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No Survival Benefit for Adding 5-FU to Gemcitabine: Two Trials

No Survival Benefit for Adding 5-FU to Gemcitabine: Two Trials

SAN FRANCISCO—Two studies presented at the 37th Annual Meeting of
the American Society of Clinical Oncology (ASCO) show no advantage to adding
fluorouracil (5-FU) to gemcitabine (Gemzar) in patients with advanced
pancreatic cancer.

In a phase III Eastern Cooperative Oncology Group trial (ECOG 2297) (ASCO
abstract 505), the addition of 5-FU to gemcitabine did not significantly increase overall survival compared
with single-agent gemcitabine, although some trends were favorable for the
combination, said Jordan Berlin, MD, Vanderbilt University School of Medicine.

Dr. Berlin noted that earlier trials have established gemcitabine as the
standard first-line therapy, and have also suggested a median survival range
between 4.4 and 11 months for the combination of gemcitabine plus 5-FU. Those
trials, however, have left in question the role of 5-FU.

Study Protocol

In the current trial, patients were randomized to gemcitabine 1,000 mg/m²
weekly for 3 of 4 weeks or to gemcitabine 1,000 mg/m² followed by 5-FU 600
mg/m², both given weekly for 3 of 4 weeks.

The primary endpoint of the study was increase in median survival, Dr.
Berlin said. Patients were also evaluated for response rate, progression-free
survival, chemotherapy toxicity, and level of pain. No maximum number of cycles
or stratification factors were established.

Included patients (gemcitabine = 163, gemcitabine plus 5-FU = 164) had
metastatic or locally advanced pancreatic cancer (measurable or evaluable),
with performance status 0-2, adequate organ function, and no previous treatment
except adjuvant therapy more than 6 months prior to enrollment.

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