Giorgio Arcangeli

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5th International Conference of Intraoperative
Radiation Therapy Madrid 10-13 June 2008
IOERT vs EBRT in breast cancer Update of an
ongoing multicenter study
Giorgio Arcangeli
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Phase III randomized Italian multicenter study of
IORT vs EBRT in breast tumors
Partecipanting centers
Regina Elena tumor institute, Roma
(coordination) S. Chiara hospital, Trento S.
Maria hospital Treviso S. Chiara University
hospital, Pisa S. Andrea university hospital, Roma
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Study Design
EBRT ( 50Gy boost)
?
Random ?
IORT ( 21Gy)

Patient selection
HISTOLOGY ductal UNICENTRIC DIAMETER ?
2.5cm RESECTION MARGINs gt2mm Age ? 48 anni
MENOPAUSAL STATUS
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Objectives of the study

• Main objective evaluation of the 5-year true
• local and outside-quadrant recurrence rates.
• b. Secondary objectives overall survival,
  disease-free interval, late toxicity and
• cosmetic results.

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IOERT PROCEDURES AFTER TUMOR RESECTION
MOBILIZATION OF THE RESIDUAL MAMMARY TISSUE FROM
PECTORALIS MUSCLE FASCIA AND FROM SUBCUTANEOUS
LAYER
GLANDULAR MARGIN SUTURE AND ANATOMY RESTORATION.
MEASUREMENT OF THE TISSUE THICKNESS TO DEFINE THE
APPROPRIATE ELECTRON ENERGY.
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CHEST WALL PROTECTION BY MEANS OF A 1 CM THICK
PERSPEX DISC PLACED BETWEEN THE GLANDULAR TISSUE
AND PECTORALIS MUSCLE.
SKIN REMOVAL FROM RADIATION FIELD. THE CTV IS
REPRESENTED BY THE WHOLE INVOLVED MAMMARY
QUADRANT.
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Dedicated mobile treatment unit in the operating
room, delivering 3 to 9 MeV electron beam energy
(Novac 7)
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Patient selectionInclusion criteria
1.Age lt 75 years gt 48 years 2.Postmenopause 3.Sing
le tumor lt 2.5 cm 4. lt 4 axillary N or SN- 5.No
previous treatment 6.No other primary tumors
with the exception of. 7. Written consent to
partecipate in the study
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Sample Size
Number of patients required to demonstrate
an equivalence of the 5-year true local
recurrence rates between the conventional and
experimental arm at 5 significance level and
90power of a two-sided test
938
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Italian multicenter randomized study
PATIENT ACCRUAL PER CENTRE AND YEAR
89
171
78
58
44
33
34
26
IRE 03/08
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Italian multicenter randomized study
Patient accrual and evaluation status
Centers Procedure IORT
EBRT Total Roma Randomized
40 40 80 IRE
Evaluated 37 34
71 Trento Randomized 87
85 172
Evaluated 87 85
172 Treviso Randomized 43
39 82
Evaluated 29 20
49 Pisa Randomized 39
38 77
Evaluated 22 17
39 Roma Randomized 20
20 40 S. Andrea Evaluated
0 0 0 Total
Randomized 229 222
451 Evaluated
175 156 331
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Italian multicenter randomized study
Patient distribution according to T stage
171
157
154
133
21
13
1
0
IRE 03/08
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Italian multicenter randomized study
Patient distribution according to N stage
171
154
123
116
44
33
4
5
IRE 03/08
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Italian multicenter randomized study
Patient distribution according to surgical margin
distance
160
139
128
113
16
18
14
10
IRE 03/08
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Italian multicenter randomized study
Patient distribution according to adjuvant therapy
145
157
84
86
37
27
21
19
13
15
IRE 03/08
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Italian multicenter randomized study
Patient distribution according to late toxicity
grade
175
165
156
59
60
37
9
1
IRE 03/08
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RTOG/EORTC late toxicity scale
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Phase III randomized Italian multicenter study of
IOERT vs EBRT in breast tumors
Median Follow-up 35 months (range 7-61) No
breast recurrences 2 lymph-node progressions 1
in EBRT arm
1 in IORT arm
IRE 03/08
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Thank You for Your attention