Τίτλος:
Weekly gemcitabine plus fluorouracil-folinic acid given weekly for two
days in patients with advanced pancreatic cancer - A phase II study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Objective: To investigate the efficacy and toxicity of gemcitabine
administration followed by the combination of fluorouracil (5-FU)
modulated by folinic acid in patients with advanced, symptomatic
pancreatic cancer. The main objective was to estimate tumour response
and any improvement in patients’ quality of life.
Patients: The study included 48 evaluable patients with metastatic
disease with no prior chemotherapy. The study duration was 3 years.
Interventions: Gemcitabine 1000 mg/m(2) intravenously was given on days
1 and 8 followed by fluorouracil 350 mg/m(2) intravenously as a bolus
biologically modulated by folinic acid 350 mg/m(2) intravenously given
on days 1, 2, 8 and 9 in order to develop the conditions for any
potential drug synergism. The regimen was administered every 3 weeks for
1 year or until disease progression.
Results: Objective partial responses were documented in ten (21%)
patients (95% CI 10.5, 35). Twenty-two (46%) patients had stable
disease while 16 (33%) patients had progressive disease. The median
response duration was 8 months (range 4-20). The median time to
progression was 6 months (range 2-24), while the median survival of the
group was 7 months (range 3-36) and the probability of surviving beyond
12 months was 20%. Of the 44 patients with tumour-related symptoms who
were considered evaluable for clinical-benefit response, 28 (70%)
patients had pain improvement, 25 (52%) patients had improvement of
their performance status, and nine (28%) patients experienced weight
gain during treatment. Serum concentrations of cancer antigen (Ca-19-9)
were decreased by more than 50% in 14 (37%) of the 38 assessable
patients. Chemotherapy was well tolerated, with mild myelotoxicity.
Gastrointestinal toxicity was moderate with mild mucositis.
Conclusion: The regimen of gemcitabine and fluorouracil administered in
this study was well tolerated and showed a moderate antitumour activity
and a significant palliative effect on tumour-related symptoms. Because
fluoruracil is a low toxicity combination agent for gemcitabine, other
forms of the two-drug combination warrant further investigation.
Συγγραφείς:
Polyzos, A
Tsavaris, N
Kosmas, C
Gogas, H
Koutinos, G
and Nikiteas, NI
Felekouras, E
Kouraklis, G
Papadopoulos, O
and Papachristodoulou, A
Stamatiadis, D
Safioleas, M
Nikou,
G
Περιοδικό:
Clinical Drug Investigation
Εκδότης:
Adis International Ltd
DOI:
10.2165/00044011-200424110-00005
