Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma

Abstract

A I M :To e v a l u a t e t h e e f f i c a c y a n d s a f e t y o f 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. Nonhematologic 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.

The advantages of using traditional Chinese medicine as an adjunctive therapy in the whole course of cancer treatment instead of only terminal stage of cancer

“…A pilot study of Huachansu injection in patients with HCC, NSCLC, and pancreatic cancer showed that Huachansu injection could improve the quality of life of patients and even enhanced tumor shrinkage with little toxicity (77). Another clinical study using Huachansu injection in combination with gemcitabine and oxaliplatin in treating gallbladder carcinomas showed that Huachansu injection substantially enhanced the antitumor efficacy of gemcitabine and oxaliplatin and improved the quality of life of patients (78). Moreover, a case-control trial (n = 120) was conducted to assess the effects of Huachansu injection plus Jiedu granules (a Chinese medicine compound) versus transcatheter arterial chemoembolization (TACE) in post-surgical patients with HCC in Changhai Hospital (Shanghai, China).…”

Traditional Chinese medicine in the prevention and treatment of cancer and cancer metastasis

“…In clinical studies, Hua Chan Su has been identified to improve performance status in HCC, non-small cell lung cancer and pancreatic cancer patients (38). One of the constituents, cinobufagin, when used alone or in combination with other chemotherapy agents, has also demonstrated anticancer activities in HCC, non-small cell lung cancer, pancreatic cancer and gallbladder carcinoma patients (39). The combination of Hua Chan Su and chemotherapy has been used for the treatment of advanced gastric cancer.…”

Apoptosis-inducing activity of compounds screened and characterized from cinobufacini by bioassay-guided isolation

“…cinobufacini (huachansu), an aqueous extract of B. bufo gargarizans cantor skin, is a traditional chinese medicinal preparation widely used in clinical cancer therapy in china. It was demonstrated to have significant anti-cancer effects in a variety of cancers, including hepatic, gastric, pancreatic and esophageal carcinoma (5)(6)(7)(8)(9). Our previous studies and other related investigations have shown that cinobufacini inhibits cell growth by inducing apoptosis in human hepatoma and gastric neoplasm cells (10)(11)(12).…”