Franco, P., Migliaccio, F., Angelini, V., Cante, D., Sciacero, P., Peruzzo Cornetto, A., . . . Ricardi, U. (2014). Palliative radiotherapy for painful bone metastases from solid tumors delivered with static ports of tomotherapy (TomoDirect): Feasibility and clinical results. Cancer Investigation, 32, 458–463. 

DOI Link

Study Purpose

To evaluate the feasibility and efficacy of palliative radiation therapy given via static ports of tomotherapy

Intervention Characteristics/Basic Study Process

Tomotherapy is a treatment modality that delivers a series of highly modulated linear beam paths for hypofractionated palliative radiation therapy (RT). Doses given were 3 Gy in 10 fractions, 4 Gy in five fractions, or 8 Gy in one fraction. The selection of a schedule was individualized to patients. Pain was evaluated by physicians immediately before RT for current, worst within the past 24 hours, least, and average pain. Opioid consumption in the previous 24 hours was evaluated.

Sample Characteristics

  • N = 130
  • MEDIAN AGE = 68 years (range = 36–89 years)
  • MALES: 41%, FEMALES: 59%
  • KEY DISEASE CHARACTERISTICS: Various tumor types were included with the most common being non-small cell lung, breast, and prostate cancers. All participants had painful bone metastases. The most common RT sites were the pelvis, lumbar region, and thoracic columns.
  • OTHER KEY SAMPLE CHARACTERISTICS: In total, 64% of participants were receiving active antitumor treatment.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Italy

Phase of Care and Clinical Applications

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

Study Design

Prospective, observational study

Measurement Instruments/Methods

  • 11-point Numeric Rating Scale (NRS) for pain
  • Pain response definitions were identified according to score reductions or increases by two points and by stable, increased, or decreased opioid consumption.

Results

At two weeks, response rates ranged from 49%–55% with no significant difference between the fractionation groups. Among all patients, opioid consumption decreased (p < 0.001). At two months, response rates decreased to 40%. The rate of no response was highest in the 8 Gy single fraction group. This group also had increased opioid use and more frequent retreatment.

Conclusions

RT is effective for pain relief in patients with painful bone metastases. This study suggested that the TomoDirect™ delivery of RT can be feasible and effective.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Unintended interventions or applicable interventions not described that would influence results 
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Other limitations/explanation: No information regarding the use of bone modifying agents was given. Pain was assessed by physicians rather than patient-reported. Which pain scores were used for analysis was not clear.

 

 

Nursing Implications

RT was effective for pain reduction in patients with painful bone metastases; however, the duration of palliation may be brief. Studies have suggested that multiple fractionation for RT delivery may be more effective.