DCIS North American Menopause Society Orlando, FL 6 October 2016 - - PDF document

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DCIS North American Menopause Society Orlando, FL 6 October 2016 - - PDF document

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DCIS North American Menopause Society Orlando, FL 6 October 2016 DCIS: Surgical Treatment Monica Morrow, MD Chief, Breast Surgery Service Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan Kettering Cancer Center DCIS Incidence Rates

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SLIDE 1

DCIS: Surgical Treatment

Monica Morrow, MD

Chief, Breast Surgery Service Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan Kettering Cancer Center

North American Menopause Society Orlando, FL

6 October 2016

DCIS DCIS Incidence Rates 1992-2011

Ward E, CA Cancer J Clin 2015;65:481

Rate per 100,000 Year of diagnosis

70-79 years 50-69 years 40-49 years

Treatment Options in DCIS

  • Mastectomy
  • Excision + RT
  • Excision

± Endocrine Therapy

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SLIDE 2

Outcome of Surgical Treatment in DCIS

Breast Cancer Specific Mortality 3.3% (95% CI 3.0-3.6%) Narod et al, JAMA Oncol 2015 SEER Study DCIS 1998-2011 n = 108,196 Mean f/u 7.5 yrs (0-24)

Narod S, JAMA Oncol 2015;1:888

Outcome of Surgical Treatment in DCIS

Worni et al, J Natl Cancer Inst 2015 SEER Study DCIS 1991-2010 n = 121,080

Worni M, J Natl Cancer Inst 2015;107:djv263

Outcome of Surgical Treatment in DCIS

Sagara et al, J Clin Oncol 2016 SEER Study DCIS 1998-2007 n = 32,144 BCS ± RT Mean f/u 8.0 yrs 10 yr Breast Cancer Specific Mortality 1.8% RT n = 20,329 2.1% no RT n = 11,815

Sagara Y, J Clin Oncol 2016;34:1190

Incidence rate (per 100,000)

SEER9 Age Adjusted Incidence Rate of Breast Cancer by Stage (1973–2005)

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SLIDE 3

Do excellent outcomes with treatment translate to excellent outcomes with less or no treatment?

  • Mortality is not a useful endpoint—low with all

treatments

  • Local recurrence varies with treatment and is

important to patients

DCIS Factors Influencing Patient Decisions

recurrence

60% 50% 40% 30% 20% 10% 0% 80% 70% 90% 100% greatly moderately not/slightly

radiation recovery body/sexuality

Katz S, J Clin Oncol 2005;23:5526

  • Exclude the presence of invasive cancer at

diagnosis

  • Reduce the risk of future development of invasive

cancer

Why Do We Perform Surgery in DCIS? Presence of Invasive Cancer After Core Needle Biopsy of DCIS

All Cases n = 7350 Underestimate: 25.9% (95% CI 22.5-29.5) Brennan M, Radiology 2011;260:119

Predictors

14g vs 11g Bx Palpable Mammographic mass High nuclear grade Size > 20mm Low Risk Lesions Low/Int grade Underestimate n = 1385 21.1% (15.4, 28.3) Size on imaging ≤20mm n = 2783 20.1% (12.3, 31)

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SLIDE 4

Metaanalysis of Long Term Outcomes

  • f Local Therapy for DCIS

5 prospective, 21 retrospective studies Follow up ≥ 10 yrs n = 9404

Treatment 10 yr LR 95% CI Mastectomy 2.6% 0.8-4.5 BCS + RT 13.6% 9.8-17.4 BCS 25.5% 18.1-32.9

Stuart K, BMC Cancer 2015;15:890

Metaanalysis of Long Term Outcomes

  • f Local Therapy for DCIS

Treatment 10 yr LR BCS 25.1% BCS + Tam 24.7% BCS + RT 14.1% BCS + RT + Tam 9.7%

Stuart K, BMC Cancer 2015;15:890

Is the outcome of excision alone in selected, low risk DCIS patients good enough that we should consider eliminating excision?

DCIS Excision Alone in Favorable DCIS: ECOG-ACRIN E5194

Cohort 1 Cohort 2 Low/int grade High grade ≤ 2.5 cm ≤ 1 cm n = 561 n = 104

Median f/u 12.3 years

* Protocol specified 3 mm or greater margin

Solin L, J Clin Oncol 2015;33:3938

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SLIDE 5

LR After Excision Alone for DCIS

12 Year Results of ECOG-ACRIN E5194

Solin L, J Clin Oncol 2015;33:3938

Low/Int grade High grade

Margins and LR: ECOG-ACRIN E5194

Margin Width, mm 12 yr IBTR 3‒5 15.5% 5‒9 14.0% > 10 13.4%

Solin L, J Clin Oncol 2015;33:3938

Cohort 1: Low/int grade T ≤ 2.5 cm n = 561

p = .87

What Is the Risk of Invasive Recurrence After Excision Alone in Low Risk DCIS?

