GBC has very poor prognosis. Conventional surgery is considered the most effective treatment, but many cases are inoperable at the time of diagnosis. More recently, chemotherapy has shown activity in gallbladder cancer. However, no generally accepted standard chemotherapy for advanced, non-resectable cancer of the gallbladder or biliary tree has yet been established.
In addition, more and more people pay close attention to the research of Chinese medicine for prevention and treatment of cancer recently. Huachansu (cinobufagin) is just a widely used antitumor agent of traditional Chinese medicine in China. It is recommended that further clinical trials, especially large multi-institutional RCTs (phase III studies) using novel agents such as gemcitabine should be performed as soon as possible in order to establish a standard treatment.
A research article to be published on September, 2008 in the World Journal of Gastroenterology addresses this question. The research team led by Dr. Qin and Prof. Zhao from Department of Medical Oncology, First Affiliated Hospital of Medical School of Xi'an Jiaotong University, evaluated the efficacy and safety of GEMOX combined with huachansu in patients with advanced GBC, and assessed the patients' QOL.
In their study, patients with locally advanced or metastatic GBC were treated with gemcitabine 1000 mg/m2 intravenously over 30 minutes on d 1 and 8, oxaliplatin 120 mg/m2 as a 2-h infusion on d 1, and huachansu injection 20 mL/m2 (0.5 g/mL) as a 2 - 3 h infusion on d 3 through 11. Treatment was continued until unacceptable toxicity or disease progression. Quality of life was assessed by means of the EORTC QLQ-C30.
Out of the 23 patients whose response could be evaluated, 8 partial responses (PR) were observed (34.8%), while a further 7 patients (30.4%) demonstrated stable disease (SD). Disease control rate was 65.2%. In another 8 (34.8%) patients, the cancer progressed. The median progression-free survival and median overall survival were 5.8 mo and 10.5 mo, respectively.
The therapy was well tolerated, with moderate myelosuppression as the main toxicity. Non-hematologic toxicity ranged from mild to moderate. There were no toxic deaths.
"Huachansu injection was given three days before the GEMOX in our study and the effectiveness of huachansu in pain relief appeared 1 to 2 d after administration (9/14 patients)." Said Dr. Qin. "It showed an improvement for quality of life after the combination chemotherapy, and the scores of the QOL improved by 10 to 20 points."
The investigators believed that the GEMOX combined with huachansu injection provides a safe, well-tolerated, and effective treatment for patients with advanced GBC.
Source: World Journal of Gastroenterology