Partial Breast

Irradiation
Dawn Radsek, RN
Froedtert Hospital
9200 W Wisconsin Ave
Milwaukee, WI
414/805-4440
I have no financial ties to any
company to disclose
 Objectives
• Participant will be able to define partial breast
irradiation and be able to educate patients on
eligibility.
• Participant will be able to differentiate between the
three established methods for PBI
• Participant will be able to discuss the potential
benefits of PBI
 Acknowledgements
ƒ I would like to thank:
• Julia White, MD for her expertise and knowledge
in preparing this talk and the use of her slides
• Jessica Kotowitz, for her help in proofreading
and organizing my presentation
• Our patients for allowing us to share their
information and pictures
 Agenda
ƒ Rationale & Definitions
ƒ Background
ƒ Phase I-II Trials for PBI methods
ƒ PBI Methods & Nursing Care
ƒ Randomized Phase III Trials
ƒ Treating off protocol
ƒ Conclusion
 Pattern of In-Breast Cancer Recurrences
Following Breast Conserving Therapy
The majority of cancer recurrences in the treated
breast occur at the lumpectomy site
# Follow-up Elsewhere Failure (Outside
Cases Interval Lumpectomy Region)
Randomized Trials (BCT) (mos) No XRT XRT
Crude % Crude %
Ontario 837 43 15/421 3.5 4/416 0.9

Milan III 579 109 8/280 2.8 2/299 0.6

NSABP B06 1265 144 17/636 2.7 24/629 3.8

Uppsala-Orebro 381 33 3/194 1.5 1/187 0.5

Finland 152 80 4/72 5.5 4/80 5.0

 Partial Breast Irradiation (PBI)
Scientific Rationale
ƒ Major Effect Of Post-Lumpectomy RT:
• Reduce Risk Of Recurrence In Tumor Bed Region

ƒ Recurrences Away From Tumor Bed

(‘Elsewhere’ Failures-New Primary cancers):
• Much Lower Frequency After Lumpectomy Alone
Or Followed By Whole Breast RT
 Partial Breast Irradiation
- Definition -
ƒ Delivery of larger doses/fraction of radiation
therapy (RT) to the lumpectomy cavity (plus
1-2 cm margin) after breast conserving
surgery in patients with early stage breast
cancer using brachytherapy or external beam
irradiation techniques

ƒ Complete RT in < 5-8 days after lumpectomy

instead of 6-7 weeks
 Potential Benefits of Partial
Breast Irradiation
ƒ Reduce time and inconvenience of BCT
ƒ Improve documented underutilization of
breast conserving therapy (BCT)?
ƒ Reduce inadvertent irradiation of normal
tissue
ƒ Potentially reduce acute and chronic toxicity
ƒ Reduce burden of care for patients
ƒ Eliminate scheduling problems with systemic
chemotherapy
Early Attempts at PBI after Lumpectomy
Local
Trial Eligibility Treatment FU Recurrence
• T < 4 cm
• All histo
Christie • No Electrons to
Hospital margin quadrant 65 mo. 25%
(n=353) Assessme (500 cGy x 8)
nt

• T 3.5 cm
Single plane IR
Guy’s Trial • All histo 192 implant
• 37% 72 mo. 36%
(n=27) (5500 cGy LDR-
pos. --40 cGy / hr)
margins
 Next Generation of PBI Studies
Multi-catheter Brachytherapy
Breast
Institution Eligibility Treatment # FU Failure
- T < 4cm
Kuske - All Histo
LDR (45 Gy) 26 75
Oschner -Neg. 2%
Clinic margins HDR (4Gy x 8) 25 mo

Vicini -T < 4 cm
LDR (50 Gy) 12
William - No EIC, ILC
0 36
HDR (4Gy x 8) 1%
Beaumont - Neg. mo
Hospital margins (3.4 x 10) 54
 Three Established Methods For PBI

3-D Conformal

MammoSite®
Multi-Catheter
 RTOG 95-17
A phase I/II trial to evaluate multi-catheter
brachytherapy as the sole method of radiation
therapy for stage I - II Breast Cancer

