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| |  Quadramet Is Effective In Relieving Pain Of Spreading Cancer N. BILLERICA, MA -- March 30, 1998 -- A newly-published multi-center study confirms that DuPont Pharma’s cancer therapy agent Quadramet(R) (Samarium Sm 153 Lexidronam Injection) provides significant pain relief from metastatic prostate and breast cancer that has spread to bone. The study also concludes that Quadramet may lead to the decreased use of opioid analgesics which often are associated with undesirable side effects. The landmark study appears in the April issue of the Journal of Clinical Oncology. Quadramet offers new hope to the estimated 200,000 cancer patients who every year experience the severe and debilitating pain associated with bone metastases -- resulting from the spread of cancer throughout the body. Quadramet is indicated for the relief of pain in patients with confirmed osteoblastic bone lesions that enhance on radionuclide bone scan. These patients often survive for long periods of time and therefore face prolonged periods of pain. According to the study, a single injection of the drug may relieve the pain caused by multiple osteoblastic (bone-forming) lesions. "Traditional therapies -- including opioid analgesics and external beam radiation therapy -- are rarely adequate or appropriate for the long-term management of metastatic bone pain," said Aldo Serafini, M.D., the principal investigator of the study and professor of radiology and medicine at the University of Miami/Sylvester Comprehensive Cancer Center. "The positive results of this study should serve as a call-to-action, encouraging all physicians and patients to evaluate the ways in which they are treating cancer bone pain. "With the availability of Quadramet, physicians have a much- needed new option for those patients who meet the treatment's indication." This is the first published report of a multi-center, double-blind, randomized, placebo-controlled study involving Quadramet. Throughout the study, patients kept a daily diary, recording their pain intensity for 13 body regions and rating the pain on a scale from zero (no pain) to 10 (worst possible pain). The type and dose of all opioid analgesic medications also were recorded daily in the pain diary. Any Quadramet not taken up by the bone is excreted from the body within six to 12 hours. The drug causes a transient and reversible suppression of bone marrow. In clinical trials, patients' white blood cell and platelet counts tended to return to pretreatment levels by week eight. This recovery allows a patient's physician to better plan the timing of appropriate cancer treatments. Before administering Quadramet, the patient's current clinical and hematological status and history of bone marrow response to treatment with myelotoxic agents should be considered and the clinical benefit should outweigh the risks. Please consult the Package Insert for additional information on adverse events. More information on: Quadramet and DuPont Pharma.
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