BREAST CONSERVATION TREATMENT IN EARLY STAGE DISEASE AND DCIS LAWRENCE J. SOLIN, MD, FACR, FASTRO

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1 BREAST CONSERVATION TREATMENT IN EARLY STAGE DISEASE AND DCIS LAWRENCE J. SOLIN, MD, FACR, FASTRO Chairman Department of Radiation Oncology Albert Einstein Healthcare Network Philadelphia, PA Professor (Adjunct) Temple University Philadelphia, PA Professor Emeritus University of Pennsylvania Philadelphia, PA

2 Radical mastectomy Breast conservation treatment with radiation

3 COMPONENTS OF BREAST CONSERVATION TREATMENT (BCT) 1. Excise the primary tumor 2. Stage the axilla (invasive cancer) 3. Radiation treatment (whole breast) 4. Systemic therapy as indicated

4 ELIGIBILITY FOR BCT Stage: DCIS or clinical T1-2, N0-1 Unicentric disease - Clinical examination - Radiologic imaging Able to excise primary tumor - Negative margins preferred Satisfactory cosmetic outcome Absence of contraindications to BCT

5 CONTRAINDICATIONS TO BCT Absolute Diffuse microcalcifications Gross multicentric disease (GMD) Diffusely positive margins of resection Collagen vascular disease - e.g., SLE, scleroderma - Excluding rheumatoid arthritis Pregnancy (except late pregnancy?) Previous radiation to the breast (?) Relative (cosmetic contraindications) Large tumor-to-breast ratio (neoadjuvant chemo?) Subareolar location of tumor (?)

6 RANDOMIZED TRIALS OF RADIATION AFTER BREAST CONSERVATION SURGERY Whole Breast Fractionation No. of Length reported No. of randomized of follow-up Study trials patients (years) locations Standard Many >10,000 >20 Worldwide BCS/RT vs. mastectomy BCS +/- RT Accelerated Accelerated partial breast irradiation (APBI)

7 RADIATION FRACTIONATION SCHEMAS Fisher C, JCO, 2014

8 LONG TERM OUTCOMES AT 20 YEARS OR MORE AFTER STANDARD (WHOLE BREAST) RADIATION Endpoints Outcome - Local control High - Survival High - Cosmesis High - Complications Low Standard RT remains the gold standard and sets the bar very high for other RT techniques

9 DIRECT RELATIONSHIP OF LOCAL CONTROL TO SURVIVAL: OVERVIEW DATA FOR RANDOMIZED TRIALS OF RADIATION AFTER LUMPECTOMY FOR INVASIVE PRIMARY BREAST CARCINOMA 10-y gain 21.7% Modeling of data: 4 Local recurrences directly lead to 1 avoidable breast cancer death with standard whole breast radiation Overview, Lancet, 2005 Updated data: Local recurrence 25.1% no RT 7.1% with RT 4:1 ratio confirmed Overview, Lancet, 2011

10 DIRECT RELATIONSHIP OF LOCAL CONTROL TO SURVIVAL: OVERVIEW DATA FOR RANDOMIZED TRIALS OF RADIATION AFTER LUMPECTOMY FOR INVASIVE PRIMARY BREAST CARCINOMA Overview, Lancet, :1 Ratio confirmed

11 STANDARD WHOLE BREAST RADIATION TREATMENT

12 BREAST IMRT (INTENSITY MODULATED RT) Standard dose distribution Segmented IMRT Vicini, 2006

13 PROGNOSTIC FACTORS FOR LOCAL CONTROL AFTER BREAST CONSERVATION TREATMENT WITH RADIATION Significant factors for local control Lower risk Higher risk Pathology margins of Negative Positive tumor excision or close Patient age Older Younger Radiation boost dose to Boost No boost the primary tumor site (Higher dose) (Lower dose) Adjuvant systemic therapy Yes No Hormone receptor Positive Negative status Emerging biologic Lower Higher factors risk risk

14 SSO-ASTRO CONSENSUS GUIDELINE ON MARGINS The use of no ink on tumor as the standard for an adequate margin.. is associated with low rates of IBTR and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease health care costs. Moran, JCO, IJROBP, Ann Surg Oncol, 2014

15 LOCAL RECURRENCE (%) 10-YEAR PREDICTED LOCAL RECURRENCE ACCORDING TO MARGIN STATUS AND MINIMUM NEGATIVE MARGIN WIDTH: META-ANALYSIS P =.097 Adjusted test for trend P >.2 Adjusted for endocrine therapy or radiation boost Positive Close Negative % 12% 7% 12% 10% 6% 9% 7% 4% mm 2 mm 5 mm MINIMUM NEGATIVE MARGIN WIDTH Houssami, EJC, 2010

16 ODDS RATIO META-ANALYSIS FOR LOCAL RECURRENCE ACCORDING TO MARGIN WIDTH 1.47 P = 0.12 P = 0.21 (test for trend) 1.0 (reference) Positive vs negative Odds Ratio = 2.44 P <.001 Close vs negative Odds Ratio = 1.74 P <.001 >0 mm vs 5 mm P =.021 MINIMUM NEGATIVE MARGIN WIDTH Houssami, Ann Surg Oncol, 2014

