Patient-centered decision making for DCIS Rinaa Punglia, MD, MPH - - PowerPoint PPT Presentation

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Patient-centered decision making for DCIS Rinaa Punglia, MD, MPH - - PowerPoint PPT Presentation

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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 |

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ANNUAL MEETING

  • OCT. 31-NOV. 2, 2017

ARLINGTON, VA

#PCORI2017

Patient-centered decision making for DCIS

Rinaa Punglia, MD, MPH

Associate Professor of Radiation Oncology, HMS Dana-Farber Cancer Institute/BWH November 1, 2017

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ANNUAL MEETING | #PCORI2017

COI

  • I have nothing to disclose
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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
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ANNUAL MEETING | #PCORI2017

DCIS

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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

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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)

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ANNUAL MEETING | #PCORI2017

Trial # Follow up (years) Excision alone Excision + Radiation

NSABP B-17 813 12 31% 15% EORTC 1010 10 26% 15% Sweden 1067 8 27% 12% UK/ANZ 1030 12.7 26% 9%

Randomized Trials of Excision +/- RT

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ANNUAL MEETING | #PCORI2017

Randomized Trials of Excision +/- RT

Trial # Follow up (years) Excision alone Excision + Radiation

NSABP B-17 813 12 31% 15% EORTC 1010 10.5 26% 15% Sweden 1067 8 27% 12% UK/ANZ* 811 12.7 26% 9%

16% 15% 8% 8% 13% 13% 8% 7% 12% 15% 7% 5% 4% 5% 10% 16%

*Arms without tamoxifen

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ANNUAL MEETING | #PCORI2017

EBCTCG, J Natl Cancer Inst Monogr 2010;2010:162-177

Survival benefit with RT?

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ANNUAL MEETING | #PCORI2017

RT or not?

Sumner WE et al. Ann Surg Onc 2007;14(5)

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ANNUAL MEETING | #PCORI2017

RT or not?

Dodwell et al. Br J Cancer 2007;97(6)

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ANNUAL MEETING | #PCORI2017

RT or not?

Punglia RS, Schnitt SJ, Weeks JC. J Natl Canc Inst 2013;105(20)

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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

  • f nod
  • dal 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

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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

  • f n

normal t l tis issue t tol

  • lerance
  • Mastec

tectomy s sta tandard o

  • ption
  • Costs
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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

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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

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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

  • ve

ver-es estimate t thei heir r risk o

  • f rec

ecur urrence

  • Over 2

25% belie lieve t there is is at le leas ast a a mod

  • derate lik

likelih lihood of

  • f

DCIS s sprea eading to to o

  • ther

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)

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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

  • f

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

  • f L

LR

  • Fully d

delinea neate t e the natur ure a e and m d magni nitud ude o

  • f the

tradeo deoffs a associated ed with R h RT a and t d tamoxifen en

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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

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ANNUAL MEETING | #PCORI2017

Results and tradeoffs

  • Lumpectomy wi

y with radiation a and tamoxife fen and m mastect ectomy were a e assoc

  • ciated

ed w with improvem emen ents i in ov

  • ver

eral all s survival al relative t e to l lumpect ectomy a alon

  • ne (12 months).
  • Adding r

g radi diation t therapy t to l lumpectomy r y resulted in a 6- mon

  • nth i

improvem emen ent i in over eral all s survival al, b but decreas ased ed l lon

  • ng-

term b m breast-pres eser ervation o

  • utcom
  • mes
  • This d

decrem emen ent w with r radiation

  • n t

ther erap apy w was mitigated ed b by t the e addition of

  • f tamoxife

fen

Soeteman DI et al. JNCI, 2013; 105 (11)

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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

  • utcomes o
  • f the a

alternative e treatment ent s strateg egies es, includi uding t the r risks o

  • f 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

  • wn p

personal l values es a and p pref efer erences

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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

  • f benefits a

s and h d harms o

  • f 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.

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ANNUAL MEETING | #PCORI2017

Decision Aid design

  • Lay l

lang ngua uage d e descriptions o ns of trea eatmen ent o

  • pt

ptions ns a available to women w n who have b been d n diagno nosed w ed with D h DCIS

  • Likelihood
  • od of
  • f time-sp

spec ecific ( (10 10-yea ear a and nd lifet etime) recu currence ce a and s survival o

  • utcomes f

for an i individual patient

Ozanne et al. BCRT, 2015

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ANNUAL MEETING | #PCORI2017

Decision Aid design

  • Proj
  • jection
  • ns of
  • f down-stream e

effec ects o s of ea each t h treatment

  • p
  • ption
  • n
  • Key po

points des designed ed t to facilitate t e the dec he decisi sion-making ng conve versation

  • Referral t

to

  • ot
  • ther on

r online r resou

  • urces

Ozanne et al. BCRT, 2015

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ANNUAL MEETING | #PCORI2017

Future directions

  • Patie

ient c communic icatio ion

  • Pilot t

t tes esti ting

  • RC

RCT

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ANNUAL MEETING | #PCORI2017

Decision Aid inputs

  • Patie

ient a age+

  • 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

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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

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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

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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
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ANNUAL MEETING | #PCORI2017

Webtool introduction

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ANNUAL MEETING | #PCORI2017

Sample output