Physician- and Patient-Reported Outcomes of the MC1635 Phase 3 Trial of Ultrahypofractionated Versus Moderately Hypofractionated Adjuvant Radiation Therapy After Breast-Conserving Surgery.

Autor:	Laughlin BS; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., Corbin KS; Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota., Toesca DAS; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., Thorpe CS; Department of Radiation Oncology, Sanford Health, Fargo, North Dakota., Golafshar MA; Department of Qualitative Health Sciences, Section of Biostatistics, Mayo Clinic, Scottsdale, Arizona., Pockaj B; Department of General Surgery, Mayo Clinic, Phoenix, Arizona., Cronin P; Department of General Surgery, Mayo Clinic, Phoenix, Arizona., McGee LA; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., Halyard MY; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., Mutter RW; Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota., Keole SR; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., Park SS; Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota., Shumway DA; Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota., Vern-Gross TZ; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., Vallow L; Department of Radiation Oncology, Mayo Clinic, Jacksonville, Florida., Wong WW; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona., DeWees TA; Department of Qualitative Health Sciences, Section of Biostatistics, Mayo Clinic, Scottsdale, Arizona., Vargas CE; Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona. Electronic address: Vargas.Carlos@mayo.edu.
Jazyk:	angličtina
Zdroj:	International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2024 Mar 15; Vol. 118 (4), pp. 1049-1059. Date of Electronic Publication: 2023 Oct 31.
DOI:	10.1016/j.ijrobp.2023.10.018
Abstrakt:	Purpose: Our aim was to report physician- and patient-reported outcomes of patients with localized breast cancer treated with moderate versus ultrahypofractionated whole breast irradiation (WBI) after breast-conserving surgery (BCS). Methods and Materials: Between February 2018 and February 2020, patients with localized breast cancer (pT0-3 pN0-1 M0) were offered participation in a phase 3 randomized clinical trial assessing adjuvant moderate hypofractionation (MHF) to 40 Gy in 15 fractions versus ultrahypofractionation (UHF) to 25 Gy in 5 fractions after BCS, with an optional simultaneously integrated boost. Toxicities, cosmesis, and quality of life were assessed at baseline, end of treatment (EOT), and 3 months, 1 year, 2 years, and 3 years from irradiation using validated metric tools. Results: One hundred seven patients were randomized to MHF (n = 54) or UHF (n = 53) adjuvant WBI. The median follow-up was 42.8 months. Grade 2 radiation dermatitis was experienced by 4 patients (7.4%) in the MHF arm and 2 patients (3.7%) in the UHF arm at EOT (P = .726). No grade 3 or higher toxicities were observed. Deterioration of cosmesis by physician assessment was observed in 2 (6.7%) patients treated in the UHF arm and 1 (1.9%) patient treated in the MHF arm at EOT (P = .534), whereas at 3 months, only 1 (1.8%) patient treated in the MHF arm demonstrated deterioration of cosmesis (P = .315). At EOT, 91% and 94% of patients reported excellent/good cosmesis among those treated with MHF and UHF regimens, respectively (P = .550). At 3 months, more patients within the MHF arm reported excellent/good cosmesis compared with those in the UHF arm (100% vs 91%; P = .030). However, the difference in patient-reported cosmesis disappeared at the 1-, 2-, and 3-year time points. Conclusions: UHF WBI showed similar treatment-related late toxicities and similar provider-scored cosmesis compared with MHF radiation in patients treated adjuvantly after BCS. (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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