MedicalResearch.com Interview with:
Charles L. Shapiro, MD
Professor of Medicine
Co-Director of Dubin Breast Center
Director of Translational Breast Cancer Research
Director of Cancer Survivorship, Tisch Cancer Institute
Mount Sinai Health System
Division of Hematology / Medical Oncology: Tisch Cancer Institute
New York, NY 10029
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Metastases to bone are frequent in many cancers and cause pain, pathological fractures, necessitate surgical and/or radiation treatments, cause spinal chord compression that can lead to paralysis, and significantly increase health care costs.
Zoledronic acid, a bisphosphonate that inhibits bone resorption, is used in standard practice because it reduces the risks skeletal-related events including cancer-related pathological fractures, the need for surgery and/or radiation to bone metastases, and spinal chord compression in patients with breast cancer, prostate cancer and multiple myeloma.
However, the optimal dosing interval for zoledronic acid is unknown and based on prior studies and empiricism it is administered monthly along with anti-cancer treatments.
In this trial, over 1800 breast cancer, prostate cancer and multiple myeloma patients with bone metastases were randomized to the standard dosing interval of monthly zoledronic acid versus every 3-months zoledronic acid for a duration of two years.
The results overall, and in each specific disease site, show that giving zoledronic acid once every 3-months as opposed to monthly did not result in any increase in skeletal-related
MedicalResearch.com: What should readers take away from your report?
Response: This trial is a prime example of less treatment being comparable in benefit to more treatment, with less side-effects and decreasing health care costs. Relatively recently, cancer treatments increasingly will be evaluated in terms their “value.” Value is the outcome or benefits of a treatment divided the total costs of providing treatment.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: In this trial every 3-months of zoledronic has increased value for patient with bone metastases because it provides comparable outcomes to monthly dosing at lower costs. Future clinical trials will incorporate value as an important endpoint so as to be able to understand what our “return” patients receive for our health care dollars.
MedicalResearch.com: Is there anything else you would like to add?
Response: No disclosures or conflicts of interest.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O’Connor T, Velasco MR, Weckstein D, O’Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases A Randomized Clinical Trial.
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