Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall-cell lung cancer, or pancreatic cancer.
BACKGROUND
Huachansu, a Chinese medicine that comes from dried toad venom from the skin glands of Bufo gargarizans or B. melanostictus, has been used in the treatment of various cancers in China. The authors conducted a pilot study, using a phase 1 trial design, of huachansu in patients with advanced cancer.


METHODS
Huachansu was administered intravenously for 14 days followed by 7 days off (1 cycle). Without significant adverse events or progressive disease, treatment continued beyond 2 cycles. The dose of huachansu was escalated as follows with 3 patients per cohort: 10 (level 1), 20 (level 2), 40 (level 3), 60 (level 4), and 90 (level 5) mL/m(2).


RESULTS
Fifteen patients (hepatocellular cancer, n = 11; nonsmall cell lung cancer, n = 2; pancreatic cancer, n = 2) were enrolled in the trial, and no dose-limiting toxicities (DLTs) were found. Eleven patients had no drug-related toxicity greater than grade 1. Six (40%) had stable disease (median duration, 6.0 months; range, 3.5-11.1 months). One of these patients (with hepatocellular cancer) had 20% regression (duration, 11 months) (dose level 1). Quality of life improved for patients with stable disease. Plasma bufalin concentration reached maximal levels at the end of the 2-hour infusion and was proportional to the amount of drug being administered (0.81-3.38 ng/mL).


CONCLUSIONS
No DLT was observed with the use of huachansu at doses up to 8x higher than typically used in China. Six patients had prolonged stable disease or minor tumor shrinkage.
Meng
Zhiqiang
Z
International Center of Integrative Oncology, Fudan University Cancer Hospital, Shanghai, China.
Yang
Peiying
P
Shen
Yehua
Y
Bei
Wenying
W
Zhang
Ying
Y
Ge
Yongqian
Y
Newman
Robert A
RA
Cohen
Lorenzo
L
Liu
Luming
L
Thornton
Bob
B
Chang
David Z
DZ
Liao
Zongxing
Z
Kurzrock
Razelle
R
D000368:Aged; D000664:Amphibian Venoms / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy*; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D010865:Pilot Projects
D000664:Amphibian Venoms; D000970:Antineoplastic Agents; C545813:huachansu
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