Ducreux M, Rougier P
Gastroenterology Unit, Institut Gustave Roussy, Villejuif, France.
J Infus Chemother. 1996 Fall;6(4):203-5.
Ninety-five patients with metastatic pancreatic (n = 38) or gastric (n = 57) carcinomas were treated by 5-day continuous infusion of 5-fluorouracil (5-FU) plus cisplatin in two parallel phase II trials. 5-fluorouracil was given at a dose of 1000 mg/m2 for 5 consecutive days and cisplatin was given on day 2 at a dose of 100 mg/m2. The total number of cycles administered was 425, and each patient received a median number of four cycles. Severe toxicities were observed in around 20% of the patients and 2 toxic deaths occurred. Response rate assessed in 92 evaluable patients was 34%. The overall median survival was 8 months. There were no clinical or biological factors predictive of response, but a better survival was observed in patients with objective response and CA 19-9 blood levels lower than 100 UI/I. These two predictive factors are independent when tested in a multivariate model. The combination of infusion 5-FU plus cisplatin can be considered as a standard for the treatment of gastric metastatic carcinomas and as a promising schedule for pancreatic carcinomas.
在两项平行的II期试验中，95例转移性胰腺癌（n = 38）或胃癌（n = 57）患者接受了5-氟尿嘧啶（5-FU）加顺铂的5天持续输注治疗。5-氟尿嘧啶以1000 mg/m²的剂量连续给药5天，顺铂在第2天以100 mg/m²的剂量给药。给药的总周期数为425个，每位患者接受的中位周期数为4个。约20%的患者出现严重毒性反应，发生了2例毒性死亡。在92例可评估患者中评估的缓解率为34%。总体中位生存期为8个月。没有可预测缓解的临床或生物学因素，但在客观缓解且CA 19-9血水平低于100 UI/I的患者中观察到了更好的生存期。在多变量模型中进行检验时，这两个预测因素是独立的。5-氟尿嘧啶加顺铂输注联合方案可被视为治疗胃转移性癌的标准方案，并可作为胰腺癌的一种有前景的治疗方案。
