High-Dose Hypofractionated Radiation Therapy for Noncompressive Vertebral Metastases in Combination With Zoledronate: A Phase 1 Study.

Details

Serval ID
serval:BIB_CC104D8A51CB
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
High-Dose Hypofractionated Radiation Therapy for Noncompressive Vertebral Metastases in Combination With Zoledronate: A Phase 1 Study.
Journal
International journal of radiation oncology, biology, physics
Author(s)
Pichon B., Campion L., Delpon G., Thillays F., Carrie C., Cellier P., Pommier P., Laude C., Mervoyer A., Hamidou H., Mahé M.A., Supiot S.
ISSN
1879-355X (Electronic)
ISSN-L
0360-3016
Publication state
Published
Issued date
15/11/2016
Volume
96
Number
4
Pages
840-847
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
Hypofractionated stereotactic radiation therapy (HSRT) for vertebral metastases gives good results in terms of local control but increases the risk of fracture in the treated volume. Preclinical and clinical studies have shown that zoledronate not only reduces the risk of fracture and stimulates osteoclastic remodeling but also increases the immune response and radiosensitivity. This study aimed to evaluate the tolerability and effectiveness of zoledronate in association with radiation therapy.
We conducted a multicenter phase 1 study that combined HSRT (3 × 9 Gy) and zoledronate in patients with vertebral metastasis (NCT01219790). The principal objective was the absence of spinal cord adverse reactions at 1 year. The secondary objectives were acute tolerability, the presentation of a bone event, local tumor control, pain control, progression-free survival, and overall survival.
Thirty patients (25 male, 5 female), median age 66 years, who were followed up for a median period of 19.2 months, received treatment for 49 vertebral metastases. A grade 3 acute mucosal adverse event occurred in 1 patient during the treatment and in 2 more at 1 month. No late neurologic adverse events were reported at 1 year. The mean pain scores diminished significantly at 1 month (1.35; P=.0125) and 3 months (0.77; P<.0001) compared with pain scores at study entry (2.49). Vertebral collapse in the irradiated zone occurred in 1 (2%) treated vertebra. Control of local disease was achieved in 94% of irradiated patients (3 local recurrences).
The combination of zoledronate and HSRT in the treatment of vertebral metastasis is well tolerated and seems to reduce the rate of vertebral collapse, effectively relieve pain, and achieve good local tumor control with no late neurologic adverse effects.
Pubmed
Create date
13/02/2017 17:34
Last modification date
28/10/2020 6:27
Usage data