Description
Breast Tumors
Early-stage primary breast cancers are treated surgically. The selection of lumpectomy, modified radical mastectomy, or another approach is balanced against the individual's desire for breast conservation, the need for tumor-free margins in resected tissue, and the individual's age, hormone receptor status, and other factors. Adjuvant radiotherapy decreases local recurrences, particularly for those who select lumpectomy. Adjuvant hormonal therapy and/or chemotherapy are added, depending on the presence and number of involved nodes, hormone receptor status, and other factors. Treatment of metastatic disease includes surgery to remove the lesion and combination chemotherapy.
Fibroadenomas are common benign tumors of the breast that can present as a palpable mass or a mammographic abnormality. These benign tumors are frequently surgically excised to rule out a malignancy.
Lung Tumors
Early-stage lung tumors are typically treated surgically. Individuals with early-stage lung cancer who are not surgical candidates may be candidates for radiotherapy with curative intent. Cryoablation is being investigated in individuals who are medically inoperable, with small primary lung cancers or lung metastases. Individuals with a more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment is rarely curative; rather, it seeks to retard tumor growth or palliate symptoms.
Pancreatic Cancer
Pancreatic cancer is a relatively rare solid tumor that occurs almost exclusively in adults, and it is largely considered incurable. Surgical resection of tumors contained entirely within the pancreas is currently the only potentially curative treatment. However, the nature of the cancer is such that few tumors are found at such an early and potentially curable stage. Individuals with a more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment focuses on slowing tumor growth and palliation of symptoms.
Renal Cell Carcinoma
Localized renal cell carcinoma is treated with radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney capsule because chemotherapy is relatively ineffective against metastatic renal cell carcinoma.
Cryosurgical Treatment
Cryosurgical treatment of various tumors including malignant and benign breast disease, lung cancer, pancreatic cancer, and renal cell carcinoma has been reported in the literature.
Regulatory Status
Several cryoablation devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, proctology, thoracic surgery, and ear, nose, and throat. Examples include:
Cryocare(R) Surgical System (Endocare);
CryoGen Cryosurgical System (Cryosurgical);
CryoHit(R) (Galil Medical) for the treatment of breast fibroadenoma;
- IceSense3, ProSense, and MultiSense Systems (IceCure Medical);
SeedNet System (Galil Medical); and
Visica(R) System (Sanarus Medical).
FDA product code: GEH.
Summary of Evidence
For individuals with early stage kidney cancer who are surgical candidates treated with cryoablation, the evidence includes comparative observational studies and systematic reviews. Relevant outcomes are overall survival (OS), disease-specific survival, quality of life, and treatment-related morbidity. Multiple comparative observational studies and systematic reviews of these studies have compared cryoablation to partial nephrectomy for early stage renal cancer. These studies have consistently found that partial nephrectomy is associated with better oncological outcomes than cryosurgery, but cryosurgery was associated with better perioperative outcomes, lower incidence of complications, and less decline in kidney function. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with early stage kidney cancer who are not surgical candidates and who are treated with cryoablation, the evidence includes comparative observational studies of cryoablation compared to partial nephrectomy or other ablative techniques, systematic reviews of these studies, and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. Although oncological outcomes were better with surgery, in comparative observational studies, cryoablation was associated with less decline in kidney function. Recent case series totaling more than 400 individuals showed cryoablation was associated with good oncological outcomes and preservation of renal function. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with non-small cell lung cancer (NSCLC) who are not surgical candidates, the evidence includes uncontrolled observational studies and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. Medically inoperable patients with early stage primary lung tumors were treated with cryoablation in a consecutive series of 45 individuals. Five year survival was 68%; the main complications were hemoptypsis in 40% of patients and pneumothorax in 51%. A prospective single arm Phase 2 study of 128 patients reported on cryoablation for treatment of metastases to the lung. Cryoablation for metastatic lung cancer was studied in a single arm trial in 40 individuals. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with with non-small cell lung cancer who require palliation for a central airway obstructing lesion who are treated with cryoablation, the evidence includes case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. There are no comparative studies. A series of 521 consecutive individuals reported improvement in symptoms in 86% of individuals, but multiple study design, conduct, and relevance limitations preclude drawing conclusions about efficacy or safety of cryoablation in this population. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with solid tumors located in the breast, pancreas, or bone who are treated with cryoablation, the evidence includes uncontrolled observational studies and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. Due to the lack of prospective controlled trials, it is not possible to conclude that cryoablation improves outcomes for any indication better than alternative treatments. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
