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Who Can Benefit From  APBI  &  The Changing Treatment Landscape   Joe L. Meadows, M.S. Medical Physicist The Lacks Cancer Center Saint Mary’s Health Care Grand Rapids, MI Joe Meadows M.S. St Mary’s March 2009 Joe Meadows M.S. St Mary’s March 2009
Objectives ,[object Object],[object Object],[object Object],[object Object],Joe Meadows M.S. St Mary’s March 2009
Joe Meadows M.S. St Mary’s March 2009 Breast Conservation Therapy (BCT) is a standard of care supported by years of data. ,[object Object],[object Object],[object Object],[object Object]
Joe Meadows M.S. St Mary’s March 2009 Prospective Randomized Trials: BCT vs.Mastectomy
Joe Meadows M.S. St Mary’s March 2009 Prospective Randomized Trials:  Lumpectomy +/-  Radiation Therapy
Joe Meadows M.S. St Mary’s March 2009 So although BCT is equivalent to mastectomy in terms of recurrence and survival rates, it is still very underutilized. But even today, more than 15 years later, many women eligible for breast-conserving surgery are getting mastectomies.  ,[object Object],[object Object],[object Object],[object Object],In 2007, upwards of 180,000 women will be eligible for breast conservation therapy. However, according to SEER data, only about 40% of eligible women receive BCT each year. Another 41% receive mastectomy and 19% get a lumpectomy without follow-up radiation therapy. In 2007, this means that over 108,000 women may not receive the preferred method of treatment for their early-stage breast cancer. And sadly, over  34,000 are risking recurrence  by not having their recommended course of radiation therapy. An idea behind MammoSite Targeted Radiation Therapy and other forms of APBI is that this treatment modality can help increase the number of women who receive breast conservation therapy and help reduce the numbers of women who receive mastectomy and lumpectomy only.  Under-Utilization of BCT 240,000 Breast Cancer Cases in 2007 1 ~180,000 Eligible for Breast Conservation Therapy (BCT) 2 ~72,153 40% ~34,273 19% ~73,957 41% Mastectomy BCT Lumpectomy No Radiation 108,230 3 No Radiation
Benefit of Post Op Treatment Doctors in some parts of the United States may be more old-fashioned and less likely to offer lumpectomy with radiation as an option for their patients, particularly their  older patients . Such doctors  may urge mastectomy , even for women who should be offered the choice. But recent research has shown that women 75 or older who get radiation after lumpectomy are more likely to live longer and remain free of breast cancer longer than women who do not get radiation.  http://www.breastcancer.org/treatment/surgery/lumpectomy/index.jsp Joe Meadows M.S. St Mary’s March 2009
Standard Of Care ,[object Object],[object Object],[object Object],[object Object],http://www.breastcancer.org/treatment/surgery/lumpectomy/index.jsp Joe Meadows M.S. St Mary’s March 2009
Breast Conserving Therapy ,[object Object],[object Object],[object Object],Joe Meadows M.S. St Mary’s March 2009
Breast Conserving Therapy +  =  BCT candidate Joe Meadows M.S. St Mary’s March 2009 A. Tumor B. Lumpectomy specimen
Whole  Breast or Partial? For patients with node-negative breast cancer who undergo breast conserving surgery (BCS), RT to the  whole  breast  is  standard  adjuvant local treatment. Clearly demonstrated in randomized trials to provide local control and survival comparable to mastectomy . h ttp://www.medscape.com/viewprogram/8355
A ccelerated  P artial  B reast  I rradiation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Dr.F.Vicini Beaumont Hospital Joe Meadows M.S. St Mary’s March 2009
A ccelerated  P artial  B reast  I rradiation   ,[object Object],[object Object],[object Object],[object Object],Dr.F.Vicini Beaumont Hospital  Joe Meadows M.S. St Mary’s March 2009
A ccelerated  P artial  B reast  I rradiation   ,[object Object],[object Object],[object Object],[object Object],[object Object],Dr.F.Vicini Beaumont Hospital Joe Meadows M.S. St Mary’s March 2009
Changing Paradigm? ,[object Object],[object Object],[object Object]
A ccelerated  P artial  B reast  I rradiation   ,[object Object],[object Object],[object Object],[object Object],Dr.F.Vicini Beaumont Hospital
