Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform
Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated mult...
Ausführliche Beschreibung
Autor*in: |
Scorsetti, Marta [verfasserIn] |
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E-Artikel |
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Englisch |
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2023 |
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Anmerkung: |
© The Author(s) 2023 |
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Übergeordnetes Werk: |
Enthalten in: Radiation oncology - London : BioMed Central, 2006, 18(2023), 1 vom: 07. Feb. |
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Übergeordnetes Werk: |
volume:18 ; year:2023 ; number:1 ; day:07 ; month:02 |
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DOI / URN: |
10.1186/s13014-023-02216-5 |
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SPR051429284 |
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245 | 1 | 0 | |a Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform |
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520 | |a Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods Adults patients with 1–4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2–3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9–7.4%) in Arm-B, and 9.3% (95% CI 6.2–13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25–1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613. | ||
650 | 4 | |a Randomized phase 3 trial |7 (dpeaa)DE-He213 | |
650 | 4 | |a Radiosurgery |7 (dpeaa)DE-He213 | |
650 | 4 | |a Gamma Knife-radiosurgery |7 (dpeaa)DE-He213 | |
650 | 4 | |a Linac-based radiosurgery |7 (dpeaa)DE-He213 | |
650 | 4 | |a Radionecrosis |7 (dpeaa)DE-He213 | |
650 | 4 | |a Brain metastases |7 (dpeaa)DE-He213 | |
700 | 1 | |a Navarria, Pierina |4 aut | |
700 | 1 | |a Cozzi, Luca |4 aut | |
700 | 1 | |a Clerici, Elena |4 aut | |
700 | 1 | |a Bellu, Luisa |4 aut | |
700 | 1 | |a Franceschini, Davide |4 aut | |
700 | 1 | |a Marzo, Antonio Marco |4 aut | |
700 | 1 | |a Franzese, Ciro |4 aut | |
700 | 1 | |a Torri, Valter |4 aut | |
700 | 1 | |a Reggiori, Giacomo |4 aut | |
700 | 1 | |a Lobefalo, Francesca |4 aut | |
700 | 1 | |a Raspagliesi, Luca |4 aut | |
700 | 1 | |a Attuati, Luca |4 aut | |
700 | 1 | |a Pessina, Federico |4 aut | |
700 | 1 | |a Franzini, Andrea |4 aut | |
700 | 1 | |a Picozzi, Piero |4 aut | |
700 | 1 | |a Tomatis, Stefano |4 aut | |
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10.1186/s13014-023-02216-5 doi (DE-627)SPR051429284 (SPR)s13014-023-02216-5-e DE-627 ger DE-627 rakwb eng Scorsetti, Marta verfasserin aut Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods Adults patients with 1–4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2–3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9–7.4%) in Arm-B, and 9.3% (95% CI 6.2–13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25–1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613. Randomized phase 3 trial (dpeaa)DE-He213 Radiosurgery (dpeaa)DE-He213 Gamma Knife-radiosurgery (dpeaa)DE-He213 Linac-based radiosurgery (dpeaa)DE-He213 Radionecrosis (dpeaa)DE-He213 Brain metastases (dpeaa)DE-He213 Navarria, Pierina aut Cozzi, Luca aut Clerici, Elena aut Bellu, Luisa aut Franceschini, Davide aut Marzo, Antonio Marco aut Franzese, Ciro aut Torri, Valter aut Reggiori, Giacomo aut Lobefalo, Francesca aut Raspagliesi, Luca aut Attuati, Luca aut Pessina, Federico aut Franzini, Andrea aut Picozzi, Piero aut Tomatis, Stefano aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 07. Feb. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:07 month:02 https://dx.doi.org/10.1186/s13014-023-02216-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 1 07 02 |
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10.1186/s13014-023-02216-5 doi (DE-627)SPR051429284 (SPR)s13014-023-02216-5-e DE-627 ger DE-627 rakwb eng Scorsetti, Marta verfasserin aut Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods Adults patients with 1–4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2–3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9–7.4%) in Arm-B, and 9.3% (95% CI 6.2–13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25–1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613. Randomized phase 3 trial (dpeaa)DE-He213 Radiosurgery (dpeaa)DE-He213 Gamma Knife-radiosurgery (dpeaa)DE-He213 Linac-based radiosurgery (dpeaa)DE-He213 Radionecrosis (dpeaa)DE-He213 Brain metastases (dpeaa)DE-He213 Navarria, Pierina aut Cozzi, Luca aut Clerici, Elena aut Bellu, Luisa aut Franceschini, Davide aut Marzo, Antonio Marco aut Franzese, Ciro aut Torri, Valter aut Reggiori, Giacomo aut Lobefalo, Francesca aut Raspagliesi, Luca aut Attuati, Luca aut Pessina, Federico aut Franzini, Andrea aut Picozzi, Piero aut Tomatis, Stefano aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 07. Feb. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:07 month:02 https://dx.doi.org/10.1186/s13014-023-02216-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 1 07 02 |
allfields_unstemmed |
10.1186/s13014-023-02216-5 doi (DE-627)SPR051429284 (SPR)s13014-023-02216-5-e DE-627 ger DE-627 rakwb eng Scorsetti, Marta verfasserin aut Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods Adults patients with 1–4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2–3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9–7.4%) in Arm-B, and 9.3% (95% CI 6.2–13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25–1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613. Randomized phase 3 trial (dpeaa)DE-He213 Radiosurgery (dpeaa)DE-He213 Gamma Knife-radiosurgery (dpeaa)DE-He213 Linac-based radiosurgery (dpeaa)DE-He213 Radionecrosis (dpeaa)DE-He213 Brain metastases (dpeaa)DE-He213 Navarria, Pierina aut Cozzi, Luca aut Clerici, Elena aut Bellu, Luisa aut Franceschini, Davide aut Marzo, Antonio Marco aut Franzese, Ciro aut Torri, Valter aut Reggiori, Giacomo aut Lobefalo, Francesca aut Raspagliesi, Luca aut Attuati, Luca aut Pessina, Federico aut Franzini, Andrea aut Picozzi, Piero aut Tomatis, Stefano aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 07. Feb. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:07 month:02 https://dx.doi.org/10.1186/s13014-023-02216-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 1 07 02 |
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10.1186/s13014-023-02216-5 doi (DE-627)SPR051429284 (SPR)s13014-023-02216-5-e DE-627 ger DE-627 rakwb eng Scorsetti, Marta verfasserin aut Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods Adults patients with 1–4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2–3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9–7.4%) in Arm-B, and 9.3% (95% CI 6.2–13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25–1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613. Randomized phase 3 trial (dpeaa)DE-He213 Radiosurgery (dpeaa)DE-He213 Gamma Knife-radiosurgery (dpeaa)DE-He213 Linac-based radiosurgery (dpeaa)DE-He213 Radionecrosis (dpeaa)DE-He213 Brain metastases (dpeaa)DE-He213 Navarria, Pierina aut Cozzi, Luca aut Clerici, Elena aut Bellu, Luisa aut Franceschini, Davide aut Marzo, Antonio Marco aut Franzese, Ciro aut Torri, Valter aut Reggiori, Giacomo aut Lobefalo, Francesca aut Raspagliesi, Luca aut Attuati, Luca aut Pessina, Federico aut Franzini, Andrea aut Picozzi, Piero aut Tomatis, Stefano aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 07. Feb. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:07 month:02 https://dx.doi.org/10.1186/s13014-023-02216-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 1 07 02 |
allfieldsSound |
10.1186/s13014-023-02216-5 doi (DE-627)SPR051429284 (SPR)s13014-023-02216-5-e DE-627 ger DE-627 rakwb eng Scorsetti, Marta verfasserin aut Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods Adults patients with 1–4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2–3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9–7.4%) in Arm-B, and 9.3% (95% CI 6.2–13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25–1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613. Randomized phase 3 trial (dpeaa)DE-He213 Radiosurgery (dpeaa)DE-He213 Gamma Knife-radiosurgery (dpeaa)DE-He213 Linac-based radiosurgery (dpeaa)DE-He213 Radionecrosis (dpeaa)DE-He213 Brain metastases (dpeaa)DE-He213 Navarria, Pierina aut Cozzi, Luca aut Clerici, Elena aut Bellu, Luisa aut Franceschini, Davide aut Marzo, Antonio Marco aut Franzese, Ciro aut Torri, Valter aut Reggiori, Giacomo aut Lobefalo, Francesca aut Raspagliesi, Luca aut Attuati, Luca aut Pessina, Federico aut Franzini, Andrea aut Picozzi, Piero aut Tomatis, Stefano aut Enthalten in Radiation oncology London : BioMed Central, 2006 18(2023), 1 vom: 07. Feb. (DE-627)508725739 (DE-600)2224965-5 1748-717X nnns volume:18 year:2023 number:1 day:07 month:02 https://dx.doi.org/10.1186/s13014-023-02216-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2119 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 1 07 02 |
