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Breast Conservation Therapy
• alternative to mastectomy: equal outcome
• outcomes have improved over time
Outcome of BCT in 2013Outcome of BCT in 2013
• outcomes have improved over time
– screening: early stage
– improved breast imaging
– improved pathology/surgery
– use of systemic therapy
– improve radiation delivery
Low Rates of Local RecurrenceLow Rates of Local Recurrence
96%
Breast Recurrence Rates At MDACC Over Time
96.5%96%
Cabiogula, Cancer, 2005
96.5%
Radiation Plays a Critical Radiation Plays a Critical Role in Achieving TheseRole in Achieving These
Excellent OutcomesExcellent Outcomes
Early Breast Cancer Trialist’s Group• meta-analysis of lumpectomy +/- XRT• long term outcome
Radiation and Breast Conservation: Radiation and Breast Conservation: Invasive Breast CancerInvasive Breast Cancer
• long term outcome• 17 trials, 10,801 patients• conclusions
– XRT reduces breast recurrence– XRT improves overall survival
Lancet 378, 2011
Oxford MetaOxford Meta--Analysis of Analysis of BCT +/BCT +/-- Radiation TrialsRadiation Trials
Lancet 378, 2011
Oxford MetaOxford Meta--Analysis of Analysis of BCT +/BCT +/-- Radiation TrialsRadiation Trials
Lancet Lancet
378, 2011
New Research Focus:New Research Focus:Make Radiation Less Make Radiation Less Make Radiation Less Make Radiation Less
BurdensomeBurdensome
6-7 weeks of daily treatment
• impractical for some
– pts who live away from facility
There Is a Need to MakeThere Is a Need to MakeWhole Breast Radiation FasterWhole Breast Radiation Faster
– pts who live away from facility
– countries with limited number of rad onc depts
• forces many to have mastectomy
• expensive
New Research Strategies
• hypofractionated whole breast radiation
• intraoperative single fraction PBI
Four Approaches ToFour Approaches ToDecreasing Radiation BurdenDecreasing Radiation Burden
• intraoperative single fraction PBI
• 3D conformal PBI
• brachytherapy PBI
• interstitial
• catheters
Can the Rx be shorten from 5 wks to 3 wks• two prospective trials: Canada and UK • both mostly enrolled LN- disease, postmen
Whole Breast HypofractionationWhole Breast Hypofractionation
• both mostly enrolled LN- disease, postmen• Fractionation
– Canada: 42.5 Gy/16 fx vs 50 Gy/25 fx– UK START B: 40/15 fx vs. 50/25 fx
Canadian• 10 yr result equivalent
– breast recurrence: 6.2% vs. 6.7%
ResultsResults
– good/excellent cosmesis: 70% vs. 71%
UK• 5 yr result equivalent
– breast recurrence: 2.8% vs. 2.8%– good/excellent cosmesis: equivalent
Can the Rx be shorten to 1 – 5 days• most tumors recur at tumor bed site • treat limited breast volume
Partial Breast IrradiationPartial Breast Irradiation
• treat limited breast volume• target tumor bed + 1 cm
– allows for treating with fewer fractions– possible lower complications
Treatment of a small volume around tumor Treatment of a small volume around tumor bedbedmay not prevent all recurrencesmay not prevent all recurrences
Treatment Volume Rationale(Con Side of Debate)
Pathology
• Vaidya JS et al.: 30 cases
– 63% had other foci of disease
Disease Extent DataDisease Extent Data
– 79% of these outside index quadrantMRI Data
• International collaborative study– 24% had incidental lesions
• Bedrosian et al.– 18% had additional disease found
Treated with a surgical PBI target volume
• 85% T1 primary, 67% LN -
Milan Quadrantectomy TrialMilan Quadrantectomy Trial
24%
Veronsi et al, Ann Oncol, 12:997, 2001
Intraoperative XRTIntraoperative XRT
(Veronesi U, et al.
Eur J Cancer
2001;37:2178-83)
(Vaidya JS, et al.
