5-Year Results of a Prospective Phase 2 Trial Evaluating 3-Week Hypofractionated Whole Breast Radiation Therapy Inclusive of a Sequential Boost

Apar Gupta, Atif Khan, Nikhil Yegya-Raman, Mutlay Sayan, Stuti Ahlawat, Nisha Ohri, Sharad Goyal, Dirk Moore, Firas Eladoumikdachi, Deborah Toppmeyer, Bruce Haffty

Research output: Contribution to journalArticle

Abstract

Purpose: To report 5-year outcomes of a phase 2 trial of hypofractionated whole breast irradiation (HF-WBI) completed in 3 weeks, inclusive of a sequential boost. Methods and Materials: Women with stage 0-IIIA breast cancer (ductal carcinoma in situ through T2N2a) were enrolled on a prospective, phase 2 trial of accelerated HF-WBI. We delivered a whole breast dose of 36.63 Gy in 11 fractions of 3.33 Gy, with an equivalent dose to the regional nodes when indicated, followed by a tumor bed boost of 13.32 Gy in 4 fractions of 3.33 Gy over a total of 15 treatment days. The primary endpoint was locoregional control; secondary endpoints included acute/late toxicity and physician-assessed and patient-reported breast cosmesis. Results: Between 2009 and 2017, we enrolled 150 patients, of whom 146 received the protocol treatment. Median age was 54 years (range, 33-82) and median follow-up was 62 months. Patients with higher-risk disease comprised 59% of the cohort, including features such as young age (33% ≤50 years), positive nodes (13%), triple-negative disease (11%), and treatment with regional nodal irradiation (11%) and/or neoadjuvant/adjuvant chemotherapy (36%). Five-year estimated locoregional and distant control were 97.7% (95% confidence interval [CI], 93.0%-99.3%) and 97.9% (95% CI, 93.6%-99.3%), respectively. Five-year breast cancer–specific and overall survival were 99.2% (95% CI, 94.6%-99.9%) and 97.3% (95% CI, 91.9%-99.1%), respectively. Acute/late grade 2 and 3 toxicities were observed in 30%/10% and 1%/3% of patients, respectively. There were no grade 4 or 5 toxicities. Physicians assessed breast cosmesis as good or excellent in 95% of patients; 85% of patients self-reported slight to no difference between the treated and untreated breast. Conclusions: Our phase 2 trial offers one of the shortest courses of HF-WBI; at 5 years of follow-up there continues to be excellent locoregional control and low toxicity with favorable cosmetic outcomes in a heterogeneous cohort of patients.

Original languageEnglish (US)
Pages (from-to)267-274
Number of pages8
JournalInternational Journal of Radiation Oncology Biology Physics
Volume105
Issue number2
DOIs
StatePublished - Oct 1 2019

Fingerprint

acceleration (physics)
breast
radiation therapy
Breast
Radiotherapy
toxicity
confidence
Confidence Intervals
intervals
irradiation
physicians
grade
cancer
Physicians
Carcinoma, Intraductal, Noninfiltrating
dosage
Adjuvant Chemotherapy
Clinical Protocols
Cosmetics
chemotherapy

