CIO 2021-1 The ECLIPSE Study: Efficacy of cryoablation in patients with metastatic lung cancer over 5 years

Purpose: The primary objective of ECLIPSE was to assess long-term efficacy of cryoablation for local tumor control in patients with pulmonary metastatic disease over the course of five years.

Material and Methods: ECLIPSE was a prospective, multicenter, single-arm study of cryoablation in subjects with 1 to 5 metastatic lung tumors, each with a diameter of ≤ 3.5 cm, with five years of follow-up. The primary endpoint was local tumor control (defined as the absence of progression of the lesion and provided per evaluable tumor and subject); additional secondary endpoints were cancer-specific survival, overall survival, and quality of life, as measured using the Karnofsky Performance Score, ECOG Performance Score, and Short Form-12 health survey.

Results: A total of 40 patients with 60 tumors were enrolled across 4 study sites; 48 procedures were performed to treat the 60 lesions. Of the enrolled subjects, 42.5% were treated for colorectal cancer metastases to the lung. Though 42.5% had received previous systemic treatment and 75% had received prior local treatment to other lung metastases, no target tumors treated in ECLIPSE had received locoregional therapy. Local tumor control rates per index tumor were 87.9% and 79.2% at three and five years, respectively; five patients demonstrated local progression. For lesions 2 cm or greater, local tumor control rates were 84.2% and 73.3% at three and five years. The local control rates per patient were 83.3% at three and 75.0% at five years. Kaplan-Meier estimates for freedom from local failure at 3 years were 91.3% per tumor and 87.1% per subject; at 5 years, it was 81.1% per tumor and 74.6% per subject. Disease-specific survival was 74.8% at 3 years and 55.3% at 5 years; overall survival was 63.2% and 46.7% at 3 and 5 years, respectively. Over the 5 years, quality of life scores improved slightly, but were not statistically significant from baseline.

Conclusions: Cryoablation is effective for long-term local tumor control in patients with metastatic pulmonary tumors. Most patients who receive cryoablation maintain local tumor control at the treated tumor and maintain quality of life over the course of five years.