Renal Insufficiency: Patients with renal insufficiency have not been studied.

Drug-drug interaction studies have not been studied.

The beta particle of ¹⁵³Sm-EDTMP travels an average of 3.1 mm in soft tissue and 1.7 mm in bone. In clinical trials of 78 patients with meta-static bone lesions who had 13 specific bone scan sites evaluated, the presence or absence of ¹⁵³Sm-EDTMP uptake is similar to the presence or absence of ^99mTc diphosphonate uptake (range 67 to 96% agreement depending upon the blinded reader and the site of the body). Whether the amount of ¹⁵³Sm-EDTMP uptake varies with the size of the lesion or to the presence of osteolytic components has not been studied. The clinical benefit of Sm-153-EDTMP in patients with osteolytic lesions is not known. The relationship of different tumor cell types to clinical response has not been studied.

Overall Quadramet was evaluated in 580 patients (see Adverse Events Section for demographic description). Of these patients, 270 (244 men, 26 women) were studied in two randomized, blinded, placebo controlled clinical trials. These patients had a mean age of 67, and a range 22 to 87 years. Eligible patients had painful metastatic bone lesions that had failed other treatments, had at least a 6 month expected survival and had a positive radionuclide bone scan. Routine x-rays to evaluate the metastatic lesions were not part of the protocol.

In study A, 118 patients were randomized to receive 0.5 mCi/kg Quadramet, 1.0 mCi/kg Quadramet, or a placebo intravenous injection. In study B, 152 patients were randomized to receive either 1.0 mCi/kg Quadramet or a placebo intravenous injection. Both studies were double blind over a 4 week period. Patients scored their daily pain intensity on a visual ana-logue scale rated from 0 (no or low pain) to 10 (excruciating pain). The area under the pain curve (AUPC) was obtained by integrating the daily pain scores by week. Opioid analgesic use was recorded daily and averaged over each week and expressed in oral morphine milligram equivalents.

Of the 270 patients studied, 232 (86%) had prostate cancer and 38 (14%) had other primary cancers. In study A, 80 (68%) of the patients had prostate cancer and 38 (32%) had a variety of other primary tumors. In study B, all (100%) patients had prostate cancer.

The results of the patients' AUPC scores are shown in Table 3. In both trials for each of the 4 weeks of study, the mean AUPC scores decreased in patients who received Quadramet (1.0 mCi/kg). In study A, pain (the AUPC) decrease from baseline was significantly different in Quadramet 1.0 mCi/kg and placebo groups at weeks 3 and 4. In study B, pain (the AUPC) decrease from baseline was significantly different in Quadramet 1.0 mCi/kg and placebo groups at weeks 2, 3 and 4.

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