Trisenox® is highly active in refractory multiple myeloma patients when combined with Vitamin C and melphalan
According to Cell Therapeutics, Inc., which markets Trisenox® (arsenic trioxide) injection, data presented at this year’s meeting of the American Society of Clinical Oncology (ASCO) reported that patients with refractory multiple myeloma had shown a high objective response.
A case study review of seven refractory multiple myeloma patients treated with a combination of Trisenox®, vitamin C and melphalan (MAC) revealed that all patients had a 29-85% reduction in M-protein while four of the seven patients (57 percent) remained free of cancer progression for a median of 34 weeks.
Two of the seven patients (29 percent) in the study had failed stem cell transplant, five (71 percent) had failed thalidomide treatment, and three (43 percent) had failed bortezomib prior to receiving the MAC regimen. All seven patients responded to therapy, with one patient achieving a near complete response (85 percent reduction in M-protein).
MAC therapy resulted in a marked improvement in renal function in four out of four patients with myeloma kidney damage of whom two were close to requiring dialysis. Responses lasted between 17 and 48 weeks.
Dr James R. Berenson, M.D., Director, of the Myeloma and Bone Metastasis Program at Cedars-Sinai Medical Center considered the results with the MAC combination "were very encouraging." He explained that the results: "have prompted the development of a phase II, multicenter trial testing MAC therapy in 100 patients at 15 sites throughout the United States."
About Trisenox®
Trisenox® (arsenic trioxide) is marketed by Cell Therapeutics, Inc. (CTI) and was approved for marketing in 2000 by the U.S. Food and Drug Administration to treat patients with relapsed or refractory Acute Promyelocytic Leukemia. (APL), a rare, life-threatening cancer of the blood. Trisenox® was granted marketing authorization from the European Commission in March 2002. APL, one of eight subtypes of acute myeloid leukemia (AML), represents 10-15 percent of the more than 20,000 patients diagnosed with AML each year. Trisenox® is currently being studied in more than 40 clinical trials in a variety of cancers.
Safety information
Trisenox® should be administered under the supervision of a physician who is experienced in the management of patients with acute leukemia. Some patients with acute promyelocytic leukemia (APL) treated with Trisenox® have experienced APL differentiation syndrome -- with symptoms similar to retinoic acid-acute promyelocytic leukemia (RA-APL) syndrome. Arsenic trioxide can cause QT prolongation (which can lead to torsade de pointes) and complete atrioventricular block.
The most common adverse events associated with Trisenox® have been generally manageable, reversible and usually did not require interruption of therapy. These have included hypokalemia, hypermagnesemia, hyperglycemia and thrombocytopenia as reported in 13 percent of the patients (n=40). Abdominal pain, dyspnea, hypoxia, bone pain and neutropenia were reported in 10 percent of these patients, while arthralgia, febrile neutropenia and disseminated intravascular coagulation were reported in eight percent of patients.
Keywords : Cell Therapeutics Inc. Trisenox® (arsenic trioxide) ASCO Oncology Combination Melphalan Arsenic Vitamin C (MAC) Refractory multiple myeloma Objective response M-protein Safety FDA approval Acute myeloid leukemia (AML) Development Trials
