ANNUAL OCT. 31-NOV. 2, 2017 MEETING ARLINGTON, VA Patient-centered decision making for DCIS Rinaa Punglia, MD, MPH Associate Professor of Radiation Oncology, HMS Dana-Farber Cancer Institute/BWH November 1, 2017 #PCORI2017
ANNUAL MEETING | #PCORI2017 COI • I have nothing to disclose
ANNUAL MEETING | #PCORI2017 US breast cancer incidence • Invasive disease • 185,000 cases/year • Ductal carcinoma in situ (DCIS) • 68,000 cases/year • Incidence of DCIS increased dramatically over the past 25 years • Corresponding to increased use of screening mammography
ANNUAL MEETING | #PCORI2017 DCIS
ANNUAL MEETING | #PCORI2017 DCIS • One-half of malignancies identified by mammographically-directed biopsies • Over 1/3 of new breast cancer diagnoses • By 2020, estimated 1 million women living with a DCIS diagnosis in the US
ANNUAL MEETING | #PCORI2017 Surgical treatment for DCIS • Mastectomy • Breast-conserving surgery or excision or “lumpectomy” Sumner WE et al. Ann Surg Onc 2007;14(5)
ANNUAL MEETING | #PCORI2017 Randomized Trials of Excision +/- RT Trial # Follow Excision Excision + up alone Radiation (years) NSABP 813 12 31% 15% B-17 EORTC 1010 10 26% 15% Sweden 1067 8 27% 12% UK/ANZ 1030 12.7 26% 9%
ANNUAL MEETING | #PCORI2017 Randomized Trials of Excision +/- RT Trial # Follow Excision Excision + up alone Radiation (years) NSABP 16% 8% 15% 813 12 31% 15% 8% B-17 13% 8% EORTC 1010 10.5 26% 15% 13% 7% 12% 7% Sweden 1067 8 27% 12% 15% 5% 10% 4% UK/ANZ * 811 12.7 26% 9% 16% 5% *Arms without tamoxifen
ANNUAL MEETING | #PCORI2017 Survival benefit with RT? EBCTCG, J Natl Cancer Inst Monogr 2010;2010:162-177
ANNUAL MEETING | #PCORI2017 RT or not? Sumner WE et al. Ann Surg Onc 2007;14(5)
ANNUAL MEETING | #PCORI2017 RT or not? Dodwell et al. Br J Cancer 2007;97(6)
ANNUAL MEETING | #PCORI2017 RT or not? Punglia RS, Schnitt SJ, Weeks JC. J Natl Canc Inst 2013;105(20)
ANNUAL MEETING | #PCORI2017 Pros of radiation therapy • Redu eduction i in n local r rec ecur urrence • Reduc uction i n in invasi sive e local r recurrence nce • Ris isk of of nod odal an l and d dis istant d dis isease • Link bet etween een i invasive l e local r recurren ence a e and over erall s survival now f w firmly e established ed in the invasive s e set etting
ANNUAL MEETING | #PCORI2017 Cons to radiation therapy • Time me • Side-effe fects • Ina nability t to ha have br brea east pr preser eservation i if local r rec ecur urrence • Lim imit its of of n normal t l tis issue t tol olerance • Mastec tectomy s sta tandard o option • Costs
ANNUAL MEETING | #PCORI2017 Long-Term Results from NSABP B-24 (Median FU = 163 mos) RT RT + Tam Ipsilateral event 16.6% 13.2% Ipsilateral invasive 9.0% 6.6% Ipsilateral DCIS 7.6% 6.7% Contralateral event 8.1% 4.9% Reduction = 32% for ipsilateral and contralateral events Nonsignificant reduction in ipsilateral DCIS events Wapnir JNCI 2011
ANNUAL MEETING | #PCORI2017 Adding Tamoxifen to Excision: UK/ANZ Trial • • Randomized 2 x 2 trial of RT and tamoxifen • Tamoxifen randomized: 1536 • RT randomized: 1030 • Median FU: 12.7 years • RT and no tamoxifen: 59% reduction LR (p < 0.0001) • Tamoxifen and no RT: 29% reduction in LR (p < 0.002)) – 30% reduction in ipsilateral DCIS LR – 5% non-significant reduction in invasive recurrence Cuzick, et al., Lancet Oncol 2011
ANNUAL MEETING | #PCORI2017 Patient perceptions of DCIS • Physicians no note t e tha hat dec decisi sion-making ng a about ut t trea eatmen ent for DCIS i S is very d difficult f t for pati tients ts • DCIS p patients o ove ver-es estimate t thei heir r risk o of rec ecur urrence • Over 2 25% belie lieve t there is is at le leas ast a a mod oderate lik likelih lihood of of DCIS s sprea eading to to o other er p places in thei eir b body Partridge A et al. Clin Br Ca 2008;8(3) Partridge A et al. J Natl Canc Instit 2008; 100(4)
ANNUAL MEETING | #PCORI2017 Why a model? • Clini nical s studi udies es w will r requi uire t thous usands o nds of patien ents t s to be powered • Man any y year ars o of f follow u up • Us Use e e existing da data f for the dec he decisi sion no now • Fairly consisten ent regarding r g rates es o of L LR • Fully d delinea neate t e the natur ure a e and m d magni nitud ude o of the tradeo deoffs a associated ed with R h RT a and t d tamoxifen en
