COOKING ALL THE WAY

Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall-cell lung cancer, or pancreatic cancer
Zhiqiang Meng, MD, PhD 1, Peiying Yang, PhD 2, Yehua Shen, MD 1, Wenying Bei, RN 1, Ying Zhang, RN 1, Yongqian Ge, MD 1, Robert A. Newman, PhD 3 a, Lorenzo Cohen, PhD 2 4 *, Luming Liu, MD, PhD 1 *, Bob Thornton, MPH 2 b, David Z. Chang, PhD 5, Zongxing Liao, MD 6, Razelle Kurzrock, MD 7
1International Center of Integrative Oncology, Fudan University Cancer Hospital, Shanghai, China
2The Integrative Medicine Program, Department of General Oncology, The University of Texas M. D. Anderson Cancer, Houston, Texas
3Department of Experimental Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
4Department of Behavioral Science, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
5Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
6Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
7Department of Investigational Cancer Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
email: Luming Liu (llm1010@163.com)


*Correspondence to Lorenzo Cohen, Department of Behavioral Science, Unit 145, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030

*Correspondence to Luming Liu, International Center of Integrative Oncology, Fudan University Cancer Hospital, 270 Dong An Road, Shanghai, 200032, China

aCurrent address: New Chapter Inc, Brattleboro, Vermont

bCurrent address: Merck & Co, Inc., Whitehouse Station, New Jersey
Fax: (011) 862164437657

Funded by:
 National Cancer Institute; Grant Number: CA108084, CA12153031
Keywords
pancreatic cancer • hepatocellular cancer • nonsmall cell lung cancer • phase 1 • traditional Chinese medicine

Abstract

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/m2.

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.