IORT What We ve Learned So Far

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1 IORT What We ve Learned So Far The 16 th Annual Conference on A Multidisciplinary Approach to Comprehensive Breast Care and Imaging Einsley-Marie Janowski, MD, PhD Assistant Professor Department of Radiation Oncology Shayna Lefrak Showalter, MD Associate Professor Department of Surgery University of Virginia Health System

2 Disclosures none

3 Objectives To understand the indications for partial breast irradiation To review the various methods available for partial breast irradiation, including IORT To review the data pertaining to national and international IORT trials To review the unique method of IORT performed at UVA Precision breast IORT

4 Early Stage Breast Cancer Mastectomy Simple Mastectomy with or without reconstruction +/- chemotherapy/hormonal therapy Breast Conserving Therapy Lumpectomy + Adjuvant Radiation Therapy +/- chemotherapy/hormonal therapy

5 Breast Conserving Therapy NSABP B06

6 Breast Conserving Therapy Majority of ipsilateral recurrences occur within the index quadrant NSABP B06

7 Breast Conserving Therapy

8 Radiation Therapy Whole breast irradiation Partial breast irradiation (PBI)

9 Radiation Therapy Downsides of whole breast irradiation Time consuming Deleterious effect on heart, lung, skin, adjacent normal breast Increased long-term incidence of ischemic heart disease Relationship of surgical procedure and distance to nearest radiation therapy (XRT) facility

10 Radiation Therapy Potential Upsides of APBI Many studies and a meta-analysis have shown improved rate of excellent/good cosmetic result Shortened treatment time Reduced breast pain Improved quality of life. Ye, et al, Translational Oncology 2013; 6 (6):

11 APBI

12 APBI B-39 Rapid 10 year recurrence was 6.5% for WBI and 6% for PBI (NS) San Antonio Breast Cancer Symposium 2018

13 Breast IORT Intraoperative radiation therapy (IORT) increasingly popular choice Convenience (1 treatment) At time of surgery Cost: less $$ for patients Good cosmesis Downsides: no imaging, no treatment planning, low dose

14 Phase III studies IORT Study N f/up RT dose LR (WB) LR (PBI) Comments Elliot 1305 T < 2.5 cm, ages 48-75, 26% + LN Targit 3,451 T1, T2; N0, age 45+, IDC 5 yrs 50 Gy + 10 Gy boost WB vs 21 Gy wt electrons 5 yrs 50 Gy WB vs 20 Gy to surface 0.4% 4.4% Patients wt tumors > 2cm, + positive nodes, G3, triple negative, wt high Ki-67 had increased LR 1.3% 3.3% Higher rate of local recurrence; (post op XRT for certain factors 15%)

15 Guideline Update Correa, et al., Practical Radiation Oncology, 2017; 7, 73-79

16 Intraoperative Radiation Therapy with CT-guided HDR Brachytherapy: Precision Breast IORT Shayna Lefrak Showalter, MD D e p a r t m e n t o f S u r g e r y

17 Precision Breast IORT Chance to address published technical criticisms of TARGIT method, using HDR brachytherapy to offer: CT-guided high dose rate (HDR) brachytherapy Higher RT dose to 1 cm from lumpectomy cavity Integral use of imaging (CT-on-rails) for Applicator placement Customized treatment planning D e p a r t m e n t o f S u r g e r y

18 UVA Brachytherapy Suite with CT-on- Rails Orcutt et al (Showalter), Future Oncology 2014

19 Precision Breast IORT: Imaging & Customized Treatment Planning CT acquired at time of lumpectomy; used for 3D computerized treatment planning Skin and ribs receive less than prescription dose Cardiac-sparing High (12.5 Gy) prescription dose covers target volume CT imaging to confirm that balloon placed in right location and has optimal fit 5-channel design permits sculpting of radiation dose by changing how long source in each position along each channel

20 Precision Breast IORT Development Steps Dosimetric Study Hospital approval, staffing, dry runs Buchanan award: support staff, marketing Phase I- 28 patient safety and feasibility trial Phase II- 358 patient trial- efficacy 238 patients treated to date 189 at UVA 49 at Thomas Jefferson University D e p a r t m e n t o f S u r g e r y

21 Precision Breast IORT Phase I Trial (28 patients) Treatment is safe and feasible No major toxicities Part of a Phase II Clinical trial (IRB #18004) Long-term efficacy Cosmetic outcome Quality of life

22 D e p a r t m e n t o f S u r g e r y

23

24 Planning the IORT treatment D e p a r t m e n t o f S u r g e r y

25 Phase I Clinical Trial Pre and post- pathology cohorts Inclusion: Invasive or in situ disease < 3cm Pathologic N0 Age >50 years Exclusion History of ipsilateral breast radiation Known genetic mutation D e p a r t m e n t o f S u r g e r y

