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.
Abstract | BACKGROUND: 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 < 0.0001, p = 0.01, respectively). The addition of radiopharmaceuticals to ZA led to a significant reduction in pain at 1 month based on BPI worst score (p = 0.02). No other group differences were noted for QOL or toxicity. CONCLUSION: CLINICAL TRIAL REGISTRY: This protocol (RTOG 0517) is registered with ClinicalTrials.gov (NCT00365105), and may be viewed online at http://www.clinicaltrials.gov/ct2/show/NCT00365105?term=RTOG+0517&rank=1 .
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Authors | Michael J Seider, Stephanie L Pugh, Corey Langer, Gwen Wyatt, William Demas, Afshin Rashtian, Cathy L Clausen, Jerome David Derdel, Sean F Cleary, Christopher A Peters, Ashok Ramalingam, James E Clarkson, Michael Tomblyn, Rachel A Rabinovitch, Lisa A Kachnic, Lawrence B Berk, NRG Oncology |
Journal | Annals of nuclear medicine
(Ann Nucl Med)
Vol. 32
Issue 8
Pg. 553-560
(Oct 2018)
ISSN: 1864-6433 [Electronic] Japan |
PMID | 30094545
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Diphosphonates
- Imidazoles
- Radiopharmaceuticals
- Zoledronic Acid
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Bone Neoplasms
(secondary, therapy)
- Breast Neoplasms
(pathology)
- Diphosphonates
(adverse effects, therapeutic use)
- Female
- Humans
- Imidazoles
(adverse effects, therapeutic use)
- Lung Neoplasms
(pathology)
- Male
- Middle Aged
- Osteoblasts
(pathology)
- Palliative Care
(methods)
- Prostatic Neoplasms
(pathology)
- Quality of Life
- Radiopharmaceuticals
(adverse effects, therapeutic use)
- Safety
- Survival Analysis
- Zoledronic Acid
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