Phase II Trial Evaluating the Palliative Benefit of Second-Line Zoledronic Acid in Breast Cancer Patients With Either a Skeletal-Related Event or Progressive Bone Metastases Despite First-Line Bisphosphonate Therapy

2007 ◽  
Vol 18 (3) ◽  
pp. 313
Author(s):  
A.M. Brufsky
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Cancer Patients ◽  
Phase Ii Trial ◽  
Bisphosphonate Therapy ◽  
Second Line ◽  
Breast Cancer Patients ◽  
Related Event ◽  
First Line ◽  
Skeletal Related Event

Phase II Trial Evaluating the Palliative Benefit of Second-Line Zoledronic Acid in Breast Cancer Patients With Either a Skeletal-Related Event or Progressive Bone Metastases Despite First-Line Bisphosphonate Therapy

2006 ◽  
Vol 24 (30) ◽  
pp. 4895-4900 ◽  
Author(s):  
Mark J. Clemons ◽  
George Dranitsaris ◽  
Wei S. Ooi ◽  
Geetha Yogendran ◽  
Tatjana Sukovic ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Bone Turnover ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Pain Control ◽  
Second Line ◽  
Breast Cancer Patients ◽  
First Line ◽  
The Impact

Purpose This study evaluated whether additional palliative benefits could be derived from the second-line use of the more potent bisphosphonate zoledronic acid in metastatic breast cancer patients with either progressive bone metastases or skeletal-related events (SRE), despite first-line therapy with either pamidronate or clodronate. Patients and Methods This prospective study evaluated the impact of second-line zoledronic acid on pain, quality of life, and markers of bone turnover (for example, urinary N-telopeptide [NTX]). Patients received monthly zoledronic acid (4mg) for 3 months. Study evaluations were made weekly during the first month and again at week 8. No changes in chemotherapy or endocrine therapy were allowed in the month before or after commencing study treatment. Results Thirty-one women completed this study. By week 8, patients had experienced significant improvements in pain control (P < .001). There was a downward trend in urinary NTX levels over the same time period (P = .008). Overall, there was a trend towards a positive correlation between improvement in pain control and reduction in week one urinary NTX relative to baseline (Spearman's rho r = 0.27; P = .15). Conclusion This is the first study to demonstrate that patients with either progressive bone metastases or SREs while on clodronate or pamidronate can have relevant palliative benefits with a switch to the more potent bisphosphonate zoledronic acid. This is reflected by significant improvements in pain control and bone turnover markers. If confirmed in randomized trials, these findings have major implications to the use of bisphosphonates in both the metastatic and adjuvant settings.

Urinary n-telopeptide (NTX) predicts palliative pain response in metastatic breast cancer patients receiving second-line zoledronic acid

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 679-679
Author(s):  
G. Dranitsaris ◽  
M. Clemons ◽  
W. Ooi ◽  
D. Cole
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Pain Score ◽  
Cancer Patients ◽  
Clinical Utility ◽  
Metastatic Breast ◽  
Brief Pain Inventory ◽  
Second Line ◽  
Breast Cancer Patients ◽  
Unit Reduction

679 Background: A substantial number of breast cancer patients will have bony progression or develop skeletal related events (SRE) despite treatment with a bisphosphonate (BP) such as clodronate or pamidronate. What could be of use to the practicing oncologist is a marker for predicting which patients will derive palliative benefit with the second-line use of a more potent BP such as zoledronic acid. In this study, we assessed the clinical utility of using early changes in urinary NTX as a predictor of palliative response to second-line zoledronic acid. Methods: 30 patients with either a documented SRE or bony progression while on either clodronate or pamidronate were switched to infusions of zoledronic acid (4 mg) every 4 weeks for 12 weeks. Urinary NTX and worst pain score using the Brief Pain Inventory were evaluated weekly for the first 4 weeks & again at week 8. No change in systemic anti-cancer treatment was allowed in the month before or after commencing study treatment. A palliative response was defined as a reduction of at least two units in the worst pain score. Logistic regression analysis was used to determine if a decrease in urinary NTX at week 1 relative to baseline was a significant predictor of palliative response to zoledronic acid when measured at week 8. Results: At week 1, 23 of 30 (76.7%) had a drop in their urinary NTX excretion relative to baseline. At week 8, these 23 patients experienced a 2.4 unit decline in their worst pain score, compared to only a 0.28 unit reduction in the 7 patients whose week 1 urinary NTX increased relative to baseline (P=0.11). A week 1 drop in urinary NTX was identified as an important predictor for palliative response to zoledronic acid when measured at week 8 (OR=9.4; 95%CI: 2.28 to 79.8, P=0.014). Conclusions: Our findings imply that a decline in urinary NTX at week 1 is a useful marker for identifying which patients will derive palliative benefits from second-line zoledronic acid. Additional data on a larger sample of patients is needed to validate the clinical utility of using early changes in urinary NTX as a rapid predictor of patient benefit. [Table: see text]

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