P07.01.A MR-GUIDED LITT THERAPY IN PATIENTS WITH PRIMARY IRRESECTABLE GLIOBLASTOMA: A CONTROLLED, PROSPECTIVE PILOT STUDY (EMITT PILOT-STUDY)

Abstract

Abstract BACKGROUND Laser interstitial thermal therapy (LITT) is growing as a minimally invasive procedure in the treatment of brain tumours, even if high-quality evidence is lacking. We aimed to assess practical feasibility of a randomized controlled trial (RCT) in patients with primary irresectable glioblastoma (nGBM) and to collect pilot data on technical feasibility and safety of LITT. METHODS Adult patients with radiologically suspected glioblastoma where the multidisciplinary tumour board advised biopsy-only with KPS ≥70 and feasible trajectories to reach ≥70% ablation were prospectively included. Patients were randomized to receive either biopsy combined with LITT or biopsy alone, followed by chemoradiation (CRT). Main endpoints were practical feasibility of RCT (inclusion rate, willingness to be randomized and ability to complete the follow-up procedures), technical feasibility (time from indication to procedure, time from procedure to CRT, duration of procedure) and safety (complications reported following the Clavien Dindo classification (CD). RESULTS A total of 15 patients with an irresectable nGBM were included in the study (5 in the control and 10 in the LITT arm). Patients were highly motivated to participate to the study and all patients completed the follow-up procedure. After including 9 patients randomization was stopped. All patients were planned within 2 weeks after indication and no delay was observed in referring patients for adjuvant CRT. One, two or three laser probes were used to reach ≥70% expected ablation. Total procedure time varied between 200-540 minutes. Two CD≥3 complications occurred in the LITT arm. CONCLUSION Our pilot data suggest an RCT investigating LITT in patients with an irresectable nGBM is feasible, with initial safety data appearing in line with that of tumour resection. As a next step, we have designed a national multicenter RCT in order to evaluate survival benefit, quality of life and cost-effectiveness of LITT in this population.