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Breast Flashcards

1
Q

What was study population for EBCTCG DCIS meta-analysis?

A

N = 3729 pts, DCIS s/p lumpectomy, WBrT vs observation, combined data from SweDCIS, EORTC, UK/ANZ and NSABP B17 trials

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2
Q

What were results of EBCTCG DCIS metanalysis in terms of IBTR? BCM?

A

~50% reduction in IBTR (28% vs 13%), no reduction in BCM (or OS benefit)

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3
Q

What was study populton for NSABP B-17?

A

N=818 pts, DCIS s/p negative margin resection, 50 Gy WBRT vs observation

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4
Q

What were results of NSABP B-17 in terms of IBTR?

A

50% reduction in IBTR (32% vs 16%), benefit observed for both DCIS and invasive recurrences, no survival benefit

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5
Q

What was study population for SweDCIS trial?

A

N = 1067 pts, DCIS <1/4 of breast s/p WLE sector resection, 50 Gy WBRT vs observation

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6
Q

What were outcomes of SweDCIS on IBTR?

A

~50% reduction in IBTR (27% vs 12%), less effect observed with younger age

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7
Q

What was study population for EORTC 10853?

A

N = 1002, DCIS s/p WLE, 50 Gy WBRT vs observation (5% received boost)

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8
Q

What were outcomes of EORTC 10853 in terms of IBRT?

A

~50% reduction in IBTR; 10 yr (26% vs 15%), 15 yr (31% vs 18%), benefit also observed in positive margin and high risk pts in this trial

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9
Q

Are there data supporting BCM benefit for addition of RT for DCIS post-lumpectomy?

A

Yes, Giannakeas SEER analysis (JAMA, 2018) demonstrated 15-yr BCM benefit with lumpectomy + RT with clear benefit for grade 3 and tumors 1-1.9 cm and >5 cm. *Interpret large database studies with caution as have been shown to correlate with Ph3s at essentially chance

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10
Q

Does risk impact benefit of RT s/p lumpectomy for DCIS patients?

A

Yes, Sagara SEER (2016), propensity score matching. High nuclear grade, young age, large tumor associated with greater survival benefit. BCM improved across all subcategories. *Interpret database analyses with caution, has not been replicated in RCTs

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11
Q

What is the approximate recurrence rate of low risk DCIS post-lumpectomy per year on RTOG 9804 (adjuvant RT vs observation)?

A

1% per year (11.4% at 12 years)

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12
Q

What was the benefit of adjuvant RT compared to observation after lumpectomy on RTOG 9804 (low risk DCIS)?

A

Reduced LRR and mastectomy rates, no benefit on OS

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13
Q

What were the rates of IBTR at 5 and 12 yrs from the ECOG ACRIN E5194 study (WBRT vs observation) for low/intermediate and high grade?

A

5 yrs: 6.1% low/int, 15.3% high<br></br>12 yrs: 14.4% low/int, 24.6% high

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14
Q

How does age impact IBTR lifetime risk on ECOG ACRIN E5194 (WBRT vs observation for DCIS post-lumpectomy)?

A

Age <45 yrs 54% recurrence, age >45 10%

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15
Q

What the principal geographic pattern of recurrence of DCIS post lumpectomy without RT or tamoxifen?

A

In same quadrant (74% per Harvard series)

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16
Q

What were the arms of the UK/ANZ DCIS trial?

A

1) observation, 2) TAM x 5 years, 3) WBRT 50 Gy, 4) RT + TAM

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17
Q

What benefit was observed with tamoxifen in patients that received RT on the UK/ANZ DCIS trial?

A

No benefit in ipsilateral invasive or DCIS recurrence for tamoxifen when RT was given (RT reduced 10 yr IBTR from ~15% to ~2%, no additional benefit of TAM)<div><br></br></div><div>*Notable limitation: receptor analysis not performed in this study</div>

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18
Q

What were the study arms on NSABP B-24 s/p lumpectomy for DCIS?

A

1) 50 Gy + TAM x 5 yrs, 2) 50 Gy alone (38.5% did receive boost across trial)

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19
Q

Was a benefit of tamoxifen observed in combination with whole breast RT in women with DCIS s/p lumpectomy on NSABP B-24?

A

Slight reduction in invasive recurrence (all comers), reduced total invasive breast cancer events with tamoxifen (ER+ subset analysis)<div><br></br></div><div>Local control benefit of RT is why it remains category 1 on NCCN compared to TAM (probably just tumoristatic)</div>

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20
Q

Is there a benefit of anastrazole vs tamoxifen x 5 yrs for post-menopausal women with ER+ DCIS s/p lumpectomy and RT? (IBIS-II DCIS trial)

A

No, no difference observed in overll recurrences or death with anastrazole vs tamoxifen x 5 yrs

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21
Q

How do the side effect profiles differ for anastrazole vs tamoxifen?

A

Tamoxifen: more muscle spasms, gyn cancers, gyn symptoms, vasomotor symptoms, DVTs<div><br></br></div><div>Anastrazole: more fractures, MSK events, hypercholesteremia, strokes</div>

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22
Q

Is there a benefit of anastrazole compared to tamoxifen for women under 60 with ER+ DCIS s/p lumpectomy and RT (NSABP B-35)?

A

Yes, anastrazole improved breast cancer free interval compared to tamoxifen for women under 60

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23
Q

What effects were observed with hypofractionation and/or boost for non-low risk DCIS from the BIG 3-07/TROG 07.01 trial?