ƒ Could the results from single institution trials be

reproduced in the cooperative group setting
ƒ Emphasized quality assurance- all institutions had
to be credentialed to participate
ƒ Each case had individual central review of the
brachytherapy plan prior to beginning treatment
 RTOG 95-17
Eligibility
ƒ T size < 3 cm

ƒ N0, N1 (< 3 positive nodes)

ƒ No infiltrating lobular, EIC
ƒ Negative Margins
ƒ 6 surgical clips to delineate the lumpectomy
ƒ Dose coverage to lumpectomy volume + 2
cm
 RTOG 95-17
Multi-catheter brachytherapy
ƒ 99 patients accrued between 1997- 2000

• 66 HDR 3.4 Gy x 10 BID over 5 days

• 33 LDR 45 Gy over 4.5 days
ƒ 10 institutions
ƒ Adequate coverage of target volume 97%
ƒ Implants: 2 planes -74, > 2 planes - 24,
1 plane - 1
 RTOG 95-17: Multi-catheter PBI
HDR LDR

n=66 n=33

Median F/U (yrs) 6.55 7.09

Local recurrence (%) 3 6

Regional Recurrence (%) 5 0

New Contralateral (%) 2 6

Distant Failure (%) 5 3

Disease Free Survival (%) 86 85

Overall Survival (%) 92 94

Arthur et al, ASTRO, 2006

 Preoperative Prep
ƒ MD performs H&P & obtains consent
ƒ Nurse reviews patient meds & allergies
• Instructs pt. which meds to hold
ƒ NPO after midnight the night prior to
procedure
ƒ CBC/Diff, PT, PTT ordered and reviewed
ƒ Cefazolin (Ancef) 1-2 grams ordered to be
given during procedure (depends on wt. < or
> than 70 kg.)
 Day of Procedure
ƒ Nurse performs pt. assessment and
completes surgical checklist
ƒ Radiation Oncologist marks lumpectomy site,
applies Emla cream and places plastic wrap
on breast 30-45 minutes prior to procedure
ƒ Anesthesiologist or CRNA starts IV, gives
Cefazolin (Ancef)
 Multi-catheter Procedure
ƒ Patient positioned on CT-sim table with vac-fix
ƒ MD removes plastic wrap and re-marks the site
ƒ Radiation therapist obtains initial CT-sim
ƒ RN or MA perform surgical scrub to breast, axilla,
and chest wall
ƒ MD places drapes and sterile markers and begins
placing catheters
ƒ Multiple CT-sims are performed as MD places
catheters
 RTOG 95-17
Multi-catheter Breast Brachytherapy
Intraopertive placement of catheters following lumpectomy
 Post-op Care
ƒ Measurements performed for dosimetry and
pictures taken to document catheter numbering
ƒ Surgical site cleansed with sterile 4x4’s, cotton tip
applicators, and saline
ƒ Area thoroughly dried
ƒ Dry 4x4’s placed between planes of catheters,
fluffed on top, ABD pads enveloped around
catheters for protection, and surgical bra placed
ƒ Two pain scripts for mild and moderate pain given
ƒ Pt is sent to recovery and then discharged home
Dose Distribution of MultiCatheter PBI

