Multicenter Phase III Trial supports a potential practice change in treating bone metastases
A widely used treatment — approved by the FDA to reduce and delay bone complications caused by cancer that has spread to the bone — called zoledronic acid (ZA) may now be given at intervals three times longer than the current standard with similar benefit, according to new results presented by Andrew L. Himelstein, M.D., a medical oncologist at Christiana Care’s Helen F. Graham Cancer Center & Research Institute, during the 2015 Annual Meeting of the American Society of Clinical Oncology, held May 29 to June 2 in Chicago.
“These findings support a potential practice change in our approach to treating bone metastases,” said Dr. Himelstein. “Lengthening the time period between doses will greatly improve the quality of life for our patients, many of whom are highly symptomatic, and find it a significant burden to make the monthly trips for treatment.” Fewer treatments and fewer office visits translate into lower costs and added value for patients.
Dr. Himelstein, along with co-investigators at seven institutions, tested 1,822 patients with bone metastasis from multiple myeloma or solid tumors including breast and prostate cancer. Patients
were randomized to receive either the standard course of therapy —intravenous ZA monthly for 24 months — or ZA administered at a longer interval, every three months for two years. Study results indicate that the longer dosing interval was comparable to standard dosing in relieving bone pain and preventing the incidence of skeletal related events, defined as radiation therapy to bone, fractures, spinal cord compression, loss of function or surgery to bone.
“There is some evidence that ZA persists in the body much longer than the three or four weeks between standard treatments,” said Dr. Himelstein. “Bone turnover markers were still lowered by ZA given every 12 weeks. Indicating a persistent effect of ZA in the bone. That these levels are suppressed provides further evidence that ZA every 12 weeks is effective.”ZA is also approved for the treatment of high calcium levels caused by cancer and, in a slightly higher dose, as a once-a-year treatment for osteoporosis. These formulations of ZA were not part of the present study, initiated by the Alliance for Clinical Trials in Oncology in collaboration
Recognized nationally as a leader in U.S. clinical trial enrollment, Christiana Care was a top recruiter in this study. Medical Oncologist Stephen Grubbs, M.D., a co-investigator, enrolled the highest number of patients at the Helen F. Graham Cancer Center & Research Institute. Other lead investigators are Rui Qin, Paul J. Novotny, Drew K. Seisler, James L. Khatcheressian, John D. Roberts, Tracey O’Connor, Douglas Weckstein, Charles L. Loprinzi, Charles L. Shapiro; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; Virginia Cancer Institute, Richmond, VA; Yale University, New Haven, CT; Roswell Park Cancer Institute, Buffalo, NY; New Hampshire Onc-Hem PA, Hooksett, NH; Mayo Clinic, Rochester, MN; Mount Sinai School
About Christiana Care Health System
Christiana Care Health System is one of the country’s largest health care systems, ranking as the 22nd leading hospital in the nation and 12th on the East Coast in terms of admissions. The health system includes The Christiana Care Medical Group, a network of primary care physicians, medical and surgical specialists as well as home health care, preventive medicine, rehabilitation services and patient/family advisors for core health care services. A not-for-profit teaching hospital affiliated with Sidney Kimmel Medical College at Thomas Jefferson University, Christiana Care is recognized as a regional center for excellence in cardiology, cancer and women’s health services. Christiana Care has an extensive range of outpatient services, and through Christiana Care Quality Partners, Christiana Care works closely with its medical staff to achieve better health, better access to care and lower cost. Christiana Care is home to Delaware’s only Level I trauma center, the highest capability center and the only one of its kind between Philadelphia and Baltimore. Christiana Care also features a Level III neonatal intensive care unit, the only delivering hospital in Delaware that offers the highest level of non-surgical care to the most critically ill newborns. Christiana Care includes two hospitals with 1,100 patient beds. For more information about Christiana Care, visit www.christianacare.org/whoweare.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.