The clinical efficacy of adjuvant systemic chemotherapy with gemcitabine and NSC-631570 in advanced pancreatic cancer.
OBJECTIVE
Recently we have shown that NSC-631570 (Ukrain) is a safe and effective drug in the treatment of unresectable pancreatic cancer. The aim of this study was to determine the effectiveness of the combined treatment with Gemcitabine and NSC-631570 in the adjuvant treatment of resected advanced pancreatic cancer.


METHODS
30 patients received adjuvant chemotherapy following surgical resection for pancreatic cancer. Chemotherapy consisted of Gemcitabine according to the Burris-protocol with weekly infusions of 1000 mg/sqm. Immediately following Gemcitabine infusion 20mg of NSC-631570 were administered intravenously over 15 minutes.


RESULTS
WHO grade II toxicities were observed in 53%, no WHO grade III or IV toxicities occurred. In 80% of the patients recurrence of the disease was observed. The relapse-free survival time was 21.7 months. The actuarial survival rates were 86.7% after one year, 76.6% after two years, 46.7% after three years and 23.3% after five years. The median survival time according to Kaplan-Meier regression analysis was 33.8 months.


CONCLUSIONS
Adjuvant chemotherapy in advanced stages of pancreatic cancer using the combination of Gemcitabine and NSC-631570 is a safe treatment and seems to lead to a prolonged survival. Although further investigation is needed to confirm these results, the combined treatment of Gemcitabine and NSC-631570 is a promising therapy for the adjuvant treatment of resectable advanced pancreatic cancer.
Gansauge
Frank
F
Center for Oncological, Endocrinological and Minimal-access Surgery, University of Ulm, Silcherstr. 36, 89231 Neu-Ulm, Germany. frank.gansauge@eurosurgery.de
Ramadani
Marco
M
Schwarz
Michael
M
Beger
Hans G
HG
Lotspeich
Erkki
E
Poch
Bertram
B
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D001600:Berberine Alkaloids / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010617:Phenanthridines / Q000627:therapeutic use*; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
D001600:Berberine Alkaloids; D010617:Phenanthridines; D003841:Deoxycytidine; C060921:ukrain; D000093542:Gemcitabine