Department of Internal Medicine 1 of Erlangen University, Erlangen, Germany.
Med Sci Monit. 2010 Mar;16(3):CR124-131.
The aim of this study was to evaluate the efficacy and toxic side effects of combined gemcitabine plus weekly high-dose 5-Fluorouracil (5-FU) as 24h-infusion in patients with metastatic pancreatic cancer (UICC IV) as validation group of an earlier phase II study. Primary endpoints were to assess the response and tumour control rate.
MATERIAL/METHODS: This study comprised 60 prospectively registered patients with metastatic pancreatic cancer (UICC IV). A locally advanced disease was defined as exclusion criteria. The treatment schedule was weekly gemcitabine (1.000 mg/m(2)) as a 0.5h-infusion combined with 5-FU (2.000 mg/m(2)) as a 24h-infusion on day 1, 8 and 15 every 28 days.
Response rate (CR+PR) was achieved in 7% of the patients, tumour control rate (CR+PR+SD) was achieved in 59%. Median time-to-progression was 4 months, median overall survival was 7.3 months (95% CI 5.4-9.1). The median survival of patients with normal CEA value was 10.6 months (95% CI 7.8-13.4); with a normal CA 19-9 median survival was 10.1 months (95% CI 4.6-15.7) and with ECOG performance status 0 median survival was 10.1 months (95% CI 8.6-15.3). As higher grade toxicity (grade 3/4) leukopenia (15%), anaemia (10%) and thrombopenia (5%) were observed. Nausea and diarrhea (grade 3/4) occurred in 5% of the patients and vomiting in 2%.
The administration of gemcitabine and 5-FU as a 24h-infusion is feasible and offers good tumour control rate accompanied by tolerable toxicity. The subgroup of patients with a good performance status (ECOG 0) and tumour markers within the normal range benefit from the gemcitabine combination therapy.
本研究旨在评估吉西他滨联合每周高剂量 5-氟尿嘧啶（5-FU）作为 24 小时输注治疗转移性胰腺癌（UICC IV 期）患者的疗效和毒副作用，作为早期 II 期研究的验证组。主要终点是评估反应率和肿瘤控制率。
材料/方法：本研究纳入了 60 例转移性胰腺癌（UICC IV 期）患者，前瞻性注册。局部进展性疾病被定义为排除标准。治疗方案为每周吉西他滨（1000mg/m²）作为 0.5 小时输注，联合 5-FU（2000mg/m²）作为 24 小时输注，第 1、8 和 15 天，每 28 天一次。
患者的缓解率（CR+PR）为 7%，肿瘤控制率（CR+PR+SD）为 59%。中位无进展时间为 4 个月，中位总生存期为 7.3 个月（95%CI 5.4-9.1）。CEA 值正常的患者中位生存期为 10.6 个月（95%CI 7.8-13.4）；CA19-9 正常的患者中位生存期为 10.1 个月（95%CI 4.6-15.7）；ECOG 表现状态为 0 的患者中位生存期为 10.1 个月（95%CI 8.6-15.3）。观察到更高等级的毒性（3/4 级）包括白细胞减少（15%）、贫血（10%）和血小板减少（5%）。恶心和腹泻（3/4 级）在 5%的患者中发生，呕吐在 2%的患者中发生。
吉西他滨联合 5-FU 作为 24 小时输注是可行的，提供了良好的肿瘤控制率，同时伴有可耐受的毒性。表现状态良好（ECOG 0）和肿瘤标志物在正常范围内的患者亚组从吉西他滨联合治疗中获益。
