RTOG 0518: randomized phase III trial to evaluate zoledronic acid for prevention of osteoporosis and associated fractures in prostate cancer patients. Prostate Cancer Prostatic Dis 2013 Dec;16(4):382-6
Date
10/02/2013Pubmed ID
24080992Pubmed Central ID
PMC3830691DOI
10.1038/pcan.2013.35Scopus ID
2-s2.0-84887613817 (requires institutional sign-in at Scopus site) 29 CitationsAbstract
BACKGROUND: RTOG 0518 evaluated the potential benefit of zoledronic acid therapy in preventing bone fractures for patients with high grade and/or locally advanced, non-metastatic prostate adenocarcinoma receiving luteinizing hormone-releasing hormone (LHRH) agonist and radiotherapy (RT).
METHODS: Eligible patients with T-scores of the hip (<-1.0, but >-2.5 vs >-1.0) and negative bone scans were prospectively randomized to either zoledronic acid, 4 mg, concurrently with the start of RT and then every six months for a total of 6 infusions (Arm 1) or observation (Arm 2). Vitamin D and calcium supplements were given to all patients. Secondary objectives included quality of life (QOL) and bone mineral density (BMD) changes over a period of three years.
RESULTS: Of 109 patients accrued before early closure, 96 were eligible. Median follow-up was 36.3 months for Arm 1 and 34.8 months for Arm 2. Only two patients experienced a bone fracture (one in each arm) resulting in no difference in freedom from any bone fracture (P=0.95), nor in QOL. BMD percent changes from baseline to 36 months were statistically improved with the use of zoledronic acid compared to observation for the lumbar spine (6% vs -5%, P<0.0001), left total hip (1% vs -8%, P=0.0002), and left femoral neck (3% vs -8%, P=0.0007).
CONCLUSIONS: For patients with advanced, non-metastatic prostate cancer receiving LHRH agonist and RT, the use of zoledronic acid was associated with statistically improved BMD percent changes. The small number of accrued patients resulted in decreased statistical power to detect any differences in the incidence of bone fractures or QOL.
Author List
Kachnic LA, Pugh SL, Tai P, Smith M, Gore E, Shah AB, Martin AG, Kim HE, Nabid A, Lawton CAAuthor
Elizabeth M. Gore MD Professor in the Radiation Oncology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AgedAged, 80 and over
Androgen Antagonists
Antineoplastic Agents, Hormonal
Bone Density
Bone Density Conservation Agents
Diphosphonates
Fractures, Bone
Humans
Imidazoles
Male
Middle Aged
Neoplasm Grading
Neoplasm Staging
Osteoporosis
Prostatic Neoplasms
Treatment Outcome
