title: Pilot randomised study of early intervention based on tumour markers in the follow-up of patients with primary breast cancer.
abstract: BACKGROUND
  This pilot study aimed to test the possibility of therapeutic benefit imparted by early intervention based on sequential tumour marker (TM) measurements during follow-up of primary breast cancer (PBC) patients.
  
  
  METHODS
  Patients with oestrogen receptor positive PBC with no clinical and/or radiological evidence of metastases were recruited and followed-up 3-monthly with clinical assessment and TM (CA15.3 and CEA) measurements. The clinical team was blinded to the TM results. Asymptomatic patients who developed raised TMs (based on pre-defined cut-offs) were randomised to either 'treatment change' (either start or change of adjuvant endocrine agent to another agent) or 'no change' (control). Patients who developed symptomatic metastases came off the study. The primary and secondary endpoints were intervals from randomisation to symptomatic metastases and to last follow-up/death respectively.
  
  
  RESULTS
  Eighty-five patients (median age = 54 years (30-72)) were recruited with a median follow-up of 81 months (1-124). Sixteen patients were randomised as described. There was no significant difference (treatment change versus no change) with regards to interval from randomisation to symptomatic metastases - 23 (2-62) and 22 (1-63) months respectively (p = 0.9), as well as interval from randomisation to last follow-up/death - 36 (7-63) and 37 (10-63) months respectively (p = 0.9).
  
  
  CONCLUSIONS
  Despite long follow-up (up to 10+ years), this small study has thus far shown no significant difference in outcome. However, we have confirmed the feasibility of this study design but a larger study will be required to show if there is a benefit to this approach.
authors.affiliation: School of Medicine, University of Nottingham, UK. Electronic address: mathewjohn9@aol.com.
authors.forename: J
authors.initials: J
authors.lastname: Mathew
authors.affiliation: School of Medicine, University of Nottingham, UK; Department of Clinical Pathology, Nottingham University Hospitals, Nottingham, UK.
authors.forename: P
authors.initials: P
authors.lastname: Prinsloo
authors.affiliation: School of Medicine, University of Nottingham, UK.
authors.forename: A
authors.initials: A
authors.lastname: Agrawal
authors.affiliation: School of Medicine, University of Nottingham, UK.
authors.forename: E
authors.initials: E
authors.lastname: Gutteridge
authors.affiliation: School of Medicine, University of Nottingham, UK; Department of Clinical Pathology, Nottingham University Hospitals, Nottingham, UK.
authors.forename: C
authors.initials: C
authors.lastname: Marenah
authors.affiliation: School of Medicine, University of Nottingham, UK.
authors.forename: J F R
authors.initials: JF
authors.lastname: Robertson
authors.affiliation: School of Medicine, University of Nottingham, UK. Electronic address: kl.cheung@nottingham.ac.uk.
authors.forename: K L
authors.initials: KL
authors.lastname: Cheung
mesh_terms: D000328:Adult; D000368:Aged; D000077384:Anastrozole; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy / Q000556:secondary*; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy / Q000473:pathology*; D002272:Carcinoembryonic Antigen / Q000097:blood*; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D017273:Goserelin / Q000008:administration & dosage; D006801:Humans; D008113:Liver Neoplasms / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy / Q000556:secondary*; D008175:Lung Neoplasms / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy / Q000556:secondary*; D008875:Middle Aged; D018396:Mucin-1 / Q000097:blood*; D009570:Nitriles / Q000008:administration & dosage; D010865:Pilot Projects; D016037:Single-Blind Method; D013629:Tamoxifen / Q000008:administration & dosage; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage
chemical_list: D002272:Carcinoembryonic Antigen; D018396:Mucin-1; D009570:Nitriles; D014230:Triazoles; D013629:Tamoxifen; D017273:Goserelin; D000077384:Anastrozole
keywords: Primary breast cancer; Symptom free interval; Tumour markers