Changes of bone resorption marker (NTX) in chemotherapy plus zoledronic acid versus chemotherapy alone for nasopharyngeal cancer patients with bone metastases.
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.
State Key Laboratory of Oncology in South China, Department of Medical Oncology, Cancer Centre, Sun Yat-Sen University, Guangzhou, PR China.
Yuan-Yuan
YY
Zhao
Cong
C
Xue
Xue
X
Hou
Hai
H
Liao
Su
S
Li
Hong-Yun
HY
Zhao
Yan
Y
Huang
Li-Kun
LK
Chen
Fei
F
Xu
Jun-Ling
JL
Liu
Li
L
Zhang
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D015415:Biomarkers / Q000378:metabolism; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000556:secondary*; D001862:Bone Resorption / Q000139:chemically induced; D024042:Collagen Type I / Q000378:metabolism*; D004164:Diphosphonates / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy*; D010455:Peptides / Q000378:metabolism*; D016896:Treatment Outcome; D000077211:Zoledronic Acid
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D004164:Diphosphonates; D007093:Imidazoles; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D000077211:Zoledronic Acid