1. CORRADO TINTERRI
Good afternoon, welcome to Humanitas Cancer Center, I thank the Steering committee for giving me the opportunity to talk to you about our Breast Unit and the Breast Cancer Surgery activity during the first year of Humanitas Cancer Center. 1

2. RT 55-75 Breast conservative surgery with and without RT
clinical trial
Breast conservative surgery with and without RT
in women aged with early breast cancer.
Italian multicentre Trial
results at 108 months of medianFollow-Up

3. Total randomized pts at the 31.12.2005
RT 55-75
clinical trial
Partecipating Centres
N° pts
Pavia
176
Ortona
110
Bergamo
109
Reggio Emilia 80
Alba 65
Bologna 56
Ciriè 35
San Giovanni Rotondo 31
Torino 26
Udine 21
Roma 20
TOTAL
749
Start : January
End : December 2005
Total randomized pts at the

4. According to the data RT
MILAN TRAIL III: CONCLUSION AFTER 12 YEARS OF FU
According to the data RT
seems to be ….
in patients < 55 years
in presence of E.I.C
indicated
avoidable
in patients > a 65 years
controversial
in between 56 and 65 years
Veronesi et Al. 2001

5. RT 55-75 Study design R Quadrantectomy Axillary dissection / SNB
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

6. 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

7. 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.

8. RT 55-75 Age : > 55 < 75 yrs Maximum tumor size 2.5 cm.
clinical trial
INCLUSION CRITERIA
Age : > < 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

9. 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

10. EVENTS - Median Follow-up 108 months
RT 55-75
clinical trial
EVENTS - Median Follow-up 108 months
EVENTS
S + RT
(373)
N % S
(376)
N %
Tot
(749)
N %
Local relapses
Same quadrant
- Other quadrant
7 (1.88)
5 (1.34)
7 (1.86)
9 (2.39)
14 (1.86)
Controlateral Tumor
6 (1.61)
5 (1.33)
11 (1.46)
Distant relapses
26 (6.97)
28 (7.45)
54 (7.21)
Total
44 (11.79)
49 (13.10)
93 (12.51)
Last analysis

11. RT 55-75 Medium Follow-up 108 mth Patients status clinical trial Alive
Surgery
N° %
Surgery + RT
N° %
Alive
- without relapses
- whit relapses
274 20
72,9
5,4
266 18
71,5
4,8
Death 53
14,0 51
13,7
Lost at F.U.
(longer than 12 months) 29
7,7 38
10,0
TOT
376
100
373
Last analysis

12. RT 55-75 Medium Follow-up 108 Mth Cause of death clinical trial
Surgery
(376)
N° %
Surgery + RT
(373)
N° %
Breast cancer 29
7,7 26
7.0
Other cancer (not breast) 4
1,1 8
2,1
Other pathology 20
5,3 17
4.6
TOT 53
14,1 51
13,7

13. Nine year cumulative incidence
RT 55-75
clinical trial 20 40 60 80
100
0.00
0.02
0.04
0.06
0.08
0.10
months
cum inc
BCT alone
BCT + WBI
Nine year cumulative incidence
of Local Recurrence
4.4%
3.4%

14. Distant Diseases Free-Survival (108 months)
RT 55-75
clinical trial
Distant Diseases Free-Survival (108 months)
Red : surgery only 85,5 % (95% CI 81.9 – 89.3)
Blue: surgery plus WBI 86.9 % (95% CI 83.3 – 90.6)

15. Overall Survival (108 months)
RT 55-75
clinical trial
Overall Survival (108 months)
Red : surgery only 83,7 % (95% CI 79.8 – 87.8)
Blue: surgery plus WBI 81.4 % (95% CI 77.4 – 85.6)

16. in selected patients with early breast cancer aged 55-75 years
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 years
without increased risk of local and distant disease recurrence
Longer follow-up is needed to consolidate this preliminary results

17. 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

18. RT 55-75 Acknowledgements clinical trial
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).