PTV

100% isodose
 Treatment
ƒ Pt instructed to take pain medication 1 hour prior to
arriving for 1st treatment
ƒ Pt is positioned on table with vac fix to duplicate
positioning at time of catheter placement
ƒ Surgical bra and dressings are removed,
assessment of drainage and skin
ƒ Transfer tubes connected to catheters using head
to toe, lateral to medial approach with medical
physicist present
ƒ Sterile gloves used
ƒ Sterile towel placed between each plane of implant
 PBI:
Multi-catheter
Brachytherapy
 Skin Care During Treatments
ƒ Each site cleansed with sterile cotton tip applicators
and saline
ƒ Dried thoroughly, ointment or cream may be
applied
ƒ Sterile 4x4’s placed between each plane and fluffed
on top of entire site
ƒ ABD pads placed and enveloped around the
catheters for protection
ƒ Minimal tape used on patient’s skin
ƒ Surgical bra placed to hold dressing in place
ƒ Antibiotic started after 7th treatment x 7 days
 Multi-catheter removal
ƒ Pt instructed to take pain medication ½ hour prior to final
treatment
ƒ Following final treatment vac-fix is removed; pillow placed
under head
ƒ MD and RN perform Betadine scrub to sites and entire chest
wall and breast
ƒ MD cuts medial end of catheters and removes pulling from
lateral end
ƒ Pressure held at least 10 minutes, assessing for bleeding
and drainage at sites
ƒ Entire area cleansed with sterile saline, dried, triple
antibiotic ointment applied with sterile cotton tip applicators,
sterile 4x4’s applied and covered with occlusive dressing
 Discharge Instructions
ƒ Pt instructed to continue antibiotics until gone
ƒ No showering or getting breast wet for 48 hours
ƒ Remove dressing from breast in 2 days (may begin
showering if sites are healed over)
ƒ Resume normal activity as tolerated
ƒ Take pain meds as needed
ƒ Return to see radiation oncologist the following week
ƒ Report any of the following problems:
• Redness and warmth of the breast or chest skin
• Oral temperature over 100.5 degrees
• Excessive pain in the breast that is not relieved by your pain
medication
• Drainage that soaks through the bandage
 PBI: Multi-catheter
Brachytherapy
3 days post treatment 6 weeks post treatment
Breast Appearance Following Multi-
catheter Brachytherapy
5 years post treatment
 MultiCatheter PBI (HDR/ LDR): Summary
Exc/ good
Pt. Median F/U T size (cm) N+ ER + Tam LR
Cosmesis
Institution No. age mo. median % % % %
%
Oschner 163 63 65 - 15 65 - 3 -

Beaumont 199 65 65 1.1 12 - 57 1.2 99

Tufts-NEMC 32 63 84 1.3 9 79 61 9 93

VCU 44 62 42 1.2 18 - 66 0 80

Nat. Inst. Onc. 45 56 81 1.2 2 82 16 6.7 97

Budapest

Guys Cs 137 49 58 75 2.5 46 - - 18 81

U of WI 240 - 30 - - - - 1 95

MCW 67 68 30 1.2 1.5 88 76 1.3 79

RTOG-9517 99 62 80 88% T-1 20 75 - 4 -

Average: 62 yo 61 mo 1.4 cm 15% 78% 4.9% 89%

 MammoSite PBI
MammoSite® Breast Brachytherapy Applicator
ƒ Simplified brachytherapy
method for PBI
ƒ Dual lumen single catheter
with expandable balloon at
end
ƒ Balloon expands to fill the
lumpectomy cavity
ƒ Radiation dose prescribed
to 1 cm beyond balloon
surface
ƒ FDA approval May 2002
ƒ 12,000- 15,000 used
 MammoSite® Initial Clinical Trial -
Eligibility
ƒ Tumor size < 2 cm
ƒ > 45 years old
ƒ Node Negative
ƒ Negative Margins (NSABP)
ƒ No EIC, infiltrating lobular
ƒ No cavities < 3 x 3 x 3 or > 5 x 5 x 5 cm
ƒ No cavity edge < 5mm from skin
ƒ Placement within 4 weeks of lumpectomy
PBI: MammoSite® Initial Clinical Trial
ƒ 6 institutions
ƒ 70 patients enrolled between 2000 – 2001
ƒ 16 patients not implanted
ƒ 54 implanted – 34 open, 20 closed
ƒ 43 brachytherapy completed – 25 open, 18
closed
ƒ 3.4 Gy x 10 treatments over 5 days
 MammoSite® Phase II Study-
4 year Results Keisch, et al
Overview:
43 patients enrolled 5/2000- 10/2001
34 Gy in 10 fractions over 5 days
dose 1 cm from applicator surface
Results: Median follow-up 48 months
No local recurrences
80% good/ excellent cosmesis
Cosmesis correlates with skin spacing < 7
mm
98 % patient satisfaction
ASTRO 2005
 American Society of Breast Surgeons
MammoSite® Breast Brachytherapy Registry Trial

ƒ 5/4/2002 – 7/30/2004
ƒ 1270 evaluable patients - 87 institutions
ƒ 227 investigators
ƒ 50% registered pre-treatment
ƒ 43% registered after treatment
ƒ Median follow-up 5 months Vicini, et. al
 Characteristic Finding
Median Age 65 Years (Range 35-93)
AJCC Tumor Stage Number (%)
ASBS Tis (in-situ)
Invasive Carcinoma
169 (13.7%)
1068 (86.3%)