A

Compared conventional vs hypofrac, and boost (16 Gy) vs no boost.<div><br></br></div><div>No diff with fractionation (5-yr LC 94%)</div><div><br></br></div><div>Boost improved 5-yr LC(97% vs 93%)</div>

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24
Q

Is hypofractionation acceptable for patients with DCIS s/p lumpectomy?

A

Yes, DBCG HYPO study compared 40 Gy/15 fx to 50 Gy/25 fx with allowed boost. No difference in LRR or OS with fractionation. No increased induration with hypofx, and better cosmetic outcomes

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25
Q

What are rates of discontinuation of adjuvant endocrine therapy in IBC/DCIS patients?

A

20-60%

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26
Q

How can Oncotype be used in DCIS patients?

A

327 pts from ECOG trial with DCIS s/p surgery without RT were examined. 10-yr invasive breast cancer risk incresed linearly with Oncotype score (low 4%, int 12%, high 19%).<div><br></br></div><div>Could be used to determine if TAM is needed in a patient that is considering no therapy, or does not wish to pursue RT</div>

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27
Q

What did the EBCTCG meta-analyses demonstrate in terms of benefit of RT vs observation following breast conservation surgery?

A

78 trials included with 42k patients (major trials included NSABP B-06, Milan I, EORTC, Danish, NCI, Gustave-Roussy)<div><br></br></div><div>RT after BCS improved LRR and BCM, halves LRR and DM and reduces mortality by about 1/6th in all populations</div><div><br></br></div><div>1 breast cancer death avoided for every 4 LRRs avoided</div>

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28
Q

What were the design and arms on NSABP B-06?

A

Stage I/II, <4 cm, 1851 pts, 1) total mastectomy, 2) lumpectomy, 3) lumpectomy + RT. Negative margins required, ALND required in all arms

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29
Q

What were the results of mastectomy vs BCS from NSABP B-06?

A

No diff in OS (46%), CSS (60%) or distant DFS at 20 years, IBTR 14% with RT vs 39% w/o, local control reduced with BCS

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30
Q

What were the results of the Milan I study (mastectomy vs BCS)?

A

cT1N0, <70 (N=701 pts), no difference in OS (58%) or CSS (75%) at 20 years<div><br></br></div><div>LR 8.8% with BCS+RT, vs 2.3% with mastectomy</div>

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31
Q

What benefit was observed with tamoxifen in addition to RT in early stage IBC on NSABP B-21?

A

Design: <=1 cm s/p WLE, 1) TAM x 5 yrs, 2) TAM + 50 Gy, 3) 50 Gy alone<div><br></br></div><div>RT reduces 8-yr IBTR (17% TAM, 3% TAM+RT, 9% RT alone), some possible synergy with TAM</div>

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32
Q

Was benefit of RT added to TAM preserved in elderly in CALGB C9343?

A

Yes, trial included age >=70 cT1N0, ER+ s/p lumpetctomy. 1) TAM + RT 45 Gy + 14 Gy boost, vs 2) TAM alone. RT improves 10-yr LRR (10% vs 2%), no diff in OS or DM<div><br></br></div><div>-</div>

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33
Q

What is benefit of RT vs observation after lumpectomy from PRIME II?

A

Improved 10-yr IBRT (9.8% vs 0.9%), no diff in OS or DM<div><br></br></div><div>Age >65, T1-2, <3 cm, ER/PR+, >=1 mm margins, 1) RT 40-50 Gy/15-25 fx vs 2) observation</div>

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34
Q

What are risk factors for recurrence that may benefit from boost (per EORTC 22881)?

A

Young age, adjacent DCIS (at 20-yr MVA), grade 3 was shown initially but fell out at later time points<div><br></br></div><div>Pts randomized to 50 Gy and 1) no boost, or 2) 16 Gy boost</div>

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35
Q

“What was benefit of boost in ““Lyon study”” at 5 yrs?”

A

N = 1024 pts, <=3 cm tumor s/p WLE and ALND, 1) 50 Gy vs 2) 50 Gy + 10 G boost<div><br></br></div><div>Improved 5-yr LC (4.5% vs 3.6%), more telangectasias but no difference in self-assessed cosmesis</div>

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36
Q

What is the data for breast SIB following BCS from the UK IMPORT HIGH study?

A

pT1-3, N0-3a, M0 randomized to 1) 40 Gy/15 fx + sequential 16 Gy boost, 2) SIB IMRT 36 Gy WBRT + 40 Gy PBI (1.5 cm CTV from tumor bed) + 48 Gy boost in 15 fractions, 3) SIB IMRT 36 Gy WBRT + 40 PBI + 53 Boost in 15 f<div><br></br></div><div>-No difference in cosmesis at 3 yrs, borderline worse induration with 53 Gy boost</div><div><br></br></div><div>IBTR results are pending</div>

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37
Q

What is the deigns of the ongoing RTOG 1005 trial for SIB boost + hypofrac?

A

Early stage, high risk: age <50, +axillary N, LVI, >=2 close margins, 1 close and EIC, + margin, ER/PR-, grade 3, oncotype >25, ypstage 0-II, grade 3 DCIS, <50 yrs<div><br></br></div><div>1) WBRT 50 Gy or 42.7 Gy + sequential 12-14 Gy boost, or 2) hypofrac SIB 40 Gy/15 fx + 48 Gy/3.2 Gy daily boost</div>

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38
Q

What does IMRT-MC2 trial show comparing sequential vs SIB breast boost?

A

1) WBRT 50.4 Gy with SIB to 64.4 vs 2) WBRT 50.4 Gy then sequential 16 Gy boost<div><br></br></div><div>2-yr LC 100% in both, no difference in breast retraction or cosmesis</div>

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39
Q

What were design and primary results from OCOG (Canadian) trial comparing hypofractionation and conventional?

