How TARGIT Intra-operative Radiotherapy can help Older Patients with Breast cancer

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1 How TARGIT Intra-operative Radiotherapy can help Older Patients with Breast cancer Jeffrey S Tobias, Jayant S Vaidya, Frederik Wenz and Michael Baum, University College Hospital, London, UK - on behalf of the TARGIT Trialists International Group 3 rd Symposium on Primary Breast cancer in Older Women, Nottingham, UK, 6 th March 2015

2 Major problems with conventional radiotherapy for breast cancer, especially for older patients Radiotherapy typically takes 3-6 weeks to deliver Elderly patients don t like so many daily visits Long waiting lists in many centres, even now Distance from RT centre an issue journeys tiring Radiotherapy skin reactions and other side effects Delay between surgery and RT common, especially if chemo is part of the treatment, which it may well be...

3 and what s more, many are grossly overtreated using current techniques! We now see predominantly small tumours. Many are screen detected. Most are ER +ve. In this large group, tamoxifen or AI s reduce local as well as systemic relapse. Local recurrence clearly age-related, yet 75% of patients in the UK, USA and Europe are over 50 yrs old.

4 Late-onset Radiotherapy Side-effects: Meta-analysis of +/- RT studies by EBCTCG There is a clear excess incidence of contralateral breast cancer, and also non-breast-cancers and heart disease - with significant numbers of cardiac events. These excesses are slight during the first 5 years, but continue after year 15. Are they due to older methods of RT? We are now more sophisticated but who knows for sure?

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6 4.8% increased survival at 20 years 4.3% decreased survival at 20 years EBCTCG, Lancet

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8 Br J Cancer 1996;74: Breast cancer is frequently multicentric But most recurrences occur near the primary tumour So, it makes sense to target radiotherapy to the tumour bed

9 A possible but radical solution Can we treat only the index quadrant of the breast? Is it sufficient to prevent recurrence? Could we possibly do this by means of a single treatment with radiotherapy? What about the effect on overall survival could this be reduced by limiting our RT fields to a smaller volume of tissue?

10 The Intrabeam device for intraoperative breast irradiation

11 The TARGIT Technique Intrabeam device Gy at 10 mm 20 Gy to the tumour bed Theoretically this dose corresponds to the density of any residual tumour cells

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13

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15 TARGeted Intraoperative radiotherapy: TARGIT 1st case performed at University College London on 2 July Mobile machine used in a standard operating room Physical dose of 20Gy at the surface, delivered over 30 min

16 The operative cavity or tumour bed conforms to the irradiation source, to ensure perfect dosimetry..

17 The operative cavity or tumour bed conforms to the irradiation source, to ensure perfect dosimetry. We regard this as a form of conformal intra-operative brachytherapy

18 Potential advantages of Intra-operative radiotherapy Precision avoidance of the geographical miss which is a serious issue even in modern RT yet common. Immediacy, avoidance of toxicity i.e unwanted and unnecessary RT to normal tissues, convenience to the patient. Completion of surgery and RT in a single session. Usually overnight stay. If chemo is to be delivered (which increasingly is the case), no concern about delaying the RT component of treatment.

19 Potential advantages of Intra-operative radiotherapy Precision avoidance of the geographical miss which is a serious issue even in modern RT yet common. Immediacy, avoidance of toxicity i.e unwanted and unnecessary RT to normal tissues, convenience to the patient. Completion of surgery and RT in a single session. Usually overnight stay. If chemo is to be delivered (which increasingly is the case), no concern about delaying the RT component of treatment. But is it sufficient?

20 1998

21 TARGIT is TARGeted Intra-operative radio-therapy EBRT is External Beam Radio-Therapy The TARGIT-A trial is an international multicentre randomised clinical trial comparing TARGIT with EBRT

22 Risk-Adapted Radiotherapy Single dose of TARGIT with Intrabeam If high risk factors are found, add EBRT (in ~15%) San Antonio San Breast Antonio Cancer Breast Symposium Cancer Symposium December December 4-8, , 2012 Early breast cancer suitable for Breast Conserving Surgery Unifocal invasive duct carcinoma, 45 yrs or older - Size preferably < 3.5cm TARGIT Randomisation EBRT One-size-fits-all radiotherapy Standard fractionated External Beam Radiotherapy (EBRT) : 3,451 patients randomised

23 TARGIT-A Study Design 3451 Patients were randomized in 33 centres from 10 countries between 2000 and TARGIT-A is currently the largest multicentre randomized clinical trial of P B I January

24 Timing of randomisation and TARGIT delivery: separate randomisation tables 1. Randomisation BEFORE lumpectomy pre-pathology (Concurrent TARGIT, n = 2298) 2. Randomisation AFTER lumpectomy post-pathology (Delayed TARGIT as a second procedure, in patients more highly selected, n = 1153)

25 Outcomes and number of events Total number of patients 3451 Primary outcome: Local recurrence in the ipsilateral breast Secondary outcome: Deaths Breast cancer deaths Non Breast cancer deaths N B - - Cause of Death classified by assessment of CRF and where possible, case note review, by an independent senior clinician blinded to the randomisation group

26 Main results

27 Results [ 1 ] :Primary Outcome - Rates for Ipsilateral Recurrence (IBR) January

28 Primary Outcome - Absolute Differences for IBR January

29 All patients, n = 3451 Primary end point San Antonio Breast Cancer Symposium December 4-8, 2012 Results [ 2 ] Local recurrence in the Breast 34 events Difference between TARGIT and EBRT 2.01% Secondary end point 12 more recurrences but 14 fewer deaths Death 88 events Difference between TARGIT and EBRT - 1.4%

