Why Choose Brachytherapy and Not External Beam RT or IORT?
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1 May 30 31, 2014 Miami Beach, FL USA Why Choose Brachytherapy and Not External Beam RT or IORT? Csaba Polgár, MD, PhD, MSc National Institute of Oncology Budapest, Hungary 1
2 Disclosure Csaba Polgár, MD, PhD, MSc, does not have any financial relationships or products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months. Outline of the Presentation Why to Choose Brachytherapy? Overview of clinical results with: Multicatheter th t BT Balloon based BT Why Not to Choose External Beam RT? Critical review of clinical results Why Not to Choose IORT? Critical review of clinical results ELIOT Ti l ELIOT Trial TARGIT Trial 2
3 Motto: Before implementation of APBI into routine clinical practice, in addition to non inferior local control and survival results in comparison with WBI, at least a comparable toxicity profile should be documented according to each APBI technique! Accelerated partial breast irradiation (APBI)trials with 4 years FUP Early APBI series (80 s early 90 s) 7 trials: 2D teletherapy 2 trials LDR, MDR & HDR brachytherapy 5 trials Contemporary APBI series 25 trials: Multicatheter brachytherapy 12 trials MammoSite brachytherapy 4 trials 3D CRT & IMRT 6 trials IORT 3 trials Phase III APBI clinical studies 8 trials 3
4 Results of Early APBI studies Institute Study period APBI technique Patient No. Median FUP (y) Crude LR% Annual LR% Christie Hospital* ELE Guy s Hospital I LDR BT 192 Ir Cookridge Hospital* EBI Guy s Hospital II MDR BT 137 Cs Uzsoki Hospital MDR BT 60 Co University Florence LDR BT 192 Ir London Reg. Cancer Center HDR BT All pts * Phase III trial Patient Selection and Results of Early APBI Studies Criteria Christie Hosp. Guy s Hosp. I. Cookridge Hosp. Guy s Hosp. II. Uzsoki Hosp. Univ. Florence London Reg. Ca. C. T size 4 cm 5 cm 4.5 cm 4 cm 5 cm 5 cm 4.5 cm Margins 10% pos. 90% UK 56% pos. 7% UK 100% UK 43% pos. 100% UK 8% pos. 7% UK neg., 31% close EIC yes 41% yes yes yes yes 8% Nodes 100% pnx 44% N+ 41% N+ 44% N+ 4% N+ 80% pnx 38% N+ 15% N+ 5% pnx Age Any Any Any > 40 year Any Any Any LR rate 20% 37% 12% 18% 24% 6% 15% Annual LR 2.5% 6.2% 1.5% 2.9% 2% 1.4% 2.0% APBI with outdated techniques for unselected pts. Annual LR: % 4
5 Results of Contemporary APBI Studies (Median FUP 4 y) Multicatheter Brachytherapy Series Institute Study period APBI technique Patient No. Median FUP (ys) Crude LR% Annual LR% Interstitial brachytherapy series Oschner Clinic LDR/HDR BT W. BeaumontHospital l LDR/HDR BT Örebro Medical Center PDR BT Budapest HDR BT RTOG LDR/HDR BT Tufts University HDR BT Harvard, Boston LDR BT Budapest Phase III HDR BT/ELE Ninewells Hospital 1999 LDR BT German Austrian PDR/HDR BT University Navarra HDR BT Washington University HDR BT 202 > All patients Criteria Patient Selection and Results in Contemporary APBI Studies Beaumont Hospital Örebro Budapest Phase III German Austrian Phase II T size 3 cm 4.2 cm 2 cm 3 cm Margins 2 mm clear clear 2 mm ( 2 mm; 1999 ) Unifocal EIC DCIS Nodes < 4 pos. (ECE neg.) < 4 pos. N0 N1mi (micromet.) N0 N1mi (micromet.) Age 40 y 40 y 40 y (2001 ) > 35 y Actuarial LR 5% (12 year) 4% (7 year) 5.9% (10 year) 5% (8 year) rate Annual LR 0.42% 0.57% 0.59% 0.63% APBI for selected pts. Annual LR ~ 0.5% 5
6 IJROBP 2011;100: Radiother Oncol 2009;90: patients 50 Gy PDR BT Median FUP: 7.2 years 7 y actuarial LR rate: 4% G3 fibrosis: 8% Telangiectasia: 22% Fat necrosis: 20% Excellent/good cosmesis: 56% 4.0% OS LC DFS PTV = tumor bed + 3 cm margin 6
