Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial.

PURPOSE: To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study. PATIENTS AND METHODS: Patients with painful bone metastases secondary to a variety of primary malignancies were randomized to receive 153Sm-EDTMP 0.5 or 1.0 mCi/kg, or placebo. Treatment was unblinded for patients who did not respond by week 4, with those who had received placebo eligible to receive 1.0 mCi/kg of active drug in an open-label manner. Patient and physician evaluations were used to assess pain relief, as was concurrent change in opioid analgesia. RESULTS: One hundred eighteen patients were enrolled onto the study. Patients who received 1.0 mCi/kg of active drug had significant reductions in pain during each of the first 4 weeks in both patient-rated and physician-rated evaluations. Pain relief was observed in 62% to 72% of those who received the 1.O-mCi/kg dose during the first 4 weeks, with marked or complete relief noted in 31% by week 4. Persistence of pain relief was seen through week 16 in 43% of patients who received 1.0 mCi/kg, of active drug. A significant correlation (P = .01) was observed between reductions in opioid analgesic use and pain scores only for those patients who received 1.0 mCi/kg 153Sm-EDTMP. Bone marrow suppression was mild, reversible, and not associated with grade 4 toxicity. CONCLUSION: A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded.

Hyperthyroxinemia in patients receiving thyroid replacement therapy.

Eleven patients, with a history of hypothyroidism, who had hyperthyroxinemia and an elevated free thyroxine index but normal serum triiodothyronine concentrations on levothyroxine replacement underwent levothyroxine dose reduction at three-month intervals until the free thyroxine index fell into the normal range. All were clinically euthyroid throughout. Normalization of the thyrotropin response to thyrotropin-releasing hormone occurred concomitantly, indicating correction of subtle hyperthyroidism. The mean thyroxine dose decreased from 161 micrograms/d (2.06 micrograms/kg) to 120 micrograms/d (1.51 micrograms/kg). The resting heart rate fell in eight of 11 patients (P less than .02). The left ventricular ejection fraction decreased in eight of 11 patients, although the decrease was not statistically significant. Considering the sensitivity of pituitary, cardiac, and bone tissue to even a small excess of thyroxine over time, hyperthyroxinemia associated with an elevated free thyroxine index should be corrected even in patients taking levothyroxine replacement who are clinically euthyroid and whose serum triiodothyronine concentrations are within normal limits.

Hepatobiliary imaging: the diagnostic use of intravenous morphine in fasting patients.

Fasting and parenteral nutrition are associated with a spectrum of gallbladder disorders. We reviewed the use of hepatobiliary imaging in patients (N = 42) with fasting-induced gallbladder dysfunction. Intravenous morphine was administered in patients (N = 20) whose gallbladders did not visualize at 40 minutes after administration of diisopropyl iminodiacetic acid. In those patients whose gallbladders visualized with morphine (N = 8), the diagnosis of acute cholecystitis was excluded. Of those that did not visualize after morphine administration (N = 12), all were clinically diagnosed as acute cholecystitis. Although ultrasound is effective in demonstrating the anatomical features of prolonged gallbladder stasis including sludge, stones, and thickened gallbladder wall, it cannot detect cystic duct patency. Cholescintigraphy is an accurate test of cystic duct patency, but gallbladder stasis interferes with the ability of cholescintigraphy to visualize the gallbladder. From our experience, we propose that cholescintigraphy with intravenous morphine is beneficial in demonstrating cystic duct patency in fasting patients.

Scintigraphic findings in chronic actinomycosis osteomyelitis and associated soft tissue infection.

Scintigraphic findings are reported in a patient with actinomycosis osteomyelitis and soft tissue infection to illustrate the need to understand the mechanism of localization of the radiopharmaceutical to accurately assess the clinical pathology.

Hydroxyurea in the prevention of the effects of leukostasis in acute leukemia.

Hydroxyurea was administered orally to prevent the effects of leukostasis in adults with acute leukemia who had peripheral blast cell counts greater than 100,000/cu mm. A single oral dose of 50 to 100 mg/kg was given daily until the absolute blast cell count decreased to less than 100,000/cu mm. Hydroxyurea was effective in rapidly lowering the blast cell count by an average of 50% after one dose in each of ten episodes. No patient developed symptoms or signs of the leukostasis syndrome, and no side effects directly attributable to hydroxyurea were observed. The leukostasis syndrome associated with very high blast cell counts in adults with acute leukemia can be avoided by the use of hydroxyurea in the manner described. This treatment can be particularly useful in the interval before consultation or referral and prior to the cytotoxic effect of definitive induction chemotherapy.