Pergolizzi, S., Iati, G., Santacaterina, A., Palazzolo, C., Di Pietro, A., Garufi, G., & Ferrau, F. (2006). Treatment planning in patients with bone metastases. Final results of a prospective study using pre-medication with fentanyl to improve irradiation reproducibility. Supportive and Palliative Cancer Care, 2, 71–75.

To evaluate the compliance to radiation treatment planning of patients with bone metastases who have been premedicated with transdermal fentanyl

Fentanyl was delivered at 25–50 mcg/hour starting a week before treatment planning and during simulation. Immobilization devices were not mandatory.

• The sample was composed of 42 enrolled patients.
• Mean patient age was 68.5 years.
• Of all patients, 16 were male and 26 were female.
• Patients had epithelial cancer with skeletal metastases and strong pain uncontrolled by FANS and/or steroids. The most common primary cancers were breast and prostate cancers. All patients had 1–4 metastatic bone sites.
• Median pain score at first evaluation was 12 (the range of scores was 4–36), mean Karnofsky Performance Status Score was 60 (range, 40–80). In the sample were 47 treated metastases: 27 vertebral bodies, 11 of the femur, 3 of the humerus, and one of the pelvis.
• Patients were excluded if they had bone fractures or spinal cord compression; if estimated life expectancy was longer than three months; or if they did not have brain metastases.

Italy

Prospective study

• Pretreatment measures included physical examination; bone scan; x-ray; CT and/or MR scan; and Karnofsky Performance Status Score, with special emphasis on pain
• Modified Radiation Therapy Oncology Group (RTOG) scale (including domains measuring severity and frequency of pain and use of analgesic drugs), to measure modified pain
• Spitzer Quality of Life Index, or QL-I (0–10, with 10 being best quality of life), to measure quality of life
• Primary endpoint: patients’ compliance to maintaining established position
• Secondary endpoint: quality of life at end and at 40 days after external-beam radiation therapy

• Median pain score at treatment planning was 8 (range, 3–36).
• During simulation, 39 of 42 patients maintained position throughout the entire treatment period.
• The day after first external-beam radiation therapy, median pain score was 8. Median QL-I of 35 of 42 patients was 5 (range, 2–9).
• At end of treatment, pain score median was 6 (range, 1–36), QL-I was 6 (range, 2–10).
• Two patients died within 40 days of the end of radiation therapy.
• At 40 days after radiation therapy, median pain score of 40 patients was 3.5 (range, 0–24) and median QL-I score of 33 patients was 7 (range, 2–10).
• Treatment with fentanyl was well tolerated. The most common adverse responses were nausea, vomiting, constipation, and dizziness.
• According to the treating physician, 95% of patients maintained best position. This result suggests that patients’ comfort was acceptable.
• The intervention resulted in amelioration of quality of life for all patiients at end of radiation therapy and at 40 days after completion of therapy.

Transdermal fentanyl is efficacious and associated with minimal side effects.

• The study had a small sample size.
• Other factors affecting pain, such as use of analgesics, were not clearly defined. The scale accounted for such use in a general way but not specifically.
• Authors did not identify the specific drug being studied.
• During pain assessment, what was the site of pain? Was it at the site of metastasis or elsewhere?
• The treating physician decided whether a patient maintained the position. The report mentioned no quantitative measure associated with compliance.
• Were patients mobile? Where they at home or in an inpatient or hospice setting?

Previous studies have shown that perception of improved quality of life positively influences duration of survival.