30 Results [ 3 ] : Probability [%] of remaining free of local recurrence in the breast at 5 years Pre-pathology n=2298 EBRT TARGIT during lumpectomy No significant difference non-inferiority satisfied Post-pathology n=1153 EBRT 98.3 Difference more than 2.5% TARGIT delayed : 2 nd op beyond non-inferiority

31 Results [ 4 ] : Primary and Secondary Outcome - Number of Events January

32

33 Is the follow-up long enough?

34 Stable result across cohorts with increasing median follow-up periods TARGIT concurrent with lumpectomy Whole cohort N=2298 Med. FU 2.3 years Mature cohort N=1450 Med. FU 3.7 years Earliest cohort N=817 Med. FU 5 years

35 The risk of recurrence peaks in the first 2-3 years following initial diagnosis and treatment % hazard of recurrence by yearly interval Node (4+) Tumour size (>3cm) ER Postmen Total Premen ER+ Tumour size ( 1cm) Node Years Adapted from Saphner et al s meta-analysis of ECOG studies Data from Early Breast Cancer Trialists Collaborative Group. Lancet 1998; 351: Saphner T et al. J Clin Oncol 1996; 14: Rack B et al. Breast Cancer Res Treat 2003; 82:

36 Sector Resection With or Without Postoperative Radiotherapy for Stage I Breast Cancer: 20-Year Results of a Randomized Trial. A Wickberg, L Holmberg, H-O Adami et al - from Sweden, London and Harvard School of Public Health J Clin Oncology, 3 February The similar rate of recurrences beyond 5 years in the two groups indicates that late recurrences are new tumors. [ n = 381, all pt1 N0 with fully excised margins ]

37 Is No-radiotherapy an option, esp for older patients? CALGB BASO 2 PRIME 2 TARGIT-A Prepathology Number Age >=70 >=65 >=65 T Size <=2cm <=2cm <=2cm Grade Grade 1 Grade 1 or Grade 2 Nodes Negative Negative Negative LV invasion Negative Negative ER status Positive Positive Positive 5-year local recurrence (LR) 4% vs 1% Stat Sig. 6% vs 2% Stat Sig. 4.1% vs 1.3% Stat Sig. 5-year LR in each experimental arm 1 in 25 1 in 17 1 in 25

38 CALGB BASO 2 PRIME 2 TARGIT-A Prepathology Number Age >=70 >=65 >=65 >=45 T Size <=2cm <=2cm <=2cm <=3.5cm Grade Grade 1 Grade 1 or Grade 2 No restriction Nodes Negative Negative Negative No restriction LV invasion Negative Negative No restriction ER status Positive Positive Positive No restriction 5-year local recurrence (LR) 4% vs 1% Stat Sig. 6% vs 2% Stat Sig. 4.1% vs 1.3% Stat Sig. 5-year LR in each experimental arm 1 in 25 1 in 17 1 in 25

39 No-radiotherapy is not a good option! CALGB BASO 2 PRIME 2 TARGIT-A Prepathology Number Age >=70 >=65 >=65 >=45 T Size <=2cm <=2cm <=2cm <=3.5cm Grade Grade 1 Grade 1, 2 No restriction Nodes Negative Negative Negative No restriction LV invasion Negative Negative No restriction ER status Positive Positive Positive No restriction 5-year local recurrence [ LR ] 5-yr LR in exptl. arm 4% vs 1% Stat Sig. 6% vs 2% Stat Sig. 4.1% vs 1.3% Stat Sig. 2.1% vs. 1.1% overall 1.4% vs. 1.1% if ER pos. Both not statistically significant 1 in 25 1 in 17 1 in 25 1 in 48 overall 1 in 71 if ER +

40

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42 230 centres worldwide currently offer TARGIT IORT with INTRABEAM in 35 countries Germany =60 centres

43 230 centres worldwide currently offer TARGIT IORT with INTRABEAM in 35 countries Over 10,000 patients have now been treated with TARGIT IORT Germany =60 centres

44 TARGIT IORT during lumpectomy should be made more widely available, particularly for older patients, because 1. TARGIT is both more convenient and easier for the patient 2. Better QOL, satisfaction and cosmesis 3. Less expensive ( actually much less expensive when you think about it ) 4. Relatively simple to deliver even a surgeon can do it 5. Now supported by one of the largest randomized trials in early breast cancer. It s being rapidly introduced all over the world. 6. It s quicker all done and dusted during lumpectomy 7. It s individualized, or risk-adjusted can add EBRT if required: let the M D T decide! For individual case decisions, who better? 8. It s accurate no geographical miss. 9. It s timely - no temporal miss- immediately after lumpectomy. 10. It s time-tested 1 st case done in years ago. 11. When EBRT is not an option, TARGIT can avoid mastectomy.

45 Nature Reviews Clinical Oncology

46 Daily Mail 31 Dec 2013

47 Daily Telegraph

48 U C L H in the sunlight

49 U C L in the twilight

50 Teleconference at the TARGIT Trial headquarters in London (l to r): N Williams, I Potyka, M Keshtgar, C Brew-Graves, M Baum, JS Vaidya, JS Tobias

51

52 Health Technology Assessment University of Dundee

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