title: A role for radiotherapy in neuropathic bone pain: preliminary response rates from a prospective trial (Trans-tasman radiation oncology group, TROG 96.05)
abstract: OBJECTIVE
  Radiotherapy (RT) has a proven role in palliation of pain from bone metastases with numerous randomized trials obtaining response rates (RRs) of typically 70-80% regardless of the fractionation employed. However RT for neuropathic bone pain (NBP), i.e., pain with a radiating cutaneous component due to compression/irritation of nerves by tumor has not previously been studied, and its role is thus uncertain.
  
  
  METHODS
  In February 1996, the Trans-Tasman Radiation Oncology Group (TROG) initiated a multicenter randomized trial comparing a single 8 Gy fraction with 20 Gy in 5 fractions for NBP with an accrual target of 270. Formal interim analyses were planned at 90 and 180 patients. The 90th patient was accrued in June 1998, and data from the first interim analysis with both arms combined form the basis of this report.
  
  
  RESULTS
  Forty-four patients were randomized to a single 8 Gy, 46 to 20 Gy in 5 fractions. The commonest primary sites were prostate (34%), lung (28%) and breast (10%). Median age was 68 years (range 37-89). The index site was spine (86%), rib (13%), base of skull (1%). On an intention-to-treat basis, the overall RR was 53/90 = 59% (95% CI = 48-69%), with 27% achieving a complete response and 32% a partial response. The overall RR for eligible patients was 49/81 = 60% (95% CI = 49-71%) with 27% and 33% achieving complete and partial responses respectively. Estimated median time to treatment failure was 3.2 months (95% CI = 2.1-5.1 months), with estimated median survival of 5.1 months (95% CI = 4.2-7.2 months). To date, six spinal cord/cauda equina compressions and four new or progressive pathological fractures have been detected at the index site after randomization, although one cord compression occurred before radiotherapy was planned to commence. In February 1999, the Independent Data Monitoring Committee strongly recommended continuation of the trial.
  
  
  CONCLUSIONS
  Although these results are preliminary, it seems clear that there is indeed a role for RT in the treatment of NBP. Analysis of outcome by treatment arm awaits completion of the randomized trial.
authors.affiliation: Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
authors.forename: D E
authors.initials: DE
authors.lastname: Roos
authors.forename: P C
authors.initials: PC
authors.lastname: O'Brien
authors.forename: J G
authors.initials: JG
authors.lastname: Smith
authors.forename: N A
authors.initials: NA
authors.lastname: Spry
authors.forename: P J
authors.initials: PJ
authors.lastname: Hoskin
authors.forename: B H
authors.initials: BH
authors.lastname: Burmeister
authors.forename: S L
authors.initials: SL
authors.lastname: Turner
authors.forename: D M
authors.initials: DM
authors.lastname: Bernshaw
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001859:Bone Neoplasms / Q000150:complications / Q000532:radiotherapy* / Q000556:secondary; D001943:Breast Neoplasms / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009408:Nerve Compression Syndromes / Q000150:complications / Q000532:radiotherapy*; D010146:Pain / Q000209:etiology / Q000532:radiotherapy*; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000473:pathology; D013117:Spinal Cord Compression / Q000150:complications / Q000532:radiotherapy; D016103:Spinal Fractures / Q000150:complications