Cryoablation Of Breast Cancer Research Articles

Ultrasound-guided cryoablation of early breast cancer: safety, technical efficacy, patients' satisfaction, and outcome prediction with MRI/CEM: a pilot case-control study.

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.

Optimizing Cryoablation for Breast Cancer: Proposals for Extended Follow-Up and Methodologic Enhancements.

Optimizing Cryoablation for Breast Cancer: Proposals for Extended Follow-Up and Methodologic Enhancements.

Reply to: "Optimizing Cryoablation for Breast Cancer: Proposals for Extended Follow-Up and Methodologic Enhancements".

Reply to: "Optimizing Cryoablation for Breast Cancer: Proposals for Extended Follow-Up and Methodologic Enhancements".

Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials: A Multiinstitutional Study.

BACKGROUND. Breast cancer cryoablation clinical trials have strict inclusion criteria that exclude patients with potentially treatable disease. OBJECTIVE. The purpose of this study was to evaluate the safety and outcomes of breast cancer cryoablation without surgical excision in patients ineligible for prospective cryoablation clinical trials due to unfavorable patient or tumor characteristics. METHODS. This retrospective study included women who underwent cryoablation of biopsy-proven unifocal primary breast cancer with locally curative intent, without surgical excision, despite being ineligible for (and thus excluded from) cryoablation clinical trials, across seven institutions between January 1, 2000, and August 26, 2021. Adverse events (AEs) were recorded. Cryoablation procedures were classified as technically successful if they were not prematurely terminated and achieved intended treatment parameters and if the first follow-up imaging examination showed no evidence of residual disease. The results of follow-up biopsies were recorded. Ipsilateral breast tumor recurrences (IBTRs) diagnosed during follow-up were identified and classified as true recurrence or new primary disease. A competing-risk model was used to estimate the cumulative incidence of IBTR accounting for death before IBTR as a competing risk. RESULTS. The final study sample included 112 patients (median age, 71 years). A total of seven of 112 (6.3%) patients had a minor AE; no moderate or major AEs occurred. A total of 110 of 112 cryoablation procedures (98.2%) were technically successful. During a median follow-up of 2.0 years, 22 of 110 patients (20.0%) underwent biopsy for suspicious imaging findings in the ipsilateral breast, which yielded benign concordant findings in nine of 22 patients (40.9%) and IBTR in 12 of 22 patients (54.5%). Overall, 12 of 110 patients (10.9%) experienced IBTR, including seven with true recurrence and five with new primary disease; three of 12 patients (25.0%) with IBTR had received earlier adjuvant or neoadjuvant therapy. When death was accounted for as a competing risk, the cumulative incidence of IBTR was 5.3%, 12.2%, and 18.2% at 1, 2, and 3 years, respectively. CONCLUSION. In select individuals with unfavorable patient or tumor characteristics, breast cancer cryoablation provides a safe alternative to surgery and has good outcomes. These findings may be particularly relevant in patients who are also poor surgical candidates. CLINICAL IMPACT. Breast cancer cryoablation can be safely applied in a larger patient populations than those defined by clinical trial inclusion criteria.

CT-Guided Percutaneous Cryoablation of Breast Cancer: A Single-Center Experience.

This study shall retrospectively evaluate the efficacy and safety of liquid-nitrogen based CT-guided cryoablation (CA) as a minimal-invasive technique for the curative treatment of primary breast cancer. A total of 45 female patients with 56 tumors were treated by CT-guided CA in analgosedation as an outpatient procedure. We used a liquid-nitrogen based system with a single cryoprobe and performed two freeze cycles with an intermediate thawing. The mean tumor diameter was 1.6 ± 0.7 cm. Follow-up was conducted via contrast-enhanced MR images of the breast. No complications were observed in all 56 ablations. Initial complete ablation was achieved in 100% of cases. Four cases of local tumor progression were reported, resulting in a rate of 8.9%, and 6 cases of intramammary distant recurrence at a rate of 13.3%. The extramammary tumor progression was observed in 7 patients at a rate of 15.6%. The mean overall survival was 4.13 years (95% CI: 3.7-4.5). The mean overall progression-free survival was 2.5 years (95% CI: 1.8-3.2) and the mean local progression-free survival was 2.9 years (95% CI: 2.3-3.6). Cryoablation is a safe and effective treatment for primary breast cancer tumors, which can be performed in analgosedation and as an outpatient procedure. However, potential for improvement exists and further evidence is necessary.

