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BCT - AIIMS Experience

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  • 1. Breast Conservation Therapy IRCH-AIIMS Experience Dr. Manish Varma, Dr. SVS Deo, Dr.NK Shukla, Dr. Vinod Raina*, Dr.GK Rath** Dept. of Surgical , Medical* and Radiation oncology**, IRCH, AIIMS, New Delhi
  • 2. Evolution of Surgery for BC Ultra Radical Early 19 th Century Conservation, Reconstruction 20 th century Radical Late 19 th Century
  • 3. Morbidity of Mastectomy
        • Breast - Symbol of Femininity,
        • Attractiveness and motherhood
        • Loss of feminine attractiveness
        • Altered body image perception
        • Psycho sexual problems
        • Painful reminder of cancer
        • Depression
  • 4. Evolution of Modern BCT
    • Innovative Pilot studies - 1960-70
    • BCT promising intervention for EBC
    • Retrospective comparative studies - 70s
    • BCT Safer & effective option
    • Prospective Randomized trials – 1980s
    • MRM Vs BCT- comparable out come
    • 20 yrs RCT Results - 2000
    • 20 yrs FU, BCT vs MRM – No survival difference
    • Scientifically studied & validated therapeutic intervention in Breast Cancer
  • 5. Rationale of BCT
    • Natural history
      • Breast cancer is a systemic disease with hematogenous spread early in the disease process
        • 20% of node negative patients develop distant metastases
    • Limits of surgical efficacy
      • Equivalent results of Radical and Modified radical mastectomy : More extensive surgery might not result in better cure rates
  • 6. Rationale of BCT
    • Surgery and Radiation as a combined modality
      • Surgery alone- More failure at margins
      • Radiotherapy alone- More failure at the epicenter
    • Using surgery to remove grossly visible tumor with a small margin and moderate-dose radiotherapy to treat the larger volume of tissue that may harbor residual disease
  • 7. Surgery and Radiation as combined modality
    • First used as an adjuvant after mastectomy to eradicate sub clinical disease in internal mammary,supraclavicular and axillary nodes and chest wall
    • BCT uses Radiation for control of sub clinical disease in the residual breast tissue in addition to the above mentioned sites
  • 8. Randomized Trials - BCT vs MRM Group No 10 Yr Survival (%) Loc. Rec(% ) BCT - MRM BCT - MRM NSABP 2105 62 - 62 10 - 8 French 179 78 - 79 7 - 9 Milan 701 71 - 69 4 - 2 EORTC 903 75 - 75 13 - 9 Danish 905 79 - 82 3 - 4 NCI 237 77 - 75 17 - 9
  • 9. Randomized Trials - BCT vs MRM
    • 20 Year Follow up
    • Milan Trial – NEJM 2002
    • Local Relapse – 8 % vs 2.3 % (BCT vs MRM)
    • OS – 59 % vs 59% (BCT vs MRM)
    • NCI Trial - Cancer 2003
    • DFS – 64 % vs 67 % (BCT vs MRM)
    • OS – 54 % vs 58% (BCT vs MRM)
  • 10. NCI Consensus Conference - EBC In early breast cancer breast conservation treatment is not only equivalent to mastectomy but also preferable as it preserves the breast with all the attendant psychological and breast image advantages there by enhancing quality of life.