ANNUAL MEETING | #PCORI2017 Approach • Discrete event s simula latio ion m model l followin ing i initia ial l trea eatmen ent f for DCIS • Si Six t x treatment s scenario ios 1. 1. Lumpec ectomy a alone 2. 2. Lumpec ectomy w with r radiation 3. 3. Lumpec ectomy w with t tamoxifen en 4. 4. Lumpec ectomy w with r radiation a and t tamoxifen en 5. 5. Mastec tectomy 6. 6. Mastectomy w with b brea east r t reconstructi tion
ANNUAL MEETING | #PCORI2017 Results and tradeoffs • Lumpectomy wi y with radiation a and tamoxife fen and m mastect ectomy were a e assoc ociated ed w with improvem emen ents i in ov over eral all s survival al relative t e to l lumpect ectomy a alon one (12 months). • Adding r g radi diation t therapy t to l lumpectomy r y resulted in a 6- mon onth i improvem emen ent i in over eral all s survival al, b but decreas ased ed l lon ong- term b m breast-pres eser ervation o outcom omes • This d decrem emen ent w with r radiation on t ther erap apy w was mitigated ed b by t the e addition of of tamoxife fen Soeteman DI et al. JNCI, 2013; 105 (11)
ANNUAL MEETING | #PCORI2017 Individual decision-making Women s n sho houl uld b d be f fully i informed a about ut t the e expe pected outcomes o of the a alternative e treatment ent s strateg egies es, includi uding t the r risks o of both d h death f h from b breast c canc ncer a and d ev event ntual m mastectomy, a and e encouraged ed t to choose t the strategy that i is most c consis istent w with t their ir o own p personal l values es a and p pref efer erences
ANNUAL MEETING | #PCORI2017 Decision Aid • Obj bjective: e: crea eate a e a web eb-ba based d ed decision a n aid, d, d designed t ned to provide t de tailored i ed inf nformation a n about ut a a patien ent’s l likeliho hood d of benefits a s and h d harms o of differ eren ent t treatmen ent s strategies es for DCIS t that i is inf nformed by d by a disea ease s e simul ulation m n model.
ANNUAL MEETING | #PCORI2017 Decision Aid design • Lay l lang ngua uage d e descriptions o ns of trea eatmen ent o opt ptions ns a available to women w n who have b been d n diagno nosed w ed with D h DCIS • Likelihood ood of of time-sp spec ecific ( (10 10-yea ear a and nd lifet etime) recu currence ce a and s survival o outcomes f for an i individual patient Ozanne et al. BCRT, 2015
ANNUAL MEETING | #PCORI2017 Decision Aid design • Proj ojection ons of of down-stream e effec ects o s of ea each t h treatment op option on • Key po points des designed ed t to facilitate t e the dec he decisi sion-making ng conve versation • Referral t to o ot other on r online r resou ources Ozanne et al. BCRT, 2015
ANNUAL MEETING | #PCORI2017 Future directions • Patie ient c communic icatio ion • Pilot t t tes esti ting • RC RCT
ANNUAL MEETING | #PCORI2017 Decision Aid inputs age + • Patie ient a • 10 10-year i invasi sive r e rec ecur urrence r e risk sk w with l lum umpectomy a alone • 10 10-yea ear D DCIS r recurrenc ence r risk w with l h lumpe pect ctomy a alone ne Ozanne et al. BCRT, 2015
ANNUAL MEETING | #PCORI2017 Treatment choices • Mastectomy w with h or witho hout ut r reconstruct uction • Lumpec pectomy a alone ne • Lumpec pectomy f followed by ed by radiation t n therapy • Lumpec pectomy f followed by ed by tamoxifen • Lumpec pectomy f followed by ed by radiation t n therapy and nd tamoxife fen Ozanne et al. BCRT, 2015
ANNUAL MEETING | #PCORI2017 Current updates • Patie ient-facing a and nd ne next ph physi sician v ver ersi sion • 1% i increments ts i in risk • ER ER s status i inputs ts • 1 yea ear age i ge increm ements • Ability ty t to i increase RT b ben enefit • Rev evisions ns by by C Cornerstone ne
ANNUAL MEETING | #PCORI2017 DCIS webtool • Patient-facing version • 1% increments in risk • 1 year age increments • Revisions by Cornerstone NW • https://preview.cornerstonenw.com/dfci-dcis/patient • Username: dfci • Password: tool
ANNUAL MEETING | #PCORI2017 Webtool introduction
ANNUAL MEETING | #PCORI2017 Sample output
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