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Prolonged gemcitabine infusion could improve pancreatic cancer outcomes

Last Updated: 2003-09-26 11:30:09 -0400 (Reuters Health)

NEW YORK (Reuters Health) - As a treatment for pancreatic adenocarcinoma, infusion of gemcitabine at a fixed dose rate (FDR) increases blood levels of the drug and appears to improve survival compared with standard 30-minute infusion, new research shows.

"Our study is the first to show that FDR infusion yields higher levels of gemcitabine in a patient's blood than standard infusion, potentially paving the way for new and improved treatment regimens," lead author Dr. Margaret Tempero, from the University of California at San Francisco, said in a statement.

The findings, which are published in the September 15th issue of the Journal of Clinical Oncology, are based on a phase II trial of 92 patients with pancreatic cancer who were randomized to receive a standard or FDR infusion of gemcitabine on days 1, 8, and 15 of every 4-week cycle. Ninety-one percent of patients had metastatic disease.

The standard infusion involved a gemcitabine dose of 2200 mg/m² delivered over 30 minutes. In contrast, the FDR infusion involved a dose of 1500 mg/m² given over 150 minutes.

Despite using a lower total dose, the FDR infusion achieved blood cell levels of gemcitabine that were about twice the amount achieved with standard infusion.

Although time to treatment failure was similar in each group, the FDR group had a median survival of 8 months, about 3 months longer than that of the comparison group (p = 0.013). However, when the analysis was limited to patients with metastases, the difference in median survival was no longer statistically significant.

Still, FDR infusion was associated with a significant improvement in 1- and 2-year survival rates. For example, 18.3% of FDR-treated patients were alive at 2 years, compared with only 2.2% of those treated with the standard infusion (p = 0.007).

In terms of toxic effects, more grade 3 and 4 hematologic side effects were seen in the FDR group, the researchers point out. In contrast, nonhematalogic adverse effects were equally common in each group.

"If the results of our study are confirmed, they could indicate an exciting new platform for delivering an array of existing chemotherapy drugs, expanding treatment options available to patients," Dr. Tempero noted.

The findings suggest that FDR infusion may improve patient outcomes, note Dr. Donna S. Shewach and Dr. Theodore S. Lawrence, from the University of Michigan in Ann Arbor, in a related editorial.

"However, the absence of a difference between the arms regarding the primary end point of time-to-failure and the lack of a statistically significant improvement in survival in metastatic patients means that the treatment results of this study can best be viewed as hypothesis-generating, rather than definitive," they add. The results of an ongoing phase III trial may help determine if clinical outcomes are actually improved.

J Clin Oncol 2003;21:3383-3384,3402-3408.

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