To: Cheryl Galt who wrote (29451 ) 11/20/1999 7:36:00 PM From: Cheryl Galt Respond to of 32384
Searching Medscape news, I found this nice plug for Ontak in a trade journal (Sept 1999): ------------------------- Ontak Offers Quality-of-Life Advantages in CTCL Bruce Jancin, Denver Bureau [Skin & Allergy News 30(9):26, 1999. ¸ 1999 International Medical News Group.] -------------------------------------------------------------------------------- CHICAGO -- Ontak, a new type of cytotoxic agent approved earlier this year for treatment of cutaneous T-cell lymphoma, has a substantially better quality-of-life profile than traditional cancer therapies, Dr. Madeleine Duvic said at the annual meeting of the Society for Investigative Dermatology. She reported on a phase III, 20-center study of Ontak (denileukin diftitox) in 71 cutaneous T-cell lymphoma (CTCL) patients refractory to a mean of five prior therapies. Thirty percent of CTCL patients responded to Ontak with a complete remission or partial response when tumor burden was the primary indicator. Mean duration of response was 6.7 months. The response rate was 23% in patients randomized to 8 æg/kg of Ontak and 36% in those who got 18 æg/kg, said Dr. Duvic of the University of Texas in Houston. A validated quality-of-life assessment tool for cancer patients -- the FACT-G -- showed Ontak responders had significantly improved scores in the domains of functional, social, and family well-being relative to baseline. "On the other hand, the patients who didn't respond to Ontak didn't have a reduction in their quality of life, which makes this therapy different from other things we do to patients with cutaneous T-cell lymphoma," she observed. Ontak belongs to a new class of receptor-active cytotoxic fusion proteins. It is composed of the receptor-binding domain of interleukin-2 fused to diphtheria toxin. It targets activated T cells expressing CD25, the alpha chain of the interleukin-2 receptor. When Ontak is selectively taken up by these cells, the toxin is released, resulting in cell death due to inhibition of protein synthesis. This new, highly selective approach to cancer therapy has potential applications for other T-cell-mediated skin and organ-specific autoimmune diseases, Dr. Duvic said. The majority of patients in the phase III trial responded to Ontak with a significant improvement in pruritus scores. This was gratifying because pruritus in late-stage CTCL is a major problem that's unresponsive to conventional therapies. Ontak was given by intravenous infusion over 15-60 minutes for 5 days. Courses were repeated every 3 weeks up to eight times in the absence of toxicity or disease progression. Common side effects included fever, chills, and nausea.medscape.com