Abstract PO1-01-07: Cryoablation and endocrine therapy for clinical stage I/II, ER+ breast cancer in patients with omission of surgical axillary staging. A retrospective study

Abstract OBJECTIVE To evaluate the efficacy of combined treatment with ultrasound-guided cryoablation and endocrine therapy (ET) in hormone receptor-positive (ER+), HER2-negative (HER-) invasive breast cancer (BC) patients with clinical stage I/II who are not candidates for axillary surgery. PATIENTS AND METHODS Patients with ER+, HER- invasive BC in clinical stage I/II who did not undergo sentinel lymph node biopsy (SLNB) or target axillary dissection (TAD) were included. They received treatment consisting of ultrasound-guided cryoablation combined with daily letrozole 2.5 mg orally. Cryoablation was performed as the initial treatment for BC < 15mm, followed by adjuvant ET, while neoadjuvant ET was administered for 6-12 months before cryoablation for BC ≥ 15mm. Cryoablation was performed using the ICEfx Galil argon gas system (Boston Scientific, USA) and the ProSense liquid nitrogen system (IceCure Medical Ltd, Caesarea, Israel). Follow-up breast ultrasound examinations were conducted every six months. Patients with a minimum follow-up of 12 months after cryoablation were included in the study. Core needle biopsies were performed if recurrence was suspected, and rescue cryoablation was considered for confirmed relapse. The tolerance and safety of the procedures were recorded. RESULTS From March 2019 to July 2023, a total of 96 patients with 105 ER+, HER2- invasive BC in clinical stage I/II who did not undergo SLNB or TAD were treated with ultrasound-guided cryoablation and ET. Among them, 58 patients (aged 58-96 years, mean 83, SD ±7.64) with 64 BC lesions (ranging from 5 to 60mm, mean 17, SD ±13.75) were followed up for a minimum of 12 months, with a mean follow-up period of 24 months (ranging from 12 to 50 months). The invasive carcinomas included 40 ductal, 16 lobular, 5 colloid, and 3 papillary cases. The ipsilateral breast tumor recurrence rate was 1,72% (1/58 patients). One patient with lobular carcinoma experienced a relapse at 17 months. Rescue cryoablation was performed, and after 25 months, she remains free of recurrence. Therefore, local control was achieved in all patients. Six patients died from causes unrelated to BC during the follow-up period. All procedures were well-tolerated with local anesthesia, and no serious complications were reported. CONCLUSION Ultrasound-guided cryoablation with ET constitutes an effective combined treatment for the local control of ER+, HER2- BC in patients with clinical stage I/II and omission for surgical axillary staging. Cryoablation is a very well tolerated procedure without morbidity. Citation Format: José María Oliver Goldaracena, Pilar Zamora, Covadonga Marti, Vicenta Córdoba Chicote, Maria José Roca Navarro, Diego Garrido Alonso, Ylenia Navarro Monforte, Teresa Diaz de Bustamante Durban, Fernando García Martínez, Jose Ignacio Sanchez-Mendez, Elisa York Pineda, Laura Yebenes Gregorio, Adolfo Loayza, Laura Frías Aldeguer, Elisa Moreno Palacios, Marcos Melendez Gisper, Joaquin Gomez Ramirez, Luis Asensio Gómez, Virginia Martínez Marín, David Hardisson Hernáez, Alberto Berjón García. Cryoablation and endocrine therapy for clinical stage I/II, ER+ breast cancer in patients with omission of surgical axillary staging. A retrospective study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-01-07.

The Role of Contrast-Enhanced Mammography After Cryoablation of Breast Cancer.

Image-guided cryoablation is an emerging therapeutic technique for the treatment of breast cancer and is a treatment strategy that is an effective alternate to surgery in select patients. Tumor features impacting the efficacy of cryoablation include size, location in relation to skin, and histology (e.g., extent of intraductal component), underscoring the importance of imaging for staging and workup in this patient population. Contrast-enhanced mammography (CEM) utilization is increasing in both the screening and diagnostic settings and may be useful for follow-up imaging after breast cancer cryoablation, given its high sensitivity for cancer detection and its advantages in terms of PPV, time, cost, eligibility, and accessibility compared with contrast-enhanced MRI. This Clinical Perspective describes the novel use of CEM after breast cancer cryoablation, highlighting the advantages and disadvantages of CEM compared with alternate imaging modalities, expected benign postablation CEM findings, and CEM findings suggestive of residual or recurrent tumor.

