Gansauge F, et al. The clinical efficacy of adjuvant systemic chemotherapy with gemcitabine and NSC-631570 in advanced pancreatic cancer. Hepatogastroenterology. 2007;54:917-920.
In this study, Ukrain was evaluated as adjuvant treatment in patients with resected locally advanced pancreatic cancer. One cycle consisted of weekly infusions of gemcitabine 1000 mg/m2 followed by Ukrain 20 mg for 3 weeks followed by 1 week without therapy. Thirty patients received a mean number of 9.0 cycles (range 3–12). Over half of patients (53%) experienced WHO grade II toxicities, but no WHO grade III or IV toxicities occurred. Disease recurrence occurred in 80% of patients, and median relapse-free survival time was 21.7 months. Actuarial survival rates after 1, 2, 3 and 5 years were 86.7%, 76.6%, 46.7%, and 23.3% respectively, with a median survival time of 33.8 months. The investigators concluded that Ukrain adjuvant to gemcitabine chemotherapy may prolong survival in advanced-stage pancreatic cancer patients, but these results need confirmation by a larger randomized controlled trial.
Gansauge F, et al. NSC-631570 (Ukrain) in the palliative treatment of pancreatic cancer: results of a phase II trial. Langenbecks Arch Surg 2002;386:570-4.
A randomized trial evaluated Ukrain monotherapy versus gemcitabine versus Ukrain plus gemcitabine in patients with unresectable advanced pancreatic cancer. In arm A, 30 patients received 1000 mg gemcitabine/m2 weekly (first cycle: 7 weeks of therapy, 1 week of rest; 2nd-12th cycles: 3 weeks of therapy, 1 week of rest). In arm B, 30 patients received 20 mg Ukrain weekly (following the same cycle). In arm C, 30 patients received both agents at the same doses above. In the first week of the first cycle, arms B and C received 20 mg/day Ukrain. No complete responses were documented. Significantly more partial responses were noted in arms B and C. Median survival according to Kaplan-Meier analysis was 5.2 months in arm A, 7.9 months in arm B, and 10.4 months in arm C. More patients in arms B and C had received prior chemotherapy or radiotherapy. Side effects were comparable between groups, except that arms B and C had more cases of fever, and each had 2 cases of tumor bleeding. Because of this, the authors recommended that Ukrain should only be used under medical supervision.