Current Status of Accelerated Partial Breast Irradiation. Julia White MD Professor, Radiation Oncology

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1 Current Status of Accelerated Partial Breast Irradiation Julia White MD Professor, Radiation Oncology

2 I have no disclosures relative to the presented material

3 Agenda ABPI Timeline APBI by Method Clinical Trials Consensus Guideline Summary

4 Accelerated Partial Breast Irradiation (APBI): Definition Delivery of larger doses/fraction of radiation therapy (RT) to the lumpectomy cavity (plus 1-2 cm margin) after breast conserving surgery using brachytherapy or external beam irradiation techniques Complete RT in < 5-8 days after lumpectomy instead of 6-7 weeks

5 17 years of APBI: What have we learned? RTOG 9517 Multi catheter APBI Phase II/ feasibility Mammosite APBI Phase II/ feasibility 2002 MammoSite FDA Approval ASBS Registry MammoSite APBI RTOG DCRT APBI Phase II/ feasibility 2004 NASBP B39/ RTOG 0413 Phase III opens 2006 OCOG 3DCRT RAPID Phase III opens 2009 ASTRO Consensus Guidelines 2011 OCOG 3DCRT RAPID Phase III closes 2013 NSABP B39/ RTOG 0413 Phase III closes

6 RTOG phase I/II Multi-catheter APBI patients accrued between institutions: HDR 66, LDR Gy in 10 fractions, BID 5-8 days Breast Median Tsz. 1.3 cm, N-1 19%, ER/PR+ 77% Overall satisfaction with treatment at 5 yrs: 75% 94.6% would choose multicatheter APBI again Target volume: 1.5 cm breast tissue around the cavity Lumpectomy Advantages: Irregularly shaped cavities, skin and chestwall sparing

7 RTOG 95-17: A phase I/II trial to evaluate multi-catheter interstitial PBI Median follow-up: 12.1 yrs 5 year 10 year # at # at Event # (%) risk (%) risk ISOLATED in-breast recurrence In field Out of field In-breast & Regional recurrence ALL In-breast recurrences ISOLATED Regional recurrence ALL Regional recurrences Contralateral Breast Cancer

8 MultiCatheter PBI (HDR/ LDR): Summary Institution Pt. No. Median age F/U mo. T size (cm) median N+ % ER + % Tam % LR % Exc/ good Cosmesis Oschner Median age Beaumont Tufts-NEMC *VCU T size (cm) median 1.35 N+ 13% ER + 84% Nat. In. Onc. Budapest Guys Cs * U. WI -low -high *MCW Ger-Austrian Multicenter RTOG LR 4.8% Exc/ good % Cosmesis 89%

9 APBI: Single Entry Brachytherapy Devices 1 st Generation: Mammosite balloon Target volume: 1 cm breast tissue around the balloon Dose : 34 Gy, 10 fractions 3.4 Gy BID, over 5-8 days Minimal balloon surface-skin distance - ideally 7 mm, - if 5-7 mm then confirm skin dose <145% DOSE 50% 80% 100% 120% 140% 200% Advantages: Simplified approach, improved technology access

10 Initial MammoSite Multi-institutional Phase II Study-Manufacturer Overview: 43 patients enrolled 5/ / Gy, 10 fractions 1 cm, 5-8 days Results: Median follow-up 65.2 months (n=36) - Median Age 69 years - All T1 N0, 79% > 10 mm in size Grade 1-2: 77%, G3 14% - No local recurrences - Telangiectasias 39.5%, Retraction 20.9% - 80% good/ excellent cosmesis - Cosmesis worse- skin spacing < 7 mm Keisch et al, IJROBP 2: 2003, Benitez, et al. Amer. J. Surg, 2007

11 ASBS APBI Registry : 1440 patients, 97 facilities 95% 34Gy/10 fractions BID, 89% > 7mm skin spacing > 20 Publications Median F/U: 58 months Invasive: (n=1249) median age: 66 median T-size: 10 mm 97% N-0 ER/PR: 87% In-breast failure: 3.9% DCIS: (n=194) median age: 62.1 median TIS size: 8 mm In-breast failure: 3.4% Vicini, IJROBP 79: 2011, Shah, IJROBP 2012

