p53 immunohistochemical staining and survival after adjuvant chemotherapy for breast cancer

Int J Cancer. 1997 Dec 19;74(6):605-8. doi: 10.1002/(sici)1097-0215(19971219)74:6<605::aid-ijc8>3.0.co;2-y.


We have investigated the relationship between immunohistochemically determined p53 status and outcome in 277 women with node-positive primary breast cancer who, following tumour excision and axillary clearance, were randomised to receive either 6 cycles of cyclophosphamide/methotrexate/S-fluorouracil (CMF) (n = 130) or no such post-operative treatment (n = 147). Follow-up data (median = 9 years) were available on all patients. A significant association was found between p53 status and survival. Patients with p53-positive tumours had a less favourable outcome than those with p53-negative disease. Women receiving adjuvant CMF chemotherapy had a significantly more favourable outcome compared to those who did not. The effect was seen both in women with p53-positive and p53-negative tumours; multivariate analysis showed relative risks for overall survival attributable to chemotherapy of 2.3 (95% CI 1.2-4.3) for women with p53-positive tumours and of 2.1 (95% CI 1.4-3.0) for those with p53-negative tumours. Thus, adjuvant chemotherapy with CMF is associated with a survival benefit in women with node-positive breast cancer irrespective of immunohistochemically determined p53 status.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / chemistry*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / surgery
  • Chemotherapy, Adjuvant
  • Cisplatin / administration & dosage
  • Combined Modality Therapy
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Immunohistochemistry
  • Methotrexate / administration & dosage
  • Middle Aged
  • Multivariate Analysis
  • Staining and Labeling / methods
  • Survival Analysis
  • Treatment Outcome
  • Tumor Suppressor Protein p53 / analysis*


  • Tumor Suppressor Protein p53
  • Cisplatin
  • Fluorouracil
  • Methotrexate

Supplementary concepts

  • CMF protocol