Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
Long-term cosmetic outcome after intraoperative radiotherapy boost with low-energy X-rays in breast-conserving therapy: a pooled cohort analysis of the TARGIT-BQR and ROKSM trials.
Клиническое исследование IV фазыСтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Schimmelfennig Paulina, Reuter Christiane, Kraus-Tiefenbacher Uta, Brück Viktoria, Kaiser Christina, Keymer Ralf, Abo-Madyan Yasser, Fleckenstein Katharina, Tuschy Benjamin, Sütterlin Marc, Wenz Frederik, Reichardt Hans, Fehr Mathias, Kuther Markus, Büttner Sylvia, Sperk Elena
Аннотация
PURPOSE: This study investigates objective long-term cosmetic outcomes in patients with breast cancer after intraoperative radiotherapy applied as a boost (IORT boost) from a pooled international cohort.
METHODS: A pooled analysis of two prospective studies with IORT boost (low-energy X‑rays, 20 Gy; inclusion criteria: 3.5 cm maximum tumor size and preoperative indication for a boost according to local criteria) during breast-conserving surgery followed by whole-breast radiotherapy (46-50 Gy). The analysis included photos from a subgroup of the prospective phase IV TARGeted Intraoperative radioTherapy (TARGIT) Boost Quality Registry (BQR) study (NCT01440010) with a follow-up of up to 10 years as well as patients from a Swiss study (ROKSM; Spital Thurgau AG; NCT02114086) with a follow-up of 5 years. The pooled analysis included photos from both trials taken at the same timepoints (6 weeks, 6 months, 1 year, 2 years, and 5 years after completion of whole-breast radiotherapy). Cosmetic results were evaluated with the validated BCCT.core software (BCCT.core 2.0, INESC Porto, Portugal) to assess symmetry, color, and scars. A generalized estimating equation (GEE) regression model was used to compare the two cohorts over time.
RESULTS: The pooled analysis included 777 cosmetic assessments from 276 patients. Across all follow-ups in the pooled analysis, the majority of cosmetic results were rated as excellent or good (61.9%). Patients from TARGIT-BQR had significantly more excellent or good ratings than patients from ROKSM (p < 0.0001). The proportion of patients receiving "excellent" and "good" ratings remained higher in TARGIT-BQR than in ROKSM at every timepoint during follow-up. Overall, for up to 10 years, the majority of ratings in the whole cohort were "excellent" or "good."
CONCLUSION: In this international pooled analysis, the cosmetic outcome after IORT boost followed by whole-breast irradiation shows a good esthetic long-term outcome. Further studies should explore factors that influence cosmetic outcomes and consider additional treatment-related parameters.
METHODS: A pooled analysis of two prospective studies with IORT boost (low-energy X‑rays, 20 Gy; inclusion criteria: 3.5 cm maximum tumor size and preoperative indication for a boost according to local criteria) during breast-conserving surgery followed by whole-breast radiotherapy (46-50 Gy). The analysis included photos from a subgroup of the prospective phase IV TARGeted Intraoperative radioTherapy (TARGIT) Boost Quality Registry (BQR) study (NCT01440010) with a follow-up of up to 10 years as well as patients from a Swiss study (ROKSM; Spital Thurgau AG; NCT02114086) with a follow-up of 5 years. The pooled analysis included photos from both trials taken at the same timepoints (6 weeks, 6 months, 1 year, 2 years, and 5 years after completion of whole-breast radiotherapy). Cosmetic results were evaluated with the validated BCCT.core software (BCCT.core 2.0, INESC Porto, Portugal) to assess symmetry, color, and scars. A generalized estimating equation (GEE) regression model was used to compare the two cohorts over time.
RESULTS: The pooled analysis included 777 cosmetic assessments from 276 patients. Across all follow-ups in the pooled analysis, the majority of cosmetic results were rated as excellent or good (61.9%). Patients from TARGIT-BQR had significantly more excellent or good ratings than patients from ROKSM (p < 0.0001). The proportion of patients receiving "excellent" and "good" ratings remained higher in TARGIT-BQR than in ROKSM at every timepoint during follow-up. Overall, for up to 10 years, the majority of ratings in the whole cohort were "excellent" or "good."
CONCLUSION: In this international pooled analysis, the cosmetic outcome after IORT boost followed by whole-breast irradiation shows a good esthetic long-term outcome. Further studies should explore factors that influence cosmetic outcomes and consider additional treatment-related parameters.