17 EORTC RANDOMIZED TRIAL OF A BOOST AFTER 50 GY WHOLE BREAST RADIATION IN 5,318 PATIENTS Bartelink, JCO, 2007

18 EORTC RANDOMIZED TRIAL OF A BOOST AFTER 50 GY WHOLE BREAST RADIATION IN 5,318 PATIENTS Age groups Interaction of age with boost Bartelink, JCO, 2007

19 LOCAL FAILURE ACCORDING TO BIOLOGIC FACTORS AFTER BREAST CONSERVATION TREATMENT WITH RADIATION ER/PR Neg Pos (Hormones) Solin, Clinical Breast Cancer, 2009 Yang, Breast Cancer Res Treat, 2008 Neg Pos (Hormones) p =.047 Nguyen, JCO, 2008 Haffty, IJROBP, 2008

20 Local Regional Failure at 10 Years (%) LOCAL-REGIONAL FAILURE ACCORDING TO 21-GENE RECURRENCE SCORE ASSAY AFTER BREAST CONSERVATION TREATMENT 40 NSABP B14 AND B20 ECOG E Age < 50 P =.057 Age 50 P =.66 Age < 50 P =.09 Age 50 P = Recurrence Score Mamounas, JCO, 2010 Solin, BCRT, 2012

21 Cumulative Incidence Rate LRR in Patients with Lumpectomy + Breast XRT in NSABP B Positive Nodes (N=336) >4 Positive Nodes (N=125) RS Low RS Intermediate RS High P-value = 0.12 N LRR Events % 6.2% 3.9% RS Low RS Intermediate RS High P-value = N LRR Events % 12.8% 0.0% Time in Years Time in Years

22 CONTRALATERAL BREAST CANCER (%) META-ANALYSIS OF LOCAL FAILURE ACCORDING TO THE USE OF BREAST MRI STUDY DCIS or Invasive Breast Carcinoma No difference: BCT vs mastectomy Use of RT All P >.2 Houssami, JCO, Breast MRI No breast MRI No. Subset pts P value P =.39 DCIS YEARS 6% 6% Invasive CA Solin, JCO, 2008

23 POTENTIAL ADVERSE CONSEQUENCES OF BREAST MRI Breast MRI Odds Yes No ratio P value Delay to surgery Bleicher, days.011 Hulvat, days 32 days.054 Landercasper, days 8 days.001 Krishnan, days 27 days <.001 Increased use of (ipsilateral) mastectomy Houssami, % (1%)* Turnbull, COMICE, % (2%)* 1% Pengel, % 0% Katipamula, % 36% 1.7 <.0001 Bleicher, % 20% Sorbero, Hulvat, Increased use of contralateral prophylactic mastectomy Sorbero, % 4.7% *Pathologically avoidable

24 IS THERE A GROUP OF PATIENTS FOR WHOM RADIATION CAN BE OMITTED? NSABP B-21 Fisher, JCO 2002

25 EVALUATION OF RADIATION BENEFIT IN FAVORABLE SUBSETS OF PATIENTS: RANDOMIZED TRIALS OR SEER DATA Consider comorbidity, life expectancy Fyles, EBCC, 2010 T1-2, N0 Age > 50 years 8.5% better at 10 years SEER, Smith B, JNCI, 2006 T1 N0, Age > 70 years, ER positive Underpowered for survival, other endpoints T1 N0, Age > 70 years, ER positive 4.6% better at 10 years Hughes, JCO, % better at 10 years T1, Age > 70 years, ER positive Kunkler, SABCS, % better at 5 years p =.001 T1-2 (up to 3cm) Age > 65 years, ER positive

26 DCIS: MANAGEMENT OPTIONS Local - Lumpectomy plus radiation - Lumpectomy alone - Mastectomy Systemic - Tamoxifen Optimal treatment strategy is unknown!

27 RATIONALE FOR RADIATION TREATMENT AFTER LUMPECTOMY FOR DCIS All five randomized trials show that radiation reduces the rate of local recurrence after lumpectomy, generally by about half Retrospective, institutional studies of lumpectomy alone are hypothesis generating, not hypothesis testing [P]atients who may avoid radiation therapy have not been reproducibly and reliably identified by any clinical trials. (1999 DCIS Consensus Conference Statement, Cancer, 2000)

28 Oxford Overview of Randomized Trials of BCS±RT for DCIS Study Entry Women randomised Median followup Surgery* Negative margins required % with boost Data available: NSABP B y WLE (37% ad) Yes 9% EORTC y WLE (20% ad) Yes 5% Swedish BCCG y Sect res (17% ad) No 2% UK/ANZ DCIS y WLE (No ad) Yes NR Data unavailable: RTOG N/A WLE (No ad) Yes NR * WLE: wide local excision; ad: axillary dissection; Sect res: sector resection 2x2 factorial design: ±RT±Tam Boost not recommended Some patients still taking tamoxifen Median follow-up for all trials with data available: 8.9 y Darby, JNCI Monograph, 2010