12 APBI Single Entry Brachytherapy: Next Generation Advantages: dosimetric coverage sparing of skin and chestwall SAVI Ciana medical Contura SenoRx

13 Trends in the use of implantable APBI in the U.S. FDA approval of MammoSite 0.4% in 2000 versus 6.8% in 2007 p < SEER Database Abbott, et al, Cancer 2011

14 Select Single Entry Brachy APBI: Summary Institution Initial Manufacturer Median Multi- Institution age Pt. No. Median age (yr) F/U mo. T size (cm) median N+ % ER + % Local relapse % Exc/ good Cosmesis *Rush Univ % Tis/T *Tufts/ VCU St. Vincent Hospital *Kaiser- Permanente T size (cm) median 1.1 N+ 5% ER + 88% LR 1% Exc/ good Cosmesis 87% % T *MUSC % *Pooled multiinstitution *ASBS Registry

15 RTOG 0319 Phase I/II 3DCRT APBI 58 patients accrued Feasibility of external beam method for APBI 38 Gy in 10 Fraction, BID 5-8 days Overall satisfaction at 3 years 86% 100% would choose 3DCRT APBI again sagittal Advantage: Linear accelerator delivery coronal

16 RTOG 0319 Results at 8 year median follow-up n 5-year estimate 7-year estimate Ipsilateral Breast Failure* 4 5.8% 7.7% Contralateral Breast Failure Ipsilateral Nodal Failure** 0 0% 0% 3 5.8% 5.8% Distant Failure 4 7.7% 7.7% * All IBFs were in T1N0, postmenopausal patients **All INFs were in T1N0, ER+, postmenopausal patients Rabinovitch, ASTRO 2013

17 3-DCRT APBI: Summary Institution Pt. No. Median age F/U mo. T size (cm) median N+ % ER + % Local relapse % % Exc./ Good Cosmesis Beaumont Median age NYU MGH British Columbia 64 T size (cm) median 1.0 N+ 1.8% ER + 90% Esperanza LR 2.2% Exc/ good Cosmesis 90% RTOG

18 NSABP B-39/RTOG 0413 Trial Phase III Stage 0, I-II breast cancer treated by lumpectomy Randomization WBI Gy ( Gy) Fractions to the whole breast followed by boost to Gy APBI 34 Gy in 3.4 Gy fxs bid Mammosite, Contura, SAVI or Multicatheter brachytherapy OR 38.5 Gy in 3.85 Gy fxs bid 3D-CRT Targeted accrual = 4300

19 NSABP B39 / RTOG 0413 March 21, 2005 Opened for accrual targeted accrual January 1, 2007 Accrual closed to low-risk population and targeted accrual increased April 11, 2013 Closed for accrual 4,216 accrued (Among patients with follow-up, mean follow-up time is 60.5 months.) APBI - # of patients randomized: 2107 Methods: 70.5 % (n=1474) 3-DCRT, 24.3% (n=512) MammoSite/other 5.2 % (n=109) MultiCatheter

20 NSABP B39 / RTOG 0413: Population Variable: % Age < 50 y > 70 Race/ Ethnicity White Black Hispanic Disease Stage DCIS Invasive N-0 Invasive N-1 Hormonal Status ER or PR + ER and Pr

21 Phase III Trials Comparing APBI to WBI Closed! Accrual PBI Method Eligibility NSABP B-39/ RTOG DCRT MST MCT > 18 yo, Stage 0-II, < 3cm, N-0 N-1 (< 3 LN+) GEC-ESTRO MCT > 40 yo, Stage 0-II, < 3 cm, N-0 N mi, Negative margins (2 mm) RAPID OCOG DCRT > 40 yo, Stage 0-II, < 3 cm, N-0, excludes inf. lobular (7649)

