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Annals of Oncology Advance Access published online on September 12, 2006
Annals of Oncology, doi:10.1093/annonc/mdl147
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© 2006 European Society for Medical Oncology
Received February 20, 2006
Revised May 2, 2006
Accepted May 18, 2006

original article

Evaluation of the prognostic and predictive value of p53 and Bcl-2 in breast cancer patients participating in a randomized study with dose-dense sequential adjuvant chemotherapy

V. Malamou-Mitsi 1 *, H. Gogas 2, U. Dafni 3, A. Bourli 4, T. Fillipidis 5, M. Sotiropoulou 6, D. Vlachodimitropoulos 7, S. Papadopoulos 8, O. Tzaida 9, G. Kafiri 10, V. Kyriakou 2, S. Markaki 6, I. Papaspyrou 6, E. Karagianni 11, K. Pavlakis 12, T. Toliou 13, C. D. Scopa 14, P. Papakostas 10, D. Bafaloukos 15, C. Christodoulou 16, and G. Fountzilas 17

1 University of Ioannina, School of Medicine, Ioannina
2 Laiko General Hospital, University of Athens, School of Medicine, Athens
3 Laboratory of Biostatistics, University of Athens, School of Nursing, Athens
4 Agii Anargiri Cancer Hospital, Athens
5 Micromedica Histopathology Laboratory, Athens
6 Alexandra General Hospital, Athens
7 Evgenidio Hospital, Athens
8 Hygeia Hospital, Athens
9 Metaxa Cancer Hospital, Piraeus
10 Ippokration General Hospital, Athens
11 Athens Medical Center, Athens
12 Obstetrical and Gynaecological Center Iasso
13 Theagenio Hospital, Thessaloniki
14 University of Patras Medical School, University Hospital, Rion, Patras
15 Metropolitan Hospital, Athens
16 Henry Dunant Hospital, Athens
17 Aristotle University of Thessaloniki, School of Medicine, Thessaloniki, Greece

* To whom correspondence should be addressed.
V. Malamou-Mitsi, E-mail: vmalamou{at}cc.uoi.gr


  Abstract

Purpose: To assess the prognostic and predictive significance of p53 and Bcl-2 protein expression in high risk patients with breast cancer treated with dose-dense sequential chemotherapy.

Patients and methods: From June 1997 until November 2000, 595 patients were randomized to three cycles of epirubicin (E) 110 mg/m2 followed by three cycles of paclitaxel (P) 250 mg/m2 followed by three cycles of ‘intensified’ CMF (cyclophosphamide 840 mg/m2, methotrexate 47 mg/m2 and fluorouracil 840 mg/m2) or to four cycles of E, followed by four cycles of CMF. p53 and Bcl-2 expression was investigated by immunohistochemistry in 392 and 397 patients respectively.

Results: Positive expression of p53 was detected in 104 (26.5%) patients and was significantly associated with negative hormonal status, worse histologic grade, higher incidence of disease relapse and higher rate of death. p53 positive expression was a significant negative predictor of overall survival (OS) (P = 0.002) and disease-free survival (DFS) (P = 0.001). Negative expression of Bcl-2 was detected in 203 (51%) patients and was significantly associated with negative hormonal status. Multivariate analysis revealed that, positive p53 expression, higher number of positive nodes and worse tumor grade were related to significantly poorer OS and DFS.

Conclusions: For both treatments, p53 positive expression was a significant negative prognostic factor for OS and DFS while Bcl-2 was not. No predictive ability of p53 status or Bcl-2 status for paclitaxel treatment was evident.

Keywords: breast cancer; adjuvant chemotherapy; p53; Bcl-2; paclitaxel.
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