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Annals of Oncology Advance Access published online on January 20, 2007
Annals of Oncology, doi:10.1093/annonc/mdl492
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© 2007 European Society for Medical Oncology

CA15-3 and alkaline phosphatase as predictors for breast cancer recurrence: a combined analysis of seven International Breast Cancer Study Group trials

A Keshaviah1, S Dellapasqua2, N Rotmensz2, J Lindtner3, D Crivellari4, J Collins5, M Colleoni2, B Thürlimann6,7, C Mendiola8, S Aebi7,9, KN Price1,10, O Pagani7,11, E Simoncini12, M Castiglione Gertsch13, RD Gelber1,10,14, AS Coates15, A Goldhirsch2,11,* and for the International Breast Cancer Study Group

1 International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA
2 European Institute of Oncology, Milan, Italy
3 The Institute of Oncology, Ljubljana, Slovenia
4 Centro di Riferimento Oncologico, Aviano, Italy
5 Department of Surgery, The Royal Melbourne Hospital, Melbourne, Australia
6 Kantonsspital, St Gallen, Switzerland
7 Swiss Group for Clinical Cancer Research, Bern, Switzerland
8 Hospital 12 de Octubre, Madrid, Spain
9 Institute of Medical Oncology, Inselspital, Bern, Switzerland
10 Frontier Science and Technology Research Foundation, Boston, MA, USA
11 Oncology Institute of Southern Switzerland, Bellinzona, Switzerland
12 Oncologia Medica-Spedali Civili, Brescia, Italy
13 International Breast Cancer Study Group Coordinating Center, Bern, Switzerland
14 Harvard School of Public Health, Boston, MA, USA
15 International Breast Cancer Study Group, Australian New Zealand Breast Cancer Trials Group and University of Sydney, Australia

* Correspondence to: Prof. A. Goldhirsch, MD. IBCSG at Department of Medicine, European Institute of Oncology, Via Ripamonti 435, 20141 Milan, Italy. Tel: +41 31 389 93 91; Fax: +41 31 389 92 35; E-mail: aron.goldhirsch{at}ibcsg.org

Background: We evaluated the ability of CA15-3 and alkaline phosphatase (ALP) to predict breast cancer recurrence.

Patients and methods: Data from seven International Breast Cancer Study Group trials were combined. The primary end point was relapse-free survival (RFS) (time from randomization to first breast cancer recurrence), and analyses included 3953 patients with one or more CA15-3 and ALP measurement during their RFS period. CA15-3 was considered abnormal if >30 U/ml or >50% higher than the first value recorded; ALP was recorded as normal, abnormal, or equivocal. Cox proportional hazards models with a time-varying indicator for abnormal CA15-3 and/or ALP were utilized.

Results: Overall, 784 patients (20%) had a recurrence, before which 274 (35%) had one or more abnormal CA15-3 and 35 (4%) had one or more abnormal ALP. Risk of recurrence increased by 30% for patients with abnormal CA15-3 [hazard ratio (HR) = 1.30; P = 0.0005], and by 4% for those with abnormal ALP (HR = 1.04; P = 0.82). Recurrence risk was greatest for patients with either (HR = 2.40; P < 0.0001) and with both (HR = 4.69; P < 0.0001) biomarkers abnormal. ALP better predicted liver recurrence.

Conclusions: CA15-3 was better able to predict breast cancer recurrence than ALP, but use of both biomarkers together provided a better early indicator of recurrence. Whether routine use of these biomarkers improves overall survival remains an open question.

alkaline phosphatase, breast cancer, CA15-3, tumor marker


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