Ultrasound-guided cryoablation of early breast cancer: safety, technical efficacy, patients' satisfaction, and outcome prediction with MRI/CEM: a pilot case-control study.
Breast neoplasms
Contrast-enhanced mammography
Cryosurgery
Magnetic resonance imaging
Patient satisfaction
Journal
European radiology experimental
ISSN: 2509-9280
Titre abrégé: Eur Radiol Exp
Pays: England
ID NLM: 101721752
Informations de publication
Date de publication:
22 Oct 2024
22 Oct 2024
Historique:
received:
12
03
2024
accepted:
13
09
2024
medline:
22
10
2024
pubmed:
22
10
2024
entrez:
22
10
2024
Statut:
epublish
Résumé
This pilot prospective study aimed to evaluate ultrasound-guided cryoablation of breast cancer (BC) by assessing: (i) technical efficacy as the presence of necrosis in surgical specimens and rate of complete tumor ablation; (ii) safety as incidence and severity of complications; and (iii) patients' satisfaction using a dedicated questionnaire. In addition, (iv) we tested the capability of magnetic resonance imaging (MRI) or contrast-enhanced mammography (CEM) to predict cryoablation efficacy. From 07/2022 to 01/2023, we enrolled 20 patients with early-stage BC scheduled for breast surgery. Ten of them, with a cryo-feasible cancer location, were sent to cryoablation (cryo-group) and ten to routine surgical practice (control group). Both groups underwent surgery and were asked to answer a satisfaction questionnaire. Of eleven patients screened for cryoablation, only one refused to be treated at another hospital (acceptance rate 10/11, 91%). Surgery was quadrantectomy in 19 cases and mastectomy in 1. In the cryo-group, the procedure was completed and steatonecrosis was observed in 10/10 cases, with complete tumor ablation in nine of them. The post-procedural status was evaluated with MRI in five patients, with CEM in four patients, and with ultrasound in one patient who refused MRI and CEM. MRI or CEM correctly predicted complete cryoablation in eight patients and incomplete cryoablation in one patient. Patients in both groups did not have serious complications and responded positively to satisfaction questionnaires. Ultrasound-guided cryoablation of early-stage BC is well accepted by patients, effective, and safe. MRI and CEM were able to predict the procedure's technical efficacy. https://clinicaltrials.gov/study/NCT05727813 updated February 14, 2023. Our pilot study showed that ultrasound-guided cryoablation is a promising nonsurgical alternative for treating early-stage BC. Ultrasound-guided cryoablation was effective and safe in early BC patients. The procedure was well-tolerated, with low morbidity and high patient satisfaction. MRI and CEM predicted cryoablation efficacy, in accordance with histopathologic findings. Cryoablation can be considered a potential alternative to surgery in selected patients.
Sections du résumé
BACKGROUND
BACKGROUND
This pilot prospective study aimed to evaluate ultrasound-guided cryoablation of breast cancer (BC) by assessing: (i) technical efficacy as the presence of necrosis in surgical specimens and rate of complete tumor ablation; (ii) safety as incidence and severity of complications; and (iii) patients' satisfaction using a dedicated questionnaire. In addition, (iv) we tested the capability of magnetic resonance imaging (MRI) or contrast-enhanced mammography (CEM) to predict cryoablation efficacy.
METHODS
METHODS
From 07/2022 to 01/2023, we enrolled 20 patients with early-stage BC scheduled for breast surgery. Ten of them, with a cryo-feasible cancer location, were sent to cryoablation (cryo-group) and ten to routine surgical practice (control group). Both groups underwent surgery and were asked to answer a satisfaction questionnaire.
RESULTS
RESULTS
Of eleven patients screened for cryoablation, only one refused to be treated at another hospital (acceptance rate 10/11, 91%). Surgery was quadrantectomy in 19 cases and mastectomy in 1. In the cryo-group, the procedure was completed and steatonecrosis was observed in 10/10 cases, with complete tumor ablation in nine of them. The post-procedural status was evaluated with MRI in five patients, with CEM in four patients, and with ultrasound in one patient who refused MRI and CEM. MRI or CEM correctly predicted complete cryoablation in eight patients and incomplete cryoablation in one patient. Patients in both groups did not have serious complications and responded positively to satisfaction questionnaires.
CONCLUSION
CONCLUSIONS
Ultrasound-guided cryoablation of early-stage BC is well accepted by patients, effective, and safe. MRI and CEM were able to predict the procedure's technical efficacy.
