The clinical efficacy of adjuvant systemic chemotherapy with
gemcitabine and Ukrain (NSC-631570) in advanced
pancreatic cancer.
Center for Oncological, Endocrinological and Minimal-access Surgery, University of Ulm, Silcherstr. 36, 89231 Neu-Ulm, Germany. frank. gansauge@eurosurgery.de
BACKGROUND/AIMS: 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. METHODOLOGY: 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.
翻译：
使用吉西它宾和Ukrain（NSC-631570） 的辅助化疗系统对晚期胰腺癌的临床疗效
Gansauge F, Ramadani M, Schwarz M, Beger HG, Lotspeich E, Poch B.
（德国ULM大学 内分泌和肿瘤外科中心）
背景/目的：最近我们已经证明 NSC-631570 (Ukrain)在治疗无法切除的胰腺癌病人方面是一种安全而有效的药物。该研究的目的是观察吉西它宾和NSC-631570联合应用在可切除的晚期胰腺癌的辅助治疗方面的效果。
方法：30位病人在切除胰腺癌后接受了辅助化疗。化疗方案：根据Burris给药方案以
1000 mg/sqm.的剂量每周注射吉西它宾，随后立即静脉注射UKRAIN 20mg，每次注射时间不少于15分钟。
结果：WHO II级毒性发生率53%，没有观察到WHO III和IV毒性发生。80%病人疾病复发，无复发病人的存活时间为21.7个月，准确的1年存活率为86.7%，2年存活率为76.6%，3年存活率为
46.7%，5年后的存活率为23.3%。根据Kaplan-Meie回归分析计算的中位生存时间为33.8个月。
结论：这种以吉西它宾和Ukrain（NSC-631570） 联合治疗晚期胰腺癌的辅助化疗是一种安全的治疗方法，且获得了延长的存活时间。虽然需要进一步试验去确证这个结论，但是吉西它宾和
Ukrain（NSC-631570）的联合应用在可切除的晚期胰腺癌的辅助治疗方面肯定是一种有前途的疗法。