A

BCS, T1 or T2, N0, neg margins, all had ax dissection, 1) 42.5 Gy/16 fx vs 2) 50 Gy/25 fx, no boost<div><br></br></div><div>5 and 10-yr LC equivalent, no difference in cosmetic outcomes</div><div><br></br></div><div>Grade 3 favored conventional RT (not replicated in START A/B trials)</div>

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40
Q

What was and design and arms for START A/B breast hypofrac trials?

A

pT1-3a, N0-1, some BCS, some mastectomy<div><br></br></div><div>START A: 50 Gy/25 fx vs 39 Gy/13 fx vs 41.6 Gy/13 fx</div><div><br></br></div><div>START B: 50 Gy/25 fx vs 40 Gy/15 fx</div><div><br></br></div><div>10 Gy boost allowed (61%), nodal and chest wall RT allowed</div>

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41
Q

What were important primary and subset analyses from START A/B?

A

No diff in 10-yr LRR (4-6%) with hypofrac vs conventional<div><br></br></div><div>Improved cosmesis with 39 Gy and 40 Gy</div><div><br></br></div><div>No worsened outcomes in grade 3 (contrast with Canadian trial)</div>

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42
Q

What were outcomes with ultra hypofractionation in breast from UK FAST FORWARD trial?

A

pT1-3, N0-1 M0, BCS or mastectomy (93% BCS), noninferiority<div><br></br></div><div>1) 40 Gy/15 fx vs, 2) 27 Gy/5 fx, vs 3) 26 Gy/5 fx</div><div><br></br></div><div>Recurrence and survival at 5-yr noninferior, cosmetic outcomes worse with 27 Gy, increased induration, skin changes</div><div><br></br></div><div>Why were 26 and 27 Gy both evaluated? BED calculations predicted falloff at this point</div>

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43
Q

What were results of UK meta-analysis of PBI vs WBRT?

A

IBC, suitable for BCT, 9 randomized trial of PBI vs WBRT<div><br></br></div><div>-No difference in BCM,non-BCM and OS improved by ~1% with PBI (cardiac toxicity?)</div>

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44
Q

<div>In Princess Margaret PBI Meta-analysis (9 trials), what were the outcomes in terms of local recurrence and survival?</div>

A

<div>Increased LR (OR = 1.69) with PBI, less death w/o recurrence (OR = 0.55) with PBI, trend toward improved OS with PBI</div>

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45
Q

<div>What was the best modality for PBI according to the Princess Margaret meta-analysis?</div>

A

<div>External beam</div>

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46
Q

<div>What were negative predictors of benefit for PBI in Princess Margaret meta-analysis?</div>

A

<div>Larger tumors, node positivity</div>

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47
Q

<div>What were the 3 arms in the UK IMPORT LOW trial?</div>

A

<div>40 Gy/15 fx WBRT, 36 Gy WBRT + SIB PBI to 40 Gy/15 fx, 40 Gy/15 fx PBI</div>

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48
Q

<div>What were the local recurrence, distant recurrence and survival outcomes of partial breast or reduced dose whole breast + PBI boost in UK IMPORT LOW compared to hypo-fractionated WBRT?</div>

A

Non-inferior 5-yr LR, DR, BC mortality and overall mortality at 5 year<div><br></br></div><div><div>Lower rates of adverse outcomes with partial breast and reduced dose compared to WBRT</div></div>

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49
Q

<div>What was study design of RAPID trial for EBRT PBI?</div>

A

<div>Age >40, size <3 cm, IDC or DCIS, Arm 1: 38.5 Gy/10 fx EBRT PBI vs WBRT hypofrac or conventional (boost optional)</div>

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50
Q

<div>What were recurrence and cosmetic outcomes of accelerated partial breast arm in RAPID compared to standard WBRT arm?</div>

A

<div>Non-inferior 8 yr IBRT (3% vs 2.8%), worse cosmetic outcomes with accelerated PBI (grade 2 or greater induration: 32% vs 13%, grade 3 4.5% vs 1.0%, 7-yr subjective cosmesis 18% worse)</div>

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51
Q

<div>What are the outcomes data for IMRT PBI in early stage IDC/DCIS?</div>

A

<div>Florence, Italy: 30 Gy/5 fx IMRT PBI vs WBRT 50 Gy/25 fx + 10 Gy boost, 5-yr IBRT 1.5% in both arms, improved acute and late toxicity and physician reported cosmesis with IMRT</div>

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52
Q

<div>What are outcomes data for PBI with electrons/HDR compared to WBRT?</div>

A

<div>Budapest (Polgar, 2020): APBI (either HDR 36.4 Gy/7 fx, or electrons 50 Gy/25 fx) vs WBRT 50 Gy/25 fx</div>

<div><br></br></div>

<div><div>No difference in LC, CSS, DF or OS, better cosmesis with HDR APBI</div></div>

<div><br></br></div>

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53
Q

<div>What were arms on RTOG 0413/NSABP B39 examining multiple modalities of APBI compared to standard whole breast?</div>

A

<div>50 Gy/25 fx with optional boost, APBI 34 Gy in 3.4 Gy fractions BID with multicatheter interstitial or Mammosite, OR 38.5 Gy in 3.85 Gy BID fractions with EBRT</div>

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54
Q

<div>What were recurrence and cosmetic outcomes with APBI (either interstitial or EBRT) on RTOG 0413?</div>

A

<div>IBRT equivalent at 10 years, slightly worse grade 3 toxicity with PBI, cosmetic outcomes by physician and patient not different</div>

