Upfront Radiosurgery vs a Wait-and-Scan Approach for Small- or Medium-Sized Vestibular Schwannoma : The V-REX Randomized Clinical Trial
Importance: Current guidelines for treating small- to medium-sized vestibular schwannoma recommend either upfront radiosurgery or waiting to treat until tumor growth has been detected radiographically.
Objective: To determine whether upfront radiosurgery provides superior tumor volume reduction to a wait-and-scan approach for small- to medium-sized vestibular schwannoma.
Design, Setting, and Participants: Randomized clinical trial of 100 patients with a newly diagnosed (<6 months) unilateral vestibular schwannoma and a maximal tumor diameter of less than 2 cm in the cerebellopontine angle as measured on magnetic resonance imaging. Participants were enrolled at the Norwegian National Unit for Vestibular Schwannoma from October 28, 2014, through October 3, 2017; 4-year follow-up ended on October 20, 2021.
Interventions: Participants were randomized to receive either upfront radiosurgery (n = 50) or to undergo a wait-and-scan protocol, for which treatment was given only upon radiographically documented tumor growth (n = 50). Participants underwent 5 annual study visits consisting of clinical assessment, radiological examination, audiovestibular tests, and questionnaires.
Main Outcomes and Measures: The primary outcome was the ratio between tumor volume at the trial end at 4 years and baseline (V4:V0). There were 26 prespecified secondary outcomes, including patient-reported symptoms, clinical examinations, audiovestibular tests, and quality-of-life outcomes. Safety outcomes were the risk of salvage microsurgery and radiation-associated complications.
Results: Of the 100 randomized patients, 98 completed the trial and were included in the primary analysis (mean age, 54 years; 42% female). In the upfront radiosurgery group, 1 participant (2%) received repeated radiosurgery upon tumor growth, 2 (4%) needed salvage microsurgery, and 45 (94%) had no additional treatment. In the wait-and-scan group, 21 patients (42%) received radiosurgery upon tumor growth, 1 (2%) underwent salvage microsurgery, and 28 (56%) remained untreated. For the primary outcome of the ratio of tumor volume at the trial end to baseline, the geometric mean V4:V0 was 0.87 (95% CI, 0.66-1.15) in the upfront radiosurgery group and 1.51 (95% CI, 1.23-1.84) in the wait-and-scan group, showing a significantly greater tumor volume reduction in patients treated with upfront radiosurgery (wait-and-scan to upfront radiosurgery ratio, 1.73; 95% CI, 1.23-2.44; P = .002). Of 26 secondary outcomes, 25 showed no significant difference. No radiation-associated complications were observed.
Conclusion and relevance: Among patients with newly diagnosed small- and medium-sized vestibular schwannoma, upfront radiosurgery demonstrated a significantly greater tumor volume reduction at 4 years than a wait-and-scan approach with treatment upon tumor growth. These findings may help inform treatment decisions for patients with vestibular schwannoma, and further investigation of long-term clinical outcomes is needed.
Trial Registration: ClinicalTrials.gov Identifier: NCT02249572.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:330 |
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| Enthalten in: |
JAMA - 330(2023), 5 vom: 01. Aug., Seite 421-431 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Dhayalan, Dhanushan [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 08.08.2023 Date Revised 02.02.2024 published: Print ClinicalTrials.gov: NCT02249572 Citation Status MEDLINE |
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| doi: |
10.1001/jama.2023.12222 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM360265170 |
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| 100 | 1 | |a Dhayalan, Dhanushan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Upfront Radiosurgery vs a Wait-and-Scan Approach for Small- or Medium-Sized Vestibular Schwannoma |b The V-REX Randomized Clinical Trial |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 08.08.2023 | ||
| 500 | |a Date Revised 02.02.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02249572 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Importance: Current guidelines for treating small- to medium-sized vestibular schwannoma recommend either upfront radiosurgery or waiting to treat until tumor growth has been detected radiographically | ||