Breast Cancer Cryoablation in the Multidisciplinary Setting: Practical Guidelines for Patients and Physicians.

Breast cancer cryoablation has emerged as a minimally invasive alternative to lumpectomy for treating early-stage breast cancer. However, no consensus exists on what should be considered the standard of care for the multidisciplinary management of patients treated with breast cancer cryoablation. In lieu of national guidelines, this review of the literature provides a multidisciplinary framework and an evidence-based discussion of the integration of "standard of care practices" in the comprehensive management of breast cancer cryoablation patients.

Breast cancer cryoablation with radiologic-pathologic correlation.

Breast cryoablation has become a viable option for the treatment of breast cancer in properly selected patient populations. With the increase in the use of cryoablation, post-treatment follow-up imaging and pathology has also gained increased importance. By using the proper imaging combination of diagnostic mammography, ultrasound and MRI, physicians are able to detect residual or recurrent malignancy and differentiate it from expected post-treatment findings. If suspicious imaging findings are seen, prompt biopsy and pathological diagnosis are essential. The pathologist must also be able to differentiate the expected post-procedural histological findings from those of recurrent or residual malignancy. These imaging and pathological findings must also be compared in order to ensure concordance and appropriate patient treatment.

"Breast Pathology After Cryotherapy. Office Based Cryoablation of Breast Cancer with Long - Term Follow – Up"

Mieczyslaw R Gajda1*, Masoud Mireskandari1, Ingo B Runnebaum2, Pascal AT Baltzer3,4, Stefan OR Pfleiderer3,5, Omar Camara2,6, Werner A Kaiser3 and Iver Petersen1 Author Affiliations 1Department of Forensic Medicine, Section of Pathology, University Hospital Jena, Germany 2Department of Gynecology and Obstetrics, University Hospital Jena, Germany 3Department of Radiology, University Hospital Jena, Germany 4Department of Radiology, Medical University Vienna, Austria 5Institute of Diagnostic and Interventional Radiology, Klinikum Bremerhaven-Reinkenheide, Germany 6Department of Gynecology and Obstetrics, Hufeland Klinikum Bad Langensalza, Germany Received: March 16, 2022 | Published: March 25, 2022 Corresponding author: Mieczyslaw Gajda, Department of Forensic Medicine, Section of Pathology, Jena University Hospital, Am Klinikum 1, 07740 Jena, Germany DOI: 10.26717/BJSTR.2022.42.006822

Breast Cancer Cryoablation: Assessment of the Impact of Fundamental Procedural Variables in an In Vitro Human Breast Cancer Model.

Introduction:Breast cancer is the most prominent form of cancer and the second leading cause of death in women behind lung cancer. The primary modes of treatment today include surgical excision (lumpectomy, mastectomy), radiation, chemoablation, anti-HER2/neu therapy, and/or hormone therapy. The severe side effects associated with these therapies suggest a minimally invasive therapy with fewer quality of life issues would be advantageous for treatment of this pervasive disease. Cryoablation has been used in the treatment of other cancers, including prostate, skin, and cervical, for decades and has been shown to be a successful minimally invasive therapeutic option. To this end, the use of cryotherapy for the treatment of breast cancer has increased over the last several years. Although successful, one of the challenges in cryoablation is management of cancer destruction in the periphery of the ice ball as the tissue within this outer margin may not experience ablative temperatures. In breast cancer, this is of concern due to the lobular nature of the tumors. As such, in this study, we investigated the level of cell death at various temperatures associated with the margin of a cryogenic lesion as well as the impact of repetitive freezing and thawing methods on overall efficacy.Methods:Human breast cancer cells, MCF-7, were exposed to temperatures of −5°C, −10°C, −15°C, −20°C, or −25°C for 5-minute freeze intervals in a single or repeat freeze-thaw cycle. Samples were thawed with either passive or active warming for 5 or 10 minutes. Samples were assessed at 1, 2, and 3 days post-freeze to assess cell survival and recovery. In addition, the modes of cell death associated with freezing were assessed over the initial 24-hour post-thaw recovery period.Results:Exposure of MCF-7 cells to −5°C and −10°C resulted in minimal cell death regardless of the freeze/thaw conditions. Freezing to a temperature of −25°C resulted in complete cell death 1 day post-thaw with no cell recovery in all freeze/thaw scenarios evaluated. Exposure to a single freeze event resulted in a gradual increase in cell death at −15°C and −20°C. Application of a repeat freeze-thaw cycle (dual 5-minute freeze) resulted in an increase in cell death with complete destruction at −20°C and near complete death at −15°C (day 1 survival: single −15°C freeze/thaw = 20%; repeated −15°C freeze/thaw = 4%). Analysis of thaw interval time (5 vs 10 minute) demonstrated that the shorter 5-minute thaw interval between freezes resulted in increased cell destruction. Furthermore, investigation of thaw rate (active vs passive thawing) demonstrated that active thawing resulted in increased cell survival thereby less effective ablation compared with passive thawing (eg, −15°C 5/10/5 procedure survival, passive thaw: 4% vs active thaw: 29%).Conclusions:In summary, these in vitro findings suggest that freezing to temperatures of 25°C results in a high degree of breast cancer cell destruction. Furthermore, the data demonstrate that the application of a repeat freeze procedure with a passive 5-minute or 10-minute thaw interval between freeze cycles increases the minimal lethal temperature to the −15°C to −20°C range. The data also demonstrate that the use of an active thawing procedure between freezes reduces ablation efficacy at temperatures associated with the iceball periphery. These findings may be important to improving future clinical applications of cryoablation for the treatment of breast cancer.