22 ASTRO Consensus Statement for Treatment with APBI Outside a Clinical Trial Suitable Cautionary Unsuitable Patient Factors Age > 60 years < 50 BRCA 1-2 no no Yes Path Features T-size < 2 cm cm > 3.0 cm T stage T-1 T-0 T-2 T 3- T4 Margins Negative ( 2 mm) Close (< 2 mm) Positive LVSI No Limited, focal Extensive ER Pos. Neg. - Multicentric Unicentric Unicentric Present Multifocal Clinically unifocal Clinically unifocal Clinically multifocal Histo IDC ILC - DCIS, EIC No, No Yes, Yes (< 3 cm) > 3 cm Nodes N stage pn0 (i +, -) - pn1, N2-3 Nodal Surgery yes yes no Smith, IJROBP,4:2009

23 5 year Mastectomy Rate Brachytherapy APBI versus WBI SEER-Medicare 92,735 cases Age > % 2.19% Smith, et al. JAMA, 307:2012

24 5 year Mastectomy Rate by ASTRO Consensus Guideline SEER-Medicare n Lump APBI EBRT p ALL 35, < 0.001/0.001 Suitable 9, < 0.001/0.002 Cautionary 5, < 0.001/0.006 Unsuitable 10, < 0.001/0.02 Smith G, et al., IJROBP, 2:2014

25 No Difference in Mastectomy Rate in Older Suitable SEER-Medicare Age > 70 n = 7,450

26 Distribution by ASTRO Consensus Statement Grouping SEER: 4,172 Breast Cancer Cases treated with Brachytherapy Husain, Brachytherapy, 2011

27 Outcomes after APBI Cautionary University of Wisconsin Median f/u: 60 mo.s 322 MCT APBI 79 Suitable 136 Cautionary 107 Unsuitable Reason Cautionary 63% age % DCIS 12.5 % EIC 9.6% 2 cm- 3cm T-size 8.1% ER neg. 7.4% ILC 7.4 % < 2 mm margin 27.9% multiple factors McHaffie, et al, IJROBP 2011

28 Stage I-II: IBTR by Cautionary Determinant Age: 0% Histopath: 12.7% p=0.018 McHaffie, et al, IJROBP 2011

29 MGH: 3DCRT APBI Using 32 Gy/ 8 BID 5-Year Results of a Prospective Study N= 98 Stage I Er/Pr +: 89% Median F/U: 71 mo. Pashtan, IJROBP, 2012

30 ASBS MammoSite Registry 1225 invasive breast cancer Median f/u: 60 mo. 5 yr LR: 3.6% Beitsch, Ann Surg Onc 2012

31 Breast Cancer Mortality - Absolute reduction (%) in 15-year risk (95% CI) Relationship of Breast Cancer Recurrence and Mortality by absolute reduction in 10 -year risk of Any 1 st Recurrence < 10% absolute reduction in any recurrence risk by 10 years Lancet 378: , 2011 Any First Recurrence Absolute reduction (%) in 10-year risk

32 RCT in Hormone Responsive pn0 Breast Cancer Evaluating RT Benefit in Addition to Anti Endocrine Therapy Post-lumpectomy Clinical Trial F/U yrs Age > 50 y (%) T sz < 2 cm (%) ER/PR+ (%) Tam/AI (%) Grade 1-2 (%) In-breast recurrence (%) n RT No RT PMH ABCSG 8a CALGB Low risk features: Older age, pn0, small size, ER/PR+, G1-2, anti endocrine therapy Recurrence rate indicates UNLIKELY survival benefit from breast radiotherapy

33 OCOG RAPID Early Reporting of Cosmetic Results Adverse Cosmetic Outcome ( Fair Poor) Nurse Assessment at Baseline and 3 years Baseline n= years n=850 WBI ABPI- 3DCRT Difference APBI-WBI (95% CI) p value 17% 19% 2% (-2-5%) % 32% 135 (7-19%) < Olivotto et al, JCO 2013

34 Summary: APBI APBI so far has demonstrated acceptable local control in mostly low risk cases: Stage 1, ER+, > 60 yo breast cancer patients Need to complete randomized trials to define broader applicability and durability of outcome in comparison to standard WBI Rigorous attention to technical delivery and Q/A is crucial

35 Thank you

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