TRIAL REGISTRATION
BACKGROUND
https://clinicaltrials.gov/study/NCT05727813 updated February 14, 2023.
RELEVANCE STATEMENT
CONCLUSIONS
Our pilot study showed that ultrasound-guided cryoablation is a promising nonsurgical alternative for treating early-stage BC.
KEY POINTS
CONCLUSIONS
Ultrasound-guided cryoablation was effective and safe in early BC patients. The procedure was well-tolerated, with low morbidity and high patient satisfaction. MRI and CEM predicted cryoablation efficacy, in accordance with histopathologic findings. Cryoablation can be considered a potential alternative to surgery in selected patients.
Identifiants
pubmed: 39436590
doi: 10.1186/s41747-024-00515-4
pii: 10.1186/s41747-024-00515-4
doi:
Substances chimiques
Contrast Media
0
Banques de données
ClinicalTrials.gov
['NCT05727813']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
120Informations de copyright
© 2024. The Author(s).
Références
Van de Voort EMF, Struik GM, Koppert LB et al (2021) Treatment of early-stage breast cancer with percutaneous thermal ablation, an open-label randomised phase 2 screening trial: rationale and design of the THERMAC trial. BMJ Open 11:e052992. https://doi.org/10.1136/bmjopen-2021-052992
doi: 10.1136/bmjopen-2021-052992
pubmed: 34489297
pmcid: 8422491
Van de Voort EMF, Struik GM, Birnie E et al (2021) Thermal ablation as an alternative for surgical resection of small (≤ 2 cm) breast cancers: a meta-analysis. Clin Breast Cancer 21:e715–e730. https://doi.org/10.1016/j.clbc.2021.03.004
doi: 10.1016/j.clbc.2021.03.004
pubmed: 33840627
Pediconi F, Marzocca F, Cavallo Marincola B, Napoli A (2018) MRI-guided treatment in the breast. J Magn Reson Imaging 48:1479–1488. https://doi.org/10.1002/jmri.26282
doi: 10.1002/jmri.26282
pubmed: 30318672
Al-Hilli Z, Wilkerson A (2021) Breast surgery: management of postoperative complications following operations for breast cancer. Surg Clin North Am 101:845–863. https://doi.org/10.1016/j.suc.2021.06.014
doi: 10.1016/j.suc.2021.06.014
pubmed: 34537147
Khan SY, Snitman A, Habrawi Z et al (2023) The role of cryoablation in breast cancer beyond the oncologic control: COST and breast-Q patient-reported outcomes. Ann Surg Oncol 30:1029–1037. https://doi.org/10.1245/s10434-022-12570-5
doi: 10.1245/s10434-022-12570-5
pubmed: 36171531
Niu L, Zhou L, Xu K (2012) Cryosurgery of breast cancer. Gland Surg 1:111–118. https://doi.org/10.3978/j.issn.2227-684X.2012.08.01
doi: 10.3978/j.issn.2227-684X.2012.08.01
pubmed: 25083433
pmcid: 4115688
Roknsharifi S, Wattamwar K, Fishman MDC et al (2021) Image-guided microinvasive percutaneous treatment of breast lesions: Where do we stand? Radiographics 41:945–966. https://doi.org/10.1148/rg.2021200156
doi: 10.1148/rg.2021200156
pubmed: 34197250
Galati F, Marra A, Cicciarelli F et al (2024) Cryoablation for the treatment of breast cancer: immunological implications and future perspectives. Utopia or reality? Radiol Med 129:222–228. https://doi.org/10.1007/s11547-024-01769-z
doi: 10.1007/s11547-024-01769-z
pubmed: 38296892
pmcid: 10879305
Olagunju A, Forsman T, Ward RC (2022) An update on the use of cryoablation and immunotherapy for breast cancer. Front Immunol 13:1026475. https://doi.org/10.3389/fimmu.2022.1026475
doi: 10.3389/fimmu.2022.1026475
pubmed: 36389815
pmcid: 9647043
Eisenhauer EA, Therasse P, Bogaerts J et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer.; 45:228–247. https://doi.org/10.1016/j.ejca.2008.10.026
doi: 10.1016/j.ejca.2008.10.026
pubmed: 19097774