7 IJROBP 2011;80: patients 50 Gy PDR or 8x4 Gy HDR BT 5 y actuarial LR rate: 2.3% 8 y actuarial LR rate: 5.0% G3 telangiectasia: 2.2% G3 fibrosis: 0.4% Fat necrosis: 5.1% Excellent/good cosmesis: 90% 2.3% 5.0% IJROBP 2011;80: Characteristic 5 y LR % (n) p value Age 50 years < 50 years 1.1% (4/225) 7.5% (4/49) 0.03 Hormonal therapy No Yes 15.1% (4/24) 1.0% (4/250) ER & PgR status, tumor size, histologic type, pn status, HG, and HER 2 status had no significant impact on LR rate! 7
8 Budapest Phase II APBI Study Updated 15 year Actuarial Results* 45 patients 7 x 4.33 HDR BT (n = 8) or 7 x 5.2 Gy HDR BT (n = 37) Median FUP = 13.8 years Loca al tumour control % Annual LR: 0.79% 10-y LR: 9.4% 15-y LR: 11.9% Radiother Oncol 2010;94:274 9 Time (Months) *Acta Medica Marisiensis 2011;57: Variable N (%) Cosmetic results Excellent 12 (26.7%) Good 24 (53.3%) Fair 5 (11.1%) 1%) Poor 4 (8.9%) Skin side effects Grade 0 Grade 1 Grade 2 Grade 3 Fibrosis Grade 0 Grade 1 Grade 2 Grade 3 Fat necrosis Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 39 (86.7%) 4 (8.9%) 2 (4.4%) 0 (0%) 29 (64.4%) 12 (26.7%) 3 (6.7%) 1 (2.2%) 26 (57.8%) 9 (20.0%) 9 (20.0%) 0 (0%) 1 (2.2%) 80% Radiother Oncol 2013;108: BCS (n = 258) Random 1:1 50 Gy WBI (n = 130) APBI (n = 128) 7x5.2 Gy HDR BT (n = 88) 50 Gy ELE (n = 40) 8
9 Budapest Phase III APBI Study 10 year Actuarial Results Median FUP: 10.2 years WBI APBI p value LR 5.1% 5.9% 0.77 CLBC 6.4% 8.3% 0.56 RR 1.7% 2.4% 0.65 DM 11.5% 7.3% 0.61 DFS 84% 85% 0.97 OS 82% 80% 0.73 CSS 92% 94% 0.34 LTC % p WBI vs. PBI = WBI - 10-y LR: 5.1% (95% CI: %) 65 PBI - 10-y LR: 5.9% (95% CI: %) Time (months) Radiother Oncol 2013;108: Annual LR rate: APBI: 0.59% WBI: 0.51% Budapest Phase III Trial Univariate Analysis of Prognostic Factors for LR Menopausal status, ER & PgR status, tumor size, HG, NG and MAI had no significant impact on LR rate! Characteristic 10 y LR % (n) p value Hazard Ratio Age > 40 years 40 years Systemic therapy No Yes 4.8% (11/249) % (2/9) Systemic therapy* % (7/75) 3.6% (6/183) * Chemo and/or hormonal therapy 9
10 Budapest Phase III APBI Study 10 year Cosmetic Results & Side effects APBI HDR BT APBI WBI p value ELE G 3 telangiectasia 0% 8% 3% HDR BT vs. ELE = G 3 fibrosis 2% 0% 1% NS Exc./good cosmesis 85% 75% 62% HDR BT vs. WBI = Before RT 1 y FUP 5 y FUP 10 y FUP APBI Intracavitary Balloon Brachytherapy Postimplant CT 10
11 Results of APBI studies MammoSite BT series Institute Patient No. Median FUP (years) Crude LR% Telangiectasia % FDA Trial % Kiel/Budapest % ASBS Registry Trial % NA Univ. Pittsburgh % 27% USA multicentric % 17% Medicare NR 34% SAVI Hibryd BT applicator ClearPath Hibryd BT applicator Contura Hibryd BT applicator * Presley et al.: JCO 2012;35: * Rosenkranz et al.: J Am Coll Surg 2013;2013:217:
12 p<0.001 Mastectomy rate is significantly higher after balloon based BT! * Smith GL. et al: JAMA 2012;307: APBI: 3D CRT PTV ( mm) CTV tumour bed 12
13 Results of APBI studies (median FUP 4 ys) 3 D CRT series Institute Study APBI Patient Median Crude Annual period technique No. FUP (ys) LR% LR% 3D-CRT series New York University D-CRT W. Beaumont Hospital D-CRT RTOG D-CRT Dana Farber/Harvard D-CRT/ IMRT Rocky Mountain Cancer Centers D-CRT Budapest D-CRT All patients: Median FUP = 36 months Late toxicities CTV = cavity + 1 cm PTV = CTV + 1 cm 1% 5% 1% 9% 13
14 Exc./Good 84% Cosmetic 72% Results IJROBP 2009;75: x 3.85 Gy 3D CRT (NSABP B39) Median FUP: 15 months 22/60 pts. (37%) had G2 4 toxicities 19% fair poor cosmesis 14
15 IJROBP 2010;76: x 3.85 Gy IMRT + ABC Median FUP: 2.5 years 7/32 pts. (22%) had unacceptable cosmesis Premature study closure APBI: 3D CRT Budapest Phase II study 104 pts. ( ) 3D CRT 44 pts. ( ) IMRT + IGRT 60 pts. ( ) Dose: 36.9 Gy (9x4.1 Gy/5 days) CTV = cavity + 2 cm free surgical margin PTV = CTV + 5 mm 15
16 Budapest 3D CRT APBI Phase II study Strahlenther Onkol 2014;75: Mean FUP: 58.2 months 5 y LR rate: 37% 3.7% Exc./Good Cosmesis: 84% APERT: IGRT + IMRT Planning CT Verification CT CT image fusion 16
17 APBI: IMRT + IGRT matchingtobonyanatomy PTV to CTV margin needed using daily set up correction with kv CT image guidance LAT LONG VERT SD LAT SD LONG SD VERT Mean (range) 1.4 ( ) 0.1 ( ) 0.1 ( ) 1.5 ( ) 2.0 ( ) 1.5 ( ) Systematic error Random error PTV margin 5.1 mm 5.0 mm 6.1 mm Brachytherapy PTV = CTV 3D CRT PTV = CTV + 1 cm IGRT PTV = CTV cm V V cavity = 32,4 cm 3 PTV C BT BT = 85,9 cm 3 PTV a IGRT = 162,3 cm 3 PTV 3DCRT = 252,9 cm 3 PTV 3D CRT = 3 x PTV BT PTV IGRT = 2 x PTV BT 17
18 APBI: 3D CRT versus IMRT APBI: 3D CRT versus IMRT PTV eval GTV Breast Heart Ipsilat lung Contralat breast Breast PTV Tüdő Ipsilateral non target breast is better spared with IMRT! 18
19 Dose distribution by APBI technique 3D CRT Multicatheter BT!!!!!! IMRT!!!!!! Results of APBI studies IORT series Institute Study APBI Patient Median LR Annual period technique No. FUP (ys) % LR% IORT series ELIOT* ELE TARGIT* KV photons Montpellier ELE All patients: * Phase III trial 19
20 ELIOT Phase III APBI clinical trial* Nov/2000 Dec/2007 (n=1305 pts.) Median FUP: 5.8 years BCS + WBI ( Gy boost) T <2.5 cm, cn0 AGE > 48 ys 654 R 651 BCS +ELIOT (21 Gy) ELIOT Intraoperative electrons 5 year LR ELIOT: 4.4% (95% CI: %) versus 5 year LR WBI: 0.4% (95% CI: %) 20
21 ELIOT trial Prognostic factors for LR TARGIT phase III trial March/2000 Nov/2009 Median FUP: 2.4 years TARGIT Intraoperative 50 KV photons 3451 pts. R BCS + WBI BCS +TARGIT (20 Gy) 21
22 5 year LR TARGIT: 3.3% (95% CI: %) versus 5 year LR WBI: 1.3% (95% CI: %) APBI Randomized clinical trials Trial Participants APBI technique Patient No. Study period Budapest NIO, Budapest, HU HDR BT ELIOT EIO, Milan; IT IORT electrons TARGIT GEC-ESTRO RAPID NSABP-B39/ RTOG-0413 UK/AUS multicentric European multicentric Canadian multicentric USA multicentric IORT 50 kv photons HDR/PDR BT D-CRT HDR BT/ MammoSite/ 3D-CRT Florence Univ. Florence, IT IMRT IMPORT- LOW MRC, UK multicentric IMRT pts. 22
23 GEC ESTRO Phase III Trial* May 2004 July pts. LOW RISK BREAST CC. 568 R 624 BCS + WBI ( Gy boost) BCS + HDR/PDR BT GEC ESTRO APBI Trial Click to Cosmetic edit Master results at 1 title year style Brachytherapy Doctors view EBRT 7% 1% 7% 1% 51% 41% excellent good fair poor 54% 38% excellent good fair poor Excellent + good cosmesis: 92% after APBI 92% after WBI 23
24 GEC ESTRO APBI Trial Click to Cosmetic edit Master results at 1 title year style Patients view Brachytherapy EBRT 6% 1% 8% 1% 51% 42% excellent good fair poor 56% 35% excellent good fair poor Excellent + good cosmesis: 93% after APBI 91% after WBI Conclusions based on clinical evidences Long term results of contemporary APBI series confirmed that quality assured multicatheter BT is a safe alternative of conventional WBI for low risk breast cancer patients. Skin toxicity is high after intracavitary (MammoSite) BT in case of close balloon to skin distance. Phase III IORT APBI trials trials (ELIOT & TARGIT) failed to demonstrate noninferiority of IORT. One randomized trial (RAPID) suggested that 3D CRT APBI increased the rates of adverse cosmesis and late radiation toxicity compared to WBI. Long term results of the NSABP/RTOG and GEC ESTRO Phase III APBI trials are eagerly awaited and will hopefully clarify the value of different APBI techniques. In the Meantime Choose Multicatheter Brachytherapy! 24
25 Thank you for your kind attention! 25
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