Table 1.
Study | Study design | No. of patients |
BM characteristics | Main study objective | Eligibility criteria for complicated BM | Radiation schedule |
Overall response definition | Complete response definition | When response was measured | ||
---|---|---|---|---|---|---|---|---|---|---|---|
Single fx | Multiple fx | Single fx | Multiple fx | ||||||||
Qasim, 197717 | Retrospective | 69 | 246 | BM from lung or breast cancer | Compare single- vs multiple-fx RT | None | 800-1000 rads | 2000 rads/5 fx | Pain reduction with or without the need for mild analgesic drugs | When patients became completely free from pain | 3-4 wk after RT |
Wu et al, 200618 | Based on prospectively collected data | 58 | 27 | BM mainly from breast or prostate cancer (patients who received treatment in 1 dominant area of bone pain) | Characterize effect of palliative RT | Excluded spinal cord compression; included bone lesions with neuropathic pain, established or high risk of pathologic fracture, and/or soft-tissue mass | 6-8 Gy (most received 8 Gy) | 18-30 Gy/4-10 fx | Reduction in worst pain score by ≥ 2/10 | NR | 4-6 wk after RT |
Kapoor et al, 201519 | Single-center, prospective, observational | 116 | 71 | Spine metastases mainly from lung, breast, or prostate cancer | Compare single- vs multiple-fx RT | None | 8 Gy (100%) | 30 Gy/10 fx (100%) | Reduction in visual analog scale score by at least 2 points from baseline | Not specified | 30 d after completion of RT |
Nakamura et al, 201620 | Single-institute, prospective | 5 | 12 | BM mainly from breast, lung, or prostate cancer (patients with neuropathic features) | Estimate prevalence of neuropathic pain features among patients who received palliative RT | None | 8 Gy (100%) | 30 Gy/10 fx, 20 Gy/5 fx | Pain score improvement ≥2 with no increase in analgesia or decrease in analgesia of ≥25% without increase in pain score∗ | An index pain score of 0 with no increase in analgesia∗ | 2 mo after start of RT |
Conway et al, 201621 | Based on prospectively collected data | 509 | 395 | BM mainly from genitourinary, breast, or lung cancer | Compare single- vs multiple-fx RT | Included BM with pathologic fracture and/or neurologic compromise | 4-10 Gy (median, 8 Gy) | 4-50 Gy/5-25 fx (median, 20 Gy/5 fx) | Improvement in pain score by at least 1 point | Follow-up pain score of 0 | 3-4 wk after completion of RT |
van der Velden et al, 201722 | Based on prospectively collected data | 382 | 389 | BM mainly from breast, prostate, or lung cancer | Develop and validate clinical risk score to predict pain response | None | 8 Gy | NR | Pain score improvement ≥2 with no increase in analgesia or decrease in analgesia of ≥25% without increase in pain score∗ | NR | Within 3 mo after RT |
van der Velden et al, 201723 | Two-center, prospective, observational | 82 | 36 | Spine metastases mainly from breast, prostate, lung, or kidney cancer | Evaluate relationship between mechanical stability and response to palliative RT | Excluded BM with invalidating neurologic deficits (American Spinal Injury Association E or D without progression) | 8 Gy | 30 Gy/10 fx, 20 Gy/5 fx | Pain score improvement ≥2 with no increase in analgesia or decrease in analgesia of ≥25% without increase in pain score∗ | NR | 4-8 wk after RT |
Cacicedo et al, 201824 | Multicenter, prospective observational (secondary analysis) | 37 | 88 | BM from lung, prostate, or breast cancer | Evaluate whether age is predictor of pain response | Excluded BM with pathologic fracture, spinal cord compression, or cauda equina syndrome | 8 Gy | 20 Gy/5 fx (87%), 20 Gy/4 fx (13%) | Pain score improvement ≥2 with no increase in analgesia or decrease in analgesia of ≥25% without increase in pain score† | NR | 4 wk after completion of RT |
Duraisamy et al, 201825 | Single-center, retrospective | 63 | 96 | BM mainly from breast, lung, or prostate cancer | Compare single- vs multiple-fx RT | Excluded BM with spinal cord compression or pathologic fracture | 8 Gy, 10 Gy | 20 Gy/5 fx, 30 Gy/10 fx | Reduction in pain score by at least 1 (scale 1-4) at the treated site without analgesic intake or analgesic reduction by at least 25% from baseline without increase in pain | Pain score of 0 at the treated site with no increase in analgesic intake | 12 wk after RT |
Abbreviations: BM = bone metastases; fx = fraction; NR = not reported; RT = radiation therapy.
International Consensus Endpoint published in 2012.
International Consensus Endpoint published in 2002.