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).
OBJECTIVE
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
Santasusana
Joan Maurel
JM
Departamento de Oncología Médica, Hospital Clínic, Barcelona, Spain.
García López
José Luis
JL
García
Juan José
JJ
Carbonero
Ana Isabel León
AI
Plazas
Javier Gallego
JG
Rovira
Pedro Sánchez
PS
Martos
Carlos Fernández
CF
Guzmán
M Carmen Galán
MC
Jericó
Jesús Florián
JF
Delgado
Francisco Javier Dorta
FJ
Espinosa
Javier Casinello
JC
Muñoz
Marta Llanos
ML
Aguilar
Enrique Aranda
EA
Valera
Javier Sastre
JS
García Ribas
Ignacio
I
Mena
Alfredo Carrato
AC
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D006932:Hyperbilirubinemia / Q000139:chemically induced; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010349:Patient Compliance; D011788:Quality of Life; D013030:Spain; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine