Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2025
1-year efficacy results after MR-guided risk-adapted stereotactic radiotherapy of infra-diaphragmatic oligometastases in a multicenter phase II trial.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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van Overeem Felter Mette, Møller Pia Krause, Josipovic Mirjana, Bekke Susanne Nørring, Bernchou Uffe, Serup-Hansen Eva, Parikh Parag, Kim Joshua, Geertsen Poul, Behrens Claus P, Madsen Kapser, Vogelius Ivan R, Topsøe Jakob Fink, Berthelsen Anne Kiil, Pøhl Mette, Schytte Tine, Persson Gitte Fredberg
Аннотация
BACKGROUND AND PURPOSE: The SOFT (Stereotactic ablative radiotherapy of infra-diaphragmatic sOFT tissue metastases) trial assesses the safety and efficacy of risk-adapted MR-guided stereotactic ablative radiotherapy (SABR) of infra-diaphragmatic soft tissue metastasis in patients with oligometastatic disease (OMD) (clinicaltrials.gov ID NCT04407897). This paper reports the one-year efficacy analysis and evaluates associations between local control (LC) and clinical and dosimetric parameters.
MATERIALS AND METHODS: This investigator-initiated, multicenter, single-arm, phase 2 study recruited patients from four MR-linac centers in Denmark and the US. Patients with De novo or recurrent OMD with ≤5 metastases in ≤3 organs and patients with induced OMD or oligoprogressive disease (OPD) with ≤3 metastases were eligible. Fractionation schemes were 45-75 Gy in 3-8 fractions.
RESULTS: The trial included 121 patients with 147 oligometastatic lesions, primarily in the liver (41 %), lymph nodes (35 %), or adrenal glands (14 %). The median follow-up time was 13.0 months, interquartile range (IQR) (11.7,13.7) months. The 1-year LC rate was 89 %, 95 % confidence interval (CI) (83,94 %). We did not observe any statistically significant associations between LC and clinical and dosimetric parameters. The median progression-free survival was 7.1 months, 95 % CI (6.0,9.4). One- and two-year overall survival was 82.6 %, 95 % CI (76.2 %,89.7 %), and 65.1 %, 95 % CI (56.4 %,75.3 %). Sixty-one patients (50 %) were kept off systemic therapy throughout the one-year follow-up.
CONCLUSION: In our study, treatment with risk-adapted, MR-guided SABR resulted in a high one-year local control and survival rate and could keep half of the patients off systemic therapy within the first year of follow-up.
MATERIALS AND METHODS: This investigator-initiated, multicenter, single-arm, phase 2 study recruited patients from four MR-linac centers in Denmark and the US. Patients with De novo or recurrent OMD with ≤5 metastases in ≤3 organs and patients with induced OMD or oligoprogressive disease (OPD) with ≤3 metastases were eligible. Fractionation schemes were 45-75 Gy in 3-8 fractions.
RESULTS: The trial included 121 patients with 147 oligometastatic lesions, primarily in the liver (41 %), lymph nodes (35 %), or adrenal glands (14 %). The median follow-up time was 13.0 months, interquartile range (IQR) (11.7,13.7) months. The 1-year LC rate was 89 %, 95 % confidence interval (CI) (83,94 %). We did not observe any statistically significant associations between LC and clinical and dosimetric parameters. The median progression-free survival was 7.1 months, 95 % CI (6.0,9.4). One- and two-year overall survival was 82.6 %, 95 % CI (76.2 %,89.7 %), and 65.1 %, 95 % CI (56.4 %,75.3 %). Sixty-one patients (50 %) were kept off systemic therapy throughout the one-year follow-up.
CONCLUSION: In our study, treatment with risk-adapted, MR-guided SABR resulted in a high one-year local control and survival rate and could keep half of the patients off systemic therapy within the first year of follow-up.