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CORRADO TINTERRI

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.

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CORRADO TINTERRI

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  1. CORRADO TINTERRI

  2. RT55-75 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

  3. RT55-75 clinical trial Start : January 2001 End : December 2005 Total randomized pts at the 31.12.2005

  4. 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. RT55-75 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

  6. RT55-75 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. RT55-75 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. RT55-75 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

  9. RT55-75 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. RT55-75 clinical trial EVENTS - Median Follow-up 108 months Last analysis 31.12.2012

  11. RT55-75 clinical trial Medium Follow-up 108 mth Last analysis 31.12.2012

  12. RT55-75 clinical trial Medium Follow-up 108 Mth

  13. 0.10 0.08 0.06 cum inc BCT alone BCT + WBI 0.04 0.02 0.00 0 20 40 60 80 100 months RT55-75 clinical trial Nine year cumulative incidence of Local Recurrence 4.4% 3.4%

  14. Distant Diseases Free-Survival (108 months) RT55-75 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)

  15. Overall Survival (108 months) RT55-75 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)

  16. RT55-75 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

  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. RT55-75 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).

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