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| |  Combination of High Dose Samarium Sm-153 Lexidronam Injection and Chemotherapy Shows Promise for Treatment of High-Risk Acute Myeloid Leukemia Data published in peer-reviewed journal Leukemia & Lymphoma PRINCETON, NJ -- September 18, 2006 -- Cytogen Corporation today announced the publication of new data relating to the Company's Quadramet(R) (samarium Sm-153 lexidronam injection) product. The publication, "Marrow irradiation with high-dose 153 Samarium-EDTMP followed by chemotherapy and hematopoietic stem cell infusion for acute myelogenous leukemia" by Vilmarie Rodriguez, MD, a Pediatric Oncologist at The Mayo Clinic in Rochester, Minnesota, appears in a recent issue of the peer-reviewed journal Leukemia & Lymphoma (Leuk Lymphoma. 2006 Aug;47(8):1583-92). In the study conducted by independent investigators, four high-risk acute myeloid leukemia (AML) patients (age range 15 to 20 years) received a significantly higher dose of Quadramet than the standard palliative dose in combination with chemotherapy conditioning regimens with melphalan (n = 3) or busulfan/cyclophosphamide (n = 1) as preparatory conditioning regimens prior to hematopoietic stem cell transplantation. High-risk features included secondary AML and a chromosomal defect known as monosomy 7 (n = 1), chemotherapy induction failure (n = 1), and AML in relapse (n = 2). The dose of Quadramet administered to the patients was 19 mCi/kg (n = 1) and 30 mCi/kg (n = 3), compared to the approved 1 mCi/kg dose used in the palliative setting. Complete cytogenetic and morphologic remission of AML was seen on follow- up marrow aspirate and biopsy in all patients. Two high-risk AML patients remain in continuous complete remission with excellent quality of life (one patient greater than 2-years, another greater than 4-years) following the treatment regimen with high dose Quadramet. Two patients had a complete response and subsequently relapsed (one patient at 64 days and the other at 6 months). No hemorrhagic cystitis, nephrotoxicity, or serious infections were seen. "The predominant pattern of treatment failure in AML involves incomplete elimination of the disease from the bone marrow," said Dr. Peter Anderson, a Pediatric Oncologist at The University of Texas M. D. Anderson Cancer Center, an investigator in the study and co-author of the publication. "Because Quadramet can provide substantial amounts of radiation specifically to the marrow, the use of this agent in AML may improve the therapeutic index of transplant regimens. The positive clinical responses observed in this group of high-risk patients indicate that further evaluation of this therapeutic approach is warranted." "The group at the Mayo Clinic has pioneered investigations into the use of high dose Quadramet in the treatment of hematologic malignancies including multiple myeloma and AML," said William Goeckeler, PhD, Senior Vice President of Operations at Cytogen. "These results are exciting not only for the positive clinical responses reported but also because they add to the body of data on the lack of renal and other non-hematologic toxicity associated with the use of these very high doses of Quadramet." About Acute Myeloid Leukemia (AML) About 35,070 new cases of leukemia will be diagnosed in the United States during 2006. Approximately half will be acute leukemias. The most common leukemia is acute myeloid leukemia (AML), with about 11,930 new cases expected. About 9,040 deaths from AML will occur in the United States during 2006. AML is usually treated by a combination of cytotoxic drug therapies and in some cases, bone marrow transplantation. About Quadramet Quadramet is an oncology product indicated for pain relief that pairs the targeting ability of a small molecule, bone-seeking phosphonate (EDTMP) with the therapeutic potential of radiation (samarium Sm-153). Skeletal invasion by prostate, breast, multiple myeloma, and other cancers often creates an imbalance between the normal process of bone destruction and formation. Quadramet selectively targets such sites of imbalance, thereby delivering radioactivity to areas of the skeleton that have been invaded by metastatic tumor. Quadramet has demonstrated a range of characteristics that may be advantageous for the treatment of pain arising from metastatic bone disease, including early onset of pain relief (patients may experience pain relief within the first week with maximal relief generally occurring at three to four weeks after injection), length of pain relief, lasting a median of four months in responding patients, and predictable and reversible bone marrow toxicity or myelosuppression that tends to return to pretreatment levels after eight weeks. Quadramet is administered as a single intravenous injection, usually on an outpatient basis, and exhibits selective uptake in areas of bone formation with little or no detectable accumulation in soft tissue. Quadramet Safety Profile Blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function. Non- hematologic adverse events that occurred in 5% or more of patients and greater than placebo were pain flare (7%), diarrhea (6%), infection (7%), spinal cord compression (6.5%), arrhythmias (5%), and hematuria (5%). Patients who receive Quadramet should be advised that for several hours following administration, radioactivity will be present in excreted urine. To help protect themselves and others in their environment, precautions need to be taken for 12 hours following administration.
SOURCE: Cytogen Corporation
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