The Lancet regional health. Europe · 2026
Microwave ablation versus stereotactic body radiotherapy for oligometastatic colorectal liver metastases (LAVA-CRLM): a prospective, randomised, phase II trial.
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Risumlund Signe Lenora, Stick Line Bjerregaard, Appelt Ane, Vogelius Ivan Richter, Nyhuus Bo, Schultz Nicolai Aagaard, Penninga Luit, van Overeem Felter Mette, Josipovic Mirjana, Larsen Peter Nørgaard
Аннотация
BACKGROUND: Local therapies can achieve durable disease control in selected patients with oligometastatic colorectal liver metastases. Microwave ablation (MWA) is widely used, whereas stereotactic body radiotherapy (SBRT) is a non-invasive alternative with limited prospective comparative evidence. We aimed to compare freedom from local progression and safety of MWA versus SBRT.
METHODS: LAVA-CRLM was a randomised, phase II trial conducted at two centres in Copenhagen, Denmark. Adults with one to three colorectal liver metastases, each ≤4.0 cm, deemed suitable for both MWA and SBRT with curative intent by a multidisciplinary team were randomly assigned (1:1) to MWA or SBRT. The primary endpoint was freedom from local progression in the modified intention-to-treat population. Toxicity was assessed in the safety population. The trial is registered with ClinicalTrials.gov (NCT03654131).
FINDINGS: Between Jan 29, 2019, and Dec 3, 2024, 100 patients were randomly assigned; 92 were included in the modified intention-to-treat population. At a median follow-up of 34.9 months, 1-year freedom from local progression was 77.7% (95% CI 66.5-90.9) with MWA and 83.0% (72.3-95.4) with SBRT (hazard ratio 0.87, 95% CI 0.43-1.74; p = 0.70). Grade 2 or higher treatment-related toxicity occurred in 13 (25%) of 52 patients treated with MWA and one (3%) of 40 treated with SBRT. Grade 3 or higher toxicity occurred only with MWA (four [8%] patients), including one treatment-related death.
INTERPRETATION: SBRT demonstrated a more favourable treatment-related safety profile, with no difference in freedom from local progression detected between SBRT and MWA in this phase II study. These findings support consideration of SBRT as a non-invasive local treatment option for selected patients with oligometastatic colorectal liver metastases.
FUNDING: Danish Cancer Society.
METHODS: LAVA-CRLM was a randomised, phase II trial conducted at two centres in Copenhagen, Denmark. Adults with one to three colorectal liver metastases, each ≤4.0 cm, deemed suitable for both MWA and SBRT with curative intent by a multidisciplinary team were randomly assigned (1:1) to MWA or SBRT. The primary endpoint was freedom from local progression in the modified intention-to-treat population. Toxicity was assessed in the safety population. The trial is registered with ClinicalTrials.gov (NCT03654131).
FINDINGS: Between Jan 29, 2019, and Dec 3, 2024, 100 patients were randomly assigned; 92 were included in the modified intention-to-treat population. At a median follow-up of 34.9 months, 1-year freedom from local progression was 77.7% (95% CI 66.5-90.9) with MWA and 83.0% (72.3-95.4) with SBRT (hazard ratio 0.87, 95% CI 0.43-1.74; p = 0.70). Grade 2 or higher treatment-related toxicity occurred in 13 (25%) of 52 patients treated with MWA and one (3%) of 40 treated with SBRT. Grade 3 or higher toxicity occurred only with MWA (four [8%] patients), including one treatment-related death.
INTERPRETATION: SBRT demonstrated a more favourable treatment-related safety profile, with no difference in freedom from local progression detected between SBRT and MWA in this phase II study. These findings support consideration of SBRT as a non-invasive local treatment option for selected patients with oligometastatic colorectal liver metastases.
FUNDING: Danish Cancer Society.