吉西他滨与每周高剂量5-氟尿嘧啶48小时持续输注方案用于晚期胰腺癌患者的II期试验。西班牙胃肠道肿瘤治疗合作组（TTD）的一项研究。

A phase II trial of gemcitabine and weekly high-dose 5-fluorouracil in a 48-hour continuous-infusion schedule in patients with advanced pancreatic carcinoma. A study of the Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD).

作者信息

Santasusana Joan Maurel, García López José Luis, García Juan José, Carbonero Ana Isabel León, Plazas Javier Gallego, Rovira Pedro Sánchez, Martos Carlos Fernández, Guzmán M Carmen Galán, Jericó Jesús Florián, Delgado Francisco Javier Dorta, Espinosa Javier Casinello, Muñoz Marta Llanos, Aguilar Enrique Aranda, Valera Javier Sastre, García Ribas Ignacio, Mena Alfredo Carrato

机构信息

Departamento de Oncología Médica, Hospital Clínic, Barcelona, Spain.

出版信息

Clin Transl Oncol. 2005 Dec;7(11):493-8. doi: 10.1007/BF02717002.

DOI:10.1007/BF02717002

PMID:16373060

Abstract

AIM

A multi-centred, open-labelled, phase 11 study containing 46 patients was conducted to evaluate the clinical benefit of gemcitabine (1,400 mg/m(2)) combined with 5-FU (3 g/m(2)) in a 48 h continuous infusion (CI).

METHODS

Both drugs were administered on days 1, 8 and 15 of every 4 week cycle in chemotherapy-naïve patients with locally advanced unresectable metastatic pancreatic carcinoma. The minimum follow-up was 6 months.

RESULTS

Clinical benefit response was the primary endpoint and this was achieved by 24.4% of the patients. Quality of life (QoL) improved in 16.6% of patients. Objective response was observed in 7% of the patients. The median progression-free survival (PFS) was 14.4 weeks and the median overall survival (OS) time was 22.7 weeks. One-year survival was 25%. The most frequent grade 3-4 toxicities were neutropenia (45%), mucositis (7.5%) and hyperbilirubinaemia (10.5%).

CONCLUSIONS

This schedule was not superior in terms of clinical benefit, response rate, PFS and OS than standard gemcitabine treatment

摘要

目的

开展一项多中心、开放标签的II期研究，纳入46例患者，以评估吉西他滨（1400mg/m²）联合5-氟尿嘧啶（3g/m²）持续输注48小时的临床获益情况。

方法

对于初治的局部晚期不可切除转移性胰腺癌患者，每4周为一个周期，在第1、8和15天给予两种药物。最短随访时间为6个月。

结果

临床获益反应是主要终点，24.4%的患者达到该终点。16.6%的患者生活质量得到改善。7%的患者观察到客观缓解。中位无进展生存期（PFS）为14.4周，中位总生存期（OS）为22.7周。1年生存率为25%。最常见的3-4级毒性反应为中性粒细胞减少（45%）、粘膜炎（7.5%）和高胆红素血症（10.5%）。