  • 11. BCT - Multidisciplinary approach
        • Surgical Oncologist
        • Radiation Oncologist
        • Medical Oncologist
        • Radiologist
        • Pathologist
  • 12. Goals of Breast Conservation
        • Acceptable cosmetic outcome
        • Minimal local recurrence
        • Uncompromised - DFS and OS
        • Good quality of life
  • 13. Breast Conservation Therapy Patient Selection
    • Indications for BCT
    • Patient motivation
    • Stage I & II B.C (Tumor < 5 cm)
    • Availability of adequate infrastructure
      • Mammography
      • Radiotherapy
      • good pathology services
    • Reliability regarding Rx compliance & Follow up
  • 14. Contraindications to BCT
    • Absolute
      • High probability of recurrence
          • Multicentric disease
          • Positive surgical margins (EIC)
      • High probability of complications from irradiation
          • CVD
          • Prior irradiation to chest wall
          • Early pregnancy
  • 15. Contraindications to BCT
    • Relative
      • High probability of subsequent breast cancers
        • BRCA1 and BRCA2 mutations
      • Poor cosmetic results
        • Unfavorable tumor-breast ratio
        • Oncologically necessary removal of nipple-areola complex
        • Large medial lesions
      • Personal preference of the patient
  • 16. BCT Surgical Margins
    • Ideal margin – No consensus
      • 3D excision with minimum of 1 cm gross margin(0.5 to 2 cm)
    • Local Relapse - Quadrantectomy vs Tumerectomy
      • Milan study - 5 % vs 13%
    • Fine balance between cosmesis and margins
    • India - Main fear is local relapse - Wide margins
  • 17. Breast Conservation Surgery Indications for Re-excision
        • EIC & Margin + ve
        • > focal microscopic margin +ve
        • Uncertain resection margins
        • Residual microcalcification
  • 18. Breast Conservation Therapy Radiotherapy
    • Integral part of BCT
    • With in 4 to 6 weeks of BCS
    • To control Microscopic residual disease
    • WBRT – 50Gy / 25 Fr / 5 weeks
    • Linac / Cobalt
    • Tumor Bed Boost - 15 Gy
      • Electron beam
      • Brachytherapy
  • 19. Breast Conservation Therapy Tumor Bed Boost
  • 20. Breast Conservation Therapy Tumor Bed Boost
  • 21. Breast Conservation Therapy: Radiotherapy
    • Meta analysis “ Vinh Hung et al”, JNCI, 2004
        • Pooled data from all trials on BCT with and with out RT
        • 8.6 % survival benefit apart
        • Decreased local relapse
    • Definite role in eradicating microscopic tumor foci .
    Group No. Local Failure (%) - RT + RT NSABP '92 1141 39 12 Ontario '92 837 26 6 Milan '93 567 9 0.3 Sweden '94 381 20 3
  • 22. BCT- Recent Advances
    • Accelerated Partial Breast Irradiation (APBI)
    • 80- 90 % recurrences after BCT occur around tumor bed
    • APBI - R.T . Limited area of Breast over short duration
    • Accelerated Partial Breast Irradiation equivalent to WBRT
    • Advantages – Short duration of treatment
    • Limited Breast Irradiation
    • Several phase I & II Studies – Promising results
    • Technique – Mammosite / IORT / Brachytherapy / IMRT
  • 23. BCT- Recent Advances
    • Surgery - Oncoplastic Techniques – BCS
    • Recent data – 1 cm tumor free margin is more important than absolute tumor size
    • BCT > 5 cm tumor is not an absolute CI for BCT
    • Volume loss > 30%
    • Central quadrant tumors
    • Cavity – RT – Fibrosis Deformities
    • Skin loss – Breast Asymmetry
    • To Improve Cosmesis - Oncoplastic Techniques – BCS
  • 24. BCT- Recent Advances Surgery - Oncoplastic Techniques – BCS
    • Aims
    • Improving Cosmetic outcome, limiting deformity, and reduce scarring
    • Types of Oncoplasty – BCT
    • Volume Displacement Procedures
    • Volume Replacement Method - Mini LD Flap Reconstruction (MLDF)
    • Anderson B et al , Lancet Oncology 2005
  • 25. Oncoplastic Techniques for BCS : Volume Displacement