55
Q

<div>What were results of GEC-ESTRO APBI brachy trial compared to WBRT?</div>

A

<div>32 Gy/8 fx or 30.3 Gy/7 fx BID compared to WBRT 50 Gy/25 fx + 10 Gy boost, no difference in 5-yr LR or DFS, toxicity and cosmetic outcomes no different between arms</div>

56
Q

<div>What was design and arms of TARGIT-A trial for partial breast treatment?</div>

A

<div>Early stage breast, age >45, unifocal, TARGIT IORT 20 Gy/1 fx vs WBRT 45-56 Gy, if adverse features seen on path in TARGIT group they received supplemental RT boost</div>

57
Q

<div>What were primary outcomes of TARGIT-A in terms of recurrence, survival and toxicity?</div>

A

<div>15% of TARGIT patients required supplemental EBRT due to high risk features</div>

<div><br></br></div>

<div>Non-inferior 5-yr LR (2.11% vs 0.95%), decreased non-cancer deaths (1.4% vs 3.5%) with TARGIT vs EBRT, mortality increased when EBRT added to TARGIT</div>

58
Q

<div>What was design of ELIOT trial for IORT?</div>

A

<div>IORT 21 Gy/1 fx with electrons vs WBRT 50 Gy + 10 Gy boost, equivalency trial, early stage breast, suitable for lumpectomy with tumor size < 2.5 cm</div>

59
Q

<div>What were outcomes of ELIOT trial in terms of IBTR and what is the contention?</div>

A

<div>IORT is equivalent to WBRT as defined by trial design although is generally statistically worse (4.4% vs 0.4%)</div>

60
Q

<div>How does anastrazole compare to tamoxifen in postmenopausal women with early stage breast cancer?</div>

A

<div>ATAC Group: 1) TAM x 5 yrs, 2) anastrazole, 3) TAM + anastrazole; 10-yr recurrence risk decreased with anastrazole, no difference in OS. Fractures increased with anastrazole, while more serious adverse events with tamoxifen</div>

61
Q

<div>How does short term tamoxifen (2 yrs) impact long term survival in the SBII:2pre trial?</div>

A

<div>15-yr cumulative mortality decreased (HR = 0.84), 15-yr BCM reduced (HR = 0.72)</div>

62
Q

<div>What effect does anastrazole have on recurrence risk compared to placebo in early stage breast cancer?</div>

A

<div>IBIS-II: anastrazole vs placebo, post-menopausal, any ER; 40% reduction in breast cancer recurrence, 54% in ER+, 59% in DCIS (mostly ER+), no benefit in OS or BCM</div>

63
Q

<div>What impact does addition ovarian suppression to tamoxifen have on in pre-menopausal women distant metastases from the SOFT/TEXT trial?</div>

A

<div>TAM vs TAM + ovarian suppression vs exemestane + ovarian suppression</div>

<div>Improved 8-yr OS with addition of OS to TAM (91.5% vs 93.3%), improved DM survival by about 5%, even further benefit observed with exemestane (10-15% in highest risk patients), lots of toxicity with ovarian suppression (1/4th withdrew), ovarian suppression = triptorelin, oophorectomy or RT</div>

64
Q

<div>Is there benefit of 10-yrs of tamoxifen vs 5 years?</div>

A

<div>Yes, ATLAS trial showed reduction in BCM between 5-14 years (12.2% vs 15%), and decreased risk of recurrence (21% vs 15%)</div>

65
Q

<div>Does addition of 5-yrs of letrozole after 5 years of tamoxifen or AI improve outcomes vs observation in post-menopausal early stage breast?</div>

A

<div>No, no additional DFS or OS benefit observed with addition of 5-years of letrozole (NSABP B-42)</div>

66
Q

<div>What data exists for BCT vs MRM +/- RT in triple negative early stage breast cancer (T1-2N0)?</div>

A

<div>Cross Cancer Institute, Alberta, Canada: 768 pts, LRR better with BCT (96%) vs MRM w/o RT (90%), retrospective study</div>

67
Q

<div>Are there differences in outcomes observed between radical and total mastectomy on NSABP B-04?</div>

A

<div>No, patients randomized to radical mastectomy vs TM+RT to axilla vs TM (cN- axilla), if cN+, radical mastectomy + TM+RT to axilla. No significant benefit in LF, DFS or OS out to 25 years with radical mastectomy. *notably no systemic therapy given in this trial</div>

68
Q

<div>How does SLN+ guided ALND perform vs ALND in all patients (NSABP B-32)?</div>

A

<div>SLNBx had accuracy of 97.1%, false negative rate of 9.8%, NPV 96.1%</div>

<div><br></br></div>

<div>No difference in OS, DFS or LRC at 7-yrs with SLNBx guided approach</div>

69
Q

<div>Is ALND required for 1-2 micromets or can these patients be observed?</div>

A

<div>IBCSG 23-01: 1-2 micromets (N1mi <=2mm), SLNBx followed by ALND or observation; not required, no difference in LRR, DFS or OS at 10-yrs, increased risk of lymphedema with ALND (13% vs 4%)</div>

70
Q

<div>What was the design of ACOSOG Z0011?</div>

A

<div>T1-2, clinical N0, lumpectomy with 1-2 SLN+, randomized to completed ALND vs no ALND, RT given as WBRT tangents (RT to SCV or targeted axilla were prohibited)</div>

71
Q

<div>What were the results of ACOSOG Z0011 in terms of LRR, DFS and OS?</div>

A

<div>OS worse at 10 years with ALND (83.6% vs 86.3%), no difference in 5-ur LRR, 5 or 10 yr DFS</div>

