title: Long-term analysis and prospective validation of a prognostic model for patients with high-risk primary breast cancer receiving high-dose chemotherapy.
abstract: OBJECTIVE
  We described previously a prognostic model for high-risk primary breast cancer patients receiving high-dose chemotherapy (HDC). Such model included nodal ratio (no. involved nodes:no. dissected nodes), tumor size, hormone receptors, and HER2. In the present study we intended to test this model prospectively in a second patient cohort. In addition, we analyzed the long-term overall outcome of our HDC trials.
  
  
  METHODS
  We analyzed all 264 patients enrolled since 1990 in our prospective trials for 4-9+, > or = 10+ nodes, or inflammatory disease. Patients of the second cohort (treated since 1997) had their prognostic score estimated prospectively before receiving HDC.
  
  
  RESULTS
  Fourteen patients (5.3%) died from HDC-related complications. At median follow-up of 7.1 years, relapse-free survival and overall survival of the whole group were 69.8% and 73%, respectively. Median time to relapse was 14 months (63.5% relapses within the first 2 years, 6.7% after year 5). The model was validated in the second cohort, establishing the following pretransplant risk categories: low risk (low score, HER2-), 44% patients, 87% freedom from relapse (FFR); intermediate risk (low score, HER2+), 29% patients, 68% FFR; and high risk (high score, any HER2), 27% patients, 49% FFR.
  
  
  CONCLUSIONS
  Few relapses are seen after year 5 of follow-up, which indicates the need for mature results of the randomized trials before their final interpretation or meta-analysis. Our prospectively validated prognostic model, if additionally confirmed in the randomized trial populations, may provide an insight into the relative benefit of HDC in different risk patient subsets.
authors.affiliation: University of Colorado Bone Marrow Transplant Program, Denver, Colorado 80262, USA. yago.nieto@uchsc.edu
authors.forename: Yago
authors.initials: Y
authors.lastname: Nieto
authors.forename: Samia
authors.initials: S
authors.lastname: Nawaz
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Shpall
authors.forename: Scott I
authors.initials: SI
authors.lastname: Bearman
authors.forename: James
authors.initials: J
authors.lastname: Murphy
authors.forename: Roy B
authors.initials: RB
authors.lastname: Jones
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D015331:Cohort Studies; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D008875:Middle Aged; D008962:Models, Theoretical; D015999:Multivariate Analysis; D011379:Prognosis; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases