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Thalidomide, Gemcitabine Combination Shows Benefit in Pancreatic Cancer: Presented at ASCO
By Ed Susman
NEW ORLEANS, LA -- June 6, 2004 -- Thalidomide appears to improve the quality of life and perhaps the quantity of life among patients with pancreatic cancer, researchers reported here June 5th.
"Combining thalidomide with gemcitabine appears to double the time to progression among pancreatic cancer patients in our study," said William Maples, MD, Department of Haematology/Oncology, Mayo Clinic, Jacksonville, Florida. "While this treatment is not a great leap forward, it does push everything forward."
Dr. Maples said 3 of the 25 patients in his phase 2 study achieved a partial response. That 12% response rate is similar to what is seen in studies of gemcitabine alone among pancreatic cancer patients. In addition, in his new study, 16 other patients achieved a stable disease state, providing an overall clinical benefit of 76%.
In his poster presentation during the American Society of Clinical Oncology 40th Annual Meeting, he reported that about 26% of his patients survived for 1 year, while in other studies with gemcitabine alone 1-year survival was about 18%.
Dr. Maples said the most encouraging aspect of the study was that 45% of patients thought that treatment was having a clinical benefit, compared with 25% of patients in trials where gemcitabine was administered alone.
These patients, he said, had more than a 20-point improvement in their Karnofsky Performance Status scores, decreased their consumption of analgesics for more than 4 weeks, had improvements of more than 2 points on a 7-paint pain scale, and achieved a 7% increase in weight. One patient in the study showed negative clinical responses which are generally quantification of that person's quality of life.
"We believe that thalidomide is an effective antiangiogenesis drug," Dr. Maples said. "But it also may have additional properties that combat cancer and decrease symptoms such as pain."
He said the researchers monitored patients to make sure they were not experiencing somnolence, a known adverse side effect of the drug. He said thalidomide appears to have heterogeneic effects on patients, making it necessary to carefully monitor the effects of the drug on a patient-to-patient basis.
"Thalidomide, which has immunomodulatory and antiangiogenesis properties, has shown promising results in malignant and non-malignant conditions," he said. "K-ras mutations, which are present in 90% of patients with pancreatic adenocarcinoma, can result in overexpression of VEGF [vascular endothelial growth factor], making thalidomide an agent to explore."
Dr. Maples also said that there may be something about thalidomide that interferes with the cellular functioning of the tumor itself. He said the results he saw in his study warrant further investigation of the combination in pancreatic cancer.
The study was sponsored by Celgene.
[Presentation title: Advanced Pancreatic Cancer: A Multi-Institutional Trial With Gemcitabine and Thalidomide. Abstract 4082]
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