Long-Term Results of a Randomized, Observation-Controlled, Phase III Trial of Adjuvant Interferon Alfa-2b in Hepatocellular Carcinoma After Curative Resection

Chen, Li Tzong; Chen, Miin Fu; Li, Lung An; Lee, Po‐Huang; Jeng, Long Bin; Deng, Lin; Wu, Cheng Chung; Mok, King Tong; Chen, Chao Long; Lee, Wei Chen; Chau, Gar Yang; Chen, Yaw Sen; Wy, Lui; Hsiao, Chin‐Fu; Whang‐Peng, Jacqueline; Chen, Pei‐Jer

doi:10.1097/sla.0b013e3182363ff9

Cited by 116 publications

(99 citation statements)

References 41 publications

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“…One of the meta-analysis reported by S. Breitenstein [29] included one trial less than ours. And this trial [28] was published recently by LT Chen and its conclusion was contrary to the trials which were included in Breitenstein's report [29]. Meanwhile, samples in Chen's [28] report were much larger than any other RCTs [8,10,[21][22][23][24]27], which were all included in our metaanalysis.…”

Section: Discussioncontrasting

confidence: 48%

“…In recent years, several randomized controlled trials [8,10,[21][22][23][24][25][26][27][28] have revealed that IFN can have some influence on the recurrence of HCC. Some of them give a promising conclusion that the adjuvant IFN can reduce recurrence, while the others hold the opposite opinion.…”

Section: Original Papersmentioning

confidence: 99%

“…Nine articles were excluded, of which 4 applied non-curative treatments for HCC, 4 did not undergo IFN therapy and 1 was a Chinese article. Ten articles studies were thought to meet the inclusion criteria, of which 3 were published from the same institution and the most recent one was selected in our analysis [28]. Finally, 8 articles [8, 10, 21-24, 27, 28] were eligible for this meta-analysis (Fig.…”

Section: Study Descriptionmentioning

confidence: 99%

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Effect of Adjuvant Interferon Therapy on Hepatitis B/C Virus-Related Hepatocellular Carcinoma After Curative Therapy - Meta-Analysis

Xu¹,

Li²,

Chen³

et al. 2015

Adv Clin Exp Med

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Background. Hepatocellular carcinoma is the fifth most common malignant cancer in the world. Liver resection and local ablation are the most effective therapeutic approaches for most HCC patients. Recurrence after curative therapy is very common. Some studies reveal that IFNs have an effect on recurrence. While the opinion is disagreement. Objectives. The aim of this meta-analysis was to evaluate whether interferon therapy could reduce the recurrence of patients of hepatitis B/C virus-related hepatocellular carcinoma after curative therapy. Material and Methods. All randomized controlled trials about interferon on recurrence of hepatitis B/C virus--related hepatocellular carcinoma patients after curative surgery treatment were searched from PubMed, Embase, Cochrane library (all from 1977 to January 2014). Two reviewers independently assessed the quality of each included study and extracted data. RevMan 5.1 was used for meta-analysis. Results. Pooled data analysis revealed that the interferon group had no statistical significance on the recurrence of hepatitis-related hepatocellular carcinoma compared to the control group (RR = 0.91, 95% CI, 0.82 to 1.00); p = 0.11). While from the subgroup analysis of adjuvant interferon can reduce the recurrence of the median tumor size below 3 cm (RR 0.50, p = 0.00002). Conclusions. Adjuvant IFN after curative treatment of hepatitis-related HCC can improve the survival of HCC patients. In addition, IFN could decrease the recurrence rate of HCC patient with median tumor size below 3 cm but not exceeding 3 cm (Adv Clin Exp Med 2015, 24, 2, 331-340).

