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CORRADO TINTERRI. Italian multicentre Trial results at 108 months of medianFollow-Up Breast conservative surgery with and without RT in women aged 55-75.

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Presentation on theme: "CORRADO TINTERRI. Italian multicentre Trial results at 108 months of medianFollow-Up Breast conservative surgery with and without RT in women aged 55-75."— Presentation transcript:

1 CORRADO TINTERRI

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

3 Partecipating Centres N° pts Pavia176 Ortona110 Bergamo109 Reggio Emilia 80 Alba65 Bologna56 Ciriè35 San Giovanni Rotondo 31 Torino26 Udine21 Roma20 TOTAL749 Total randomized pts at the Start : January 2001 End : December 2005 RT clinical trial

4 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 between 56 and 65 years indicated avoidable controversial Veronesi et Al According to the data RT seems to be …. MILAN TRAIL III: CONCLUSION AFTER 12 YEARS OF FU

5 Quadrantectomy R R RT of the breast No RT Axillary dissection / SNB Adjuvant treatment according to Center policy and related to axillary nodal status and biological tumor parameters Histology Study design RT clinical trial

6 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 clinical trial

7 RATIONAL 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 clinical trial

8 INCLUSION CRITERIA 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 clinical trial

9 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 clinical trial INCLUSION CRITERIA INCLUSION CRITERIA

10 EVENTS - Median Follow-up 108 months RT clinical 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) Controlateral Tumor6 (1.61)5 (1.33)11 (1.46) Distant relapses26 (6.97)28 (7.45)54 (7.21) Total44 (11.79)49 (13.10)93 (12.51) Last analysis

11 Patients status Surgery N° % Surgery + RT N° % Alive - without relapses - whit relapses ,9 5, ,5 4,8 Death5314,05113,7 Lost at F.U. (longer than 12 months) 297,73810,0 TOT Medium Follow-up 108 mth RT clinical trial Last analysis

12 Cause of death Surgery (376) N° % Surgery + RT (373) N° % Breast cancer 297, Other cancer (not breast) 41,182,1 Other pathology 205, TOT5314,15113,7 Medium Follow-up 108 Mth RT clinical trial

13 months cum inc BCT alone BCT + WBI Nine year cumulative incidence of Local Recurrence RT clinical trial 4.4% 3.4%

14 RT clinical trial 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)

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

16 Conclusions Current data indicate that breast irradiation Current data indicate that breast irradiation after conservative surgery might be avoided after conservative surgery might be avoided in selected patients with early breast cancer aged years in selected patients with early breast cancer aged years without increased risk of local and distant disease recurrence without increased risk of local and distant disease recurrence Longer follow-up is needed to consolidate this preliminary results Longer follow-up is needed to consolidate this preliminary results RT clinical trial

17 If RT could be omitted …. 1) broader use of breast conserving treatment 1) broader use of breast conserving treatment 2) no complications and risks of RT 2) no complications and risks of RT 3) better cosmetic result 3) better cosmetic result 4) easier diagnosis of local recurrence 4) easier diagnosis of local recurrence 5) easier reconstruction after MX in case of LR 5) easier reconstruction after MX in case of LR 6) cost reduction for the NHS 6) cost reduction for the NHS 7) reduction of waiting list 7) reduction of waiting list 8) better QoL for the patient 8) 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 life

18 Acknowledgements 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). To the 749 women participating in the study RT clinical trial


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