TY - JOUR
T1 - Prospective randomised evaluation of traditional Chinese medicine combined with chemotherapy
T2 - A randomised phase II study of wild toad extract plus gemcitabine in patients with advanced pancreatic adenocarcinomas
AU - Meng, Z.
AU - Garrett, C. R.
AU - Shen, Y.
AU - Liu, L.
AU - Yang, P.
AU - Huo, Y.
AU - Zhao, Q.
AU - Spelman, A. R.
AU - Ng, C. S.
AU - Chang, D. Z.
AU - Cohen, L.
N1 - Funding Information:
This work was supported by National Institute of Health grant U19CA121503-01. The study drug huachansu was
PY - 2012/7/24
Y1 - 2012/7/24
N2 - Background: An intravenous formulated extract of the venom of the wild toad Bufo bufo gargarizans Cantor or Bufo melanostictus Schneider, huachansu, is currently used in China for the treatment of lung, liver, pancreatic, and colorectal cancers. We performed a randomised, single-blinded, phase II clinical study of huachansu plus gemcitabine versus placebo plus gemcitabine in patients with locally advanced and/or metastatic pancreatic adenocarcinomas.Methods: Patients with tissue-proven locally advanced and/or metastatic pancreatic adenocarinoma were randomly assigned to receive either gemcitabine 1000 mg m 2 on days 1, 8, and 15 with huachansu 20 ml m 2 daily for 21 days (arm A) or placebo (arm B); treatment cycles were 28 days in length. Primary end point was 4-month progression-free overall survival (PFS); secondary end points were objective radiographical response rate (ORR), time to progression (TTP), and toxicity.Results:A total of 80 subjects were enrolled; 76 patients were evaluable (received at least 1 week therapy). Median overall survival was 160 days for arm A and 156 days for arm B (P<0.339); ORR was 9 and 3% in arms A and B, respectively (P<0.332), median TTP was 98 and 115 days, respectively (P<0.825); the median 4-month PFS was 99 and 98 days, respectively (P<0.679).Conclusion:Huachansu when combined with gemcitabine did not improve the outcome of patients with locally advanced and/or metastatic pancreatic cancer.
AB - Background: An intravenous formulated extract of the venom of the wild toad Bufo bufo gargarizans Cantor or Bufo melanostictus Schneider, huachansu, is currently used in China for the treatment of lung, liver, pancreatic, and colorectal cancers. We performed a randomised, single-blinded, phase II clinical study of huachansu plus gemcitabine versus placebo plus gemcitabine in patients with locally advanced and/or metastatic pancreatic adenocarcinomas.Methods: Patients with tissue-proven locally advanced and/or metastatic pancreatic adenocarinoma were randomly assigned to receive either gemcitabine 1000 mg m 2 on days 1, 8, and 15 with huachansu 20 ml m 2 daily for 21 days (arm A) or placebo (arm B); treatment cycles were 28 days in length. Primary end point was 4-month progression-free overall survival (PFS); secondary end points were objective radiographical response rate (ORR), time to progression (TTP), and toxicity.Results:A total of 80 subjects were enrolled; 76 patients were evaluable (received at least 1 week therapy). Median overall survival was 160 days for arm A and 156 days for arm B (P<0.339); ORR was 9 and 3% in arms A and B, respectively (P<0.332), median TTP was 98 and 115 days, respectively (P<0.825); the median 4-month PFS was 99 and 98 days, respectively (P<0.679).Conclusion:Huachansu when combined with gemcitabine did not improve the outcome of patients with locally advanced and/or metastatic pancreatic cancer.
KW - gemcitabine
KW - huachansu
KW - pancreatic cancer
KW - traditional Chinese medicine
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U2 - 10.1038/bjc.2012.283
DO - 10.1038/bjc.2012.283
M3 - Article
C2 - 22782343
AN - SCOPUS:84864377344
SN - 0007-0920
VL - 107
SP - 411
EP - 416
JO - British journal of cancer
JF - British journal of cancer
IS - 3
ER -