MammoSite® T1a (< 0.5 cm)

T1b (> 0.5 and < 1.0 cm)
144 (11.6%)
424 (34.3%)
T1c (> 1.0 and < 2.0 cm) 423 (34.2%)
Registry Trial T2 (> 2.0 and < 5.0 cm)
Stage 0
77 (6.2%)
169 (13.7%)
n=1270 Stage I
Stage II
991 (80.1%)
77 (89.3%)
N0 977 (91.5)%
N(+) 33 (3.1)%
Patient Population NX 58 (5.4)%
Margins
ƒ median age - 65 Positive
Negative
14 (1.1%)
1223 (98.9%)
EIC
ƒ median tumor size - (+) 58 (5%)
(-) 1010 (95%)
1 cm Systemic Therapy
Chemotherapy 118 (11.0%)
ƒ 3.1% node positive Hormonal Therapy
Both
501 (46.9%)
39 (3.7%)
 Table II. Treatment Related Characteristics
Characteristic Finding
Time of Catheter Placement Number (%)
Open Cavity 554 (44.8%)
ASBS MammoSite® Closed Cavity
SET Technique
683 (55.2%)
170 (24.9%)
US guidance 508 (74.4%)
Registry Trial Unknown
Skin Spacing
5 (0.7%)

Median 10 mm
≥ 10 mm 791 (63.9%)
Technique: ≥ 9 mm
≥ 8 mm
875 (70.7%)
987 (79.8%)
≥ 7 mm 1099 (88.8%)
ƒ Open cavity 45% ≥ 6 mm
≥ 5 mm
1158 (93.6%)
1215 (98.2%)

ƒ
Enrolled Patients (n=1419)
Closed cavity 55% Treated with Brachytherapy
Partial Breast Irradiation
1280 (90.2%)
1237 (87.2%)
Boost 43 (3.0%)
ƒ Median balloon fill - Not implanted
Explanted Cases
16 (1.1%)
123 (8.7%)
Open Cavity 69 (56.1%)
55 cc (20-126 cc) Closed Cavity
Reasons for Non-Implanting
54 (43.9%)

Positive Nodes 9 (56.2%)

ƒ 89% 7 mm minimum Patient Request
Lobular Histology
4 (25.0%)
3 (18.8%)
Reason for Explanatation
skin spacing Skin distance
Cavity Conformance
43 (35.0%)
35 (28.5%)
Positive Margins 13 (10.6%)
ƒ 95% 34Gy/10 Balloon Failure
Positive Nodes
11 (8.9%)
9 (7.3%)
Other 12 (9.8%)
fractions
 ASBS MammoSite® Registry Trial
Cosmetic Outcome

ƒ 95% good/excellent cosmesis

ƒ < 7 mm skin spacing associated with
worse cosmesis (86.8 vs 96.1 %, p=0.001)
Variable Analyzed
Excellent Good Fair Poor
# of pts (% of total) 598 (55.2%) 432 (39.9%) 45 (4.2%) 9 (0.8%)
Median Skin Spacing (mm) 10.0 10.0 8.0 8.0 < 0.0001a
7 mm Skin Spacing (n=121) 46 (38.0%) 59 (48.8%) 14 (11.6%) 2 (1.6%) 0.0001b
≥7 mm Skin Spacing (n=964) 552 (57.3%) 373 (38.7%) 31 (3.2%) 7 (0.7%)
 Preoperative Prep
ƒ MD performs H&P & obtains consent
ƒ Nurse reviews patient meds & allergies
• Instructs pt. which meds to hold
ƒ NPO after midnight the night prior to
procedure
ƒ CBC/Diff, PT, PTT ordered and reviewed
ƒ Cefazolin (Ancef) 1-2 grams ordered to be
given during procedure (depends on wt. < or
> than 70 kg.)
 Day of Procedure
ƒ Nurse performs pt. assessment and
completes surgical checklist
ƒ Radiation Oncologist marks lumpectomy site,
applies Emla cream and places plastic wrap
on breast 30-45 minutes prior to procedure
ƒ Anesthesiologist or CRNA starts IV, gives
Cefazolin (Ancef)
 MammoSite® Procedure
ƒ Patient positioned on CT-sim table with vac-fix
ƒ MD removes plastic wrap and re-marks site
ƒ Radiation therapist obtains initial CT-sim
ƒ RN or MA perform surgical scrub to breast, axilla,
and chest wall
ƒ Radiation oncologist places drapes, sterile markers
and inserts MammoSite
ƒ Multiple CT-sims are performed as MD places
MammoSite and fills balloon
 Post-op Care
ƒ Measurements performed for dosimetry
ƒ Surgical site cleansed with sterile 4x4’s, cotton tip
applicators, and saline
ƒ Area thoroughly dried
ƒ Dry drain sponge placed around MammoSite
catheter at skin surface, covered with occlusive
dressing, and surgical bra placed
ƒ Two pain scripts for mild and moderate pain given
ƒ Pt is sent to recovery and then discharged home
 Home Care Instructions
ƒ No showering or getting the breast/dressing wet.
Instructions on when to resume showering will be given at
the final treatment
ƒ Do not take aspirin products or non-steroidal anti-
inflammatory drugs unless you have been given permission
to do so by the radiation oncologist
ƒ You may eat all the regular foods that you normally eat
ƒ Do not remove the bandage/dressing on your breast
ƒ Your surgical bra should be worn at all times
ƒ Call your MD for any of the following problems:
• Redness and warmth of the breast or chest skin
• Oral temperature over 100.5 degrees
• Excessive pain in the breast that is not relieved by your pain
medication
• Drainage that soaks through the bandage
 CT Planning for MammoSite Brachytherapy

Isodose Lines
50%
80%
100%
120%
140%
200% Mammosite®
balloon
 Treatment
ƒ Pt positioned in CT-sim with vac fix to duplicate
positioning at time of MammoSite placement
ƒ Surgical bra removed, assessment of drainage and
skin
ƒ Inner cannula is removed from red lumen and
afterloader attached
ƒ Dummy seeds inserted in red lumen, x-rays
obtained to verify balloon placement and volume of
fluid in balloon
ƒ Pt taken to HDR suite and positioned with vac-fix
ƒ Transfer tube is connected to lumen of MammoSite
• Clean gloves used
 Skin Care During Treatments
ƒ Dressing is changed after 1st treatment daily
ƒ Remove dressing with clean gloves
ƒ Sterile gloves used to clean site with sterile cotton
tip applicators and saline
ƒ Area dried, ointment or cream may be applied to
skin
ƒ Sterile drain sponge replaced at skin surface
around MammoSite
ƒ Occlusive dressing applied
ƒ Surgical bra placed and lumens tucked inside
ƒ Antibiotics after 7th treatment x 7 days
 MammoSite® Removal
ƒ Pt instructed to take pain medication 1 hour prior to final
treatment
ƒ Following final treatment vac-fix is removed & pillow placed
under head
ƒ MD and RN perform Betadine scrub to site and surrounding
area
ƒ MD removes sutures at skin surface and removes fluid from
balloon
ƒ Mammosite is removed
ƒ Pressure is held for at least 10 minutes, assessing for
bleeding and drainage at sites
ƒ Entire area cleansed with sterile saline, dried, triple
antibiotic ointment applied with sterile cotton tip applicators,
sterile 2x2’s applied and covered with occlusive dressing
 Discharge Instructions
ƒ Pt instructed to continue antibiotics until gone
ƒ No showering or getting breast wet for 48 hours
ƒ Remove dressing from breast in 2 days (May begin
showering if sites are healed over)
ƒ Resume normal activity as tolerated
ƒ Take pain meds as needed
ƒ Return to see radiation oncologist the following week
ƒ Report any of the following problems:
• Redness and warmth of the breast or chest skin
• Oral temperature over 100.5 degrees
• Excessive pain in the breast that is not relieved by your pain
medication
• Drainage that soaks through the bandage
Breast Appearance after
MammoSite®
2 years post treatment
Breast Appearance after
MammoSite®

4 years post treatment

 MammoSite PBI: summary
Local Exc/ good
Median F/U T size (cm) N+ ER +
Institution Pt. No. relapse Cosmesis
age (yr) mo. median % %
% %

