Cryoablation for Palliation of Painful Bone Metastases: The MOTION Multicenter Study.
Ablation Techniques
Metastases
Pain Management
Radiation Therapy/Oncology
Journal
Radiology. Imaging cancer
ISSN: 2638-616X
Titre abrégé: Radiol Imaging Cancer
Pays: United States
ID NLM: 101765309
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
14
07
2020
revised:
19
08
2020
revised:
18
11
2020
accepted:
04
12
2020
entrez:
5
4
2021
pubmed:
6
4
2021
medline:
18
9
2021
Statut:
epublish
Résumé
To assess the clinical effectiveness of cryoablation for palliation of painful bone metastases. MOTION (Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases) (ClinicalTrials.gov NCT02511678) was a multicenter, prospective, single-arm study of adults with metastatic bone disease who were not candidates for or had not benefited from standard therapy, that took place from February 2016 to March 2018. At baseline, participants rated their pain using the Brief Pain Inventory-Short Form (reference range from 0 to 10 points); those with moderate to severe pain, who had at least one metastatic candidate tumor for ablation, were included. The primary effectiveness endpoint was change in pain score from baseline to week 8. Participants were followed for 24 weeks after treatment. Statistical analyses included descriptive statistics and logistic regression to evaluate changes in pain score over the postprocedure follow-up period. A total of 66 participants (mean age, 60.8 years ± 14.3 [standard deviation]; 35 [53.0%] men) were enrolled and received cryoablation; 65 completed follow-up. Mean change in pain score from baseline to week 8 was -2.61 points (95% CI: -3.45, -1.78). Mean pain scores improved by 2 points at week 1 and reached clinically meaningful levels (more than a 2-point decrease) after week 8; scores continued to improve throughout follow-up. Quality of life improved, opioid doses were stabilized, and functional status was maintained over 6 months. Serious adverse events occurred in three participants. Cryoablation of metastatic bone tumors provided rapid and durable pain palliation, improved quality of life, and offered an alternative to opioids for pain control.
Identifiants
pubmed: 33817650
doi: 10.1148/rycan.2021200101
pmc: PMC8011449
doi:
Banques de données
ClinicalTrials.gov
['NCT02511678']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e200101Informations de copyright
2021 by the Radiological Society of North America, Inc.
Déclaration de conflit d'intérêts
Disclosures of Conflicts of Interest: J.W.J. Activities related to the present article: disclosed grant to author’s institution from Washington University for study support for data collection and cryoprobes for ablation; author received consultancy fees from Galil Medical and BTG regarding development of a microwave device, not related to cryoablation; Galil Medical and BTG provided cryoprobes for the study and assistance with manuscript, including graphs and tables. Activities not related to the present article: author received consultancy fees from Bard, Merit Medical, and Stryker. Other relationships: disclosed no relevant relationships. J.D.P. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: author received consultancy fees from Galil Medical and BTG; author’s institution is a study grant recipient from Galil Medical and BTG for an investigator-initiated study. Other relationships: author’s institution has patents pending from Focused Cryo involving a new cryoablation device. J.G. Activities related to the present article: author received fees from BTG and Galil for participation in review activities. Activities not related to the present article: author received payment for lectures including service on speakers bureaus from Canon, J&J, Medtronic, and BTG. Other relationships: disclosed no relevant relationships. A.G. disclosed no relevant relationships. X.B. disclosed no relevant relationships. J.P. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: disclosed consultancy fees paid to author’s institution from Boston Scientific; disclosed money paid to author from Philips for development of educational presentations. Other relationships: disclosed no relevant relationships. A.N.K. Activities related to the present article: disclosed grant to author’s institution from Galil Medical as sponsor for this trial. Activities not related to the present article: disclosed grants/grants pending to author’s institution from Philips and EDDA Technology; author received royalties from UpToDate. Other relationships: disclosed no relevant relationships. M.C. Activities related to the present article: author’s institution received grant from Galil Medical; author received consultancy fees or honorarium from Medtronic and Varian. Activities not related to the present article: disclosed no relevant relationships. Other relationships: disclosed no relevant relationships. S.G. disclosed no relevant relationships. F.A. Activities related to the present article: author’s institution participated in MOTION clinical trial and received expenses from Galil as per study protocol. Activities not related to the present article: disclosed no relevant relationships. Other relationships: disclosed no relevant relationships. A.J.H. disclosed no relevant relationships. J.I. disclosed no relevant relationships. F.P. disclosed no relevant relationships. C.M. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: author received consultancy fees from Deeplink Medical. Other relationships: disclosed no relevant relationships. P.J.L. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: author received honoraria and support for travel to meetings from Endocare and Galil Medical for invited talks on cryoablation, not related to the trial or associated data. Other relationships: disclosed no relevant relationships. T.d.B. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: author received consultancy fees from Terumo and Guerbet; author’s institution has grants/grants pending from Terumo; author received payment for lectures including service on speakers bureaus from Guerbet, Boston Scientific, Terumo, AstraZeneca, GE Healthcare, and Nanobiotix. Other relationships: disclosed no relevant relationships. F.D. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: author received consultancy fees from Medtronics, Ablatech, GE, Galil Medical, and Terumo. Other relationships: disclosed no relevant relationships.
Références
J Pain Symptom Manage. 2016 Jun;51(6):1070-1090.e9
pubmed: 27112310
JAMA. 2016 Apr 19;315(15):1624-45
pubmed: 26977696
Int J Urol. 2016 Oct;23(10):825-832
pubmed: 27488133
Clin Radiol. 2017 Aug;72(8):645-656
pubmed: 28363660
Radiology. 2019 May;291(2):529-530
pubmed: 30829558
Ann Palliat Med. 2017 Apr;6(2):125-142
pubmed: 28249544
J Clin Oncol. 2016 Sep 20;34(27):3325-45
pubmed: 27458286
Skeletal Radiol. 2014 Nov;43(11):1551-9
pubmed: 24972918
Pract Radiat Oncol. 2017 Jan - Feb;7(1):4-12
pubmed: 27663933
J Clin Oncol. 2014 Jun 1;32(16):1727-33
pubmed: 24799490
BMC Cancer. 2018 Jan 6;18(1):44
pubmed: 29306325
Radiother Oncol. 2002 Sep;64(3):275-80
pubmed: 12242115
Oncol Lett. 2019 Mar;17(3):3362-3370
pubmed: 30867771
AJR Am J Roentgenol. 2011 Aug;197(2):510-5
pubmed: 21785102
J Surg Oncol. 2019 Sep;120(3):376-381
pubmed: 31140605
Ann Oncol. 2018 Oct 1;29(Suppl 4):iv166-iv191
pubmed: 30052758
J Vasc Interv Radiol. 2013 Mar;24(3):347-50
pubmed: 23433410
Skeletal Radiol. 2019 Aug;48(8):1161-1169
pubmed: 30627778
Skeletal Radiol. 2009 Sep;38(9):835-9
pubmed: 19590871
Eur J Cancer. 2017 Jan;71:80-94
pubmed: 27984770
Cancer. 2013 Mar 1;119(5):1033-41
pubmed: 23065947
Pain Pract. 2018 Nov;18(8):1083-1098
pubmed: 29734509
Radiology. 2019 May;291(2):521-528
pubmed: 30806603
J Vasc Interv Radiol. 2016 Dec;27(12):1788-1796
pubmed: 27745968
Clin Epidemiol. 2012;4:87-93
pubmed: 22570568