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Section: Discussioncontrasting

confidence: 48%

Section: Original Papersmentioning

confidence: 99%

Section: Study Descriptionmentioning

confidence: 99%

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Effect of Adjuvant Interferon Therapy on Hepatitis B/C Virus-Related Hepatocellular Carcinoma After Curative Therapy - Meta-Analysis

Xu¹,

Li²,

Chen³

et al. 2015

Adv Clin Exp Med

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“…Various postoperative interventions, such as adjuvant therapy with interferon, Vitamin E or K2, or I 131 , are used to reduce the incidence of tumor recurrence after curative treatment (6,7). The adjuvant application of interferon (7)(8)(9)(10) and antiviral treatment (11,12) seems promising but should be confirmed in further multi-center phase III clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Adjuvant sorafenib reduced mortality and prolonged overall survival and post-recurrence survival in hepatocellular carcinoma patients after curative resection: A single-center experience

Zhang

Zhao

Wei

et al. 2014

BST

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“…2 Unfortunately, recurrence after resection occurs in up to 80% of patients within five years following surgery, which together with concomitant hepatic decompensation, are the main causes of death. 3 Several adjuvant treatments including arterial infusional chemotherapy, 4 I 131 lipiodol, 5,6 and interferon 7,8 have been used. Unfortunately, the clinical use of these adjuvant therapies is either controversial or requires further evaluation.…”

Section: Introductionmentioning

confidence: 99%

A randomized controlled trial on patients with or without adjuvant autologous cytokine-induced killer cells after curative resection for hepatocellular carcinoma

Xu¹,

Wang²,

Kim

et al. 2015

OncoImmunology

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Background & Aims: There is no generally accepted adjuvant therapy for hepatocellular carcinoma (HCC) after curative resection. Autologous cytokine-induced killer (CIK) cells therapy has been reported to improve outcomes of patients with HCC, but its role as an adjuvant therapy remains unclear. This study aimed to evaluate the efficacy and safety of CIK as an adjuvant therapy for HCC after curative resection.Methods: This is a single center, phase 3, open label, randomized controlled trial (RCT). Two hundred patients who were initially diagnosed with HCC of Barcelona Clinic Liver Cancer (BCLC) stage A or B, and underwent curative hepatectomy were randomly assigned to receive four cycles of CIK treatment (the CIK group, n D 100) or no treatment (the control group, n D 100). The primary outcome was time to recurrence. The secondary outcomes included disease-free survival (DFS), overall survival (OS) and adverse events.Results: All patients in the CIK group finished the treatment by protocol. The median time to recurrence (TTR) was 13.6 (IQR 6.5-25.2) mo in the CIK group and 7.8 (IQR 2.7-17.0) mo in the control group (p D 0.01). There were no significant differences between the groups in DFS and OS. All adverse events were grade 1 or 2. There were no significant differences in incidence between the two groups.Conclusions: Four cycles of CIK therapy were safe and effective to prolong the median TTR in patients with HCC after curative resection, but the treatment did not improve the DFS and OS.

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Long-Term Results of a Randomized, Observation-Controlled, Phase III Trial of Adjuvant Interferon Alfa-2b in Hepatocellular Carcinoma After Curative Resection

Abstract: In this study, adjuvant IFNα-2b did not reduce the postoperative recurrence of viral hepatitis-related HCC. More potent antiviral therapy deserves to be explored for this patient population. This study is registered at ClinicalTrials.gov and carries the identifier NCT00149565.

Cited by 116 publications

References 41 publications

Effect of Adjuvant Interferon Therapy on Hepatitis B/C Virus-Related Hepatocellular Carcinoma After Curative Therapy - Meta-Analysis

Effect of Adjuvant Interferon Therapy on Hepatitis B/C Virus-Related Hepatocellular Carcinoma After Curative Therapy - Meta-Analysis

Adjuvant sorafenib reduced mortality and prolonged overall survival and post-recurrence survival in hepatocellular carcinoma patients after curative resection: A single-center experience

A randomized controlled trial on patients with or without adjuvant autologous cytokine-induced killer cells after curative resection for hepatocellular carcinoma

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