Number of included patients:
Cancer. 2009 Aug 21.
Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall-cell lung cancer, or pancreatic cancer.
Meng Z, Yang P, Shen Y, Bei W, Zhang Y, Ge Y, Newman RA, Cohen L, Liu L, Thornton B, Chang DZ, Liao Z, Kurzrock R.
International Center of Integrative Oncology, Fudan University Cancer Hospital, Shanghai, China.
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. Cancer 2009. (c) 2009 American