Intensity-Modulated Radiotherapy with Concomitant Boost After Breast Conserving Surgery: A Phase I–II Trial

Figures & data

Table 1 Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer Scale Late Toxicity Scale

Organ Tissue	0	Grade 1	Grade 2	Grade 3	Grade 4
Skin	None	Slight atrophy, Pigmentation change, Some hair loss	Patch atrophy, Moderate Telangiectasia, Total hair loss	Marked atrophy, Gross telangiectasia	Ulceration
Subcutaneous tissue	None	Slight induration (fibrosis) and loss of subcutaneous fat	Moderate fibrosis but asymptomatic, Slight field contracture <10% linear reduction	Severe induration and loss of subcutaneous tissue, Field contracture, >10% linear measurement	Necrosis

Notes: Reprinted from International Journal of Radiation Oncology*Biology*Physics, Volume 31, edition 5, Cox JD, Stetz J, Pajak TF, Toxicity criteria of the Radiation TherapyOncology Group (RTOG) and the European Organization for Researchand Treatment of Cancer (EORTC), Pages 1341–1346, Copyright 1995, with permission from Elsevier.¹⁵

Table 2 Patients’ Characteristics

		Patients Number (%)
Age	Median: 49 [25–81]
	≤50 years	186 (57.9)
	>50 years	135 (42.1)
Menopausal status	Pre- or peri-menopausal	227 (70.7)
	Post-menopausal	94 (29.3)
Cancer site	Right	199 (62.0)
	Left	122 (38.0)
Tumor stage	1	216 (67.3)
	2	102 (31.8)
	3	1 (0.3)
	4	2 (0.6)
Nodal stage	0	172 (53.6)
	1	93 (29.0)
	2a	39 (12.1)
	3a	17 (5.3)
Surgical margins	Negative	236 (73.5)
	Close	57 (17.8)
	Positive	28 (8.7)

Table 3 Treatment Characteristics

		Patients Number (%)
Regional node irradiation	No	227 (70.7)
	Yes	94 (29.3)
Adjuvant chemotherapy	No	111 (34.6)
	Anthracycline + docetaxel	111 (34.6)
	Other anthracycline-based regimens	90 (28.0)
	CMF	9 (2.8)
Adjuvant endocrine therapy	No	61 (19.0)
	Tamoxifen (± Lh-Rh analogue)	169 (52.7)
	Aromatase Inhibitors	91 (28.3)

Table 4 Late Toxicity in Selected Studies

Author, Year	Number Patients	WBI Dose (Dose/fr), Gy	WBI EQD2 (α/β=2), Gy	Boost Dose (Dose/fr), Gy	Boost EQD2 (α/β=2), Gy	Median Follow-up Months (Range)	Toxicity Scale	G≥2 Late Toxicity	G≥3 Late Toxicity
Bantema-Joppe et al, 2012^Citation19	436	50.4 (1.8)	47.9	64.4 (2.3) or 67.2 (2.4)	69.2–73.9	NR (NR)	CTCAE v3.0	Fibrosis: 8.5%*† Telangiectasia: 3.7%†	NR
Alford et al, 2013^Citation25	53	45 (1.8)	42.8	60 (2.4)	66.0	13.3 (3–27)	CTCAE v3.0	Fibrosis: 1.9% ‡ Telangiectasia: 0.0% ‡	0.0%
Current series	321	50 (2.0)	50	60 (2.4)	66.0	52 (3–115)	RTOG/ EORTC	Fibrosis: 20.0% § Skin: 4.4% §	Subcutaneous: 1.4% § Skin: 0.0% §

Notes: *In the boost area; ^†Crude rate (3 years); ^‡Crude rate; ^§actuarial (5 years).

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; EQD2, equivalent dose in 2 Gy per fraction; fr, fraction; NR, not reported; RTOG/EORTC, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer; WBI, whole breast irradiation.

Table 5 Outcome Results in Selected Studies

Author, Year	Number Patients	WBI Dose (Dose/fr), Gy	Boost Dose (Dose/fr), Gy	Median Follow-up (Range), Months	Local Recurrences	Distant Metastases	Overall Survival
Bantema-Joppe et al, 2013^Citation22	752	50.4 (1.8)	64.4 (2.3) or 67.2 (2.4)	60 (3–93)	3.3% *	5.8% *	93.3% *
McDonald et al, 2010^Citation18	282	45 (1.8)	59.92 (2.14) †	33 (4–73)	2.9% ‡	2.7% ‡	97.0% ‡
Current series	321	50 (2.0)	60 (2.4)	52 (3–115)	2.0% *	8.2% *	96.3% *

Notes: *Actuarial (5 years); ^†A small number of patients (8% and 3%, respectively) were treated with two alternative schedule: 50.4 Gy (1.8 Gy/fr) to the breast and 59.92 Gy (2.12 Gy/fr) as a boost in 28 fractions or 45 Gy (1.8 Gy/fr) to the breast and 60 Gy (2.4 Gy/fr) as a boost in 25 fractions; ^‡Actuarial (3-years).

Abbreviations: fr, fraction; WBI, whole breast irradiation.

CoxJD, StetzJ, PajakTF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995;31(5):1341–1346. doi:10.1016/0360-3016(95)00060-C7713792

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