Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma.
cisplatin
hepatic arterial infusion chemotherapy
hepatocellular carcinoma
neoadjuvant therapy
radiofrequency ablation
Journal
Hepatology research : the official journal of the Japan Society of Hepatology
ISSN: 1386-6346
Titre abrégé: Hepatol Res
Pays: Netherlands
ID NLM: 9711801
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
revised:
24
02
2021
received:
29
01
2021
accepted:
27
02
2021
pubmed:
10
3
2021
medline:
10
3
2021
entrez:
9
3
2021
Statut:
ppublish
Résumé
Hepatic arterial infusion chemotherapy (HAIC) with cisplatin is beneficial to patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib. This study aimed to examine the effect of HAIC with cisplatin before radiofrequency ablation (RFA) in patients with HCC. This was a multicenter, single-blinded, randomized controlled study (UMIN000007267). Early-stage HCC patients were randomly assigned (1:1) to receive HAIC with cisplatin before RFA therapy (HAIC group) or RFA monotherapy (non-HAIC group). The primary end-point was recurrence-free survival. Efficacy analysis and safety analysis followed the intention-to-treat principle. Between August 2012 and July 2016, 74 patients were recruited. A total of 70 eligible patients were randomly assigned to the HAIC group (n = 35) and non-HAIC group (n = 35). Recurrence-free survival rates at 1 (3) year in the HAIC group and non-HAIC group were 82.9% (54.3%) and 74.3% (34.3%), respectively (hazard ratio [HR], 0.597; 95% confidence interval [CI], 0.320-1.091; p = 0.094]. Subgroup analysis showed that the beneficial effect of HAIC was observed in patients with a single nodule and Child-Pugh score 5. Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022). Adverse events were observed in just two patients in the HAIC group (6%) - grade 2 cholecystitis and grade 2 hyperkalemia. HAIC with cisplatin before RFA did not significantly decrease recurrence in patients with early-stage HCC. However, it might be effective in preventing intrahepatic distant recurrence.
Types de publication
Journal Article
Langues
eng
Pagination
694-701Subventions
Organisme : Nippon Kayaku Co. Ltd., Tokyo, Japan
Informations de copyright
© 2021 The Japan Society of Hepatology.
Références
Forner A , Reig M , Bruix J . Hepatocellular carcinoma. Lancet. 2018;391:1301-14.
Forner A , Vilana R , Ayuso C , Bianchi L , Solé M , Ayuso JR , et al. Diagnosis of hepatic nodules 20 mm or smaller in cirrhosis: prospective validation of the noninvasive diagnostic criteria for hepatocellular carcinoma. Hepatology. 2008;47:97-104.
Ogawa S , Kumada T , Toyoda H , Ichikawa H , Kawachi T , Otobe K , et al. Evaluation of pathological features of hepatocellular carcinoma by contrast-enhanced ultrasonography: comparison with pathology on resected specimen. Eur J Radiol. 2006;59:74-81.
Nouso K , Kobayashi Y , Nakamura S , Kobayashi S , Toshimori J , Kuwaki K , et al. Evolution of prognostic factors in hepatocellular carcinoma in Japan. Aliment Pharmacol Ther. 2010;31:407-14.
Zytoon AA , Ishii H , Murakami K , El-Kholy MR , Furuse J , El-Dorry A , et al. Recurrence-free survival after radiofrequency ablation of hepatocellular carcinoma. A registry report of the impact of risk factors on outcome. Jpn J Clin Oncol. 2007;37:658-72.
Nouso K , Matsumoto E , Kobayashi Y , Nakamura S-i , Tanaka H , Osawa T , et al. Risk factors for local and distant recurrence of hepatocellular carcinomas after local ablation therapies. J Gastroenterol Hepatol. 2008;23:453-8.
Ando E , Tanaka M , Yamashita F , Kuromatsu R , Yutani S , Fukumori K , et al. Hepatic arterial infusion chemotherapy for advanced hepatocellular carcinoma with portal vein tumor thrombosis. Cancer. 2002;95:588-95.
Iida T , Mizunaga Y , Okazawa T , Tsuchiya M , Inamoto Y , Kaino S , et al. [Complete response to treatment with hepatic arterial infusion of cisplatin powder (IA-call) in a case of hepatocellular carcinoma with multiple lung metastases]. Nihon Shokakibyo Gakkai Zasshi. 2007;104:1738-44.
Minami Y , Kudo M . Adjuvant therapy after radical surgery for hepatocellular carcinoma: still an unmet need. Hepatobiliary Surg Nutr. 2019;8:414-6.
