Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma
Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma
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DOI：
10.3748/wjg.14.5210
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发表时间：
2008-09-07
影响因子：
4.3
通讯作者：
Pan, Bo-Rong
中科院分区：
文献类型：
--
作者：
Qin, Tian-Jie;Zhao, Xin-Han;Pan, Bo-Rong
目的：评价吉西他滨-奥沙利铂（GEMOX）联合华产素（cinobufagin）注射液治疗局部晚期或转移性胆囊癌（GBC）患者的疗效和安全性，并评价患者的生活质量（QOL）。方法：25例局部晚期或转移性GBC患者在第1天和第8天静脉注射吉西他滨（1000 mg/m(2)） 30分钟，第1天输注奥沙利铂（120 mg/m(2)） 2小时，第3-11天输注花血素（20 mL/m(2)） 2-3小时，每3-4周。继续治疗，直到出现不可接受的毒性或疾病进展。在基线、第一、第三、第六个化疗周期结束时以及治疗后1个月，采用EORTC QLQ-C30评估患者的生活质量。结果：25例患者中位年龄为64岁（42-78岁），其中23例在研究中可评估。总共进行了137个周期的治疗，中位周期为每位患者5个周期（范围1-8）。在23例可评价反应的患者中，观察到8例部分缓解（PR）（34.8%）， 7例（30.4%）表现为疾病稳定（SD）。疾病控制率为65.2%。8例（34.8%）患者出现肿瘤进展。中位无进展生存期和总生存期分别为5.8个月（95% CI: 4.5-7.1个月）和10.5个月。该疗法耐受性良好，主要毒性为中度骨髓抑制。2级贫血患者占16.0%，3级中性粒细胞减少患者占8.0%，3级血小板减少患者占24.0%。非血液学毒性从轻度到中度不等。未发生中毒死亡。化疗后患者的生活质量得到改善，生活质量评分提高10 ~ 20分。结论：GEMOX联合华川素注射液耐受性好，疗效显著，可改善晚期GBC患者的生活质量。(c) 2008 WJG出版社。版权所有。
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/m(2)) over 30 min on days 1 and 8, 2 h infusion of oxaliplatin (120 mg/m(2)) on day 1, and 2-3 h infusion of huachansu (20 mL/m(2)) 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. (c) 2008 The WJG Press. All rights reserved.