<div><br></br></div>

<div>Established that ALND is not required in T1-2 breast cancer with 1-2 SLN+ receiving WBRT and adjuvant systemic therapy</div>

72
Q

<div>What are some of the concerns around interpretation of ACOSOG Z0011?</div>

A

<div><div>Surprisingly 21% in ALND had 3 or more nodes suggesting that RT can control nodal disease, OS favored group without ALND but not appropriately powered. </div><div><br></br></div> <div>High tangents were used in some patients although no benefit was observed, but those that had high tangents had more nodes. Additionally 15% of patients received axillary RT despite it being a protocol violation</div></div>

73
Q

<div>What is the trial design of AMAROS (EORTC)?</div>

A

<div>Noninferiority trial of ALND vs RNI to axilla (levels I-III) and medical SCV for SLNB+ patients after mastectomy or BCS</div>

<div><br></br></div>

<div>Optional RT to CW post-mastectomy. If in ALND group and >=4 nodes, RNI allowed.</div>

74
Q

<div>What were the results of AMAROS trial in terms of recurrence, survival and lymphedema?</div>

A

<div>Axillary recurrences were non-inferior and rare in both arms. Doubling of lymphedema risk (28% vs 14%) at 5-yrs. NO difference in OS or DMFS at 10 years.</div>

<div></div>

75
Q

What is the role of sentinel lymph node biopsy with neoadjuvant chemotherapy (SENTINA)?

A

cN0: SLNB before neoadj. chemo, and if SLN+ another SLNB after chemo<div><br></br></div><div>cN+: neoadjuvant chemo, if ycN0 SLNB and ALND, yf ycN1, ALND with no SLNB</div><div><br></br></div><div>SLN detection rate before chemo if cN0: 99%, 52% false negative rate after chemo</div><div><br></br></div><div>cN+, ycN0: 80% detection rate, 14% false negatives, FNR <10% if 3+ nodes removed, 8.6% if using dual tracer</div>

76
Q

What are results of SLN after neoadjuvant CHT from ACOSOG Z1071?

A

Design: T0-4, cN1-2, M0, neoadjuvant chemo<div>SLN –> ALND (BCS or mastectomy)</div><div><br></br></div><div>cN1 disease with >=2 SLNs removed the false negative rate as 12.6% (exceeded 10% prespecified limit), improved with dual techniques and at least 3 nodes (closed early due to poor accrual)</div><div><br></br></div>

77
Q

What was benefit of PMRT in locally advanced patients from EBCTCG metanalysis? Did this depend on number of nodes involved?

A

Mastectomy + ALND to at least level II, N+ (included 22 trials from 1964-1986)<div><br></br></div><div>pN0 patient did not benefit</div><div>10-yr LRR reduced for 1-3 nodes (20% vs 4%) and >=4 nodes (32% vs 13%), BCM decreased at 20-yrs by ~10%, also reduced distant mets</div><div><br></br></div><div><br></br></div>

78
Q

What are some caveats to benefit of PMRT from EBCTCG analyses?

A

Old studies (no Her2 therapies, older surgical and RT techniques, older endocrine therapies)<div><br></br></div><div>Only included patients with full axillary dissections (ACOSOG Z0011 has shown that this is not necessary for 1-2 SLN+)</div>

79
Q

What was study design of Danish DBCG 82b study for locally advanced patients?

A

Premenopausal, high risk (axillary N+, >5 cm or invasion of skin or pec fascia)<div><br></br></div><div>Randomized to CMF + 48-50 Gy to CW and nodes vs CMF alone</div>

80
Q

What benefit of PMRT was observed in Danish 82b trial (premenopausal high risk locally advanced)?

A

“10-yr OS improved with PMRT (54% vs 34%)<div>Improved LRR at 10 yrs (9% vs 32%), ““good”” risk group had LC and BCM benefit with mortality benefit lost in high risk group</div>”

81
Q

What was design of Danish DBCG 82c study?

A

Postmenopausal, <70 y/o with high risk (N+, >5 cm or invasion of sin or pec fascia)<div><br></br></div><div>TAM+RT 48-50 Gy to CW and nodes vs TAM alone</div>

82
Q

What were results (survival and LRR) of Danish DBCG 82c study (locally advanced post-menopausal)?

A

PMRT improved 10-yr OS (45% vs 36%), DFS and LRR (8% vs 35%)

83
Q

What is design and question being answered of ongoing TAILOR RT trial?

A

Is there benefit to RNI for low Oncotype?<div><br></br></div><div>Oncotype <18, ER+, Her2-</div><div>1-3 LNs after LND, or 1-2 LNs ater SLNB + BCS, or 1 LN after SLNB + MRM</div><div><br></br></div><div>Randomzied to no RT (except WBRT for BCS) or WBRT + RNI or PMRT + RNI</div><div><br></br></div><div>No neoadjuvant chemo included</div>

84
Q

What evidence exists for hypofractionated PMRT with chemo?

A

British Columbia (Rogaz, JCNI 2005): premenopausal women s/p MRM with LN+ randomized to 1) CMF alone, or 2) CMF with 37.5 Gy/16 fx PMRT RNI to CW, SCV, axilla and bilateral IMNs<div><br></br></div><div>-Improved 20-yr LRF (26% vs 10%), 20-yr OS by 10% (37% vs 47%)</div><div><br></br></div><div>Higher cardiac toxicity with RT (0.6% vs 1.8%)</div>

85
Q

What is design and question being answered of ongoing SUPREMO trial for locally advanced breast?

