title: Evaluating Cryoablation of Metastatic Lung Tumors in Patients--Safety and Efficacy: The ECLIPSE Trial--Interim Analysis at 1 Year.
abstract: BACKGROUND
  To assess the feasibility, safety and local tumor control of cryoablation for treatment of pulmonary metastases.
  
  
  METHODS
  This Health Insurance Portability and Accountability Act (HIPAA) compliant, IRB-approved, multicenter, prospective, single arm study included 40 patients with 60 lung metastases treated during 48 cryoablation sessions, with currently a minimum of 12 months of follow-up. Patients were enrolled according to the following key inclusion criteria: 1 to 5 metastases from extrapulmonary cancers, with a maximal diameter of 3.5 cm. Local tumor control, disease-specific and overall survival rates were estimated using the Kaplan-Meier method. Complications and changes in physical function and quality of life were also evaluated using Karnofsky performance scale, Eastern Cooperative Oncology Group performance status classification, and Short Form-12 health survey.
  
  
  RESULTS
  Patients were 62.6 ± 13.3 years old (26-83). The most common primary cancers were colon (40%), kidney (23%), and sarcomas (8%). Mean size of metastases was 1.4 ± 0.7 cm (0.3-3.4), and metastases were bilateral in 20% of patients. Cryoablation was performed under general anesthesia (67%) or conscious sedation (33%). Local tumor control rates were 56 of 58 (96.6%) and 49 of 52 (94.2%) at 6 and 12 months, respectively. Patient's quality of life was unchanged over the follow-up period. One-year overall survival rate was 97.5%. The rate of pneumothorax requiring chest tube insertion was 18.8%. There were three Common Terminology Criteria for Adverse Events grade 3 procedural complications during the immediate follow-up period (pneumothorax requiring pleurodesis, noncardiac chest pain, and thrombosis of an arteriovenous fistula), with no grade 4 or 5 complications.
  
  
  CONCLUSIONS
  Cryoablation is a safe and effective treatment for pulmonary metastases with preserved quality of life following intervention.
authors.affiliation: *Department of Radiology, Gustave Roussy-Cancer Campus, Villejuif, France; †Université Paris-Sud XI, UFR Médecine Le Kremlin-Bicêtre, Le Kremlin Bicêtre, France; ‡Department of Radiology, Mayo Clinic and Mayo Medical School, Rochester, Minnesota; §Department of Radiological Sciences, Ronald Reagan UCLA Medical Center, Los Angeles, California; and ‖Department of Radiology, Karmanos Cancer Institute, Detroit, Michigan.
authors.forename: Thierry
authors.initials: T
authors.lastname: de Baere
authors.forename: Lambros
authors.initials: L
authors.lastname: Tselikas
authors.forename: David
authors.initials: D
authors.lastname: Woodrum
authors.forename: Fereidoun
authors.initials: F
authors.lastname: Abtin
authors.forename: Peter
authors.initials: P
authors.lastname: Littrup
authors.forename: Frederic
authors.initials: F
authors.lastname: Deschamps
authors.forename: Robert
authors.initials: R
authors.lastname: Suh
authors.forename: Hussein D
authors.initials: HD
authors.lastname: Aoun
authors.forename: Matthew
authors.initials: M
authors.lastname: Callstrom
mesh_terms: D003452:Cryosurgery / Q000379:methods*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome