Shaitelman SF, Schlembach PJ, Arzu I, Ballo M, Bloom ES, Buchholz D, Chronowski GM, Dvorak T, Grade E, Hoffman KE, Kelly P, Ludwig M, Perkins GH, Reed V, Shah S, Stauder MC, Strom EA, Tereffe W, Woodward WA, Ensor J, Baumann D, Thompson AM, Amaya D, Davis T, Guerra W, Hamblin L, Hortobagyi G, Hunt KK, Buchholz TA, Smith BD, et al.
JAMA oncology. Date of publication 2015 Oct 1;volume 1(7):931-41.
1. JAMA Oncol. 2015 Oct;1(7):931-41. doi: 10.1001/jamaoncol.2015.2666.
Acute and Short-term Toxic Effects of Conventionally Fractionated vs
Hypofractionated Whole-Breast Irradiation: A Randomized Clinical Trial.
Shaitelman SF(1), Schlembach PJ(1), Arzu I(1), Ballo M(2), Bloom ES(1), Buchholz
D(3), Chronowski GM(1), Dvorak T(3), Grade E(4), Hoffman KE(1), Kelly P(3),
Ludwig M(5), Perkins GH(1), Reed V(1), Shah S(1), Stauder MC(1), Strom EA(1),
Tereffe W(1), Woodward WA(1), Ensor J(6), Baumann D(7), Thompson AM(8), Amaya
D(1), Davis T(1), Guerra W(1), Hamblin L(1), Hortobagyi G(9), Hunt KK(8),
Buchholz TA(1), Smith BD(1).
Author information:
(1)Department of Radiation Oncology, The University of Texas MD Anderson Cancer
Center, Houston.
(2)Department of Radiation Oncology, The University of Tennessee Health Science
Center, Memphis.
(3)Department of Radiation Oncology, University of Florida Health Cancer Center,
Orlando Health, Orlando.
(4)Department of Radiation Oncology, Banner MD Anderson Cancer Center, Gilbert,
Arizona.
(5)Department of Radiation Oncology, Baylor College of Medicine, Houston, Texas.
(6)Houston Methodist Research Institute, The Methodist Hospital, Houston, Texas.
(7)Department of Plastic Surgery, The University of Texas MD Anderson Cancer
Center, Houston, Texas.
(8)Department of Surgical Oncology, The University of Texas MD Anderson Cancer
Center, Houston, Texas.
(9)Department of Breast Medical Oncology, The University of Texas MD Anderson
Cancer Center, Houston, Texas.
Comment in
JAMA Oncol. 2015 Oct;1(7):941-2.
IMPORTANCE: The most appropriate dose fractionation for whole-breast irradiation
(WBI) remains uncertain.
OBJECTIVE: To assess acute and 6-month toxic effects and quality of life (QOL)
with conventionally fractionated WBI (CF-WBI) vs hypofractionated WBI (HF-WBI).
DESIGN, SETTING, AND PARTICIPANTS: Unblinded randomized trial of CF-WBI (n = 149;
50.00 Gy/25 fractions + boost [10.00-14.00 Gy/5-7 fractions]) vs HF-WBI (n = 138;
42.56 Gy/16 fractions + boost [10.00-12.50 Gy/4-5 fractions]) following
breast-conserving surgery administered in community-based and academic cancer
centers to 287 women 40 years or older with stage 0 to II breast cancer for whom
WBI without addition of a third field was recommended; 76% of study participants
(n = 217) were overweight or obese. Patients were enrolled from February 2011
through February 2014 and observed for a minimum of 6 months.
INTERVENTIONS: Administration of CF-WBI or HF-WBI.
MAIN OUTCOMES AND MEASURES: Physician-reported acute and 6-month toxic effects
using National Cancer Institute Common Toxicity Criteria, and patient-reported
QOL using the Functional Assessment of Cancer Therapy for Patients with Breast
Cancer (FACT-B). All analyses were intention to treat, with outcomes compared
using the χ2 test, Cochran-Armitage test, and ordinal logistic regression.
RESULTS: Of 287 participants, 149 were randomized to CF-WBI and 138 to HF-WBI.
Treatment arms were well matched for baseline characteristics, including FACT-B
total score (HF-WBI, 120.1 vs CF-WBI, 118.8; P = .46) and individual QOL items
such as somewhat or more lack of energy (HF-WBI, 38% vs CF-WBI, 39%; P = .86) and
somewhat or more trouble meeting family needs (HF-WBI, 10% vs CF-WBI, 14%;
P = .54). Maximum physician-reported acute dermatitis (36% vs 69%; P < .001),
pruritus (54% vs 81%; P < .001), breast pain (55% vs 74%; P = .001),
hyperpigmentation (9% vs 20%; P = .002), and fatigue (9% vs 17%; P = .02) during
irradiation were lower in patients randomized to HF-WBI. The rate of overall
grade 2 or higher acute toxic effects was less with HF-WBI than with CF-WBI (47%
vs 78%; P < .001). Six months after irradiation, physicians reported less fatigue
in patients randomized to HF-WBI (0% vs 6%; P = .01), and patients randomized to
HF-WBI reported less lack of energy (23% vs 39%; P < .001) and less trouble
meeting family needs (3% vs 9%; P = .01). Multivariable regression confirmed the
superiority of HF-WBI in terms of patient-reported lack of energy (odds ratio
[OR], 0.39; 95% CI, 0.24-0.63) and trouble meeting family needs (OR, 0.34; 95%
CI, 0.16-0.75).
CONCLUSIONS AND RELEVANCE: Treatment with HF-WBI appears to yield lower rates of
acute toxic effects than CF-WBI as well as less fatigue and less trouble meeting
family needs 6 months after completing radiation therapy. These findings should
be communicated to patients as part of shared decision making.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01266642.
DOI: 10.1001/jamaoncol.2015.2666
PMCID: PMC4635441
PMID: 26247543 [Indexed for MEDLINE]
