NSC-631570 (Ukrain) in the palliative treatment of pancreatic cancer. Results of a phase II trial.
BACKGROUND
NSC-631570 (Ukrain) is a semisynthetic compound of thiophosphoric acid and the alkaloid chelidonine from the plant Chelidonium majus. It has been used in complementary herbal medicine for more than 20 years for the treatment of benign and malignant tumors.


METHODS
Between August 1999 and June 2001, 90 patients with histologically proven unresectable pancreatic cancer were randomized in a monocentric, controlled, randomized study. Patients in arm A received 1000 mg gemcitabine/m2, those in arm B received 20 mg NSC-631570, and those in arm C received 1000 mg gemcitabine/m2 followed by 20 mg NSC-631570 weekly. End point of the study was overall survival.


RESULTS
In all three arms therapy was well tolerated and toxicity was moderate. At the first re-evaluation in arm A 32%, in arm B 75%, and in arm C 82% showed no change or partial remission according to WHO criteria (arm A versus arm B: P<0.01, arm A versus arm C: P<0.001). Median survival according to Kaplan-Meier analysis was in arm A 5.2 months, in arm B 7.9 months, and in arm C 10.4 months (arm A versus arm B: P<0.01, arm A versus arm C: P<0.01). Actuarial survival rates after 6 months were 26%, 65% and 74% in arms A B and C, respectively (arm A versus arm B: P<0.05, arm A versus arm C P<0.01).


CONCLUSIONS
We could show that in unresectable advanced pancreatic cancer, NSC-631570 alone and in combination with gemcitabine nearly doubled the median survival times in patients suffering from advanced pancreatic cancer.
Gansauge
Frank
F
Department of General Surgery, University of Ulm, Germany.
Ramadani
Marco
M
Pressmar
Jochen
J
Gansauge
Susanne
S
Muehling
Bernd
B
Stecker
Kerstin
K
Cammerer
Gregor
G
Leder
Gerd
G
Beger
Hans G
HG
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000470:Alkaloids / Q000008:administration & dosage / Q000627:therapeutic use*; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001600:Berberine Alkaloids; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D010617:Phenanthridines; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
D000470:Alkaloids; D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D001600:Berberine Alkaloids; D010617:Phenanthridines; D003841:Deoxycytidine; C060921:ukrain; D000093542:Gemcitabine