Efficacy and Safety of the FOLFOX4 Regimen Versus Doxorubicin in Chinese Patients With Advanced Hepatocellular Carcinoma: A Subgroup Analysis of the EACH Study. (15th September 2014)

• Record Type: Journal Article
• Authors: Qin, Shukui; Cheng, Ying; Liang, Jun; Shen, Lin; Bai, Yuxian; Li, Jianfeng; Fan, Jia; Liang, Lijian; Zhang, Yaqi; Wu, Gang; Rau, Kun-Ming; Yang, Tsai-Shen; Jian, Zhixiang; Liang, Houjie; Sun, Yan
• Is Part Of: Oncologist. Volume 19:Number 11(2014)
• Page Start: 1169
• Page End: 1178
• Publication Date: 2014-09-15
• Subjects: Hepatocellular carcinoma -- Oxaliplatin -- FOLFOX4 regimen -- Systemic chemotherapy; Oncology -- Periodicals; Tumors -- Periodicals; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Oncology; Tumors; Neoplasms; Electronic journals; Periodicals; Periodicals; 616.994
• DOI: 10.1634/theoncologist.2014-0190
• Languages: English
• ISSNs: 1083-7159

Abstract

Abstract: Background: The EACH study assessed the efficacy of oxaliplatin, 5-fluorouracil, and leucovorin (the FOLFOX4 regimen) compared with doxorubicin alone in terms of overall survival (OS), progression-free survival (PFS), and safety in patients with advanced hepatocellular carcinoma (HCC). We present the results of this study in Chinese patients. Methods: In a multicenter, open-label, randomized, phase III study (00471965 ), 371 patients (279 patients from the People's Republic of China) were randomized 1:1 to receive either FOLFOX4 or doxorubicin until disease progression, intolerable toxicity, death, or surgical resection. Results: Baseline characteristics of the Chinese patients enrolled in the study were similar for the 2 treatment groups and in comparison with the whole EACH cohort. Median OS at the prespecified time point of treatment was 5.7 months with FOLFOX4 and 4.3 months with doxorubicin (hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.55–0.98; p = .03). At the end of the follow-up period, median OS was 5.9 months with FOLFOX4 and 4.3 months with doxorubicin (HR: 0.75; 95% CI: 0.58–0.98; p = .03). Median PFS was 2.4 months and 1.7 months in the FOLFOX4 and doxorubicin groups, respectively (HR: 0.55; 95% CI: 0.45–0.78; p = .0002). The response rate (RR) and disease control rate (DCR) were significantly higher in the FOLFOX4 group than in the doxorubicin group (RR: 8.6% vs. 1.4%, p = .006; DCR: 47.1% vs. 26.6%, p = .0004). Hematological toxicity was more frequently reported in the FOLFOX4 group. Conclusion: For Chinese HCC patients enrolled in the EACH study, FOLFOX4 significantly improved the RR and DCR and prolonged survival compared with doxorubicin. Systemic chemotherapy with oxaliplatin-based regimens may play an important role in the treatment of Chinese patients with advanced HCC. Abstract : The authors report the results of the EACH study for the subgroup of Chinese patients with advanced hepatocellular carcinoma (HCC) who are ineligible for curative resection or local treatment. FOLFOX4 significantly improved response and disease-control rates and prolonged survival compared with doxorubicin. Systemic chemotherapy with oxaliplatin-based regimens may play an important role in the treatment of Chinese patients with advanced HCC.