A

<div>Hypofractionated PMRT?</div>

<div><br></br></div>

Post-mastectomy T1-2 and 1-3 nodes, T2N0 grade 3 or T2N0 with LVSI<div><br></br></div><div>RT choice of 40 Gy/15 fx (70%), 45 Gy/20 fx or 50 Gy/25 fx</div><div><br></br></div><div>Low toxicity of hypofractionated RT at 2 year data cut</div>

86
Q

Is there benefit to PMRT in early stage triple negative patients?

A

China (Wang, Radiother Oncol, 2011): 681 pts stage I-II TNBC s/p MRM + chemo (80% of patients were node negative)<div><br></br></div><div>Improved 5-yr RFS and OS by about 10% each</div>

87
Q

Is there a benefit of chest wall boost with PMRT?

A

No, large retrospective review from MGH (IJROBP, 2019) of 746 pts demonstrated 10 Gy CW boost increased implant failures and skin toxicity without improving local control<div><br></br></div><div>*Retrospective analysis</div>

88
Q

What is design of ongoing Alliance RT CHARM study?

A

Stage IIa-IIIa with planned reconstruction after MRM (excludes T3, N3 or positive IMNs)<div><br></br></div><div>Randomized to 1) 42.56 Gy/16 fx RNI vs 50 Gy/25 fx RNI</div>

89
Q

What is design/question for ALLIANCE A011202 (ongoing)?

A

Similar to AMAROS but with neoadj. CHT (is ALND needed in N+ after CHT?)<div><br></br></div><div>cT1-3N1 –> NAC –> surgery –> SLNB (ypN+)</div><div><br></br></div><div>1) ALND + RNI vs 2) axillary RT and RNI</div>

90
Q

What is design/question of RTOG 1304/NSABP B-51 (ongoing)?

A

Is RNI needed for ypN0 after neoadj. CHT?<div><br></br></div><div>cT1-3N1 –> NAC –> surgery –> SLNB ypN0</div><div><br></br></div><div>Lumpectomy: WBRT vs WBRT + RNI</div><div>Mastectomy: observation vs PMRT + RNI</div><div><br></br></div><div>*Differentiate from Alliance A011202 (these are SLNB negative after NAC)</div>

91
Q

Is there benefit to regional nodal irradiation (from EBCTCG meta-analysis), and how did this depend on heart dose?

A

14 trials, 13132 pts<div><br></br></div><div>Trials 1989-2003: reduced BC recurrence, BCM and overall mortality</div><div><br></br></div><div>Trials 1961-1978: no benefit in BCR or BCM, OS worse</div><div><br></br></div><div>Older trials estimated to have heart doses >8 Gy and <85% dose to nodes (heart dose is important)</div>

92
Q

Do we need to cover IMN nodes with RNI (data from DBCG-IMN)?

A

Patients (operable BC, N+) randomized to no IMN RNI (left sided) vs +IMN RNI (right sided)<div><br></br></div><div>8-yr OS (72% vs 76%) and BCM (23% vs 21%) improved with inclusion of IMNs</div>

93
Q

What were results of EORTC 22922/10925 randomizing patients to no RNI vs RNI to IMN and medical SCV?

A

Included patients with medial tumors or any N+<br></br><div><br></br></div><div>Preserved 15-yr BCM benefit, but DM, DFS and OS benefit seen at 10-yrs disappears</div><div><br></br></div><div>*Note this shows potential benefit in N0 patients, which is contradicted in EBCTCG meta-analysis</div>

94
Q

Is there a benefit of RNI after breast conservation for N+ or high risk patients (>5 cm, >2 cm with <10 nodes removed with either ER-, Grade 3 or LVI) from MA.20?

A

s/p BC and SLNB/ALND and adjuvant chemo or ET with above features<div><br></br></div><div>1) no RNI vs 2) RNI to IMN, SCV, axillary levels III (plus I-II if <10 ndoes removed or >3 nodes +)</div><div><br></br></div><div>Improved 10-yr DFS (77% vs 82%), no diff in OS or BCM</div><div><br></br></div><div>Relatively low rates of pneumonitis and lymphedema</div><div><br></br></div><div>*benefit of inclusion of IMNs? (although this was no RNI vs IMN+ RNI)</div>

95
Q

What did Paris, Hennequin et al (IJROBP, 2013) study show in regards to inclusion of IMNs?

A

<div>+Axillary nodes or medial tumor after mastectomy</div>

<div><br></br></div>

No DFS or OS benefit to inclusion of IMNs with RNI<div><br></br></div><div>*Powered to detect 10% improvement (MA.20 only showed 3% benefit)</div>

96
Q

What is primary risk for local recurrence after mastectomy for T1-2 tumors?

A

MSKCC (Mamtani et al, Cancer 2012): increasing tumor size in setting of NO chemotherapy was only significant predictor of local recurrence

97
Q

Can Oncotype be utilized to predict LRR (from retrospective review of B-14 and B-20)?

A

Yes, 10-yr LRR low (4%), int (7.2%), high (16%)

98
Q

Was Oncotype predictive of LRR risk from SWOG S8814 (post-menopausal, N+, ER/PR+, BCS or mastectomy)?

A

Yes, 10-yr LRR, low (10%), int-high (17%)

99
Q

What are general predictors of LRR post-mastectomy (from multiple retrospective reviews) that may benefit from PMRT?

A

Young age, increased nodes positive, tumor size, +LVSI, grade, ER negative, decreasing nodes examined

100
Q

What is most common site of LRR after mastectomy?

A

Chest wall (68%), SCV (41%) (MDACC, Katz 2000)

101
Q

Describe patterns of failure for node + breast cancer s/p mastectomy without PMRT (NSABP meta-analysis).

