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