All Science Journal Classification (ASJC) codes

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

@article{ec430e6c72f3480480ed6be4bd34030b,
title = "5-Year Results of a Prospective Phase 2 Trial Evaluating 3-Week Hypofractionated Whole Breast Radiation Therapy Inclusive of a Sequential Boost",
abstract = "Purpose: To report 5-year outcomes of a phase 2 trial of hypofractionated whole breast irradiation (HF-WBI) completed in 3 weeks, inclusive of a sequential boost. Methods and Materials: Women with stage 0-IIIA breast cancer (ductal carcinoma in situ through T2N2a) were enrolled on a prospective, phase 2 trial of accelerated HF-WBI. We delivered a whole breast dose of 36.63 Gy in 11 fractions of 3.33 Gy, with an equivalent dose to the regional nodes when indicated, followed by a tumor bed boost of 13.32 Gy in 4 fractions of 3.33 Gy over a total of 15 treatment days. The primary endpoint was locoregional control; secondary endpoints included acute/late toxicity and physician-assessed and patient-reported breast cosmesis. Results: Between 2009 and 2017, we enrolled 150 patients, of whom 146 received the protocol treatment. Median age was 54 years (range, 33-82) and median follow-up was 62 months. Patients with higher-risk disease comprised 59{\%} of the cohort, including features such as young age (33{\%} ≤50 years), positive nodes (13{\%}), triple-negative disease (11{\%}), and treatment with regional nodal irradiation (11{\%}) and/or neoadjuvant/adjuvant chemotherapy (36{\%}). Five-year estimated locoregional and distant control were 97.7{\%} (95{\%} confidence interval [CI], 93.0{\%}-99.3{\%}) and 97.9{\%} (95{\%} CI, 93.6{\%}-99.3{\%}), respectively. Five-year breast cancer–specific and overall survival were 99.2{\%} (95{\%} CI, 94.6{\%}-99.9{\%}) and 97.3{\%} (95{\%} CI, 91.9{\%}-99.1{\%}), respectively. Acute/late grade 2 and 3 toxicities were observed in 30{\%}/10{\%} and 1{\%}/3{\%} of patients, respectively. There were no grade 4 or 5 toxicities. Physicians assessed breast cosmesis as good or excellent in 95{\%} of patients; 85{\%} of patients self-reported slight to no difference between the treated and untreated breast. Conclusions: Our phase 2 trial offers one of the shortest courses of HF-WBI; at 5 years of follow-up there continues to be excellent locoregional control and low toxicity with favorable cosmetic outcomes in a heterogeneous cohort of patients.",
author = "Apar Gupta and Atif Khan and Nikhil Yegya-Raman and Mutlay Sayan and Stuti Ahlawat and Nisha Ohri and Sharad Goyal and Dirk Moore and Firas Eladoumikdachi and Deborah Toppmeyer and Bruce Haffty",
year = "2019",
month = "10",
day = "1",
doi = "10.1016/j.ijrobp.2019.05.063",
language = "English (US)",
volume = "105",
pages = "267--274",
journal = "International Journal of Radiation Oncology Biology Physics",
issn = "0360-3016",
publisher = "Elsevier Inc.",
number = "2",

}

5-Year Results of a Prospective Phase 2 Trial Evaluating 3-Week Hypofractionated Whole Breast Radiation Therapy Inclusive of a Sequential Boost. / Gupta, Apar; Khan, Atif; Yegya-Raman, Nikhil; Sayan, Mutlay; Ahlawat, Stuti; Ohri, Nisha; Goyal, Sharad; Moore, Dirk; Eladoumikdachi, Firas; Toppmeyer, Deborah; Haffty, Bruce.

In: International Journal of Radiation Oncology Biology Physics, Vol. 105, No. 2, 01.10.2019, p. 267-274.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 5-Year Results of a Prospective Phase 2 Trial Evaluating 3-Week Hypofractionated Whole Breast Radiation Therapy Inclusive of a Sequential Boost