29 Ips. BREAST RECURRENCE (Inv only) (%) BREAST CANCER MORTALITY (%) Oxford Overview of Randomized Trials of BCS±RT for DCIS DCIS: BCS + RT vs. BCS Ips. BREAST RECURRENCE (CIS & Inv) 3723 women 5-year gain 10.5 % (SE 1.2) 10-year gain 15.2 % (SE 1.6) logrank 2p < DCIS: BCS + RT vs. BCS Ips. BREAST RECURRENCE (Inv only) 3723 women 5-year gain 5.4 % (SE 0.8) 10-year gain 8.5 % (SE 1.3) logrank 2p < DCIS: BCS + RT vs. BCS BREAST CANCER MORTALITY 3726 women 5-year loss 0.4 % (SE 0.4) 10-year loss 0.5 % (SE 0.8) logrank 2p > 0.1; NS BCS 28.1% BCS 15.4% BCS+RT 12.9% Years since randomisation 17:41:28 9 Sep 2009 Provisional results: subject to revision (Name: gr_cis_sc_rt_rlili_all_0) BCS+RT 6.8% Years since randomisation 17:42:03 9 Sep 2009 Provisional results: subject to revision (Name: gr_cis_sc_rt_rlilii_all_0) BCS+RT 4.1% BCS 0 3.7% Years since randomisation 17:46:08 9 Sep 2009 Provisional results: subject to revision (Name: gr_cis_sc_rt_bcdth_all_0) Darby, JNCI Monograph, 2010

30 EBCTCG Overview of Randomized Trials of BCS±RT for DCIS Patient Subset Identified A Priori As Potentially At Low Risk: Low Nuclear Grade, Negative Margins, Path Tumor Size < 20 mm Darby, JNCI Monograph, 2010

31 EXCISION PLUS RADIATION FOR DCIS: RESULTS FROM INTERNATIONAL COLLABORATIVE STUDY (n = 1,003) Solin, Cancer, 2005

32 MULTIDISCIPLINARY MANAGEMENT OF DCIS: NSAPB B-17 AND B-24 All IBTR Invasive IBTR Wapnir, ASCO, 2007

33 RETROSPECTIVE SELECTION CRITERIA FOR TREATMENT WITH LUMPECTOMY ALONE AND NO RADIATION Study Criteria Lagios, 1982 Mammo detection, neg. margins, grade I-II Lagios, 1989 Mammo detection, neg. margins, grade I-II, size <2.5 cm Schwartz, 1992 Mammo detection or incidental finding, neg. margins, size <2.5 cm, (?noncomedo) Silverstein, 1992 Patient refusal of radiation treatment Silverstein, 1995 Grade I-II + necrosis Silverstein, 1996 Van Nuys Prognostic Index (VNPI) score 3-4 Silverstein, 1999 Negative margin width >10 mm Silverstein, 2002 Modified VNPI score 4-6 Silverstein, 2010 Modified VNPI score 4-6 or score 7 margins >3 mm NCCN, 2014 Low risk Not otherwise defined

34 RESULTS OF LUMPECTOMY ALONE (NO RADIATION) FOR DCIS No. of Actuarial local recurrence (%) patients At 5 yrs At 10 yrs At 15 yrs Retrospective Arnesson Blamey * Cataliotti Cutuli * Hughes 60 18* Lagios 79 15* 20* 22 Schwartz * 41* 49* Silverstein Saunders 28 12* 19* 32* Prospective NSABP B * 30* -- EORTC * Swedish * 30* -- JCRT study ECOG 5194 Low/int grade High grade RTOG *Estimated from curve

35 12-GENE DCIS SCORE: ECOG E5194 DCIS Score (0 100) evaluated 2 ways: - Continuous variable - 3 prespecified risk groups: Low, Intermediate, High Solin, JNCI, 2013

36 10-YEAR LOCAL RECURRENCE ACCORDING TO DCIS SCORE: ECOG E5194 VALIDATION DATA ANY IBE INVASIVE IBE Example of patient with DCIS Score = 20 Solin, JNCI, 2013

37 DCIS SCORE: SECOND INDEPENDENT VALIDATION STUDY Rakovitch E, Oral Abstract, SABCS, December, 2014: A large prospectively-designed study of the DCIS Score

38 SUMMARY OF RANDOMIZED TRIALS FOR DCIS Lumpectomy and RT tamoxifen vs. anastrozole NSABP B-35 Lumpectomy and RT + trastuzumab (if Her2 +) NSABP B-43 Conventional whole breast RT vs. Accelerated partial breast irradiation (APBI) NSABP/RTOG Whole breast radiation + boost BIG 3-07

39 SUMMARY Early stage invasive carcinoma Local control matters About 1 in 4 local failures results in a preventable breast cancer death 20-year survival after BCT equal to mastectomy Margins of resection are important DCIS Good long term outcome for BCT/Radiation Radiation and tamoxifen (ER +) reduce risk Molecular profiling and biologic subtyping Evolving strategy for improved risk assessment and tailored local-regional treatment

BREAST CONSERVATION TREATMENT IN EARLY STAGE DISEASE AND DCIS LAWRENCE J. SOLIN, MD, FACR, FASTRO

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