Mercadante, S., Porzio, G., Ferrera, P., Aielli, F., Adile, C., Ficorella, C., . . . Casuccio, A. (2012). Tapentadol in cancer pain management: A prospective open-label study. Current Medical Research and Opinion, 28, 1775–1779.

To evaluate the efficacy and tolerability of tapentadol (TP) in the management of cancer pain

Fifty consecutive patients with advanced cancer and moderate-to-severe pain initially were given 50 mg doses of slow-release TP twice a day, along with oral morphine 5 mg (initial dose) as breakthrough medication. Doses were managed to provide adequate pain relief or dose-limiting toxicity. Non-opioid medications were continued, provided they were tolerated. Adjuvant symptom relief medications were continued. Patients were visited or contacted at least weekly in order to change therapy. Parameters were assessed before starting therapy and at weekly intervals for four weeks. Parameters included pain intensity (0–10), symptoms associated with pain therapy, quality of life using the Spitzer scale, TP escalation index percent at week 4 ([TP maximum dose - TP starting dose] / TP starting dose / days x 100), and the presence of neuropathic pain using the PainDETECT questionnaire.

• N = 50
• MEDIAN AGE = 66.3 years
• MALES: 40%, FEMALES: 60%
• KEY DISEASE CHARACTERISTICS: Primary tumors were breast (n = 13), urogenital (n = 10), gastrointestinal (n = 9), lung (n = 7), pancreas (n = 5), and other (n = 6).
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with moderate-to-severe pain (greater than 4 on a 10-point scale); unresponsive to non-opioid drugs; with occasional use of opioids; who had a Karnofsky score of 50 or more; who did not have poor renal or hepatic function, history of substance abuse, cognitive failure, brain metastasis, or brain damage; who did not have a short anticipated survival

• SITE: Single site 
• SETTING TYPE: Not specified 
• LOCATION: University of Palermo, Italy (assumed to be a teaching facility but not clearly identified)

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

• Prospective, single-arm intervention study

• Pain on a 0–10 scale
• Symptoms related to opioid therapy
• Quality of life measured with Spitzer scale
• TP escalation index percent ([TP maximum dose - TP starting dose] / TP starting dose / days x 100)
• PainDETECT to determine prevalence of neuropathic pain

Pain intensity significantly decreased from baseline to all week intervals. Some symptoms varied in intensity during the study. Drowsiness increased in week 1 and decreased at week 4. Dry mouth increased from weeks 1–3 and decreased from weeks 1–4. No significant changes were seen in intensity of confusion, nausea, or constipation. Quality of life increased each week. TP escalation index (TPEI) percent and TPEI in mg were 1.78 and 2.26, respectively. No relationship was found between TPEI indexes and primary tumor, pain mechanism, PainDETECT, age, or gender. TPEI was lower in this study than in prior studies with a similar design. This may reflect less tolerability of TP in this study. TP had low discontinuation levels and was well tolerated.

Pain levels significantly decreased during the study. TPEI in this study was lower than in prior studies with a similar design that may reflect less tolerability of TP. TP was well tolerated with low discontinuation levels.

• Small sample (less than 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Number of patients lost to follow-up

TP is not widely used in the United States and will require education of nurses on its use and side effects.