Rand RW, Rand RP, Eggerding F et al (1987) Cryolumpectomy for carcinoma of the breast. Surg Gynecol Obstet 165:392–396
pubmed: 2823400
Graña-López L, Pérez-Ramos T, Villares A, Vázquez-Caruncho M (2022) Cryoablation of breast lesions: our experience. Radiologia 64:49–53. https://doi.org/10.1016/j.rxeng.2021.09.002
doi: 10.1016/j.rxeng.2021.09.002
pubmed: 35428468
Manenti G, Perretta T, Gaspari E et al (2011) Percutaneous local ablation of unifocal subclinical breast cancer: clinical experience and preliminary results of cryotherapy. Eur Radiol 21:2344–2353. https://doi.org/10.1007/s00330-011-2179-2
doi: 10.1007/s00330-011-2179-2
pubmed: 21681574
Fine RE, Gilmore RC, Dietz JR et al (2021) Cryoablation without excision for low-risk early-stage breast cancer: 3-year interim analysis of ipsilateral breast tumor recurrence in the ICE3 trial. Ann Surg Oncol 28:5525–5534. https://doi.org/10.1245/s10434-021-10501-4
doi: 10.1245/s10434-021-10501-4
pubmed: 34392462
Cryoablation of low risk small breast cancer-Ice3 Trial (2024) ClinicalTrials.gov ID NCT02200705. https://clinicaltrials.gov/study/NCT02200705 . Updated 20 Apr 2018. Accessed Apr 2024
Cryoablation of small breast tumors in early stage breast cancer (FROST) (2024) ClinicalTrials.gov ID NCT01992250. https://clinicaltrials.gov/study/NCT01992250 . Updated 20 Apr 2018. Accessed Apr 2024
Niu L, Wu B, Xu K (2012) Cryosurgery for breast fibroadenomas. Gland Surg 1:128–131. https://doi.org/10.3978/j.issn.2227-684X.2012.08.02
doi: 10.3978/j.issn.2227-684X.2012.08.02
pubmed: 25083435
pmcid: 4115690
Mehta A, Oklu R, Sheth RA (2016) Thermal ablative therapies and immune checkpoint modulation: Can locoregional approaches effect a systemic response? Gastroenterol Res Pract 2016:9251375. https://doi.org/10.1155/2016/9251375
doi: 10.1155/2016/9251375
pubmed: 27051417
pmcid: 4802022
Abdo J, Cornell DL, Mittal SK, Agrawal DK (2018) Immunotherapy plus cryotherapy: potential augmented abscopal effect for advanced cancers. Front Oncol 8:85. https://doi.org/10.3389/fonc.2018.00085
doi: 10.3389/fonc.2018.00085
pubmed: 29644213
pmcid: 5882833
McArthur HL, Diab A, Page DB et al (2016) A pilot study of preoperative single-dose ipilimumab and/or cryoablation in women with early stage breast cancer with comprehensive immune profiling. Clin Cancer Res 22:5729–5737. https://doi.org/10.1158/1078-0432.CCR-16-0190
doi: 10.1158/1078-0432.CCR-16-0190
pubmed: 27566765
pmcid: 5161031
Regen-Tuero HC, Ward RC, Sikov WM, Littrup PJ (2021) Cryoablation and immunotherapy for breast cancer: overview and rationale for combined therapy. Radiol Imaging Cancer 3:e200134. https://doi.org/10.1148/rycan.2021200134
doi: 10.1148/rycan.2021200134
pubmed: 33817653
pmcid: 8011444
Manenti G, Scarano AL, Pistolese CA et al (2013) Subclinical breast cancer: minimally invasive approaches. Our experience with percutaneous radiofrequency ablation vs. cryotherapy. Breast Care 8:356–360. https://doi.org/10.1159/000355707
doi: 10.1159/000355707
pubmed: 24415989
pmcid: 3861851
Simmons RM, Ballman KV, Cox C et al (2016) A phase II trial exploring the success of cryoablation therapy in the treatment of invasive breast carcinoma: Results from ACOSOG (Alliance) Z1072. Ann Surg Oncol 23:2438–2445. https://doi.org/10.1245/s10434-016-5275-3
doi: 10.1245/s10434-016-5275-3
pubmed: 27221361
pmcid: 5433250
Corines MJ, Sogani J, Hogan MP et al (2024) The role of contrast-enhanced mammography after cryoablation of breast cancer. AJR Am J Roentgenol 222:e2330250. https://doi.org/10.2214/AJR.23.30250
doi: 10.2214/AJR.23.30250
pubmed: 38019473