Solin L, J Natl Cancer Inst 2013;105:701

ECOG 5194

Years since IBTR Wapnir I, JNCI 2011;103:1 Donker M, J Clin Oncol 2013;31:4054 Invasive DCIS Breast Cancer Mortality

NSABP B17/B24 EORTC 10853

Invasive

Impact of Invasive Recurrence

  • n Mortality
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SLIDE 6

RTOG 9804: RT vs Observation in Good Risk DCIS

n = 629

Local Failure (%) Time Since Random Allocation (years) McCormick B, J Clin Oncol 2015;33:709

low/int grade < 2.5 cm size margins ≥ 3 mm

Modern molecular biology should be able to identify a truly low risk subset of DCIS patients True, but that hasn’t happened yet

DCIS Score

Solin L, J Natl Cancer Inst 2013;105:701

Comparison of Ontario Cohort to E5194 Cohort: KM 10yr Estimates of Risk of Local Recurrence

ECOG E5194 Ontario DCIS Cohort

Local Recurrence Risk (%) Local Recurrence Risk (%) Solin L, J Natl Cancer Inst 2013;105:701 Rakovitch E, SABCS 2014

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SLIDE 7

Treatment With Excision Alone

Treatment with excision alone, regardless of margin width, is associated with substantially higher rates of IBTR than treatment with excision and WBRT, even in pre-defined low risk patients Level 1 evidence

R A N D O M I Z E

Surgery vs Active Monitoring for Low Risk DCIS (LORIS)

Observation

Annual Mammogram

Age > 46 years Screen detected calcifications 11g VAB Non-high grade DCIS Core Bx Excision + margins

Surgery

Eligibility

Endpoint: Development of invasive cancer at 5 years Enrollment: 932 patients over 6 years

PI: Adele Francis

  • Surgical excision for DCIS diagnosed by core-needle

biopsy 2009-2012

  • Meeting all clinical and pathologic LORIS criteria
  • 296 patients

(approx 16% of DCIS)

What Is the Risk of Invasive Cancer in Patients Meeting LORIS Eligibility Criteria?

Pilewskie M, Ann Surg Oncol 2016 (Epub)

Total Population n = 296 Upgrade to invasive carcinoma n = 58 (20%) No Upgrade at surgical excision n = 238 (80%)

Results Rate of Upgrade to Invasive Carcinoma

Pilewskie M, Ann Surg Oncol 2016 (Epub)

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Results Tumor Characteristics of Cases with an Upgrade

Final Invasive Stage n = 58 Stage IA (pN0) 54 (93%) T1mic 13 (22%) T1a 26 (45%) T1b 14 (24%) T1c 1 (2%) Stage IB 1 (2%) T1N1mi 1 (2%) Stage IIA 3 (5%) T1N1 2 (3%) T2N0 1 (2%)

26/58 = 45% have tumor pathology that warrants genomic profiling or consideration for chemotherapy

Pilewskie M, Ann Surg Oncol 2016 (Epub)

Results Treatment Recommendations of Upgraded Cases

*treatment information missing for one patient **indications for chemotherapy: High/intermediate recurrence score, node positive or HER2 overexpressing disease, triple negative, high-risk tumor features

Invasive upgrades (n = 57)* Proportion % Radiation therapy 27/30 90% Endocrine therapy 48/54 89% Chemotherapy** 10/57 18% Adjuvant treatment recommended 53/57 93%

Pilewskie M, Ann Surg Oncol 2016 (Epub)

Mastectomy Use Based on Who Made the Surgery Decision

%

White

35 30 25 20 15 10 5

Adjusted for age, marital status, # surgeons visited, comorbidity, tumor size, grade, SEER site

Surgeon Shared Patient

Katz S, J Clin Oncol 2005;23:5526

  • Survival outcomes are excellent in DCIS

regardless of treatment, but risk of LR varies significantly

  • Good outcomes with treatment do not necessarily

mean good outcomes without treatment

  • Observation without excision is not warranted
  • utside of a clinical trial

Conclusions

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SLIDE 9
  • Patients are major drivers of radical treatment in

DCIS

  • Surgeons can reduce overtreatment by avoiding

SN biopsies in BCT patients and re-excisions for margins > 2 mm

Conclusions