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Annals of Oncology 15:455-459, 2004
© 2004 European Society for Medical Oncology

Original Paper

Baseline serum NTx levels are prognostic in metastatic breast cancer patients with bone-only metastasis

Received 10 June 2003; revised 2 October 2003; accepted 7 November 2003;

Background:

There is significant heterogeneity in survival of patients with metastatic breast cancer who have bone-only metastasis. We studied the correlation of serum N-telopeptide (NTx), a marker of bone resorption, and its correlation with clinical outcomes in patients with metastatic breast cancer with bone-only or bone plus soft tissue metastasis.

Patients and methods:

Serum was taken from 250 metastatic breast cancer patients with bone-only or bone plus soft tissue metastasis who participated in two similar randomized studies of second-line hormone therapy. An enzyme-linked immunosorbent assay specific for NTx of type I bone collagen was used to detect serum levels.

Results:

Sixty patients (24%) had elevated serum NTx levels, using the mean + 2 standard deviations (26 nanomoles Bone Collagen Equivalents per liter) of healthy women as a cut-off. The median duration of clinical benefit was significantly shorter in the group with elevated serum NTx levels compared with the group that had normal serum NTx levels (P = 0.0004). Time to progression (TTP) was also significantly shorter in the patients with elevated serum NTx at 139 days compared with 220 days (P = 0.0006). Median survival was also significantly shorter in patients with elevated baseline serum NTx levels at 663 days compared with 941 days (P <0.0001).

Conclusion:

In this study, breast cancer patients with bone-only or bone plus soft tissue metastasis and elevated serum NTx levels have a shorter duration of clinical benefit, TTP and overall survival.

S. M. Ali1,*, L. M. Demers2, K. Leitzel2, H. A. Harvey2, D. Clemens3, N. Mallinak3, L. Engle2, V. Chinchilli2, L. Costa4, C. Brady5, J. Seaman5 and A. Lipton2

1 VA Medical Center, Lebanon, PA; 2 The M. S. Hershey Medical Center, The Pennsylvania State University, Hershey, PA; 3 Ostex International, Seattle, WA; 5 Novartis Pharmaceutical Corp., East Hanover, NJ, USA; 4 Unidade de Oncologia, Hospital de Santa Maria, Lisbon, Portugal

Key words: bone-only metastasis, bone plus soft tissue metastasis, metastatic breast cancer, serum NTx, survival


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