الفهرس 
Introduction and aim of the workOnly 14 pages are availabe for public view
 |  | from | 130 |  |  |
| | | from | 130 | | |
Abstract
Twenty six patients (19 men and 7 women) with a mean of 57.69
(range 19-81years) and ECOG performance status ranged between1-3 were
enrolled in this study. Patients with histopathologically or radiologically
proved locally advanced or metastatic pancreatic cancer. Forty two percent
of patients (42.3%) were non smoker.
Their main complaint was abdominal pain (100%) then jaundices
(80.76%). As regard disease characteristics, pathological diagnosis of T3 in
15 patients was 57.7%; T4 in four patients was 15.4%. Twenty one of
patients (80.76%) had tumor at head of pancreas, three patients (11.5%) at
the tail, two patients (7.7%) at the body of pancreas. 15 of patients (57.7%)
of patients were biopsied and 11 of patients (42.3%) were stented.
After treatment of 26 patients with continuous infusion of
gemcitabine over 6 hours weekly for seven weeks and then for d1, d8 every
3 weeks the patients were followed by multi-slice CT of chest & pelviabdominal and tumor marker CA 19-9. If there is radiological or
biochemical response (partially or stationary), treatment was continued as
d1&d8 every 3 weeks then assessment by CT of chest &pelvi-abdominal
and tumor marker CA 19-9 every three cycle.
There is response rate 39.5% in the form of complete response in one
patient (3.8%), partial response in 7 patients (26.9%) and stationary
response in 2 patients (7.7%). while there is disease progression in 16
patients (61.5%). Progression free survival (P.F.S) mean value was 3.65
months and median was 2.0 month while mean value of overall survival
(O.A.S) was 5.69 months and median 4 months.
Two significant prognostic factors were detected for progression free
survival (PFS), performance status, biopsy taken and one significant
Summary
95
prognostic factor was detected for overall survival (O.A.S), which is biopsy
taken.
Hematological toxicity was the most significant adverse effect. Grade
3, 4 neutropenia observed in 8(36.7%), 4(15.4%) patients respectively.
Grade 2, 3, 4 anemia occurred in 9(34.6%), 13(50%), 2(7.7%) patients
respectively, and grade 1, 2 thrombocytopenia in 5 (19.2%), 2 (7.7%)
patients. Also non-hematological toxic effect was observed such as
increased creatinine level in 6(23.0%) patients, nausea occurred in all
patients (100%), vomiting grade 1, 2, 3 experienced in 4 (15.3%),
12(46.1%), 5(19.2%) patients respectively
CONCLUSIONS AND RECOMMENDATIONS
Improvements in gemcitabine efficacy might be achieved through
modification of infusion rate, resulting in optimization of gemcitabine
uptake and subsequent activation in tumor cells.
Administration of gemcitabine at a fixed-dose rate (FDR) of 10
mg/m2/min, rather than a 30-minute bolus infusion, typically achieves
steady-state plasma levels of 15 to 20 micromole/L, a value shown to be
above that required to achieve maximal rates of dFdCTP accumulation. For
most clinical trials of FDR gemcitabine, a dose rate of 10 mg/m2/min has
been used to ensure that this threshold concentration is achieved.
Moreover, several trials have evaluated gemcitabine at a3–6-hour
infusion and shown substantial activity at considerably lower maximum
tolerated dose ranging from 250 to 450 mg/m2.
The number of patients included in our trial is limited and does not
permit a precise assessment of this treatment approach. However, several
conclusions can be drawn:
First, treatment with gemcitabine in prolonged infusion appears as a
feasible alternative to standard dose regimen but with a comparable efficacy
for treatment of patients with advanced pancreatic cancer.
Second, because this 6-hour infusion regimen could still be given on
an outpatient basis, decreasing the costs of the drug by approximately 75%,
while not much additional costs are added, should encourage wider use of
this effective combination, especially in regions of the world where
resources are limited.
Third, applying the prolonged infusion regimen in other
malignancies (e.g., bladder, breast) should be encouraged.