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Originally published as JCO Early Release 10.1200/JCO.2003.08.017 on September 8 2003

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Journal of Clinical Oncology, Vol 21, Issue 21 (November), 2003: 4042-4057
© 2003 American Society for Clinical Oncology


ASCO SPECIAL ARTICLE

American Society of Clinical Oncology 2003 Update on the Role of Bisphosphonates and Bone Health Issues in Women With Breast Cancer

Bruce E. Hillner, James N. Ingle, Rowan T. Chlebowski, Julie Gralow, Gary C. Yee, Nora A. Janjan, Jane A. Cauley, Brent A. Blumenstein, Kathy S. Albain, Allan Lipton, Susan Brown

From the American Society of Clinical Oncology, Alexandria, Virginia.

Address reprint requests to American Society of Clinical Oncology, Cancer Policy and Clinical Affairs, 1900 Duke Street, Suite 200, Alexandria, VA 22314; e-mail: guidelines{at}asco.org.

Purpose: To update the 2000 ASCO guidelines on the role of bisphosphonates in women with breast cancer and address the subject of bone health in these women.

Results: For patients with plain radiographic evidence of bone destruction, intravenous pamidronate 90 mg delivered over 2 hours or zoledronic acid 4 mg over 15 minutes every 3 to 4 weeks is recommended. There is insufficient evidence supporting the efficacy of one bisphosphonate over the other. Starting bisphosphonates in women who demonstrate bone destruction through imaging but who have normal plain radiographs is considered reasonable treatment. Starting bisphosphonates in women with only an abnormal bone scan but without evidence of bone destruction is not recommended. The presence or absence of bone pain should not be a factor in initiating bisphosphonates.

In patients with a serum creatinine less than 3.0 mg/dL (265 µmol/L), no change in dosage, infusion time, or interval is required. Infusion times less than 2 hours with pamidronate or less than 15 minutes with zoledronic acid should be avoided. Creatinine should be monitored before each dose of either agent in accordance with US Food and Drug Administration (FDA) labeling.

Oncology professionals, especially medical oncologists, need to take an expanded role in the routine and regular assessment of the osteoporosis risk in women with breast cancer. The panel recommends an algorithm for patient management to maintain bone health.

Conclusion: Bisphosphonates provide a supportive, albeit expensive and non–life-prolonging, benefit to many patients with bone metastases. Current research is focusing on bisphosphonates as adjuvant therapy. Although new data addressing when to stop therapy, alternative doses or schedules for administration, and how to best coordinate bisphosphonates with other palliative therapies are needed, they are not currently being investigated.

Adopted on May 30, 2003 by the American Society of Clinical Oncology.


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NEJMHome page
A. E. Denes and P. D. Ryan
Case 24-2005: A Woman with Estrogen-Receptor-Positive Breast Cancer.
N. Engl. J. Med., November 24, 2005; 353(21): 2304 - 2305.
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JCOHome page
M. D. Michaelson and M. R. Smith
Bisphosphonates for Treatment and Prevention of Bone Metastases
J. Clin. Oncol., November 10, 2005; 23(32): 8219 - 8224.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
V. Guarneri, S. Donati, M. Nicolini, S. Giovannelli, R. D'Amico, and P. F. Conte
Renal Safety and Efficacy of i.v. Bisphosphonates in Patients with Skeletal Metastases Treated for up to 10 Years
Oncologist, November 1, 2005; 10(10): 842 - 848.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
J.-J. Body
Bisphosphonates in Metastatic Bone Disease: Renal Safety Matters
Oncologist, October 1, 2005; 10(suppl_1): 1 - 2.
[Full Text] [PDF]


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The OncologistHome page
R. Bell
Efficacy of Ibandronate in Metastatic Bone Disease: Review of Clinical Data
Oncologist, October 1, 2005; 10(suppl_1): 8 - 13.
[Abstract] [Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
P. E. Goss, J. N. Ingle, S. Martino, N. J. Robert, H. B. Muss, M. J. Piccart, M. Castiglione, D. Tu, L. E. Shepherd, K. I. Pritchard, et al.
Randomized Trial of Letrozole Following Tamoxifen as Extended Adjuvant Therapy in Receptor-Positive Breast Cancer: Updated Findings from NCIC CTG MA.17
J Natl Cancer Inst, September 7, 2005; 97(17): 1262 - 1271.
[Abstract] [Full Text] [PDF]


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JCOHome page
R. E. Coleman, P. Major, A. Lipton, J. E. Brown, K.-A. Lee, M. Smith, F. Saad, M. Zheng, Y. J. Hei, J. Seaman, et al.
Predictive Value of Bone Resorption and Formation Markers in Cancer Patients With Bone Metastases Receiving the Bisphosphonate Zoledronic Acid
J. Clin. Oncol., August 1, 2005; 23(22): 4925 - 4935.
[Abstract] [Full Text] [PDF]


