Prospective patient-based assessment of effectiveness of palliative radiotherapy for bone metastases

Purpose: The primary objective of this report is to prospectively evaluate pain control provided by palliative radiotherapy for all irradiated patient s with bone metastases by using their own assessments. Materials and methods: A prospective database was set up for all patients r eferred for palliative radiotherapy for bone metastases. Patients were aske d to rate their pain intensity using an 11 categorical point scale (0 = lac k of pain, 10 = worst pain imaginable). Analgesic consumption during the pr eceding 24 It was recorded and converted into equivalent total daily dose o f oral morphine. For those who received radiotherapy, follow-up was conduct ed via telephone interviews at week 1, 2, 4, 8 and 12 post treatment using the same pain scale and analgesic diary. Radiotherapy outcome was initially assessed by pain score alone. Complete response (CR) was defined as a pain score of 0. Partial response (PR) was defined as a reduction of score grea ter than or equal to2 or a greater than or equal to 50% reduction of the pr e-treatment pain score. We further analyzed outcomes using integrated pain and analgesic scores. Response was defined as either a reduction of pain sc ore greater than or equal to2 with at least no increase in analgesics or at least stable pain score with a greater than or equal to 50% reduction in a nalgesic intake. Results: One hundred and five patients were treated with palliative radioth erapy. When response evaluation was by pain score alone, the PR rates at 2, 4, 8 and 12 weeks were 44, 42, 30 and 38%, respectively; while the CR rate s were 24, 32, 31 and 29%, respectively. The overall response rate at 12 we eks was 67%. When assessed by the integrated pain and analgesic scores, the response rates were 50, 46, 43 and 43%, respectively. Conclusion: The response rate in our patient population is comparable with those reported in clinical trials. This is important when counselling our p atients on the expected effectiveness of radiotherapy outside of clinical t rials. Our observations confirm the generalizability of the trials conducte d to date. While randomized trials still remain the gold standard of resear ch, observational studies can serve as useful adjuncts to randomized trials to confirm the efficacy and guide the design of new controlled trials. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.