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Enthalten in Radiation oncology 18(2023), 1 vom: 07. Feb. volume:18 year:2023 number:1 day:07 month:02 |
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Enthalten in Radiation oncology 18(2023), 1 vom: 07. Feb. volume:18 year:2023 number:1 day:07 month:02 |
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Randomized phase 3 trial Radiosurgery Gamma Knife-radiosurgery Linac-based radiosurgery Radionecrosis Brain metastases |
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Radiation oncology |
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Scorsetti, Marta @@aut@@ Navarria, Pierina @@aut@@ Cozzi, Luca @@aut@@ Clerici, Elena @@aut@@ Bellu, Luisa @@aut@@ Franceschini, Davide @@aut@@ Marzo, Antonio Marco @@aut@@ Franzese, Ciro @@aut@@ Torri, Valter @@aut@@ Reggiori, Giacomo @@aut@@ Lobefalo, Francesca @@aut@@ Raspagliesi, Luca @@aut@@ Attuati, Luca @@aut@@ Pessina, Federico @@aut@@ Franzini, Andrea @@aut@@ Picozzi, Piero @@aut@@ Tomatis, Stefano @@aut@@ |
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Scorsetti, Marta misc Randomized phase 3 trial misc Radiosurgery misc Gamma Knife-radiosurgery misc Linac-based radiosurgery misc Radionecrosis misc Brain metastases Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform |
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Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform Randomized phase 3 trial (dpeaa)DE-He213 Radiosurgery (dpeaa)DE-He213 Gamma Knife-radiosurgery (dpeaa)DE-He213 Linac-based radiosurgery (dpeaa)DE-He213 Radionecrosis (dpeaa)DE-He213 Brain metastases (dpeaa)DE-He213 |
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Scorsetti, Marta Navarria, Pierina Cozzi, Luca Clerici, Elena Bellu, Luisa Franceschini, Davide Marzo, Antonio Marco Franzese, Ciro Torri, Valter Reggiori, Giacomo Lobefalo, Francesca Raspagliesi, Luca Attuati, Luca Pessina, Federico Franzini, Andrea Picozzi, Piero Tomatis, Stefano |
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radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase iii trial (nct02355613) comparing treatments executed with a specialized or a c-arm linac-based platform |
title_auth |
Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform |
abstract |
Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods Adults patients with 1–4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2–3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9–7.4%) in Arm-B, and 9.3% (95% CI 6.2–13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25–1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613. © The Author(s) 2023 |
abstractGer |
Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods Adults patients with 1–4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2–3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9–7.4%) in Arm-B, and 9.3% (95% CI 6.2–13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25–1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613. © The Author(s) 2023 |
abstract_unstemmed |
Background Comparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A). Methods Adults patients with 1–4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2–3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS). Results A total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9–7.4%) in Arm-B, and 9.3% (95% CI 6.2–13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25–1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. Trial registration: ClinicalTrials.gov Identifier NCT02355613. © The Author(s) 2023 |
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Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform |
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Navarria, Pierina Cozzi, Luca Clerici, Elena Bellu, Luisa Franceschini, Davide Marzo, Antonio Marco Franzese, Ciro Torri, Valter Reggiori, Giacomo Lobefalo, Francesca Raspagliesi, Luca Attuati, Luca Pessina, Federico Franzini, Andrea Picozzi, Piero Tomatis, Stefano |
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Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15–54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9–54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2–32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B. Conclusions Given the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2–3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A. 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7.399004 |