Qin Tian-Jie, Zhao Xin-Han, Yun Jun, Zhang Ling-Xiao, Ruan Zhi-Ping, Pan Bo-Rong
Department of Medical Oncology, First Affiliated Hospital of Medical School of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, China.
World J Gastroenterol. 2008 Sep 7;14(33):5210-6. doi: 10.3748/wjg.14.5210.
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.
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.
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.
GEMOX combined with huachansu (cinobufagin) injection is well tolerated, effective, thus improving the QOL of patients with advanced GBC.
评估吉西他滨-奥沙利铂（GEMOX）联合华蟾素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，并评估此类患者的生活质量（QOL）。
25例局部晚期或转移性GBC患者接受治疗，第1天和第8天静脉滴注吉西他滨（1000mg/m²），持续30分钟，第1天静脉滴注奥沙利铂（120mg/m²），持续2小时，第-3至11天静脉滴注华蟾素（20mL/m²），持续2-3小时，每3-4周重复一次。持续治疗直至出现不可接受的毒性或疾病进展。在基线、第1、3和6个化疗周期结束时以及治疗后1个月，通过欧洲癌症研究与治疗组织生活质量核心问卷（EORTC QLQ-C30）评估患者的生活质量。
25例患者年龄中位数为64岁（范围42-78岁），23例可纳入本研究。共进行了137个周期的治疗，每位患者的中位数周期数为5个（范围1-8个）。在23例可评估反应的患者中，观察到8例部分缓解（PR）（34.8%），7例患者（30.4%）疾病稳定（SD）。疾病控制率为65.2%。8例（34.8%）患者出现癌症进展。无进展生存期和总生存期的中位数分别为5.8个月（95%CI：4.5-7.1个月）和10.5个月。该治疗耐受性良好，主要毒性为中度骨髓抑制。分别有16.0%的患者出现2级贫血，8.0%的患者出现3级中性粒细胞减少，24.0%的患者出现3级血小板减少。非血液学毒性为轻度至中度。无毒性相关死亡。化疗后患者的生活质量得到改善，生活质量评分提高了10至20分。
GEMOX联合华蟾素注射液耐受性良好、疗效显著，从而改善了晚期GBC患者的生活质量。
