Phase II trial of hypofractionated VMAT-based treatment for early stage breast cancer: 2-year toxicity and clinical results

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Abstract

Background: To report toxicity and early clinical outcomes of hypofractionated simultaneous integrated boost (SIB) approach with Volumetric Modulated Arc Therapy (VMAT) as adjuvant treatment after breast-conserving surgery. Methods: Patients presenting early-stage breast cancer were enrolled in a phase II trial. Eligibility criteria: age>18 years old, invasive cancer or ductal carcinoma in situ (DCIS), Stage I-II (T<3 cm and N≤3), breast-conserving surgery without oncoplastic reconstruction. Any systemic therapy was allowed in neoadjuvant or adjuvant setting. All patients underwent VMAT-SIB technique to irradiate the whole breast and the tumor bed. Doses to whole breast and surgical bed were 40.5 Gy and 48 Gy, respectively, delivered in 15 fractions over 3 weeks. Acute and late skin toxicities were recorded. Cosmetic outcome was assessed as excellent/good or fair/poor. Results: The present study focused on results of a cohort of 144 patients with a minimum follow-up of 24 months (median 37, range 24-55 months). Median age was 62 years old (range 30-88). All patients had an invasive carcinoma (no patients with DCIS were present in this subset). At one year, the highest reported skin toxicity was G1, in 14 % of the patients; this data dropped to 4 % at the last follow-up, after more than 2 years. Breast pain was recorded in 21.6 % of the patients 6 months after treatment, while it was present in 3.5 % of the patients at the last follow-up, showing a significant improvement with time. Correlation between liponecrosis and boost target volume was found not significant. Breast pain was correlated with breast volume. No pulmonary or cardiological toxicities were recorded. After an early evaluation of clinical outcomes, only one case presented disease relapse, as liver metastases. Conclusions: The 3-week VMAT-SIB course as adjuvant treatment after breast-conserving surgery showed to be well tolerated and was associated with optimal local control. Long-term follow-up data are needed to assess late toxicity and clinical outcomes.

Original languageEnglish
Article number120
JournalRadiation Oncology
Volume11
Issue number1
DOIs
Publication statusPublished - Sep 17 2016

Fingerprint

Intensity-Modulated Radiotherapy
Breast Neoplasms
Segmental Mastectomy
Mastodynia
Carcinoma, Intraductal, Noninfiltrating
Therapeutics
Breast
Skin
Cosmetics
Neoplasm Metastasis
Carcinoma
Recurrence
Lung
Liver

Keywords

  • Breast cancer
  • Hypofractionation
  • Simultaneous integrated boost
  • Volumetric modulated arc therapy

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

@article{39e55001f39e4d339c50ea150e528e45,
title = "Phase II trial of hypofractionated VMAT-based treatment for early stage breast cancer: 2-year toxicity and clinical results",
abstract = "Background: To report toxicity and early clinical outcomes of hypofractionated simultaneous integrated boost (SIB) approach with Volumetric Modulated Arc Therapy (VMAT) as adjuvant treatment after breast-conserving surgery. Methods: Patients presenting early-stage breast cancer were enrolled in a phase II trial. Eligibility criteria: age>18 years old, invasive cancer or ductal carcinoma in situ (DCIS), Stage I-II (T<3 cm and N≤3), breast-conserving surgery without oncoplastic reconstruction. Any systemic therapy was allowed in neoadjuvant or adjuvant setting. All patients underwent VMAT-SIB technique to irradiate the whole breast and the tumor bed. Doses to whole breast and surgical bed were 40.5 Gy and 48 Gy, respectively, delivered in 15 fractions over 3 weeks. Acute and late skin toxicities were recorded. Cosmetic outcome was assessed as excellent/good or fair/poor. Results: The present study focused on results of a cohort of 144 patients with a minimum follow-up of 24 months (median 37, range 24-55 months). Median age was 62 years old (range 30-88). All patients had an invasive carcinoma (no patients with DCIS were present in this subset). At one year, the highest reported skin toxicity was G1, in 14 {\%} of the patients; this data dropped to 4 {\%} at the last follow-up, after more than 2 years. Breast pain was recorded in 21.6 {\%} of the patients 6 months after treatment, while it was present in 3.5 {\%} of the patients at the last follow-up, showing a significant improvement with time. Correlation between liponecrosis and boost target volume was found not significant. Breast pain was correlated with breast volume. No pulmonary or cardiological toxicities were recorded. After an early evaluation of clinical outcomes, only one case presented disease relapse, as liver metastases. Conclusions: The 3-week VMAT-SIB course as adjuvant treatment after breast-conserving surgery showed to be well tolerated and was associated with optimal local control. Long-term follow-up data are needed to assess late toxicity and clinical outcomes.",
keywords = "Breast cancer, Hypofractionation, Simultaneous integrated boost, Volumetric modulated arc therapy",
author = "{De Rose}, Fiorenza and Antonella Fogliata and Davide Franceschini and Piera Navarria and Elisa Villa and Cristina Iftode and Giuseppe D'Agostino and Luca Cozzi and Francesca Lobefalo and Pietro Mancosu and Stefano Tomatis and Marta Scorsetti",
year = "2016",
month = "9",
day = "17",
doi = "10.1186/s13014-016-0701-z",
language = "English",
volume = "11",
journal = "Radiation Oncology",
issn = "1748-717X",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Phase II trial of hypofractionated VMAT-based treatment for early stage breast cancer

