Li Xu1, Jun Wang2, Yuhree Kim3, Ze-Yu Shuang4, Yao-Jun Zhang4, Xiang-Ming Lao4, Yong-Qiang Li5, Min-Shan Chen4, Timothy M Pawlik3, Jian-Chuan Xia5, Sheng-Ping Li4, Wan-Yee Lau6. 1. Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, MD, USA. 2. Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; Department of Ultrasound, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China. 3. Department of Surgery, The Johns Hopkins University School of Medicine , Baltimore, MD, USA. 4. Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China. 5. State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; Department of Biotherapy, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China. 6. Faculty of Medicine, The Chinese University of Hong Kong Prince of Wales Hospital , Hong Kong S.A.R., China.
Abstract
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 = 100) or no treatment (the control group, n = 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 = 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.
RCT Entities:
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 = 100) or no treatment (the control group, n = 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 = 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.
Entities:
Keywords:
Adjuvant therapy; cytokine-induced killer cells; hepatocellular carcinoma; recurrence; surgery
Authors: T Takayama; T Sekine; M Makuuchi; S Yamasaki; T Kosuge; J Yamamoto; K Shimada; M Sakamoto; S Hirohashi; Y Ohashi; T Kakizoe Journal: Lancet Date: 2000-09-02 Impact factor: 79.321
Authors: Do Young Kim; Sang Hoon Ahn; Seung Up Kim; Sae Byeol Choi; Kwang-Hun Lee; Mi Sook Park; Jun Yong Park; Do Yun Lee; Kwang-Hyub Han; Kyung Sik Kim Journal: Oncology Date: 2011-11-08 Impact factor: 2.935
Authors: M E Osband; P T Lavin; R K Babayan; S Graham; D L Lamm; B Parker; I Sawczuk; S Ross; R J Krane Journal: Lancet Date: 1990-04-28 Impact factor: 79.321
Authors: Kota Sahara; S Ayesha Farooq; Diamantis I Tsilimigras; Katiuscha Merath; Anghela Z Paredes; Lu Wu; Rittal Mehta; J Madison Hyer; Itaru Endo; Timothy M Pawlik Journal: Hepatobiliary Surg Nutr Date: 2020-02 Impact factor: 7.293