Eur J Surg Oncol
2002;28:447-54)
Targit Trial Lancet 2010Targit Trial Lancet 2010
•• 1113 patients randomized trial1113 patients randomized trial–– favorable disease cohortfavorable disease cohort–– 14% of 14% of targittargit pts received whole breastpts received whole breast–– 14% of 14% of targittargit pts received whole breastpts received whole breast–– most ER+, still receiving most ER+, still receiving tamoxifentamoxifen
•• 4 year results excellent4 year results excellent–– 1% local recurrence in both arms1% local recurrence in both arms
ELIOT Trial EBCC 2012ELIOT Trial EBCC 2012
•• Whole breast vs. Whole breast vs. IntraoperativeIntraoperative ElectronElectron–– 66--fold higher LR in IO Electron Armfold higher LR in IO Electron Arm–– 66--fold higher LR in IO Electron Armfold higher LR in IO Electron Arm
Canadian RAPID TrialCanadian RAPID Trial
Whole Breast Irradiation after Partial Breast Irradiation prior
2135 Patients with Lumpectomy
RANDOMIZED
Whole Breast Irradiation after Adjuvant Chemotherapy
50 Gy (2.0 Gy/fraction) or42.5 Gy in 16 fractions
Partial Breast Irradiation prior to Adjuvant Chemotherapy
38.5 Gy in 3.85 Gy fractions3D Conformal External Beam
ASTRO plenary session 2012
• no data on local recurrence
• Cosmetic data assessed by nurses, photos
Cosmetic Outcome DataCosmetic Outcome Data
• prior to XRT, both arms had 18% adverse cosmesis
• 3 yrs after XRT, adverse cosmesis rates were
– 32% in partial breast arm
– 19% in whole breast arm• also had increase rates of G1/G2 late toxicity
NSABP BNSABP B--39/RTOG 041339/RTOG 0413Phase III APBI TrialPhase III APBI Trial
Whole Breast Irradiation after Partial Breast Irradiation prior
Eligible Patients with Lumpectomy
RANDOMIZED
Whole Breast Irradiation after Adjuvant Chemotherapy
50 Gy (2.0 Gy/fraction) or50.4 Gy (1.8 Gy/fraction) to whole
breast, followed by optional boost to > 60 Gy
Partial Breast Irradiation prior to Adjuvant Chemotherapy
For a total of 10 treatments given on 5 days over 5 to 10 days:
34 Gy in 3.4 Gy fractionsInterstitial Brachytherapy or
Mammosite Balloon Catheter or
38.5 Gy in 3.85 Gy fractions3D Conformal External Beam
Fractionated Brachytherapy Fractionated Brachytherapy
Mammosite Double Plane Implant
(Rt-image.com)(mammosite.com)
Mammosite DataMammosite Data
American Society of Breast Surgery RegistryAmerican Society of Breast Surgery Registry•• 1440 pts with invasive disease1440 pts with invasive disease•• 5 yr breast recurrence rate: 3%5 yr breast recurrence rate: 3%•• 5 yr breast recurrence rate: 3%5 yr breast recurrence rate: 3%•• 88% good/excellent cosmesis @ 5 yrs88% good/excellent cosmesis @ 5 yrs•• not a former clinical trialnot a former clinical trial
Vicini, ASTRO 2009
•• 130,535 women130,535 women•• medicaremedicare billing claimsbilling claims•• age ≥ 67 yearsage ≥ 67 years
MDACC Study Population
•• age ≥ 67 yearsage ≥ 67 years•• invasive breast cancer diagnosed 2000 invasive breast cancer diagnosed 2000 –– 20072007•• treated with lumpectomy + radiation treated with lumpectomy + radiation
Smith et al, JAMA, 2012Smith et al, JAMA, 2012
LN +LN +
HR
4.69
95% CI
2.83 – 7.76
P
<0.001
MV Analysis By LN Status
LN ─LN ─ 2.06 1.73 – 2.45 <0.001
No modifying effect seen with:
Age, race, comorbidity, chemotherapy, year, region
OutcomeOutcome
AnyAny
Brachy (%)
24
WBI (%)
14
P
<0.001
Postoperative Complications
AnyAny
InfectiousInfectious
NonNon--infectiousinfectious
24
16
16
14
10
8
<0.001
<0.001
<0.001
AnyAny
Rib fractureRib fracture
26
4.2
Outcome Brachy (%) WBI (%) P
18
3.6
<0.001
0.03
Post-radiation Complications
Rib fractureRib fracture
Fat necrosisFat necrosis
Breast painBreast pain
RT pneumonitisRT pneumonitis
4.2
9
15
0.1
3.6
4
12
0.8
0.03
<0.001
<0.001
<0.001
Many new catheters to deliver APBI• combination of interstitial/intraluminal• allow greater sparing of skin
New DirectionsNew Directions
• allow greater sparing of skin• greater conformality over chest wall
Depth Markers
5 Radiation Lumens
Variably Inflatable Balloon
Contura™ MLB
Stiffening StyletStiffening Stylet
Vacuum Ports Vacuum Lumen
Inflation Lumen
ASTRO Consensus StatementASTRO Consensus StatementSuitable for Suitable for APBIAPBI Unsuitable for APBIUnsuitable for APBI
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