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JCOHome page
C. L. Shapiro
Aromatase Inhibitors and Bone Loss: Risks in Perspective
J. Clin. Oncol., August 1, 2005; 23(22): 4847 - 4849.
[Full Text] [PDF]


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J Oncol Pharm PractHome page
J. S McCune, D. M Games, and J. L Espirito
Assessment of ovarian failure and osteoporosis in premenopausal breast cancer survivors
Journal of Oncology Pharmacy Practice, June 1, 2005; 11(2): 37 - 43.
[Abstract] [PDF]


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JCOHome page
N. Kohno, K. Aogi, H. Minami, S. Nakamura, T. Asaga, Y. Iino, T. Watanabe, C. Goessl, Y. Ohashi, and S. Takashima
Zoledronic Acid Significantly Reduces Skeletal Complications Compared With Placebo in Japanese Women With Bone Metastases From Breast Cancer: A Randomized, Placebo-Controlled Trial
J. Clin. Oncol., May 20, 2005; 23(15): 3314 - 3321.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
P. Conte and V. Guarneri
In Response to Jackson Letter to the Editor Regarding "Safety of Intravenous and Oral Bisphosphonates and Compliance with Dosing Regimens"
Oncologist, May 1, 2005; 10(5): 315 - 316.
[Full Text] [PDF]


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BMJHome page
M. C Gainford, G. Dranitsaris, and M. Clemons
Recent developments in bisphosphonates for patients with metastatic breast cancer
BMJ, April 2, 2005; 330(7494): 769 - 773.
[Full Text] [PDF]


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NEJMHome page
A. F. Stewart
Hypercalcemia Associated with Cancer
N. Engl. J. Med., January 27, 2005; 352(4): 373 - 379.
[Full Text] [PDF]


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JCOHome page
E. P. Winer, C. Hudis, H. J. Burstein, A. C. Wolff, K. I. Pritchard, J. N. Ingle, R. T. Chlebowski, R. Gelber, S. B. Edge, J. Gralow, et al.
American Society of Clinical Oncology Technology Assessment on the Use of Aromatase Inhibitors As Adjuvant Therapy for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Status Report 2004
J. Clin. Oncol., January 20, 2005; 23(3): 619 - 629.
[Abstract] [Full Text] [PDF]


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Clin. Cancer Res.Home page
T. Yuasa, M. Nogawa, S. Kimura, A. Yokota, K. Sato, H. Segawa, J. Kuroda, and T. Maekawa
A Third-Generation Bisphosphonate, Minodronic Acid (YM529), Augments the Interferon {alpha}/ss-Mediated Inhibition of Renal Cell Cancer Cell Growth Both In vitro and In vivo
Clin. Cancer Res., January 15, 2005; 11(2): 853 - 859.
[Abstract] [Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
F. Saad
RESPONSE: Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Metastatic Hormone-Refractory Prostate Cancer
J Natl Cancer Inst, January 5, 2005; 97(1): 70 - 71.
[Full Text] [PDF]


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The OncologistHome page
J. R. Berenson
Recommendations for Zoledronic Acid Treatment of Patients with Bone Metastases
Oncologist, January 1, 2005; 10(1): 52 - 62.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
I. J. Diel and R. Bergner
Re: Berenson J, Hirschberg R. Safety and Convenience of a 15-Minute Infusion of Zoledronic Acid
Oncologist, January 1, 2005; 10(1): 82 - 83.
[Full Text] [PDF]


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Ann OncolHome page
D. Tripathy
Reply to Letter to the Editor on "The efficacy and safety of oral ibandronate in the treatment of metastatic bone disease in patients with breast cancer", by G. Utkan, A. Buyukcelik, B. Yalcyn (Ann Oncol 2004; 15: 1574)
Ann. Onc., October 1, 2004; 15(10): 1574 - 1575.
[Full Text] [PDF]


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Endocr Relat CancerHome page
N Angelopoulos, V Barbounis, S Livadas, D Kaltsas, and G Tolis
Effects of estrogen deprivation due to breast cancer treatment
Endocr. Relat. Cancer, September 1, 2004; 11(3): 523 - 535.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
R. E. Coleman
Bisphosphonates: Clinical Experience
Oncologist, September 1, 2004; 9(suppl_4): 14 - 27.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
P. Conte and V. Guarneri
Safety of Intravenous and Oral Bisphosphonates and Compliance With Dosing Regimens
Oncologist, September 1, 2004; 9(suppl_4): 28 - 37.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
A. Lipton
Toward New Horizons: The Future of Bisphosphonate Therapy
Oncologist, September 1, 2004; 9(suppl_4): 38 - 47.
[Abstract] [Full Text] [PDF]


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JNMHome page
N. Pandit-Taskar, M. Batraki, and C. R. Divgi
Radiopharmaceutical Therapy for Palliation of Bone Pain from Osseous Metastases
J. Nucl. Med., August 1, 2004; 45(8): 1358 - 1365.
[Abstract] [Full Text] [PDF]



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