Sopata, M., Katz, N., Carey, W., Smith, M.D., Keller, D., Verburg, K.M., . . . Brown, M.T. (2015). Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain, 156, 1703–1713.

To assess tanezumab as a potential treatment for cancer pain

This is a report of two studies—one was a phase II study and the other was an open-label extension. Patients had an opioid dose adjustment phase of 3–30 days followed by a three-day assessment period. Once opioid management was stabilized, patients were randomized to receive a single dose of 10 mg tanezumab or matching placebo. Between 8 and 16 weeks, patients were given the option to enroll in the extension study. Pain was assessed at weeks 1, 2, 4, 6, 8, 12, and 16. Patients were followed for 40 weeks.

• N = 59 in phase II study, 41 in extension trial   
• MEAN AGE = 58.9 years
• MALES: 46%, FEMALES: 54%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Cancer types were breast, prostate, multiple myeloma, and renal cell cancer. All had pain from bone metastases.
• OTHER KEY SAMPLE CHARACTERISTICS: Baseline worst pain scores were an average of 6.4.

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Multiple countries

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care 

• Double-blind, randomized, controlled trial followed by open-label extension

• 11-point numeric pain rating scale
• Brief Pain Inventory (short form)
• Neuropathy Impairment Score (NIS)

No significant differences between groups in average or worst pain scores were reported, although, after week 4, pain was trending lower for the tenazumab group. No significant differences between groups in analgesic consumption existed. Pain began to increase during the extension period. Adverse events were comparable between groups. Six episodes of abnormal peripheral sensation were reported.

This study did not demonstrate a statistically significant difference in pain with tanezumab compared to placebo; however, between weeks 4 and 8, pain was lower with tanezumab.

• Small sample (< 100)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals
• No information is provided regarding previous use of any bone-modifying agents

Evidence is currently insufficient to show the efficacy of tanezumab for pain from bone metastases. However, lower pain levels shown suggest that additional research in this area is warranted.