ho fullname: Ho, C. K. organization: General Surgery, Tan Tock Seng Hospital – sequence: 25 givenname: K. C. surname: Soo fullname: Soo, K. C. organization: Surgical Oncology, National Cancer Centre Singapore |
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| Copyright | Société Internationale de Chirurgie 2013 2013 The Author(s) under exclusive licence to Société Internationale de Chirurgie |
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| References_xml | – volume: 353 start-page: 797 year: 1999 end-page: 801 article-title: Adjuvant intra‐arterial lipiodol‐iodine‐131 for resectable hepatocellular carcinoma: a prospective randomized trial publication-title: Lancet – start-page: CD001199 year: 2009 – volume: 141 start-page: 330 year: 2007 end-page: 339 article-title: Recurrence after liver resection for hepatocellular carcinoma: risk factors, treatment, and outcomes publication-title: Surgery – volume: 47 start-page: 389 year: 2002 end-page: 399 article-title: Management of hepatocellular carcinoma publication-title: J R Coll Surg Edinb – year: 2002 – volume: 38 start-page: 1237 year: 2003 end-page: 1241 article-title: Adjuvant intra‐arterial injection of iodine‐131‐labeled lipiodol after resection of hepatocellular carcinoma publication-title: Hepatology – volume: 29 start-page: 1038 year: 1988 end-page: 1044 article-title: Dosimetry of iodine‐131 ethiodol in the treatment of hepatoma publication-title: J Nucl Med – volume: 204 start-page: 1 year: 2007 end-page: 6 article-title: Outcomes and recurrence of initially resectable hepatocellular carcinoma meeting Milan criteria: rationale for partial hepatectomy as first strategy publication-title: J Am Coll Surg – volume: 3 start-page: 593 year: 2002 end-page: 603 article-title: Neoadjuvant and adjuvant therapy for resectable hepatocellular carcinoma: review of the randomized trials publication-title: Lancet Oncol – year: 1997 – volume: 353 start-page: 943 year: 1999 end-page: 944 article-title: Trials stopped early: too good to be true? 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| Snippet | Background
The purpose of the present study was to determine whether intrahepatic injection of
131
I-lipiodol (Lipiodol) is effective against recurrence of... Background The purpose of the present study was to determine whether intrahepatic injection of 131I‐lipiodol (Lipiodol) is effective against recurrence of... The purpose of the present study was to determine whether intrahepatic injection of (131)I-lipiodol (Lipiodol) is effective against recurrence of surgically... Abstract Background The purpose of the present study was to determine whether intrahepatic injection of 131 I‐lipiodol (Lipiodol) is effective against... The purpose of the present study was to determine whether intrahepatic injection of ^sup 131^I-lipiodol (Lipiodol) is effective against recurrence of... BACKGROUNDThe purpose of the present study was to determine whether intrahepatic injection of (131)I-lipiodol (Lipiodol) is effective against recurrence of... |
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| SubjectTerms | Abdominal Surgery Aged Antineoplastic Agents - therapeutic use Carcinoma, Hepatocellular - drug therapy Carcinoma, Hepatocellular - surgery Cardiac Surgery Chemotherapy, Adjuvant Ethiodized Oil - therapeutic use Female Focal Nodular Hyperplasia General Surgery Health Science Authority Humans Injections, Intra-Arterial Iodine Radioisotopes - therapeutic use Liver Neoplasms - drug therapy Liver Neoplasms - surgery Male Medicine Medicine & Public Health Middle Aged Overall Survival Prospective Studies Surgery Survival Rate Thoracic Surgery Transarterial Chemoembolization Treatment Outcome Vascular Invasion Vascular Surgery |
| Title | Adjuvant Hepatic Intra-arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Trial |
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