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| |  Drug Brings Relief From Bone Pain Of Metastatic Breast Cancer and Prostate Cancer PRINCETON, NJ. -- October 9, 1997 -- A newly-published clinical study of Cytogen Corp.'s Quadramet(R) (samarium Sm 153 lexidronam injection) suggests a single dose can significantly alleviate the pain of bone metastases from breast cancer, prostate cancer and other primary cancers in a safe and dose-dependent manner. The multi-centre study was conducted at seven sites in Europe and is reported in the October issue of the European Journal of Cancer. This is the first published report of a controlled clinical trial in which statistically-significant dose response for pain relief was observed with a radiotherapeutic agent.
Quadramet received marketing clearance by FDA in March 1997 for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan. Quadramet is not approved as treatment for prolonging survival in any tumor type. The double-blind study centrally randomized 114 cancer patients with painful bone metastases to receive a single Quadramet dose of either 0.5 mCi/kg or 1.0 mCi/kg. During the first four weeks after administration, patients assessed each day their pain intensity, daytime discomfort and quality of sleep. During the fourth week, which was the primary efficacy timepoint of the study, there was a statistically-significant difference in pain relief between the two doses in favor of the 1.0 mCi/kg dose. A predictable level of dose-related bone marrow suppression was associated with Quadramet treatment. Platelet and white blood cell counts reached low points at weeks three or four with both doses and recovered to normal levels by the fifth week. Even at their lowest, counts were generally higher than those commonly associated with serious complications. Bone marrow toxicity was no greater in women than in men despite the fact women tended to enter the study with lower platelet and white blood cell counts due to prior marrow-suppressive treatment. Quadramet is an intravenously-administered radiopharmaceuticalindicated for the treatment of pain associated with cancers that have spread to bone. This condition is most often experienced by patients with prostate, breast or lung cancers. Quadramet is a therapeutic agent that concentrates in areas of bone that have been invaded with tumor. More information on: Quadramet, Cytogen Corp.
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