National Protocol 127 Pages !! Easy  Reading
National Protocol
NSABP B-39/RTOG 0413 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Patient Selection Criteria NØ; N1 (1-3 nodes) NØ NØ Nodal status Negative microscopic surgical margins of excision by NSABP definition Negative microscopic surgical margins of excision Negative microscopic surgical margins of excision Surgical margins < 3cm < 3cm < 3cm Tumor size Invasive adenocarcinoma or DCIS Invasive ductal carcinoma or DCIS Infiltrating ductal carcinoma Diagnosis > 18 > 45 > 50 Age *NSABP B39 - RTOG 0413 Eligibility Criteria ASBS Recommendations (Updated December 2005) ABS Recommendations (Updated February 2007)
APBI  -InterstitialCatheter ,[object Object],(22).IJROBP 2007;68(2) 341-6 Vicini FA et al ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Published Interstitial APBI Data
Interstitial Experience - Selected APBI Studies - ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Dr.F.Vicini Beaumont Hospital
Dr.F.Vicini Beaumont Hospital WBH Data: Matched Pair Analysis 12 Yr Actuarial Outcome - APBI vs. WBRT 0.1 96% 99% Cosmesis (excellent/good) 0.6 2 % 2 % Clonally Distinct / Elsewhere 0.5 4 % 5 % IBTR 0.1 67 % 75 % 5 yr DFS after IBTR 0.3 93 % 95 % Cause-Specific Survival 0.4 87 % 91 % Freedom From Failure 0.08 90 % 95 % Distant Metastases Free Survival 0.3 0.5 % 2 % Regional Nodal Failure 0.2 8 % 6 % Contralateral Failure 0.6 2 % 3 % Clonally Related / TRMM p WBRT (n=199) APBI (n=199) 12 Year Outcome Measure
APBI  Criteria 3-Dimensional rendering of applicator surface Tissue Conformance- <10% air Skin Spacing- Min 5mm to skin Balloon Diameter & Symmetry- <2mm
APBI  Techniques ,[object Object],[object Object],[object Object],[object Object],[object Object]
APBI  -InterstitialCatheter ,[object Object],[object Object],[object Object],[object Object],(22).IJROBP 2007;68(2) 341-6 Vicini FA et al
APBI  –InterstitialCatheter  “Our” First Experience  ,[object Object],[object Object],[object Object],[object Object],[object Object]
APBI -  Mammosite  HDR Unit * **Over  60,000 patients  have been treated to date with Mammosite! ,[object Object],[object Object],[object Object],[object Object]
APBI  -  Mammosite  Various balloon shapes/sizes offer ability to implant a broad range of cavity shapes/volumes. 5 – 6 cm Sphere 4 x 6 cm Ellipsoidal 4 – 5 cm Sphere Balloon Configuration
APBI  -  Mammosite  ,[object Object],[object Object],[object Object],[object Object],[object Object]
Mammosite  -  Problems That Can Occur ,[object Object],[object Object],[object Object],[object Object]
APBI  –  Contura TM  Multiple Lumen Balloon (MLB) ,[object Object],[object Object],[object Object]
APBI External Beam Radiotherapy ( EBRT) ,[object Object],[object Object],LINAC Tomotherapy ,[object Object]
APBI -  EBRT ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
APBI -  Xoft   ,[object Object],[object Object],[object Object],X-ray Tube HV Cable D (Gy) 34  Red 17  Orange 10.2  Yellow 6.8  Green 5.1  Blue 3.4  Dark Blue 1.7  Magenta 40 kV source in  BrachyVision® D (Gy) 34  Red 17  Orange 10.2  Yellow 6.8  Green 5.1  Blue 3.4  Dark   Blue 1.7  Magenta
APBI -  Xoft   Film dosimetry around this miniaturized x-ray tube shows a nearly  spherical distribution  of radiation http://www.xoftinc.com/images/pdf/posters/Poster_4.pdf ,[object Object],[object Object],[object Object],[object Object],[object Object]
APBI -  Xoft   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Xoft 50kV MammoSite Ir 192  HDR
APBI -  SAVI ,[object Object],[object Object],[object Object],[object Object],[object Object]
APBI -  SAVI  ,[object Object],[object Object],[object Object],[object Object],[object Object]
APBI -  IORT ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
APBI -  IORT(Mobetron) ,[object Object],[object Object],[object Object],[object Object],What happens if the FINAL pathology comes back with a + margin?? Aetna considers intraoperative radiation therapy experimental and investigational for the treatment of brain tumors,  breast cancer , pancreatic cancer, cholangiocarcinoma, retroperitoneal sarcoma, osteosarcoma, and all other indications.
