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Randomized, Multicenter, Open-Label Study of Oxaliplatin Plus Fluorouracil/Leucovorin Versus Doxorubicin As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma From Asia 期刊论文 WOS高被引论文

编号：

c99b8245-2e0d-48e3-a792-41ed62246477
作者：

Qin, Shukui^[1];Bai, Yuxian^[2];Lim, Ho Yeong^[6];Thongprasert, Sumitra^[9];Chao, Yee^[11];Fan, Jia(樊嘉)^[3]Yang, TsaiShen^[12];Bhudhisawasdi, Vajarabhongsa^[10];Kang, Won Ki^[6,7];Zhou, Yu^[4];Lee, Jee Hyun^[8];Sun, Yan^[5];
语种：

英文
期刊：

JOURNAL OF CLINICAL ONCOLOGY ISSN：0732-183X 2013 年 31 卷 28 期 (3501 - +) ; OCT 1
收录：
摘要：

Purpose
To determine whether FOLFOX4 (infusional fluorouracil, leucovorin, and oxaliplatin) administered as palliative chemotherapy to patients with advanced hepatocellular carcinoma (HCC) provides a survival benefit and efficacy versus doxorubicin.
Patients and Methods
This multicenter, open-label, randomized, phase III study in mainland China, Taiwan, Korea, and Thailand involved 371 patients age 18 to 75 years who had locally advanced or metastatic HCC and were ineligible for curative resection or local treatment. They were randomly assigned at a ratio of one to one to receive either FOLFOX4 (n = 184) or doxorubicin (n = 187). The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS), response rate (RR) by RECIST (version 1.0), and safety.
Results
At the prespecified final analysis, median OS was 6.40 months with FOLFOX4 (95% CI, 5.30 to 7.03) and 4.97 months with doxorubicin (95% CI, 4.23 to 6.03; P = .07; hazard ratio [HR], 0.80; 95% CI, 0.63 to 1.02). Median PFS was 2.93 months with FOLFOX4 (95% CI, 2.43 to 3.53), and 1.77 months with doxorubicin (95% CI, 1.63 to 2.30; P < .001; HR, 0.62; 95% CI, 0.49 to 0.79). RR was 8.15% with FOLFOX4 and 2.67% with doxorubicin (P = .02). On continued follow-up, the trend toward increased OS with FOLFOX4 was maintained (P = .04; HR, 0.79; 95% CI, 0.63 to 0.99). Toxicity was consistent with previous experiences with FOLFOX4; proportions of grade 3 to 4 adverse events were similar between treatments.
Conclusion
Although the study did not meet its primary end point, the trend toward improved OS with FOLFOX4, along with increased PFS and RR, suggests that this regimen may confer some benefit to Asian patients, but an OS benefit cannot be concluded from these data.
推荐引用方式
GB/T 7714：

Qin Shukui,Bai Yuxian,Lim Ho Yeong, et al. Randomized, Multicenter, Open-Label Study of Oxaliplatin Plus Fluorouracil/Leucovorin Versus Doxorubicin As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma From Asia [J].JOURNAL OF CLINICAL ONCOLOGY,2013,31(28):3501-+.
APA：

Qin Shukui,Bai Yuxian,Lim Ho Yeong,Thongprasert Sumitra,&Sun Yan.(2013).Randomized, Multicenter, Open-Label Study of Oxaliplatin Plus Fluorouracil/Leucovorin Versus Doxorubicin As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma From Asia .JOURNAL OF CLINICAL ONCOLOGY,31(28):3501-+.
MLA：

Qin Shukui, et al. "Randomized, Multicenter, Open-Label Study of Oxaliplatin Plus Fluorouracil/Leucovorin Versus Doxorubicin As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma From Asia" .JOURNAL OF CLINICAL ONCOLOGY 31,28(2013):3501-+.

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