A

10-yr LRF (with or without distant) 20%, isolated LRF 12%, 10-yr DF alone 43%<div><br></br></div><div>Predictors of LRF as first event: age, tumor size, premenopausal, LN+, # LN dissected</div><div><br></br></div><div>Large tumor and >=4 nodes high risk of local failure and probably greatest benefit from PMRT</div>

102
Q

Is there benefit to PMRT with T3N0 patients?

A

Low rates of LRF: 5-yr 7.6% (MDACC, Floyd IJROBP, 2006), higher rates with LVI<div><br></br></div><div>*Probably minimal benefit</div><div><br></br></div><div><br></br></div>

103
Q

Is there benefit to a neoadjuvant vs adjuvant chemotherapy approach in breast cancer?

A

No difference in OS, BCM or DM with higher rates of LRR with neoadj. (EBCTCG meta-analysis)

104
Q

What was design of NSABP B-18?

A

T1-3N0-1, randomzied to neoadj. AC vs adjuvant AC

105
Q

What were outcomes of neoadjuvant vs adjuvant CHT on NSABP B-18?

A

<div>NAC allowed more BCS (68% vs 60%)</div>

<div>No difference in OS</div>

<div>*pCR predicts OS and DFS (OS at 9-yr 78% with CR, 67% with PR, 65% with no response)</div>

106
Q

What were arms on NSABP B-27?

A

T1c-T3 N0-1 or T1-3N1<div>1) neoadjuvant AC vs 2) neoadj. ACT vs neoadj. AC –> surgery –> T</div>

107
Q

What were outcomes with different NAC approaches in NSABP B-27?

A

Best pCR rates with neoadjuvant ACT (compared to AC alone), 13% vs 26%

108
Q

What were predictors of LRR from NSABP B-18 and B-27 after neoadjuvant chemo?

A

T-stage, N-stage, tumor size and path response (after mastectomy)<div><br></br></div><div>Age, clinical tumor and nodal status, and chemo response (BCS)</div>

109
Q

What do retrospective analyses demonstrate in terms of benefit of RT after NAC?

A

Possible benefit of PMRT in stage III, T3-T4, or >=4 nodes (note that this contradicts DBCG and EBCTCG meta-analyses that demonstrated benefit for 1-3 nodes)<div><br></br></div><div>*Retrospective single institution or NCDB analyses (randomized trials including Alliance and B-51 are ongoing)</div>

110
Q

Is there benefit to dose escalation for inflammatory breast cancer?

A

Yes, based on MDACC retrospective experience for select patients<div><br></br></div><div>Dose escalation up to 66 Gy from 60 Gy gave LRC in patients with 1) partial response to NAC, 2) close, positive or unknown margins, or 3) <45 years old</div><div><br></br></div><div>Increased grade 3-4 toxicity (29% vs 15% with 60 Gy)</div>

111
Q

Is there a survival benefit with local treatment of the primary in metastatic breast cancer?

A

No, based on Tata memorial series (350 pts)<div><br></br></div><div>Locoregional treatment to primary and nodes, no differenc ein median OS, 2-yr OS with local treatment</div>

112
Q

What were inclusion criteria and outcomes for SABR-COMET?

A

<=5 oligometas (93% were 1-3), any histology with controlled primary after definitive treatment<div><br></br></div><div>Most patients were lung, breast, colorectal or prostate</div><div><br></br></div><div>Randomized to 1) SBRT + SOC, 2) SOC</div><div><br></br></div><div>Improved median OS 50 vs 28 months, and median PFS 12 vs 6 months</div>

113
Q

What is design of NRG-BR002 (breast oligomet trial) (ongoing)?

A

<=4 oligomets, size <5 cm amenable to surgery or SBRT, excludes brain mets<div><br></br></div><div>1) SOC chemo vs 2) SBRT or surgery</div><div><br></br></div><div>Primary endpoints of PFS and OS</div>

114
Q

Is there benefit to use of IMRT vs 2D or 3DCRT techniques in early stage breast?

A

Yes, reduced toxicity observed across small trials. No compromised outcomes<div><br></br></div><div>Erasmus Cancer Institute, Netherland (Pignol, Radiother, 2016): 2D vs IMRT, reduced moist desquamation, no difference in OS, LRFS, or DFS</div><div><br></br></div><div>Royal Marsden (Donovan, Radiother, 2007): IMRT vs 2D, less palpable induration</div><div><br></br></div><div>KROG 15-03: pT1-2N0M0, IMRT 57.4 Gy/28 fx with SIB vs 3DCRT 59.4 Gy/33 fx, reduced >= grade 2 toxicity with IMRT, better coverage and lower lung doses</div>

115
Q

Is there benefit to use of hyperthermia for chest wall recurrences for locally recurrent breast cancer?

A

Yes, Datta et al, IJROBP, 2016; meta-analysis of 2210 pts, demonstrated improved CR rates when combined with RT (60.2% combined vs 38.1% alone) with low toxicity

116
Q

What evidence exists for re-irradiation outcomes for locally recurrent breast cancer?

A

RTOG 1014, local recurrence >1 yr from previous single tumor <3 cm<div><br></br></div><div>RT given as 45 Gy/30 fx BID with PBI EBRT</div><div><br></br></div><div>Grade 3 tox: 7%, no grade 4 or 5</div><div>5-yr IBTR low (5%), 5-yr mastectomy (10%), excellent DM and OS (95%)</div>

117
Q

What is the mean heart dose needed to maintain acute coronary event risk <5% with breast XRT?

A

From van den Bogaard et al, JCO 2017:<div><br></br></div><div>4-8 Gy, cumulative incidence of ACE increased 16.5% per each Gy, no threshold</div>

118
Q

What is risk of major coronary event per Gy from Darby breast XRT analysis?