| 520 | |a Objective: To determine whether upfront radiosurgery provides superior tumor volume reduction to a wait-and-scan approach for small- to medium-sized vestibular schwannoma | ||
| 520 | |a Design, Setting, and Participants: Randomized clinical trial of 100 patients with a newly diagnosed (<6 months) unilateral vestibular schwannoma and a maximal tumor diameter of less than 2 cm in the cerebellopontine angle as measured on magnetic resonance imaging. Participants were enrolled at the Norwegian National Unit for Vestibular Schwannoma from October 28, 2014, through October 3, 2017; 4-year follow-up ended on October 20, 2021 | ||
| 520 | |a Interventions: Participants were randomized to receive either upfront radiosurgery (n = 50) or to undergo a wait-and-scan protocol, for which treatment was given only upon radiographically documented tumor growth (n = 50). Participants underwent 5 annual study visits consisting of clinical assessment, radiological examination, audiovestibular tests, and questionnaires | ||
| 520 | |a Main Outcomes and Measures: The primary outcome was the ratio between tumor volume at the trial end at 4 years and baseline (V4:V0). There were 26 prespecified secondary outcomes, including patient-reported symptoms, clinical examinations, audiovestibular tests, and quality-of-life outcomes. Safety outcomes were the risk of salvage microsurgery and radiation-associated complications | ||
| 520 | |a Results: Of the 100 randomized patients, 98 completed the trial and were included in the primary analysis (mean age, 54 years; 42% female). In the upfront radiosurgery group, 1 participant (2%) received repeated radiosurgery upon tumor growth, 2 (4%) needed salvage microsurgery, and 45 (94%) had no additional treatment. In the wait-and-scan group, 21 patients (42%) received radiosurgery upon tumor growth, 1 (2%) underwent salvage microsurgery, and 28 (56%) remained untreated. For the primary outcome of the ratio of tumor volume at the trial end to baseline, the geometric mean V4:V0 was 0.87 (95% CI, 0.66-1.15) in the upfront radiosurgery group and 1.51 (95% CI, 1.23-1.84) in the wait-and-scan group, showing a significantly greater tumor volume reduction in patients treated with upfront radiosurgery (wait-and-scan to upfront radiosurgery ratio, 1.73; 95% CI, 1.23-2.44; P = .002). Of 26 secondary outcomes, 25 showed no significant difference. No radiation-associated complications were observed | ||
| 520 | |a Conclusion and relevance: Among patients with newly diagnosed small- and medium-sized vestibular schwannoma, upfront radiosurgery demonstrated a significantly greater tumor volume reduction at 4 years than a wait-and-scan approach with treatment upon tumor growth. These findings may help inform treatment decisions for patients with vestibular schwannoma, and further investigation of long-term clinical outcomes is needed | ||
| 520 | |a Trial Registration: ClinicalTrials.gov Identifier: NCT02249572 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a Tveiten, Øystein Vesterli |e verfasserin |4 aut | |
| 700 | 1 | |a Finnkirk, Monica |e verfasserin |4 aut | |
| 700 | 1 | |a Storstein, Anette |e verfasserin |4 aut | |
| 700 | 1 | |a Hufthammer, Karl Ove |e verfasserin |4 aut | |
| 700 | 1 | |a Goplen, Frederik Kragerud |e verfasserin |4 aut | |
| 700 | 1 | |a Lund-Johansen, Morten |e verfasserin |4 aut | |
| 700 | 0 | |a V-REX Trial investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Andersen, Erling |e investigator |4 oth | |
| 700 | 1 | |a Einar, Engtrø |e investigator |4 oth | |
| 700 | 1 | |a Fauske, Linda |e investigator |4 oth | |
| 700 | 1 | |a Fluge, Øystein |e investigator |4 oth | |
| 700 | 1 | |a Grüner, Eli Renate |e investigator |4 oth | |
| 700 | 1 | |a Hess-Erga, Jeanette |e investigator |4 oth | |
| 700 | 1 | |a Jablonski, Greg |e investigator |4 oth | |
| 700 | 1 | |a Myrseth, Erling |e investigator |4 oth | |
| 700 | 1 | |a Nilsen, Kathrin Skorpa |e investigator |4 oth | |
| 700 | 1 | |a Nilsen, Roy Miodini |e investigator |4 oth | |
| 700 | 1 | |a Rekdal, Magne |e investigator |4 oth | |
| 700 | 1 | |a Sundstrøm, Terje |e investigator |4 oth | |
| 700 | 1 | |a Wathle, Gaute Kjellevold |e investigator |4 oth | |
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