Background: Zoledronic acid (ZOL) is the only bisphosphonate with demonstrated efficacy for the prevention of skeletal-related events (SRE) in patients with bone metastases of diverse malignant tumours. A recent large, retrospective analysis reported that a reduction in N-telopeptide of type I collagen (NTX) provided a continuum of reduced SRE risk and survival benefit in patients with bone metastases. The present prospective, open-label, randomised, phase II trial sought to evaluate NTX changes after ZOL administration in nasopharyngeal cancer (NPC) patients with bone metastases (BM).
Methods: Newly diagnosed NPC patients (n = 60) with bone metastasis were randomised to the test group (n = 30), who received chemotherapy with cisplatin plus 5-fluorouracil (5-FU) (q3wks) and intravenous ZOL (4 mg, q4 wks) for 3 months, or a control group (n = 30), who received cisplatin plus 5-FU alone. Urinary NTX was measured by ELISA at baseline and 1, 2 and 3months after administration of ZOL.
Results: The median baseline NTX level was no different in both the test and control patients (75.4 and 94.6 nM bone collagen equivalent units/mM creatinine, respectively; p = 0.370). NTX decreased by 61.5% within 1month in the test group, but only by 6.6% in the control group (p < 0.01). After 3 months, the test group reached a maximum reduction (-85.9%) as compared to the other time points and to the control group (-51.5%) (p = 0.001). More patients in the test group achieved normal NTX than that in the control group (p=0.042).
Conclusions: ZOL administered with chemotherapy immediately and consistently reduced NTX levels for NPC patients with bone metastasis. Larger prospective randomised trial to confirm the efficacy of ZOL in NPC patients with bone metastases is pending.
Copyright © 2010 Elsevier Ltd. All rights reserved.