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Copyright ©2008 The WJG Press and Baishideng. All rights reserved.
World J Gastroenterol. Sep 7, 2008; 14(33): 5210-5216
Published online Sep 7, 2008. doi: 10.3748/wjg.14.5210
Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma
Tian-Jie Qin, Xin-Han Zhao, Jun Yun, Ling-Xiao Zhang, Zhi-Ping Ruan, Bo-Rong Pan
Tian-Jie Qin, Xin-Han Zhao, Ling-Xiao Zhang, Zhi-Ping Ruan, Department of Medical Oncology, First Affiliated Hospital of Medical School of Xi’an Jiaotong University, Xi’an 710061, Shaanxi Province, China
Bo-Rong Pan, Outpatient Department of Oncology, Cancer Institute, Fourth Military Medical University, Xi’an 710032, Shaanxi Province, China
Jun Yun, Department of the Third General Surgery, Xijing Hospital, Fourth Military Medical University, Xi’an 710032, Shaanxi Province, China
Author contributions: Qin TJ and Zhao XH contributed equally to this work; Qin TJ, Zhao XH and Pan BR designed the research; Qin TJ, Zhao XH, Yun J, Zhang LX, Ruan ZP performed the research; Qin TJ and Zhao XH analyzed the data; and Qin TJ, Zhao XH and Pan BR wrote the paper.
Correspondence to: Dr. Xin-Han Zhao, Department of Medical Oncology, First Affiliated Hospital of Medical School of Xi’an Jiaotong University, Xi’an 710061, Shaanxi Province, China. zhaoxinhan@mail.xjtu.edu.cn
Telephone: +86-29-85324136 Fax: +86-29-82655472
Received: June 19, 2008
Revised: August 14, 2008
Accepted: August 21, 2008
Published online: September 7, 2008
Abstract

AIM: To evaluate the efficacy and safety of gemcitabine-oxaliplatin (GEMOX) combined with huachansu (cinobufagin) injection treatment in patients with locally advanced or metastatic gallbladder carcinoma (GBC), and to assess the quality of life (QOL) of such patients.

METHODS: Twenty-five patients with locally advanced or metastatic GBC were treated with intravenous gemcitabine (1000 mg/m2) over 30 min on days 1 and 8, 2 h infusion of oxaliplatin (120 mg/m2) on day 1, and 2-3 h infusion of huachansu (20 mL/m2) on days -3-11, every 3-4 wk. Treatment was continued until occurrence of unacceptable toxicity or disease progression. QOL of patients was assessed by the EORTC QLQ-C30 at baseline, at the end of the first, third and sixth chemotherapy cycles, and 1 mo after the treatment.

RESULTS: Among the 25 patients with a median age of 64 years (range 42-78 years), 23 were evaluable in the study. A total of 137 cycles of therapy were performed and the median cycle was 5 (range 1-8) per patient. Out of the 23 patients whose response could be evaluated, 8 partial responses (PR) were observed (34.8%), while 7 patients (30.4%) demonstrated a stable disease (SD). The disease control rate was 65.2%. Progression of cancer was observed in 8 (34.8%) patients. The median progression-free and overall survival time was 5.8 mo (95% CI: 4.5-7.1 mo) and 10.5 mo, respectively. The therapy was well tolerated, with moderate myelosuppression as the main toxicity. Anemia grade 2 was seen in 16.0%, neutropenia grade 3 in 8.0% and thrombocytopenia grade 3 in 24.0% of patients, respectively. Non-hematologic toxicity ranged from mild to moderate. No death occurred due to toxicity. The QOL of patients was improved after chemotherapy, and the scores of QOL were increased by 10 to 20 points.

CONCLUSION: GEMOX combined with huachansu (cinobufagin) injection is well tolerated, effective, thus improving the QOL of patients with advanced GBC.

Keywords: Gallbladder carcinoma, Gemcitabine, Oxaliplatin, Huachansu injection, Quality of life