Download - CORRADO TINTERRI
CORRADO TINTERRI
Italian multicentre Trial
results at 108 months of medianFollow-Up
Breast conservative surgery with and without RT Breast conservative surgery with and without RT in women aged 55-75 with early breast cancer.in women aged 55-75 with early breast cancer.
RT 55-75clinical trial
Partecipating CentresPartecipating Centres N° ptsN° pts
PaviaPavia 176176
OrtonaOrtona 110110
BergamoBergamo 109109
Reggio EmiliaReggio Emilia 8080
AlbaAlba 6565
BolognaBologna 5656
CirièCiriè 3535
San Giovanni RotondoSan Giovanni Rotondo 3131
TorinoTorino 2626
UdineUdine 2121
RomaRoma 2020
TOTALTOTAL 749749
Total randomized pts at the
31.12.2005
Total randomized pts at the
31.12.2005
Start : January 2001 End : December 2005
RT 55-75clinical trial
• in patients < 55 years• in presence of E.I.C
• in patients < 55 years• in presence of E.I.C
• in patients > a 65 years• in patients > a 65 years
• in between 56 and 65 years• in between 56 and 65 years
indicated
avoidable
controversial
Veronesi et Al. 2001
According to the data RT
seems to be ….
MILAN TRAIL III: MILAN TRAIL III: CONCLUSION AFTER 12 YEARS OF FUCONCLUSION AFTER 12 YEARS OF FUMILAN TRAIL III: MILAN TRAIL III: CONCLUSION AFTER 12 YEARS OF FUCONCLUSION AFTER 12 YEARS OF FU
QuadrantectomyQuadrantectomy
RR
RT of the breast
No RTNo RT
Axillary dissection / SNB Axillary dissection / SNB
Adjuvant treatment according to Center policy and related to axillary nodal status and biological tumor parameters
Adjuvant treatment according to Center policy and related to axillary nodal status and biological tumor parameters
Histology
Study designRT 55-75clinical 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 55-75clinical trial
RATIONALRATIONAL
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.
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 55-75clinical trial
INCLUSION CRITERIAINCLUSION CRITERIA INCLUSION CRITERIAINCLUSION 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 55-75clinical trial
• 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 55-75clinical trial
INCLUSION CRITERIAINCLUSION CRITERIA INCLUSION CRITERIAINCLUSION CRITERIA
EVENTS - Median Follow-up 108 months
RT 55-75clinical trial
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)
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 31.12.2012
Patients status
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 376 100 373 100
Medium Follow-up 108 mthRT 55-75
clinical trial
Last analysis 31.12.2012
Cause of death
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
Medium Follow-up 108 Mth
RT 55-75clinical trial
0 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
RT 55-75clinical trial
4.4%
3.4%
RT 55-75clinical trial
0 20 40 60 80 100 120 140
0.0
0.2
0.4
0.6
0.8
1.0
months
su
rviv
al
BCT aloneBCT + WBI
Red : surgery only 85,5 % (95% CI 81.9 – 89.3)Blue: surgery plus WBI 86.9 % (95% CI 83.3 – 90.6)
Distant Diseases Free-Survival (108 months)
RT 55-75clinical trial
Red : surgery only 83,7 % (95% CI 79.8 – 87.8)Blue: surgery plus WBI 81.4 % (95% CI 77.4 – 85.6)
0 20 40 60 80 100 120 140
0.0
0.2
0.4
0.6
0.8
1.0
months
su
rviv
al
BCT aloneBCT + WBI
Overall Survival (108 months)
Conclusions
Current data indicate that breast Current data indicate that breast irradiationirradiation
after conservative surgery might be after conservative surgery might be avoidedavoided
in in selectedselected patients patients with early breast cancer with early breast cancer
aged 55-75 yearsaged 55-75 years without increased risk of local and distant without increased risk of local and distant
disease recurrencedisease recurrence
Longer follow-up is needed to consolidate Longer follow-up is needed to consolidate this preliminary resultsthis preliminary results
RT 55-75clinical trial
If RT could be omitted …. If RT could be omitted ….
1) broader use of breast conserving treatment1) broader use of breast conserving treatment 2) no complications and risks of RT2) no complications and risks of RT 3) better cosmetic result3) better cosmetic result 4) easier diagnosis of local recurrence 4) easier diagnosis of local recurrence 5) easier reconstruction after MX in case of LR5) easier reconstruction after MX in case of LR 6) cost reduction for the NHS6) cost reduction for the NHS 7) reduction of waiting list7) reduction of waiting list 8) better QoL for the patient8) better QoL for the patient 9) avoidance of indirect costs for the patient 9) avoidance of indirect costs for the patient 10) earlier return to work or active life10) earlier return to work or active life
Acknowledgements
and to the study investigatorsClaudio 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).
To the 749 women participating in the studyTo the 749 women participating in the study
RT 55-75clinical trial