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Fluorouracil (5-FU) single agent
Abstract: Improvements in survival and clinical benefit with gemcitabine
as first-line therapy for patients with advanced pancreas cancer: a randomized
trial.
PURPOSE: Most patients with advanced pancreas cancer experience pain
and must limit their daily activities because of tumor-related symptoms.
To date, no treatment has had a significant impact on the disease. In early
studies with gemcitabine, patients with pancreas cancer experienced an improvement
in disease-related symptoms. Based on those findings, a definitive trial
was performed to assess the effectiveness of gemcitabine in patients with
newly diagnosed advanced pancreas cancer. PATIENTS AND METHODS: One hundred
twenty-six patients with advanced symptomatic pancreas cancer completed
a lead-in period to characterize and stabilize pain and were randomized
to receive either gemcitabine 1,000 mg/m2 weekly x 7 followed by 1 week
of rest, then weekly x 3 every 4 weeks thereafter (63 patients), or to fluorouracil
(5-FU) 600 mg/m2 once weekly (63 patients). The primary efficacy measure
was clinical benefit response, which was a composite of measurements of
pain (analgesic consumption and pain intensity), Karnofsky performance status,
and weight. Clinical benefit required a sustained (> or = 4 weeks) improvement
in at least one parameter without worsening in any others. Other measures
of efficacy included response rate, time to progressive disease, and survival.
RESULTS: Clinical benefit response was experienced by 23.8% of gemcitabine-treated
patients compared with 4.8% of 5-FU-treated patients (P = .0022). The median
survival durations were 5.65 and 4.41 months for gemcitabine-treated and
5-FU-treated patients, respectively (P = .0025). The survival rate at 12
months was 18% for gemcitabine patients and 2% for 5-FU patients. Treatment
was well tolerated. CONCLUSION: This study demonstrates that gemcitabine
is more effective than 5-FU in alleviation of some disease-related symptoms
in patients with advanced, symptomatic pancreas cancer. Gemcitabine also
confers a modest survival advantage over treatment with 5-FU.
References
Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano
MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA,
Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit
with gemcitabine as first-line therapy for patients with advanced pancreas
cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13.
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| 5 - FU....... 600 mg / M2 IV
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