Initial Multi-
43 69 48 1.0 0 - 0 80
Institutional

Rush Univ. 112 64 - 88% Tis-T-1 7 - 0 80

Tufts-NEMC/ VCU 28 62 19 1.1 0 100 0 86

St. Vincent Hospital 32 62 11 97% T-1 9 94 - 86

Kaiser-Permanente 51 64 16 1.2 16 86 0 95

ASBS Registry 1419 65 14 1.0 3.1 - 1.2 93.5

Average: 64 y 22 mo 1.1 cm 6% 93% < 1% 87%

 3-DCRT PBI
RTOG 0319: A Phase I/II trial to Evaluate
3D-CRT PBI for Stage I and II Breast
Carcinoma
ƒ Establish the technical feasibility and acute
toxicity of irradiating the tumor bed alone
with 3D-CRT after lumpectomy

ƒ Potential advantages to replacing interstitial

brachytherapy utilized in RTOG 95-17
with 3D-CRT
 RTOG 03-19 Eligibility

ƒ Tumor size < 3 cm (unifocal)

ƒ N-0, N-1 (< 3 positive nodes)
ƒ Negative margins (2 mm)
ƒ No infiltrating lobular cancer
ƒ 6 surgical clips to delineate the
lumpectomy
ƒ Ability to meet dose constraints
 RTOG 03-19
Dose Prescription and Constraints
Prescription dose (RxD):
3.85 Gy x 10 fractions bid
5 consecutive days

Coverage: 95% RxD covers 100% PTV (ideal)

95% RxD covers 95% PTV (acceptable)
> 93% RxD covers 100% PTV
Limitations:
50% RxD includes < 50% entire breast
30% RxD includes < 10% ipsilateral lung
5% RxD includes < 5% heart
 RTOG 0319: Definition of Target Volumes

Lumpectomy
cavity

CTV (1.5 cm) +

PTV (1.0 cm)
PBI: 3D-CRT Beam Arrangement
PBI: 3D-CRT Isodose Distribution
 RTOG 0319:
3-D CRT PBI

ƒ 8/15/03 – 4/13/04
ƒ 58 patients enrolled, 42 evaluated
ƒ 19 institutions
ƒ Median age: 61 years (31-83)
ƒ Median T size: 0.85 cm (0.1 – 2.6 cm)
ƒ Stage I 86%
ƒ Toxicity: Grade I 42%, Grade II 21%
 Reproducibility and Feasibility
RTOG 0329
. 3D-RT Review for First 42 Evaluable Patients (n=42)

Per Protocol Minor Variation Major Variation

(Acceptable) (Marginally (Unacceptable)
Acceptable)

Overall Evaluation 6 (14%) 32 (76%) 4 (10%)

PTV Coverage 26 (62%) 16 (38%) 0 ( 0%)

Normal Tissues
Contralateral Lung 37 (88%) 3 ( 7%) 2 ( 5%)
Ipsilateral Lung 33 (78%) 5 (12%) 4 (10%)
Heart 38 (91%) 3 ( 7%) 1 ( 2%)
Thyroid* 35 (85%) 6 (15%) 0
Contra Breast 22 (53%) 19 (45%) 1 ( 2%)
Ipsilateral Breast 28 (67%) 14 (33%) 0

Vicini et al, IJROBP, 2005

 3-DCRT PBI: Summary
T size Local
Pt. Median (cm) N+ ER + relapse
Institution No. age F/U mo. median % % %

Beaumont 92 62 23 - 2 - 0

NYU 78 67.5 28 0.9 0 100 0

MGH 61 62 12 (min) 0.9 0 - 0

RTOG 0319 42 61 - 0.85 - - -

Summary:

63 y 21 mo. 0.9 cm 0.7 % 0

 Nursing Care
ƒ General Radiation Side Effects; may not
appear until pt’s treatment is complete
ƒ Dry skin, erythema, puritis, or rash
• Apply moisturizing cream bid during treatment and for
a month after treatment
• Steroid cream may be prescribed
ƒ Fatigue
• Activity as tolerated
 NSABP B-39/RTOG 0413 Trial
Phase III

