Efficacy and safety of the folfox4 regimen versus doxorubicin in chinese patients with advanced hepatocellular carcinoma: A subgroup analysis of the each study

Shukui Qin, Ying Cheng, Jun Liang, Lin Shen, Yuxian Bai, Jianfeng Li, Jia Fan, Lijian Liang, Yaqi Zhang, Gang Wu, Kun Ming Rau, Tsai Shen Yang, Zhixiang Jian, Houjie Liang, Yan Sun

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58 Scopus citations

Abstract

Background. The EACH study assessed the efficacy of oxali-platin, 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 (NCT00471965), 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 5.03). 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 5.03). 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 5.0002).The response rate (RR) and disease control rate (DCR) were significantly higher in the FOLFOX4group than in the doxorubicin group (RR: 8.6% vs. 1.4%, p 5.006; DCR: 47.1% vs. 26.6%, p 5.0004). 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.

Original languageEnglish
Pages (from-to)1169-1178
Number of pages10
JournalOncologist
Volume19
Issue number11
DOIs
StatePublished - 2014

Keywords

  • FOLFOX4 regimen
  • Hepatocellular carcinoma
  • Oxaliplatin
  • Systemic chemotherapy

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