A

7.4% per each Gy, no threshold<div><br></br></div><div>Absolute risk higher for those with risk factors</div><div><br></br></div><div>*Caveat: most of these patients were treated prior to 3DCRT, had to be virtually reconstructed to generate dosimetry</div>

119
Q

How does anthracycline based chemo perform compared to CMF in breast CA (from EBCTCG meta-analysis)?

A

194 randomized control trials of adjuvant CHT or hormones<div><br></br></div><div>Anthracyclines superior to CMF</div><div><br></br></div><div>*Better benefit in age <50, that is indepedent of TAM, nodal status or tumor features</div>

120
Q

What are the risks of late recurrence in breast cancer (after 5 years of endocrine therapy)?

A

EBCTCG, NEJM, 2017: 88 trials of women disease free after 5-yrs of endocrine therapy<div><br></br></div><div>Risk of distant recurrence remains that increases with increasing nodal involvement, T-stage and grade</div><div><br></br></div><div>*Best resource for chance of distant recurrence</div>

121
Q

Is there a benefit of chemotherapy in Oncotype intermediate (11-25) patients?

A

No, TAILORx demonstrated no change in 9-yr OS, DM, DFS, FFDM FF LRR/DM in score 11-25 pts<div><br></br></div><div>Benefit in age <50 in DFS, LRR+DM but not DM or OS</div>

122
Q

Is there benefit to addition of CHT to endocrine therapy in low-int. risk Oncotype with 1-3 nodes (RXPONDER)?

A

Yes, for premenopausal women (improved 5-yr IDFS 94% vs 89%), no difference in post-menopausal women

123
Q

Is there benefit to adjuvant capecitabine in women with PR in breast after neoaj. chemo and surgery (CREATE-X)?

A

Yes, capecitabine imrpoved 5-yr DFS (74% vs 68%) and OS (89% vs 84%), particularly large benefit in TNBC patients

124
Q

What were results of addition of pembrolizumab to neoadj. carbo/paclitaxel in KEYNOTE-522 (TNBC)?

A

Improved pCR (65% vs 51%) at interim analysis, PD-L1 had better pCR rates in both arms<div><br></br>*Awaiting OS data</div>

125
Q

Is there a benefit of addition of trastuzumab-emanstine (TDM-1) over trastuzumab for women with Her2+ BC after PR to NAC? (KATHERINE trial)

A

Yes, TDM-1 improves 3-yr invasive LR (88% vs 77%), DFS (HR 0.50), DM (11% vs 16%)<div><br></br></div><div>What is emtansine? (microtubule inhibitor)</div>

126
Q

Which patients with recurrent breast cancer benefit from chemotherapy?

A

CALOR: recurrent breast cancer, radical resection, chemo vs no chemo<div><br></br></div><div>Improved OS in ER negative patients only (no benefit in ER+, can be managed with endocrine therapy only)</div>

127
Q

Should adjuvant chemo be given before or after RT in patients after lumpectomy?

A

Doesn’t matter (Harvard, Bellon, JCO 2005): adjuvant cyclophospmade, doxorubicin, methotrexate, fluorouracil and predisone<div><br></br></div><div>Randomized to CHT before or after RT<br></br><div><br></br></div><div>No differences in time to any event, DM or OS base</div></div><div><br></br></div><div>*High Oncotype may indicate increased risk of DM and may benefit from earlier CHT</div>

128
Q

How does fulvestrant perform vs anastrazole in patients with locally advanced or metastatic breast cancer (FALCON)?

A

Improved PFS (16.6 vs 13.8 months), higher rates of arthralgia with fulvestrant

129
Q

How does pertuzumab-based neoadjuvant regimens perform relative to trastuzumab (NEOSPHERE)?

A

Locally advanced, inflammatory or early stage breast CA treated with NAC<div><br></br></div><div>1) Trastuzumab/docetaxel vs 2) pertuzumab/trastuzumab/docetaxel vs 3) pertuzumab/trastuzumab vs 4) pertuzumab/docetaxel</div><div><br></br></div><div>Improved PFS, DFS and pCR rates with addition of pertuzumab to trastuzumab + docetaxel</div>

130
Q

What is the optimal duration Her2 targeted therapy in Her2+ advanced breast cancer?

A

HERA BIG: 1 yr vs 2 yr Herceptin vs observation, improved 10-yrs DFS with Herceptin (69% vs 69% vs 63%), no benefit to 2 yrs of therapy<div><br></br>*1-yr of therapy is optimal</div>

131
Q

What is the addition survival benefit of Herceptin added to paclitaxel after AC (NSABP-31 and NCCTG analysis)?

A

Improved relative survival by 37%, 10-yr DFS and OS both increased by ~10% absolute

132
Q

What was the design of the HER2CLIMB study and what novel molecule was used?

A

Metastatic Her2+ breast CA, s/p trastuzumab, pertuzumab and TDM1, brain mets allowed<div><br></br></div><div>Randomized to placebo vs trastuzumab, capecitabine and tucatinib</div><div><br></br></div><div>Improved PFS and OS with or without brain mets</div><div><br></br></div><div>Tucatinib is a small molecule Her2 inhibitor with BBB penetrance</div>

133
Q

Are there response or tolerability differences between AC and CMF for breast cancer non-responsive to TAM (Fisher, NSABP B-15)?

A

1) AC vs 2) CMF, no difference in DFS, DM or OS<div>AC complted sooner with less nausea, more alopecia with CMF</div><div><br></br></div><div>*AC is better option</div>

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