UKRAIN (NSC-631570) IN THE PALLIATIVE TREATMENT OF PANCREATIC CANCER - RESULTS OF A RANDOMIZED CONTROLLED MONOCENTRIC PHASE II/III STUDY

F. Gansauge, J. Pressmar, M. Ramadani, K. Stecker, and H.G. Beger.

Department of General Surgery, University of Ulm, Germany

Introduction: Ukrain (NSC-631570) is a semisynthetic derivate of the alkaloid chelidonin. For more than 20 years Ukrain has been used in complementary medicine for the treatment of advanced cancer diseases.

Aim: The aim was to evaluate the effectivity and toxicity of Ukrain in the palliative treatment of pancreatic cancer.

Patients: A total of 90 patients suffering from unresectable, highly advanced pancreatic cancer were randomized into this three arm study. All patients included had a local infiltration of large vessels (UICC IVa; arm A: 43%, arm B: 43%, arm C: 27%) or hepatic and/or peritoneal metastases (UICC IVb; arm A: 57%, arm B: 57%, arm C: 73%). Treatment in arm A consisted of weekly Gemcitabine infusions (1000mg/sqm) as recently described. In arm B patients resceived weekly infusions of Ukrain (20mg) and in arm C patients received 1000mg/sqm Gemcitabine plus 20mg Ukrain weekly. Every three months patients were reevaluated by CT-scan, chest X-ray and ultrasound of the abdomen. Toxicity and quality of life (EORTC-QLQ30) were evaluated every cycle.

Results: In all three arms therapy was well tolerated and toxicity was moderate. At the first reevaluation in arm A 68%, in arm B 25%, and in arm C 18% of the patients showed disease progression, whereas 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 regression analysis were in arm A 5.15 months, arm B 7.85 months, and in arm C 10.4 months (arm A vs. arm B: p < 0.01, arm A vs. 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 vs. arm B: p < 0.05, arm A vs. arm C p < 0.01).

Conclusion: Therapy was well tolerated in all three arms. We observed a significant difference in survival times in patients treated with Ukrain monotherapy or Ukrain plus Gemcitabine as compared to Gemcitabine monotherapy. Our results suggests Ukrain as a potent drug for the treatment of unresectable pancreatic cancer.