Agarwal, K.K., Singla, S., Arora, G., & Bal, C. (2015). (177)Lu-EDTMP for palliation of pain from bone metastases in patients with prostate and breast cancer: A phase II study. European Journal of Nuclear Medicine and Molecular Imaging, 42, 79–88. 

To evaluate the safety and efficacy of (177)Lu-EDTMP for the palliation of pain from bone metastases

Patients with documented bone metastases from prostate or breast cancer were randomly assigned to two groups. One received low-dose and one received high-dose (177)Lu-EDTMP. The radiopharmaceutical was given over one minute via an indwelling IV catheter. Patients were examined at one, two, four, six, eight, 12, and 16 weeks.

• N = 44  
• MEAN AGE = 66 years (males), 47 years (females)
• MALES: 72%, FEMALES: 28%

• PHASE OF CARE: Active antitumor treatment

Randomized, parallel-group trial

• Analgesic score (0 = no analgesic, and 4 = regular opioids)
• Visual Analog Scale (VAS) for pain severity (> 70% VAS decrease = complete response, 40%–70% decrease = partial response, 20%–40% decrease minimal response, and < 20% decrease = no response)
• Bone lesion score based on skeletal scintigraphy
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

Overall, 13% of participants experienced a complete responses to the intervention, 48% had partial responses, and 25% had minimal responses. VAS scores were significantly lower at all time points compared to baseline (p < 0.0001) with progressive decreases till four weeks. There was no change between weeks four and eight, and thereafter, pain increased significantly. There were no significant differences in responses between the high- and low-dose groups or between patients with prostate and breast cancers. Grades 3–4 toxicities were seen in 23% of patients, including anemia. The median hemoglobin nadir occurred at three weeks, and the median time to recovery was six weeks. Leukocyte and platelet nadirs occurred at four weeks and recovered to baseline after eight weeks. There was no relationship between pain responses and bone lesion scores.

The radiopharmaceutical tested here was effective in relieving pain from bone metastases in patients with prostate and breast cancers, and it was associated with few high-grade toxicities. Low- and high-dose treatments had similar efficacy.

• Small sample (< 100)
• Risk of bias (no blinding)

This study added to the body of evidence regarding the efficacy of radiopharmaceuticals for pain relief from bone metastases. Various agents have shown different durations of pain-free periods. Nurses need to be aware that bone marrow toxicity is a major dose-limiting factor with radiopharmaceuticals, and patients who receive these agents should be monitored for toxicity. Additional research directly comparing the efficacy and duration of various radiopharmaceuticals' effects is needed.