Source: J Clin Otorhinolaryngol  |  Posted 7 years ago

By Charlene Laino

NEW YORK, NY -- November 15, 2004 -- Thalidomide appears to improve quality of life in patients with advanced pancreatic cancer, and result in better time to progression and overall clinical benefit, findings from a phase 2 study show.

William Maples, MD, oncologist in the department of hematology/oncology, Mayo Clinic, Jacksonville, Florida, reported the findings here on November 11th at the Chemotherapy FOUNDATIONS Symposium XXII: Innovative Cancer Therapy for Tomorrow.

The study involved a 1-week run-in period of thalidomide 200 mg daily, after which patients were started on a weekly schedule of gemcitabine given as a 30-minute infusion for 3 weeks, followed by a 1-week break of the gemcitabine. The dose of thalidomide was escalated in each patient based on his or her ability to tolerate the drug.

Patients underwent clinical evaluations monthly, with measurable disease assessed radiographically every 8 weeks. To be eligible for the trial, patients had to have locally advanced or metastatic disease.

Dr. Maples said 3 of 30 evaluable patients in his study achieved a partial response, while disease stabilized in another 19 patients. The 73% overall response rate is similar to what is seen in studies of gemcitabine alone in this population, he said.

One-year survival among patients treated with the thalidomide combination was 29%, Dr. Maples said, while studies of gemcitabine alone show a 1-year survival rate of 18%. The median time to progression in the study was 17 weeks, compared with 9 weeks in studies of gemcitabine alone, he added.

Importantly, 38% of patients taking the combination treatment reported clinical benefits, compared with 25% of patients in trials in which gemcitabine was administered alone, he said.

Clinical benefit was evaluated using 4 measures: more than a 20-point improvement in Karnofsky Performance Status score, a drop of more than 50% in analgesic use for more than 4 weeks, an improvement of more than 2 points on a 7-point pain scale, and a 7% increase in weight, he said.

Dr. Maples said the findings appear to show some improvement in quality-of-life parameters.

Side effects were common, "as would be expected for such a sick group," with 33 of 39 patients evaluable for safety reporting grade 3-5 toxicities, he said.

Based on the results, Dr. Maples said his team is pursuing studies of gemcitabine and second-generation immunomodulatory agents.

The research was funded by Celgene Corp.

[Presentation title: Thalidomide & Gemcitabine in First-Line Pancreatic Cancer.]