Purpose: We report long-term outcomes of phase 2 trial on patients with invasive breast cancer treated with accelerated partial-breast irradiation (APBI) using tomotherapy after breast conservative surgery. Methods and materials: From December 2010 to December 2018, we treated 338 women with APBI-tomotherapy: 38.5 Gy in 10 once-daily fractions. Patients selected were age ≥50 years old, with ≤3 cm in size unifocal tumor and at least 2 mm of clear margins. Disease outcomes were analyzed by clinicopathologic characteristics, molecular phenotypes, and American Society for Radiation Oncology (ASTRO) 2017 updated consensus groupings. Results: The median age was 65 years (range, 50-86). The invasive ductal (87.5%) and the luminal A-like molecular phenotype (70%) were the most common tumors. Overall 242 patients (71.6%) were considered "suitable" for enrollment in APBI according to the eligibility criteria of the ASTRO-2017 consensus statement. With a median follow-up of 76 months (range, 17-113), 2 patients (0.6%) had an invasive ipsilateral breast tumor recurrence (IBTR), and 2 patients (0.6%) had an axillary ipsilateral failure. The rate of local control in terms of free of IBTR was 99.4% and locoregional control (no recurrence in ipsilateral breast as well as in regional nodes) was 98.8%. Progression-free survival was 98.4% and 92% at 5 and 10 years, respectively. Acute and late skin toxicity, graded according to the Common Terminology Criteria for Adverse Events, were 7.7% (G1) and 0.6% (G2) and 4.4% (G1) and 1.1% (G2), respectively. There were no grade 3/4 toxicities, however. Very few patients (2%) or physicians (2%) assessed cosmetic outcome as fair or poor at the 2-year follow-up. Conclusions: This phase 2 trial on APBI-tomotherapy shows excellent long-term results. Once-daily fractionation schedule was well tolerated with a low rate of adverse events and worse cosmetic outcome. In this series, even among those deemed cautionary or unsuitable for APBI by ASTRO criteria, we demonstrated a low rate of IBTR.

de Paula, U., D'Angelillo, R.m., Andrulli, A.d., Apicella, G., Caruso, C., Ghini, C., et al. (2021). Long-term outcomes of once-daily accelerated partial-breast irradiation with tomotherapy: results of a phase 2 trial. INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 109(3), 678-687 [10.1016/j.ijrobp.2020.10.009].

Long-term outcomes of once-daily accelerated partial-breast irradiation with tomotherapy: results of a phase 2 trial

D'Angelillo, Rolando Maria;
2021-01-01

Abstract

Purpose: We report long-term outcomes of phase 2 trial on patients with invasive breast cancer treated with accelerated partial-breast irradiation (APBI) using tomotherapy after breast conservative surgery. Methods and materials: From December 2010 to December 2018, we treated 338 women with APBI-tomotherapy: 38.5 Gy in 10 once-daily fractions. Patients selected were age ≥50 years old, with ≤3 cm in size unifocal tumor and at least 2 mm of clear margins. Disease outcomes were analyzed by clinicopathologic characteristics, molecular phenotypes, and American Society for Radiation Oncology (ASTRO) 2017 updated consensus groupings. Results: The median age was 65 years (range, 50-86). The invasive ductal (87.5%) and the luminal A-like molecular phenotype (70%) were the most common tumors. Overall 242 patients (71.6%) were considered "suitable" for enrollment in APBI according to the eligibility criteria of the ASTRO-2017 consensus statement. With a median follow-up of 76 months (range, 17-113), 2 patients (0.6%) had an invasive ipsilateral breast tumor recurrence (IBTR), and 2 patients (0.6%) had an axillary ipsilateral failure. The rate of local control in terms of free of IBTR was 99.4% and locoregional control (no recurrence in ipsilateral breast as well as in regional nodes) was 98.8%. Progression-free survival was 98.4% and 92% at 5 and 10 years, respectively. Acute and late skin toxicity, graded according to the Common Terminology Criteria for Adverse Events, were 7.7% (G1) and 0.6% (G2) and 4.4% (G1) and 1.1% (G2), respectively. There were no grade 3/4 toxicities, however. Very few patients (2%) or physicians (2%) assessed cosmetic outcome as fair or poor at the 2-year follow-up. Conclusions: This phase 2 trial on APBI-tomotherapy shows excellent long-term results. Once-daily fractionation schedule was well tolerated with a low rate of adverse events and worse cosmetic outcome. In this series, even among those deemed cautionary or unsuitable for APBI by ASTRO criteria, we demonstrated a low rate of IBTR.
2021
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA
Settore MED/06 - ONCOLOGIA MEDICA
English
Aged; Aged, 80 and over; Breast Neoplasms; Carcinoma, Ductal, Breast; Carcinoma, Lobular; Consensus; Dose Fractionation, Radiation; Esthetics; Female; Humans; Kaplan-Meier Estimate; Margins of Excision; Mastectomy, Segmental; Middle Aged; Neoplasm Recurrence, Local; Progression-Free Survival; Radiotherapy; Radiotherapy, Intensity-Modulated; Time Factors; Treatment Outcome
de Paula, U., D'Angelillo, R.m., Andrulli, A.d., Apicella, G., Caruso, C., Ghini, C., et al. (2021). Long-term outcomes of once-daily accelerated partial-breast irradiation with tomotherapy: results of a phase 2 trial. INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 109(3), 678-687 [10.1016/j.ijrobp.2020.10.009].
de Paula, U; D'Angelillo, Rm; Andrulli, Ad; Apicella, G; Caruso, C; Ghini, C; Gomellini, S; Ponti, E; Pompei, M; Caccavari, A; Petrocchi, A; Costarelli, L; Giordano, M; La Pinta, M; Meli, Ez; Mauri, M; Minelli, M; Rossi, R; Scavina, P; Broglia, L; Ponzani, T; Loreti, A; Fortunato, L
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/283160
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