T2 - 2-year toxicity and clinical results

AU - De Rose, Fiorenza

AU - Fogliata, Antonella

AU - Franceschini, Davide

AU - Navarria, Piera

AU - Villa, Elisa

AU - Iftode, Cristina

AU - D'Agostino, Giuseppe

AU - Cozzi, Luca

AU - Lobefalo, Francesca

AU - Mancosu, Pietro

AU - Tomatis, Stefano

AU - Scorsetti, Marta

PY - 2016/9/17

Y1 - 2016/9/17

N2 - Background: To report toxicity and early clinical outcomes of hypofractionated simultaneous integrated boost (SIB) approach with Volumetric Modulated Arc Therapy (VMAT) as adjuvant treatment after breast-conserving surgery. Methods: Patients presenting early-stage breast cancer were enrolled in a phase II trial. Eligibility criteria: age>18 years old, invasive cancer or ductal carcinoma in situ (DCIS), Stage I-II (T<3 cm and N≤3), breast-conserving surgery without oncoplastic reconstruction. Any systemic therapy was allowed in neoadjuvant or adjuvant setting. All patients underwent VMAT-SIB technique to irradiate the whole breast and the tumor bed. Doses to whole breast and surgical bed were 40.5 Gy and 48 Gy, respectively, delivered in 15 fractions over 3 weeks. Acute and late skin toxicities were recorded. Cosmetic outcome was assessed as excellent/good or fair/poor. Results: The present study focused on results of a cohort of 144 patients with a minimum follow-up of 24 months (median 37, range 24-55 months). Median age was 62 years old (range 30-88). All patients had an invasive carcinoma (no patients with DCIS were present in this subset). At one year, the highest reported skin toxicity was G1, in 14 % of the patients; this data dropped to 4 % at the last follow-up, after more than 2 years. Breast pain was recorded in 21.6 % of the patients 6 months after treatment, while it was present in 3.5 % of the patients at the last follow-up, showing a significant improvement with time. Correlation between liponecrosis and boost target volume was found not significant. Breast pain was correlated with breast volume. No pulmonary or cardiological toxicities were recorded. After an early evaluation of clinical outcomes, only one case presented disease relapse, as liver metastases. Conclusions: The 3-week VMAT-SIB course as adjuvant treatment after breast-conserving surgery showed to be well tolerated and was associated with optimal local control. Long-term follow-up data are needed to assess late toxicity and clinical outcomes.

AB - Background: To report toxicity and early clinical outcomes of hypofractionated simultaneous integrated boost (SIB) approach with Volumetric Modulated Arc Therapy (VMAT) as adjuvant treatment after breast-conserving surgery. Methods: Patients presenting early-stage breast cancer were enrolled in a phase II trial. Eligibility criteria: age>18 years old, invasive cancer or ductal carcinoma in situ (DCIS), Stage I-II (T<3 cm and N≤3), breast-conserving surgery without oncoplastic reconstruction. Any systemic therapy was allowed in neoadjuvant or adjuvant setting. All patients underwent VMAT-SIB technique to irradiate the whole breast and the tumor bed. Doses to whole breast and surgical bed were 40.5 Gy and 48 Gy, respectively, delivered in 15 fractions over 3 weeks. Acute and late skin toxicities were recorded. Cosmetic outcome was assessed as excellent/good or fair/poor. Results: The present study focused on results of a cohort of 144 patients with a minimum follow-up of 24 months (median 37, range 24-55 months). Median age was 62 years old (range 30-88). All patients had an invasive carcinoma (no patients with DCIS were present in this subset). At one year, the highest reported skin toxicity was G1, in 14 % of the patients; this data dropped to 4 % at the last follow-up, after more than 2 years. Breast pain was recorded in 21.6 % of the patients 6 months after treatment, while it was present in 3.5 % of the patients at the last follow-up, showing a significant improvement with time. Correlation between liponecrosis and boost target volume was found not significant. Breast pain was correlated with breast volume. No pulmonary or cardiological toxicities were recorded. After an early evaluation of clinical outcomes, only one case presented disease relapse, as liver metastases. Conclusions: The 3-week VMAT-SIB course as adjuvant treatment after breast-conserving surgery showed to be well tolerated and was associated with optimal local control. Long-term follow-up data are needed to assess late toxicity and clinical outcomes.

KW - Breast cancer

KW - Hypofractionation

KW - Simultaneous integrated boost

KW - Volumetric modulated arc therapy

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U2 - 10.1186/s13014-016-0701-z

DO - 10.1186/s13014-016-0701-z

M3 - Article

AN - SCOPUS:84987936714

VL - 11

JO - Radiation Oncology

JF - Radiation Oncology

SN - 1748-717X

IS - 1

M1 - 120

ER -