FDA Trial: Updated Results Benitez et al: ASBS April 2007 Am J Surg 194(4):456-62, 2007 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Published APBI Results - All APBI Techniques -   Dr.F.Vicini Beaumont Hospital Technique # Series # Patients Follow-Up (Range) % IBTR  (Range) Interstitial 14 1166 27-113 0-9% Mammosite 12 3332 2-66 0-6% 3D Conformal 3D Conformal 7 367 10-36 0-2% Totals Totals 33 4865 2-113 0-9%
NSABP B-39/RTOG 0413 Dr.F.Vicini Beaumont Hospital ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSABP B-39/RTOG 0413 - Current Status - Dr.F.Vicini Beaumont Hospital ,[object Object],[object Object],[object Object],[object Object],[object Object],https://silver1.phila.acr.org/Clinical_RTOG/FileRendering.pdf
APBI Conclusions Dr.F.Vicini Beaumont Hospital ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
APBI Conclusions Dr.F.Vicini Beaumont Hospital ,[object Object],[object Object],[object Object],[object Object],[object Object]
 

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Who Benefits From Apbi March2009

  • 1. Who Can Benefit From APBI & The Changing Treatment Landscape Joe L. Meadows, M.S. Medical Physicist The Lacks Cancer Center Saint Mary’s Health Care Grand Rapids, MI Joe Meadows M.S. St Mary’s March 2009 Joe Meadows M.S. St Mary’s March 2009
  • 2.
  • 3.
  • 4. Joe Meadows M.S. St Mary’s March 2009 Prospective Randomized Trials: BCT vs.Mastectomy
  • 5. Joe Meadows M.S. St Mary’s March 2009 Prospective Randomized Trials: Lumpectomy +/- Radiation Therapy
  • 6.
  • 7. Benefit of Post Op Treatment Doctors in some parts of the United States may be more old-fashioned and less likely to offer lumpectomy with radiation as an option for their patients, particularly their older patients . Such doctors may urge mastectomy , even for women who should be offered the choice. But recent research has shown that women 75 or older who get radiation after lumpectomy are more likely to live longer and remain free of breast cancer longer than women who do not get radiation. http://www.breastcancer.org/treatment/surgery/lumpectomy/index.jsp Joe Meadows M.S. St Mary’s March 2009
  • 8.
  • 9.
  • 10. Breast Conserving Therapy + = BCT candidate Joe Meadows M.S. St Mary’s March 2009 A. Tumor B. Lumpectomy specimen
  • 11. Whole Breast or Partial? For patients with node-negative breast cancer who undergo breast conserving surgery (BCS), RT to the whole breast is standard adjuvant local treatment. Clearly demonstrated in randomized trials to provide local control and survival comparable to mastectomy . h ttp://www.medscape.com/viewprogram/8355
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17. National Protocol 127 Pages !! Easy Reading
  • 19.
  • 20. Patient Selection Criteria NØ; N1 (1-3 nodes) NØ NØ Nodal status Negative microscopic surgical margins of excision by NSABP definition Negative microscopic surgical margins of excision Negative microscopic surgical margins of excision Surgical margins < 3cm < 3cm < 3cm Tumor size Invasive adenocarcinoma or DCIS Invasive ductal carcinoma or DCIS Infiltrating ductal carcinoma Diagnosis > 18 > 45 > 50 Age *NSABP B39 - RTOG 0413 Eligibility Criteria ASBS Recommendations (Updated December 2005) ABS Recommendations (Updated February 2007)
  • 21.
  • 22.
  • 23. Dr.F.Vicini Beaumont Hospital WBH Data: Matched Pair Analysis 12 Yr Actuarial Outcome - APBI vs. WBRT 0.1 96% 99% Cosmesis (excellent/good) 0.6 2 % 2 % Clonally Distinct / Elsewhere 0.5 4 % 5 % IBTR 0.1 67 % 75 % 5 yr DFS after IBTR 0.3 93 % 95 % Cause-Specific Survival 0.4 87 % 91 % Freedom From Failure 0.08 90 % 95 % Distant Metastases Free Survival 0.3 0.5 % 2 % Regional Nodal Failure 0.2 8 % 6 % Contralateral Failure 0.6 2 % 3 % Clonally Related / TRMM p WBRT (n=199) APBI (n=199) 12 Year Outcome Measure
  • 24. APBI Criteria 3-Dimensional rendering of applicator surface Tissue Conformance- <10% air Skin Spacing- Min 5mm to skin Balloon Diameter & Symmetry- <2mm
  • 25.
  • 26.
  • 27.
  • 28.
  • 29. APBI - Mammosite  Various balloon shapes/sizes offer ability to implant a broad range of cavity shapes/volumes. 5 – 6 cm Sphere 4 x 6 cm Ellipsoidal 4 – 5 cm Sphere Balloon Configuration
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.
  • 40.
  • 41.
  • 42.
  • 43. Published APBI Results - All APBI Techniques - Dr.F.Vicini Beaumont Hospital Technique # Series # Patients Follow-Up (Range) % IBTR (Range) Interstitial 14 1166 27-113 0-9% Mammosite 12 3332 2-66 0-6% 3D Conformal 3D Conformal 7 367 10-36 0-2% Totals Totals 33 4865 2-113 0-9%
  • 44.
  • 45.
  • 46.
  • 47.
  • 48.