COX-2 inhibitor plus radiation
COX-2 inhibitors are a class of drugs that have been shown to have some anti-tumor activity against human prostate cancer, both in the lab and in tests on humans. German researchers wanted to find out if combining COX-2 inhibitors with radiation therapy causes more severe side effects than radiation alone. They conducted a Phase I trial to test this.
Twenty-two patient were recruited for the trial. They received 400 mg twice daily of Celebrex (Celecoxib) from the start of the radiation treatment. Radiation doses ranged between 70 and 74 Gy standard fractionation ( overall, a little on the low side by today’s standards). The patients were asked about gastrointestinal (GI) and genitourinary (GU) acute toxicity once a week during radiation therapy, at six weeks after therapy and three month after completing radiation treatment.
“Generally no major increase in the level and incidence of side effects potentially caused by the combined treatment was observed.” In two cases a generalised skin rash occurred, which immediately resolved upon discontinuation of the drug. No grade 3 and 4 toxicity was seen. Maximal GI toxicity grade 1 and 2 was observed in 85% and 10%, respectively. In terms of GU toxicity 80 % of the patients experienced a grade 1 toxicity and 10 % had grade 2 symptoms.
Conclusion — “The combination of irradiation to the prostate with concurrent high dose celecoxib was not associated with an increased level of side effects.”
Source: Combination of celecoxib with percutaneous radiotherapy in patients with localised prostate cancer - a phase I study.Radiat Oncol. 2006 Apr 10;1(1):9. Ganswindt U, Budach W, Jendrossek V, Becker G, Bamberg M, Belka C. CCC Tubingen, Centre for Genitourinary Oncology, Department of Radiation Oncology, University of Tubingen, Tubingen, Germany.
Merck, the manufacturer of Vioxx, has denied in court that its drug can cause cardiovascular harm in any short period of time. This has since been to be false. See:
Vioxx Heart Risks Began Earlier than Thought
by Snigdha Prakash
May 18, 2006 · New data obtained by NPR show that patients who took Vioxx even for short periods were at higher risk of heart problems and strokes. An estimated 20 million Americans took the painkiller before Merck & Co. stopped selling it in 2004.
In a confidential report to the Food and Drug Administration (FDA) last week, Merck gave new details about a large Vioxx study known by the acronym APPROVe. Results from this study led Merck to pull Vioxx from the market in 2004, and were later published in the New England Journal of Medicine (NEJM).
The new report details more heart problems. Several of the new events occurred in Vioxx patients soon after they started taking the drug.
Clinical trial expert Curt Furberg of Wake Forest University reviewed the new report for NPR. He says it shows short-term users of Vioxx were at greater risk of heart problems than previously described in the NEJM paper.
The data in that paper indicated “it takes about 18 months to see an increase in risk,” said Furberg. “With the new information, the risk appears to be present from the beginning, and it increases gradually over time.”
Comment by admin — June 24, 2006 @ 5:03 pmhttp://www.npr.org/templates/story/story.php?storyId=5413812