Evaluating cryoablation of metastatic lung/pleura tumors in patients - safety and efficacy (eclipse) preliminary safety outcomes

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Purpose To assess the safety and efficacy of cryoablation in local tumor control for lung metastases ≤3.5 cm in patients with pulmonary metastatic disease. Materials and Methods Twenty-two patients (13 males, 9 females; mean age 60 years) with up to 3 unilaterally or a maximum of 5 metastases bilaterally were enrolled in a prospective study and underwent CT guided cryoablation (Galil Medical, Arden Hills, MN). Patient Follow-up including CT imaging was assessed at 1 week, 3 and 6 months. The primary endpoint for the study is local tumor control assessed by a modified RECIST. Complications were assessed using the CTCAE 4. Results A total of 36 tumors were treated in 22 patients over 27 cryoablation procedures. Sixty-eight percent (n=15) of the patients had one tumor, 23% (n=5) had 2 to 3 tumors and 9% (n=2) of the patients had greater than 3 tumors. The mean tumor size was 1.5 cm (range 0.7 to 3.2 cm), and 91% (n=20) of patients had unilateral disease. Colon and Renal carcinoma were the two most common primary cancer diagnoses accounting for 41% (n=9) and 18% (n=4) of the treated population respectively. General anesthesia was employed in 63% (n=17) or conscious/ sedation in 37% (n=10) of procedures. One to 6 probes per patient (mean=1.9) were used for a treatment time of 45 to 176 min. (mean=97). Four chest tubes (15%) were placed in 27 procedures. All reported adverse events were classified as CTCAE grade 1 or 2. The most common events occurring within 30 days of the procedure were pneumothorax 15% (n=4), pulmonary embolism 26% (n=7), and chest wall pain 19% (n=5), associated with 27 procedures. All resolved with minimal to no intervention. We did not encountered major hemorrhage to the lung or the pleura. After a median follow-up time of 3 months (15 patients at 3 months and 5 patients at 6 months) local tumor control rate is 100% with 6 patients demonstrating new distant tumor at 3 months. Conclusion Cryoablation of metastatic lung tumors ≤3.5 cm appears to be a safe. Our preliminary results seem to demonstrate promising local tumor control but larger experience and longer follow-up is needed to confirm these data.