Randomized phase III trial to evaluate radiopharmaceuticals and zoledronic acid in the palliation of osteoblastic metastases from lung, breast, and prostate cancer: report of the NRG Oncology RTOG 0517 trial

Background Skeletal-related events (SREs), common sequelae of metastatic cancer, are reduced by bisphosphonates. In this study, it was postulated that radiopharmaceuticals, added to bisphosphonates, could further decrease the incidence of SREs. Methods NRG Oncology RTOG 0517 randomized patients with...

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Bibliographic Details
Published in:Annals of nuclear medicine 2018-10, Vol.32 (8), p.553-560
Main Authors: Seider, Michael J., Pugh, Stephanie L., Langer, Corey, Wyatt, Gwen, Demas, William, Rashtian, Afshin, Clausen, Cathy L., Derdel, Jerome David, Cleary, Sean F., Peters, Christopher A., Ramalingam, Ashok, Clarkson, James E., Tomblyn, Michael, Rabinovitch, Rachel A., Kachnic, Lisa A., Berk, Lawrence B.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Biocompatibility
Biomedical materials
Bisphosphonates
Bone cancer
Bone Neoplasms - secondary
Bone Neoplasms - therapy
Breast
Breast cancer
Breast Neoplasms - pathology
Complications
Diphosphonates - adverse effects
Diphosphonates - therapeutic use
Female
Hazards
Health risk assessment
Humans
Imaging
Imidazoles - adverse effects
Imidazoles - therapeutic use
Lung cancer
Lung diseases
Lung Neoplasms - pathology
Male
Medicine
Medicine & Public Health
Metastases
Metastasis
Middle Aged
Nuclear Medicine
Original Article
Osteoblasts
Osteoblasts - pathology
Pain
Palliation
Palliative Care - methods
Patients
Pharmaceuticals
Prostate cancer
Prostatic Neoplasms - pathology
Protocol (computers)
Quality of Life
Radiochemistry
Radioisotopes
Radiology
Radiopharmaceuticals - adverse effects
Radiopharmaceuticals - therapeutic use
Randomization
Regression models
Safety
Strontium
Survival Analysis
Toxicity
Zoledronic Acid
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Summary:Background Skeletal-related events (SREs), common sequelae of metastatic cancer, are reduced by bisphosphonates. In this study, it was postulated that radiopharmaceuticals, added to bisphosphonates, could further decrease the incidence of SREs. Methods NRG Oncology RTOG 0517 randomized patients with breast, lung, and prostate cancer and blastic bone metastases to either zoledronic acid (ZA) alone or ZA plus radiopharmaceuticals (Sr-89 or Sm-153). The primary endpoint was time to development of SREs. Secondary objectives included quality of life (QOL), pain control, overall survival (OS), and toxicity. Results 261 patients (median age 68; 62% male; 55% prostate, 35% breast, 10% lung) were accrued between July 2006 and February 2011. The study closed early due to a lower than expected rate of SREs. 52 (42%) patients in the ZA arm and 49 (40%) in the radiopharmaceutical arm experienced an SRE. Median time free of SREs was 29.9 and 27.4 months, respectively ( p  = 0.84). Median OS in the ZA arm and radiopharmaceutical arms was 32.1 and 26.9 months, respectively ( p  = 0.37). Cox proportional hazards regression model showed that primary disease site (lung) and number of bone metastases (> 2) had a negative impact on OS ( p  
ISSN:0914-7187
1864-6433
DOI:10.1007/s12149-018-1278-4