Nitta H , Beppu T , Imai K , Hayashi H , Chikamoto A , Baba H . Adjuvant hepatic arterial infusion chemotherapy after hepatic resection of hepatocellular carcinoma with macroscopic vascular invasion. World J Surg. 2013;37:1034-42.
Nouso K , Miyahara K , Miyahara K , Uchida D , Kuwaki K , Izumi N , et al. Effect of hepatic arterial infusion chemotherapy of 5-fluorouracil and cisplatin for advanced hepatocellular carcinoma in the Nationwide Survey of Primary Liver Cancer in Japan. Br J Cancer. 2013;109:1904-7.
Yoshikawa M , Ono N , Yodono H , Ichida T , Nakamura H . Phase II study of hepatic arterial infusion of a fine-powder formulation of cisplatin for advanced hepatocellular carcinoma. Hepatol Res. 2008;38:474-83.
Nishikawa H , Osaki Y , Kita R , Kimura T . Hepatic arterial infusion chemotherapy for advanced hepatocellular carcinoma in Japan. Cancers. 2012;4:165-83.
Ikeda M , Shimizu S , Sato T , Morimoto M , Kojima Y , Inaba Y , et al. Sorafenib plus hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma: randomized phase II trial. Ann Oncol. 2016;27:2090-6.
Nishikawa H , Osaki Y , Kita R , Kimura T , Inuzuka T , Takeda H , et al. Transcatheter arterial infusion chemotherapy prior to radiofrequency thermal ablation for single hepatocellular carcinoma reduces the risk of intrahepatic distant recurrence. Int J Oncol. 2012;41:903-9.
Ishikawa T , Higuchi K , Kubota T , Seki K , Honma T , Yoshida T , et al. Prevention of intrahepatic distant recurrence by transcatheter arterial infusion chemotherapy with platinum agents for stage I/II hepatocellular carcinoma. Cancer. 2011;117:4018-25.
Kudo M , Kubo S , Takayasu K , Sakamoto M , Tanaka M , Ikai I , et al. Response evaluation criteria in cancer of the liver (RECICL) proposed by the liver cancer study group of Japan (2009 revised version). Hepatol Res. 2010;40:686-92.
Ikai I , Arii S , Okazaki M , Okita K , Omata M , Kojiro M , et al. Report of the 17th nationwide follow-up survey of primary liver cancer in Japan. Hepatol Res. 2007;37:676-91.
Kudo M , Izumi N , Kubo S , Kokudo N , Sakamoto M , Shiina S , et al. Report of the 20th nationwide follow-up survey of primary liver cancer in Japan. Hepatol Res. 2020;50:15-46.
Akateh C , Black SM , Conteh L , Miller ED , Noonan A , Elliott E , et al. Neoadjuvant and adjuvant treatment strategies for hepatocellular carcinoma. World J Gastroenterol. 2019;25:3704-21.
Hsiao J-H , Tsai C-C , Liang T-J , Chiang C-L , Liang H-L , Chen I-S , et al. Adjuvant hepatic arterial infusion chemotherapy is beneficial for selective patients with hepatocellular carcinoma undergoing surgical treatment. Int J Surg. 2017;45:35-41.
Ishikawa T , Kubota T , Abe S , Watanabe Y , Sugano T , Inoue R , et al. Hepatic arterial infusion chemotherapy with cisplatin before radical local treatment of early hepatocellular carcinoma (JIS score 0/1) improves survival. Ann Oncol. 2014;25:1379-84.
Shiina S , Teratani T , Obi S , Sato S , Tateishi R , Fujishima T , et al. A randomized controlled trial of radiofrequency ablation with ethanol injection for small hepatocellular carcinoma. Gastroenterology. 2005;129:122-30.
Cholankeril G , Patel R , Khurana S , Satapathy SK . Hepatocellular carcinoma in non-alcoholic steatohepatitis: current knowledge and implications for management. World J Hepatol. 2017;9:533-43.
Morgan TR , Mandayam S , Jamal MM . Alcohol and hepatocellular carcinoma. Gastroenterology. 2004;127:S87-96.
Degasperi E , Colombo M . Distinctive features of hepatocellular carcinoma in non-alcoholic fatty liver disease. Lancet Gastroenterol Hepatol. 2016;1:156-64.
Ganne-Carrié N , Nahon P . Hepatocellular carcinoma in the setting of alcohol-related liver disease. J Hepatol. 2019;70:284-93.
Matsushita H , Takaki A . Alcohol and hepatocellular carcinoma. BMJ Open Gastroenterol. 2019;6:e000260.
Negro F . Natural history of NASH and HCC. Liver Int. 2020;40(Suppl 1):72-6.