The ECLIPSE Study: Efficacy of cryoablation on metastatic lung tumors with a 5-year follow-up
Mené en 2012-2013 sur 40 patients atteints d'un cancer du poumon métastatique, cet essai international de phase I évalue la faisabilité et l'efficacité, du point de vue du contrôle local, de la cryoablation
Introduction: The ECLIPSE study aimed to assess the feasibility and efficacy of cryoablation for local tumor control in patients with pulmonary metastatic disease over five years of follow-up. Methods: ECLIPSE was a prospective, multicenter, single-arm study which included patients treated with cryoablation if they had 1-5 metastatic lung tumors, each with a diameter of ≤ 3.5 cm. Patients were followed up over the course of five years. The primary endpoint was local tumor control, both per tumor and per patient; secondary endpoints included cancer-specific survival, overall survival (OS), and quality of life. Quality of life was assessed using the Karnofsky Performance Score, the Eastern Cooperative Oncology Group Performance Score, and the Short Form-12 health survey. Results: The study included 40 patients across 4 sites (3 US and 1 European). A total of 60 metastatic pulmonary tumors were treated with 48 cryoablation procedures. Overall local tumor control rates were 87.9% (29/33) and 79.2% (19/24) per tumor, and 83.3% (20/24) and 75.0% (15/20) per patient, at 3 and 5 years respectively. A total of 5 treated patients demonstrated local progression throughout the duration of the study. Disease specific survival rate was of 74.8% at 3 years and 55.3% at 5 years while overall survival at 3 and 5 years were of 63.2% and 46.7% respectively. Patient quality of life scores did not reach statistical significance. Conclusions: Cryoablation is an effective means of long-term local tumor control in patients with metastatic pulmonary tumors.