Cryotherapy is a cold ablation technique used in many tumor locations. The destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. Compared to other interventional radiology techniques, cryotherapy induces a higher immunogenic response. Studies describe complex responses with elevated levels of activating NK cells, circulating and anti-tumor T cells, and pro-inflammatory and NF-KB dependent cytokines. In breast cancer, whether or not an immune response is triggered depends on the type of cryoablation used. Indeed, high intensity cryoablation (rapid freezing in one cycle of the entire tumor volume) seems to induce a tumor-specific immunodestructive response, whereas low frequency cryoablation (several small repetitive cycles until a sufficient volume of ice is obtained) does not induce an immunogenic response and can even induce an immunoregulation with immunotolerance of the tumor cells The University Hospital of Nîmes has recently acquired a new liquid nitrogen cryotherapy technique, more powerful than the one classically performed with Argon. This technique is used for palliative and analgesic purposes in patients with metastatic breast cancer presenting painful subcutaneous metastases. The aim of this study is to evaluate in these patients the changes in the tumor microenvironment and the immune response potentially induced by this very high intensity cryotherapy. The study investigators hypothesize that locoregional treatment with liquid nitrogen cryotherapy of subcutaneous breast cancer metastases will allow a systemic response through the induction of an immune response. A better understanding of the type of immune response induced will allow the development of combined therapeutic strategies with curative and not only palliative and analgesic aims.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
5
Cryotherapy treatment administered by an interventional radiologist: the cryotherapy needle is placed under local anesthesia, ultrasound monitoring in real time. A complete cryotherapy cycle is performed with: freezing until the entire tumor is frozen as judged by ultrasound, then thawing for the same duration and refreezing according to the same principle.
CHU de Nimes
Nîmes, France
Description of the immunological makeup of the tumor before liquid nitrogen cryotherapy treatment
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
Time frame: Day 0
Description of the immunological makeup of the tumor after liquid nitrogen cryotherapy treatment
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
Time frame: Day 15
Patients' tolerance to cryotherapy treatment
Collection of complications and adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria
Time frame: Day 15
Level of pain related to subcutaneous metastases before cryotherapy treatment
0-10 Visual analog scale. Higher scores mean worse outcome.
Time frame: Day 0 immediately before cryotherapy treatment
Level of pain related to subcutaneous metastases after cryotherapy treatment
0-10 Visual analog scale. Higher scores mean worse outcome.
Time frame: Day 0 immediately after cryotherapy treatment
Level of pain related to subcutaneous metastases after cryotherapy treatment
0-10 Visual analog scale. Higher scores mean worse outcome.
Time frame: Day 15
Pain related to subcutaneous metastases before cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120. Higher scores mean worse outcome.
Time frame: Day 0 immediately before cryotherapy treatment
Pain related to subcutaneous metastases after cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120. Higher scores mean worse outcome.
Time frame: Day 0 immediately after cryotherapy treatment
Pain related to subcutaneous metastases after cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120. Higher scores mean worse outcome.
Time frame: Day 15
Patient reported quality of before cryotherapy treatment
European Organisation for Research and Treatment of Cancer - C30 (EORTC QLQ-C30). This questionnaire is composed of 30 items grouped into 15 scales. A good quality of life is associated with a high score for the functional scales and a low score for the symptom scales
Time frame: Day 0
Patient reported quality of after cryotherapy treatment
European Organisation for Research and Treatment of Cancer - C30 (EORTC QLQ-C30). This questionnaire is composed of 30 items grouped into 15 scales. A good quality of life is associated with a high score for the functional scales and a low score for the symptom scales
Time frame: Day 15
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