CORRADO TINTERRI
RT 55-75
clinical trial
Breast conservative surgery with and without RT
in women aged 55-75 with early breast cancer.
Italian multicentre Trial
results at 108 months of medianFollow-Up
RT 55-75
clinical trial
Start : January 2001
End : December 2005
Total randomized
pts at the
31.12.2005
Partecipating Centres
Pavia
Ortona
Bergamo
Reggio Emilia
N° pts
176
110
109
80
Alba
Bologna
Ciriè
65
56
35
San Giovanni Rotondo
Torino
Udine
31
26
21
Roma
TOTAL
20
749
MILAN TRAIL III: CONCLUSION AFTER 12 YEARS OF FU
According to the data RT
seems to be ….
indicated
• in patients < 55 years
• in presence of E.I.C
avoidable
• in patients > a 65 years
controversial
• in between 56 and 65 years
Veronesi et Al. 2001
RT 55-75
clinical trial
Study design
Quadrantectomy
Axillary dissection / SNB
RT of the
breast
Histology
No RT
R
Adjuvant treatment according to
Center policy and related to
axillary nodal status and biological
tumor parameters
RT 55-75
clinical trial
Aims of the study
Primary Aim
Cumulative incidence of local recurrences after
CS+RT vs CS alone
Secondary Aims
Disease-free survival
Distant disease-free survival
Overall survival
Ancillary studies
Long-term sequelae, costs to the NHS
RT 55-75
clinical trial
RATIONAL
The rational of the study is to define a reliable RISK
FACTOR PROFILE to determine a group of patients at “
LOW RISK “ for local recurrence in whom radiation
therapy could be avoided.
RT 55-75
clinical trial
INCLUSION CRITERIA
• Age : > 55 < 75 yrs
• Maximum tumor size 2.5 cm.
• Unifocal infiltrating carcinoma of any grading and
hormone receptor status
• Axillary nodes status pN0-pN1bi
• No extensive intraductal component
• No extensive peritumoral vascular invasion
RT 55-75
clinical trial
INCLUSION CRITERIA
• No distant disease
• No any clinical condition that can interfere with radiation
treatment and standard follow-up
• No previous history of malignant diseases except for skin
basocellular carcinoma , in situ ca of the cervix
• No previous oncological treatment
RT 55-75
clinical trial
EVENTS - Median Follow-up 108 months
EVENTS
Local relapses
- Same quadrant
- Other quadrant
Controlateral Tumor
Distant relapses
Total
S + RT
S
Tot
(373)
N
%
(376)
N
%
(749)
N
%
7 (1.88)
5 (1.34)
6 (1.61)
7 (1.86)
9 (2.39)
5 (1.33)
14 (1.86)
14 (1.86)
11 (1.46)
26 (6.97)
44 (11.79)
28 (7.45)
49 (13.10)
54 (7.21)
93 (12.51)
Last analysis 31.12.2012
RT 55-75
clinical trial
Medium Follow-up 108 mth
Surgery
Patients status
Surgery + RT
N°
%
N°
%
274
72,9
266
71,5
- whit relapses
20
5,4
18
4,8
Death
53
14,0
51
13,7
Lost at F.U.
29
7,7
38
10,0
376
100
373
100
Alive
- without relapses
(longer than 12 months)
TOT
Last analysis 31.12.2012
RT 55-75
clinical trial
Medium Follow-up 108 Mth
Surgery
(376)
Cause of death
Breast cancer
Other cancer (not breast)
Other pathology
TOT
Surgery + RT
(373)
N°
%
N°
%
29
7,7
26
7.0
4
1,1
8
2,1
20
5,3
17
4.6
53
14,1
51
13,7
RT 55-75
Nine year cumulative incidence
of Local Recurrence
0.06
4.4%
0.04
BCT alone
BCT + WBI
0.02
3.4%
0.00
cum inc
0.08
0.10
clinical trial
0
20
40
60
months
80
100
RT 55-75
clinical trial
0.4
0.6
BCT alone
BCT + WBI
0.0
0.2
survival
0.8
1.0
Distant Diseases Free-Survival (108 months)
0
20
40
60
80
100
months
Red : surgery only 85,5 % (95% CI 81.9 – 89.3)
Blue: surgery plus WBI 86.9 % (95% CI 83.3 – 90.6)
120
140
RT 55-75
clinical trial
0.4
0.6
BCT alone
BCT + WBI
0.0
0.2
survival
0.8
1.0
Overall Survival (108 months)
0
20
40
60
80
100
months
Red : surgery only 83,7 % (95% CI 79.8 – 87.8)
Blue: surgery plus WBI 81.4 % (95% CI 77.4 – 85.6)
120
140
RT 55-75
clinical trial
Conclusions
Current data indicate that breast irradiation
after conservative surgery might be avoided
in selected patients
with early breast cancer
aged 55-75 years
without increased risk of local and distant
disease recurrence
Longer follow-up is needed to consolidate this
preliminary results
If RT could be omitted ….
1) broader use of breast conserving treatment
2) no complications and risks of RT
3) better cosmetic result
4) easier diagnosis of local recurrence
5) easier reconstruction after MX in case of LR
6) cost reduction for the NHS
7) reduction of waiting list
8) better QoL for the patient
9) avoidance of indirect costs for the patient
10) earlier return to work or active life
RT 55-75
clinical trial
Acknowledgements
To the 749 women participating in the study
and to the study investigators
Claudio Amanti (Roma), Nicoletta Biglia (Torino), Marina Bissolotti (Pavia),
Ettore Cianchetti (Ortona), Wolfgang Gatzemeier (Milano), Giuliana Gentile
(Udine), Maria Adalgisa Gentilini (Trento), Privato Fenaroli (Bergamo),
Mirella Merson (Bergamo), Roberto Murgo (S.G.Rotondo), Maria Carmela
Orlandi (Cirié), Claudio Pedrazzoli (Reggio Emilia), Lea Regolo (Pavia)
Gianpaolo Sacchetto (Alba), Piero Sismondi (Torino), Carlo Tondini
(Bergamo), Mario Taffurelli (Bologna), Pinuccia Valagussa (Milano), Vittorio
Zanini (Pavia).