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Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall‐cell lung cancer, or pancreatic cancer
Author(s) -
Meng Zhiqiang,
Yang Peiying,
Shen Yehua,
Bei Wenying,
Zhang Ying,
Ge Yongqian,
Newman Robert A.,
Cohen Lorenzo,
Liu Luming,
Thornton Bob,
Chang David Z.,
Liao Zongxing,
Kurzrock Razelle
Publication year - 2009
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.24602
Subject(s) - medicine , hepatocellular carcinoma , cancer , adverse effect , lung cancer , gastroenterology , pancreatic cancer , toxicity , oncology
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 8× higher than typically used in China. Six patients had prolonged stable disease or minor tumor shrinkage. Cancer 2009. © 2009 American Cancer Society.