on Wednesday, January 10, 2007
Newly published results from a randomized, Phase III trial show that the drug sunitinib malate (Sutent®) is more effective than the conventional treatment given as an initial therapy for patients with advanced kidney cancer. The multicenter study, led by Robert Motzer, MD, at Memorial Sloan Kettering Cancer Center, is published in the January 11, 2007, issue of the New England Journal of Medicine. [PubMed Abstract]
This is the first study to demonstrate sunitinib’s effectiveness as a first-line therapy compared with the standard cytokine-based chemotherapy, Interferon-alpha (IFN-alpha). Dr. Motzer and his coauthors conclude that sunitinib, an anti-angiogenic agent, is a new “reference standard of care” for first-line treatment of advanced kidney cancer, which is known to be highly resistant to cytokine-based chemotherapy — the standard treatment for the past 20 years.
The current study included 750 patients over the age of 18 who were diagnosed with advanced kidney cancer and were previously untreated for the disease. Half were treated with a six-week cycle of sunitinib, and half were treated with a six-week cycle of IFN-alpha. The median progression-free survival for treatment with sunitinib was 11 months, compared with 5 months following treatment with IFN-alpha. In addition, 31 percent of the patients in the sunitinib arm of the study experienced substantial tumor shrinkage compared with 6 percent of the patients receiving the standard treatment.
Patients in the sunitinib group also reported significantly better health-related quality of life than those in the IFN-alpha group. Most toxicities observed with sunitinib treatment — such as hypertension, hand-foot syndrome, vomiting, and diarrhea — were ameliorated by dose interruption or modification.
Investigators from the following centers also contributed to the current study: Baylor Sammons Cancer Center/Texas Oncology PA, Dallas, TX; Klinika Oncologii Oddzial Chemioterapii, Poznan, Poland; Massachusetts General Hospital, Boston, MA; The Cleveland Clinic Foundation, Cleveland, OH; Hospital Pitie-Salpetriere, Paris, France; Hopital Europeen Georges-Pompidou, Paris, France; Centre Leon Berard, Lyon, France; Military Institute of Medicine, Warsaw, Poland; and City of Hope Comprehensive Cancer Center, Los Angeles, CA. The study was sponsored by Pfizer, Inc.