Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE)
Mené sur 128 patients présentant une à six métastases pulmonaires, cet essai de phase II évalue l'efficacité, du point de vue de l'absence de récidive locale et du taux de survie globale à 12 et 24 mois, et la sécurité d'une cryoablation percutanée
Purpose : To assess the safety and local recurrence-free survival in patients following cryoablation for treatment of pulmonary metastases. Patients and Methods : This multi-center, prospective, single arm, phase II study included 128 patients with 224 lung metastases treated with percutaneous cryoablation, with 12- and 24-months follow-up. Patients were enrolled according to the following key inclusion criteria including 1 to 6 metastases from extrapulmonary cancers with a maximal diameter of 3.5 cm. Time to progression of the index tumor(s), and metastatic disease and overall survival rates were estimated using the Kaplan–Meier method. Complications were captured for 30 days post procedure and changes in performance status and quality of life were also evaluated. Results : Median size of metastases was 1.0 ± 0.6 cm (0.2–4.5) with a median number of tumors of 1.0 ± 1.2 cm (1–6). Local recurrence-free response (local tumor efficacy) of the treated tumor at 12 months was 172 of 202 (85.1%) and 139 of 180 (77.2%) at 24 months following the initial treatment and, following a second cryoablation treatment for recurrent tumor, secondary local recurrence-free response (local tumor efficacy) at 12 months of 184 of 202 (91.1%) and 152 of 180 (84.4%) at 24 months. Kaplan-Meier estimates of 12- and 24-months overall survival rate was 97.6% (95% CI: 92.6, 99.2) and 86.6% (95% CI: 78.7, 91.7), respectively. The rate of pneumothorax requiring pleural catheter placement was 26% (44/169). There were 8 grade 3 complication events during 169 procedures (4.7%) and one (0.6%) grade 4 event. Conclusion : Percutaneous cryoablation is a safe and effective treatment for pulmonary metastases.