Cryoablation In The Management Of Breast Cancer: Evidence To Date.

Cryoablation has been successfully used to treat various type of solid tumors, including breast carcinomas. This ablation method has the advantage of being a minimally invasive procedure useful in various clinical situations, including early breast cancer and metastatic breast cancer, when co-morbidities preclude the use of surgical treatment. However, due to the small sample size of the available studies, reliable and definitive conclusions on the usefulness of cryoablation in patients with breast cancer could not be drawn. In fact, many aspects necessitate to be elucidated, regarding technical issues, indications, efficacy, imaging follow-up, and possible advantages over other percutaneous ablative methods. This review article has the aim to clarify the current evidence supporting cryoablation of breast cancer, and discuss the future perspectives, including those arising from the new studies on immunological effects related to cryoablation.

Cryosurgery for primary breast cancers, its biological impact, and clinical outcomes.

Recently, a number of new minimally invasive image-guided percutaneous ablation treatments, including cryoablation, radiofrequency ablation, microwave ablation, high-intensity focused ultrasound, laser ablation, and irreversible electroporation have been developed. Several studies have shown the feasibility and safety of these cryoablation therapies for the treatment of benign breast tumors and small invasive breast cancer. Although the complete response rate of cryoablation for breast cancer is reported to be relatively good, most studies enrolled a small number of patients, and so reliable conclusions could not be drawn. In this review, we introduce the mechanisms of action of cryoablation, and summarize the current literature on the efficacy and safety of cryoablation for breast cancer. Cryoablation also induces an immunomodulatory effect, which is an interesting topic of research in the era of immune checkpoint inhibitors. Cryoablation for primary tumor may enhance the treatment effect of immune checkpoint inhibitors in patients with breast cancer. Further investigations of this new therapeutic strategy are needed.

Harnessing ultrasound-guided cryoablation for breast cancer

Harnessing ultrasound-guided cryoablation for breast cancer

Development of an MRI-powered robotic system for cryoablation.

This study proposes a novel MRI-powered robotic system controlled with the magnetic field generated by a magnetic resonance imaging (MRI) scanner. In the proposed system, we use an MRI-powered actuator unit proposed in the previous study and a spherical positioning mechanism. The actuator unit contains a ferromagnetic sphere, which acts as a power source and is used to control the positioning unit inside the MRI environment. These elements enable the development of a remote needle tip positioning system for use within the MRI scanner. Potential applications of the developed system include the automation of procedures during under MRI inspections, especially the cryoablation of breast cancer. In this paper, we report on the performance evaluation and the MR-safety of the proposed system and describe the newly developed spherical positioning mechanism, which can be activated by the actuator units.

Single-Centre Experience with Percutaneous Cryoablation of Breast Cancer in 23 Consecutive Non-surgical Patients.

