SAN FRANCISCO—Two studies presented at the 37th Annual Meeting of the American Society of Clinical Oncology (ASCO) show no advantage to adding fluorouracil(Drug information on fluorouracil) (5-FU) to gemcitabine(Drug information on 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.