Stage 0, I-II breast cancer treated by lumpectomy

Randomization

PBI
WBI ƒ 34 Gy in 3.4 Gy fxs bid
Mammosite® or
ƒ 50-50.4 Gy (1.8-2.0 Gy)
interstitial brachytherapy
Fractions to the whole breast
OR
followed by boost to >60 Gy
ƒ 38.5 Gy in 3.85 Gy fxs
3D-CRT
 Phase III Protocol
ƒ Sample size - 3000 patients
ƒ Accrual 2.5 years
ƒ Randomization stratified by
• Stage (DCIS, node neg, node pos)
• Age (less than 50, 50+)
• ER-negative, ER-positive
ƒ Rigorous Q/A for PBI methods: rapid review for
first case, timely review for next 4.
 Endpoints

ƒ Primary endpoint: in-breast tumor recurrence

ƒ Secondary:
• Distant disease-free survival
• Overall survival
• QOL: Cosmesis, fatigue, symptoms, burden of
care
 NSABP/RTOG Phase III Trial
Eligibility (selected)
ƒ Stage 0, I, II breast cancer
ƒ DCS or invasive adenocarcinoma
ƒ Tumor size < 3 cm (unifocal)
ƒ N-0, N-1 (< 3 positive nodes)
ƒ Negative margins (NSABP)
ƒ MUST be randomized within 42 days of last
breast/axillary surgery
ƒ Lumpectomy/whole breast ratio on CT < 30%
 CT Scan for Eligibility: Lumpectomy/whole
breast reference volume ratio < 30%

Whole breast
reference volume
Whole breast reference volume: All tissue within the boundaries of
standard whole breast tangential fields, excluding lung.
 PBI Trial Eligibility Comparison
Phase III RTOG RTOG Mammosite
NSABP/ 0319 95-17 ®
RTOG
T size < 3 cm Yes Yes Yes no (< 2 cm)
DCIS Yes no no no
EIC Yes no no no
Infiltrating Yes no no no
lobular cancer
Neg margins Yes Yes (>2 mm) Yes Yes
N-0 , N-1 Yes Yes Yes Yes
(< 1-3 nodes )
 Phase III Trials Comparing PBI to WBI

Target PBI
Opened accrual Method Eligibility
3-DCRT > 18 yo, Stage 0-II, <
NSABP B-39/ MST
3/2005 4200 3cm, N-0 – N-1 (< 3
RTOG 0413 MCT LN+)

> 40 yo, Stage 0-II, < 3

cm, N-0 – Nmi,
GEC-ESTRO 11/2004 1170 MCT
Negative margins (2
mm)

> 40 yo, Stage 0-II, < 3

RAPID
1/2006 2128 3-DCRT cm, N-0, excludes inf.
OCOG lobular
 Phase III Trials Comparing PBI to WBI

Targeted PBI
Opened accrual Method Eligibility

3-DCRT > 18 yo, Stage 0-II, <

NSABP B-39/ MST
3/2005 4200 3cm, N-0 – N-1 (< 3
RTOG 0413
MCT LN+)

> 40 yo, Stage 0-II, < 3

cm, N-0 – Nmi,
GEC-ESTRO 11/2004 1170 MCT
Negative margins (2
mm)

> 40 yo, Stage 0-II, < 3

RAPID
1/2006 2128 3-DCRT cm, N-0, excludes inf.
OCOG
lobular
 PBI Off Protocol
ABS Guidelines

ƒ Age > 50 y.o.

ƒ Histology
• T1 and T2 < 3.0 cm
ƒ Clinical stage
• Infiltrating Ductal Carcinoma
ƒ No distant metastases
 MCW Institutional Policy for
PBI Off Protocol
ƒ Age > 60 y.o.
ƒ Histology:
ƒ Ductal or Lobular Carcinoma
ƒ Negative surgical margins
ƒ Tumor size: < 2 cm
ƒ Estrogen/Progesterone Receptors:
ƒ Positive
ƒ Nodes: Negative
ƒ Anti-Endocrine Therapy: Required
ƒ Considerations: Physical or social co-morbidity that prevents
receipt of standard breast treatment
 Conclusions
ƒ 3 methods of PBI with specific eligibility
criteria
ƒ Patient education is key to a pleasant
experience for the patient:
• Explaining procedure and treatment
• Pain Control
• Skin care and infection control
• Follow up care
ƒ Several potential benefits of PBI