To present our single-centre prospective experience on the use of cryoablation (CA) applied to treat primary breast cancer (BC) in a cohort of patients unsuitable for surgical treatment. Twenty-three consecutive post-menopausal female patients (median age 85 years; range 56-96) underwent percutaneous CA of unifocal, biopsy-proven BC, under ultrasound/computed tomography (US/CT) guidance. Clinical and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) follow-ups were systematically scheduled at 3, 12, 18 and 24 months. Local tumour control was assessed by comparing baseline and follow-up DCE-MRI. Twenty-three BC (median size 14 mm) were treated under local anaesthesia (78.3 %) or local anaesthesia and conscious sedation (21.7 %). Median number of cryo-probes applied per session was 2.0. A "dual-freezing" protocol was applied for the first ten patients and a more aggressive "triple-freezing" protocol for the remaining 13. Median follow-up was 14.6 months. Five patients recurred during follow-up and two were successfully re-treated with CA. Five patients presented immediate CA-related complications: four hematomas evolved uneventfully at 3-month follow-up and one skin burn resulted in skin inflammation and skin retraction at 3 and 12 months, respectively. Percutaneous CA is safe and well tolerated for non-resected elderly BC patients. Procedures can be proposed under local anaesthesia only. Given the insulation properties of the breast gland, aggressive CA protocols are required. Prospective studies are needed to better understand the potential role of CA in the local treatment of early BC.

A30 Session 9: Women’s Health : Breast cancer cryoablation

The surgical management of breast cancer has seen a radical evolution over the past several decades, characterized by equal or improved outcomes with significantly less morbidity. Eradication of the primary tumor has progressed from radical mastectomy (and extended radical mastectomy), through modified radical mastectomy, to lumpectomy. These changes have been facilitated by a multitude of factors, including improvements in technology and screening, better-quality and more widely used adjuvant therapies, and countless patients participating in multi-institutional prospective, randomized trials. The next, seemingly inevitable, step in the evolution of breast cancer therapy would be the replacement of lumpectomy, at least for a select group of patients, with non-surgical methods for destroying the tumor. Cryoablation has emerged as an alternative to surgery for tumors of the skin, prostate, kidney, liver and bone, and given recent advances in breast imaging, and our ability to target non-palpable lesions, it seems logical that breast cancer would be an ideal clinical target. However, adoption of cryoablation for breast cancer has proven challenging, with several obstacles still to overcome. This presentation will review the clinical experience to date with breast cancer cryoablation and some of the hurdles to its clinical implementation.

16. Cryoablation as an alternative to lumpectomy for breast cancer

With improvements in technology, cryoablation as an alternative to surgery, has been used to treat cancers of the skin, prostate, liver, lung and bone. There is significant interest in cryoablation of breast cancer. Potential advantages over lumpectomy include the minimally invasive nature of the treatment, improved cosmetic results, patient comfort, decreased costs and the possible immune response to the ablated tissue. Several pre-clinical and clinical studies have demonstrated both the feasibility of breast cancer cryoablation and the generation of an anti-tumor immune response, and clinical experience with cryoablation of benign breast tumors is growing. The on-going American College of Surgeons Oncology Group Trial Z1072, a phase II trial examining the success of breast cancer cryoablation, is an important first step in possibly replacing lumpectomy with cryoablation for a subset of breast cancer patients. This discussion will review the breast cryoablation literature to date and discusses the directions the field needs to move into realize that goal.

Cryoablation as a Replacement for Surgical Resection in Early Stage Breast Cancer

With improvements in technology, freezing malignant tissue (cryoablation) as an alternative to surgery has been used to treat cancers of the skin, prostate, liver, lung, and bone. There is significant interest in cryoablation of breast cancer. Potential advantages over lumpectomy include the minimally invasive nature of the treatment, improved cosmetic results, patient comfort, decreased costs, and the possible immune response to the ablated tissue. Several pre-clinical and clinical studies have demonstrated both the feasibility of breast cancer cryoablation and the generation of an anti-tumor immune response, and clinical experience with cryoablation of benign breast tumors is growing. The ongoing American College of Surgeons Oncology Group Trial Z1072, a phase II trial examining the success of breast cancer cryoablation, is an important first step in possibly replacing lumpectomy with cryoablation for a subset of breast cancer patients. This article reviews the breast cryoablation literature to date and discusses the directions the field needs to move in to realize that goal.

Ultrasound-guided Cryoablation of Invasive Ductal Carcinoma inside the MR Room

One disadvantage of ultrasound (US)-guided cryoablation of breast cancer is the difficulty in visualizing the area behind the ice ball because of acoustic shadowing. We performed US-guided cryoablation with the patient in prone position inside the MR room. The lumpectomy specimen after cryoablation revealed dense fibrosis without residual viable cancer cells. The combination of needle insertion under US guidance with planning and verification using magnetic resonance imaging may be a feasible and promising treatment protocol.