AU - Gupta, Apar

AU - Khan, Atif

AU - Yegya-Raman, Nikhil

AU - Sayan, Mutlay

AU - Ahlawat, Stuti

AU - Ohri, Nisha

AU - Goyal, Sharad

AU - Moore, Dirk

AU - Eladoumikdachi, Firas

AU - Toppmeyer, Deborah

AU - Haffty, Bruce

PY - 2019/10/1

Y1 - 2019/10/1

N2 - Purpose: To report 5-year outcomes of a phase 2 trial of hypofractionated whole breast irradiation (HF-WBI) completed in 3 weeks, inclusive of a sequential boost. Methods and Materials: Women with stage 0-IIIA breast cancer (ductal carcinoma in situ through T2N2a) were enrolled on a prospective, phase 2 trial of accelerated HF-WBI. We delivered a whole breast dose of 36.63 Gy in 11 fractions of 3.33 Gy, with an equivalent dose to the regional nodes when indicated, followed by a tumor bed boost of 13.32 Gy in 4 fractions of 3.33 Gy over a total of 15 treatment days. The primary endpoint was locoregional control; secondary endpoints included acute/late toxicity and physician-assessed and patient-reported breast cosmesis. Results: Between 2009 and 2017, we enrolled 150 patients, of whom 146 received the protocol treatment. Median age was 54 years (range, 33-82) and median follow-up was 62 months. Patients with higher-risk disease comprised 59% of the cohort, including features such as young age (33% ≤50 years), positive nodes (13%), triple-negative disease (11%), and treatment with regional nodal irradiation (11%) and/or neoadjuvant/adjuvant chemotherapy (36%). Five-year estimated locoregional and distant control were 97.7% (95% confidence interval [CI], 93.0%-99.3%) and 97.9% (95% CI, 93.6%-99.3%), respectively. Five-year breast cancer–specific and overall survival were 99.2% (95% CI, 94.6%-99.9%) and 97.3% (95% CI, 91.9%-99.1%), respectively. Acute/late grade 2 and 3 toxicities were observed in 30%/10% and 1%/3% of patients, respectively. There were no grade 4 or 5 toxicities. Physicians assessed breast cosmesis as good or excellent in 95% of patients; 85% of patients self-reported slight to no difference between the treated and untreated breast. Conclusions: Our phase 2 trial offers one of the shortest courses of HF-WBI; at 5 years of follow-up there continues to be excellent locoregional control and low toxicity with favorable cosmetic outcomes in a heterogeneous cohort of patients.

AB - Purpose: To report 5-year outcomes of a phase 2 trial of hypofractionated whole breast irradiation (HF-WBI) completed in 3 weeks, inclusive of a sequential boost. Methods and Materials: Women with stage 0-IIIA breast cancer (ductal carcinoma in situ through T2N2a) were enrolled on a prospective, phase 2 trial of accelerated HF-WBI. We delivered a whole breast dose of 36.63 Gy in 11 fractions of 3.33 Gy, with an equivalent dose to the regional nodes when indicated, followed by a tumor bed boost of 13.32 Gy in 4 fractions of 3.33 Gy over a total of 15 treatment days. The primary endpoint was locoregional control; secondary endpoints included acute/late toxicity and physician-assessed and patient-reported breast cosmesis. Results: Between 2009 and 2017, we enrolled 150 patients, of whom 146 received the protocol treatment. Median age was 54 years (range, 33-82) and median follow-up was 62 months. Patients with higher-risk disease comprised 59% of the cohort, including features such as young age (33% ≤50 years), positive nodes (13%), triple-negative disease (11%), and treatment with regional nodal irradiation (11%) and/or neoadjuvant/adjuvant chemotherapy (36%). Five-year estimated locoregional and distant control were 97.7% (95% confidence interval [CI], 93.0%-99.3%) and 97.9% (95% CI, 93.6%-99.3%), respectively. Five-year breast cancer–specific and overall survival were 99.2% (95% CI, 94.6%-99.9%) and 97.3% (95% CI, 91.9%-99.1%), respectively. Acute/late grade 2 and 3 toxicities were observed in 30%/10% and 1%/3% of patients, respectively. There were no grade 4 or 5 toxicities. Physicians assessed breast cosmesis as good or excellent in 95% of patients; 85% of patients self-reported slight to no difference between the treated and untreated breast. Conclusions: Our phase 2 trial offers one of the shortest courses of HF-WBI; at 5 years of follow-up there continues to be excellent locoregional control and low toxicity with favorable cosmetic outcomes in a heterogeneous cohort of patients.

UR - http://www.scopus.com/inward/record.url?scp=85068444908&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85068444908&partnerID=8YFLogxK

U2 - 10.1016/j.ijrobp.2019.05.063

DO - 10.1016/j.ijrobp.2019.05.063

M3 - Article

VL - 105

SP - 267

EP - 274

JO - International Journal of Radiation Oncology Biology Physics

JF - International Journal of Radiation Oncology Biology Physics

SN - 0360-3016

IS - 2

ER -