26 Phase I Clinical Trial Primary Objectives To determine feasibility of a single fraction of IORT with CT-on-rails-guided HDR brachytherapy, delivered at the time of or within 30 days of BCS, for early stage breast cancer To assess the general safety of single fraction IORT with CT-on-rails guided HDR brachytherapy Secondary Objectives To obtain data on planning time. Total radiation time, total procedure time, and dosimetry To evaluate cosmetic outcome To assess patient QOL following treatment D e p a r t m e n t o f S u r g e r y

27 Clinical Trial Cohorts Pre-pathology cohort SLNB Lumpectomy and IORT Post-pathology cohort SLNB and lumpectomy IORT alone Positive margins Positive nodes D e p a r t m e n t o f S u r g e r y

28 Primary Results of Phase I trial of Precision Breast IORT Feasibility: median IORT treatment time 67.2 minutes, 26/28 patients <90 minutes (feasibility criterion) Safety: 6 grade 2 tox events, no grade 3 D e p a r t m e n t o f S u r g e r y

29 Utilization of CT Images I 7 of 29 patients (24.1%) had issue identified on initial planning CT that led to clinical action Applicator repositioning Air cavities or poor conformance Re-excision for clip Trifiletti et al (Showalter SL), Brachytherapy 2015 D e p a r t m e n t o f S u r g e r y

30 Utilization of CT Images II Evaluated first 103 patients treated with PB-IORT Endpoints: >1 CT (CT images prompted catheter repositioning) Dosimetry modified from skin/chest wall Results: 27/103 (26%)- change in catheter placement 81 (78%) dosimetric modification off skin/chest wall 45 (43%) dosimetric modification of both skin and chest wall D e p a r t m e n t o f S u r g e r y

31 Image Evaluation of Applicator Placement is Important! Trifiletti et al (Showalter SL), Brachytherapy 2015 D e p a r t m e n t o f S u r g e r y

32 Phase II Clinical Trial Designed to evaluate long term efficacy Single arm, two sites (3 rd site pending) 358 subjects Primary endpoint: 5-year IBTR Compare to conventional IORT and WBI Cosmetic outcome, quality of life Breast Imaging D e p a r t m e n t o f S u r g e r y

33 Phase II Clinical Trial Pre and post- pathology cohorts Inclusion: Invasive or in situ disease < 3cm, Pathologic N0 Age >45 years Exclusion Hx of ipsilateral breast radiation Known genetic mutation D e p a r t m e n t o f S u r g e r y

34 Precision Breast IORT Beyond UVA D e p a r t m e n t o f S u r g e r y

35 TJU Demonstrates PB-IORT Feasibility without Brachy Suite D e p a r t m e n t o f S u r g e r y

36 Rapid Accrual on IORT2 Trial Over 260 patients enrolled Patients enthusiastic about IORT D e p a r t m e n t o f S u r g e r y

37 Thanks to UVA s PB-IORT Team Breast Surgeons Shayna Showalter, MD Anneke Schroen, MD, MPH David Brenin, MD Radiation Oncologist Einsley Janowski, MD, PhD Tim Showalter, MD, MPH Physicist Bruce Libby, PhD Clinical Care Coordinator Tamara Fisher, RN Clinical Research Coordinator Dena Snyder, RN Linda Yarboro OR personnel, UVA administrators UVA Buchanan Endowment American Cancer Society NIH R-01 Grant

38

39 References Correa, et al., Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Practical Radiation Oncology, 2017; 7, Cuzick, J, et al. Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, doubleblind, randomised placebo-controlled trial. Lancet 2014; 383: EBCTCG, Overview of the Randomized Trials of Radiotherapy in Ductal Carcinoma in Situ of the Breast, 2010; 41: EORTC Breast Cancer Cooperative Group. Breast-conserving treatment with or without radiotherapy in ductal carcinoma in situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol 2006; 24 (21): Fisher, B, et al. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol 2001: 28 (4): Fisher, B, et al. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet 1999; 353 (9169): Groen, et al. Finding the balance between over and under treatment of ductal carcinoma in situ, The Breast 31 (2017) Holmberg, L, et al. Absolute risk reductions for local recurrence after postoperative radiotherapy after sector resection for ductal carcinoma in situ of the breast. J Clin Oncol 2008; 26 (8): Houghton, J, et al. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet 2003; 362 (9378): Hughes, L, et al. Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol 2009; 27 (32): Margolese, R, et al. Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double blind, phase 3 clinical trial. Lancet 2016; 387: McCormick, B, et al. RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation. Journal of Clinical Oncology 2015; 33 (7): Sagara, Y, et al. Patient Prognostic Score and Associations with Survival Improvement Offered by Radiotherapy After Breast- Conserving Surgery for Ductal Carcinoma in Situ: A Population-Based Longitudinal Cohort Study. J Clin Oncol, 2016; 34 (11): Shaitelman et al. Acute and Short-term Toxic Effects of Conventionally Fractionated vs Hypofractionated Whole-Breast Irradiation: A Randomized Clinical Trial. JAMA Oncol. 2015; 1 (7): Solin, LJ, et al. A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast. Journal of National Cancer Institute 2013; 105 (10): Wong, JS, et al. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol 2006; 24 (7):

40 Questions? D e p a r t m e n t o f S u r g e r y

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