  • 26. Oncoplastic Techniques for BCS : Volume Replacement -Mini Latissimus Dorsi flap (MLDF)
    • Latissmus Dorsi Flap – Skin / Muscle / Fat
    • Popular flap BR – Tansini - 1906
      • Proximity to defect/Long pedicle
      • Minimal functional impairment & donor site morbidity
    • Volume Replacement - Mini LD Flap - BCT
    • Noguchi et al 1996 & Raja et al 1997
    • Improved Cosmetic Results following BCT + MLDF Gendy et al 2003 , BJS
  • 27. Mini Latissimus Dorsi flap (MLDF)
  • 28. Mini Latissimus Dorsi flap (MLDF)
  • 29. BCT- Recent Advances MRI in BCT
    • Dense Breast on Mammogram
    • Post Surg & RT – Breast
    • Unknown primary with Axillary node
    • Indeterminate Mammogram
  • 30. BCT- Recent Advances MRI in BCT
  • 31. BCT- Recent Advances MRI in BCT
  • 32. BCT – Pushing Frontiers
    • Family H/O Breast cancer
        • Not a contraindication of BCT. Chabner et al 2004
    • Lobular carcinoma
        • Not a contraindication for BCT. C arolin et al , Breast J, 2004
    • EIC
        • Not a contraindication as long as margin status is taken care of. Smith et al , Cancer 1999
    • Young age (< 40 yrs)
        • Not a contraindication for BCT
  • 33. BCT – Pushing Frontiers
    • Expanded indications of BCT
    • BCT for Central tumors & Pagets Disease
        • Central segmentectomy with Nipple Areola Complex removal with negative margins is feasible .
            • Pierce et al, Cancer 1999 in subset of patients
    • Multifocal BC and BCT
        • 6 studies > 200 patients acceptable LR
        • Tumors encompassed in a single margin –ve resection
        • Cosmetically acceptable lumpectomy
  • 34. BCT – Pushing Frontiers
    • BCT for Non Palpable lesions
        • Mammo guided wire localization and lumpectomy feasible
        • Recently “Radio Guided Occult Lesion localization” ROLL is increasingly being used
  • 35. Mammo guided wire localization and lumpectomy
  • 36. BCT – Pushing Frontiers
    • BCT in LABC
        • Neo Adjuvant Chemotherapy BCT
        • NSABP -18 Trial
            • 1500 pts
            • Increased BCT in T3 group
            • Higher Local recurrences but no effect on overall survival
        • Unresolved issues
        • Method of response assessment
        • Tumor Localization in responders
        • Pre chemo titanium clip placement
        • ? Extent of resection
  • 37. BCT in LABC post NACT
    • Better Chemotherapeutic drugs
      • Response rates in over 2/3 rd patients
      • CR Rates –upto 1/3 rd
      • Progression on chemotherapy – 2-3%
    • Attempted in Non-inflammatory LABC
  • 38.
    • Increased likelihood of loco-regional recurrence
        • Large tumor size
        • Advanced nodal disease
        • Multifocal pattern of residual disease after NACT
        • LVI
            • Chen et al. Journal of clinical oncology, 2004
    BCT in LABC post NACT
  • 39.
    • Contraindications to BCT after NACT
        • Residual tumor size >5 cm
        • Residual skin edema or direct skin involvement
        • Chest wall fixation
        • Diffuse microcalcification on post NACT mammography
        • Multicentric disease
            • Chen et al. Journal of clinical oncology, 2004
    BCT in LABC post NACT
  • 40.
    • Nearly half of these patients can undergo successful breast conservation with acceptable long term disease free and overall survivals
      • William G et al. Annals of Surgery 2002. ( Univ of North Carolina, USA )
      • Allen M. Chen et al.J of Clinical Oncology 2004 ( M.D.Anderson, Texas, USA)
      • Viswambharan JK et al. Indian J Cancer. 2005 (JIPMER, India)
      • Asoglu O. Acta Chir Belg. 2005 ( Istanbul, Turkey)
      • Merajver SD. J Clin Oncol. 1997 (Univ of Michigan, USA)
      • Beriwal S, et al. Breast J. 2006 Drexel University College of Medicine, Philadelphia, USA
      • Shen J, et al. Ann Surg Oncol. 2004 ( University of Texas M. D. Anderson Cancer Center, Houston, USA )
    BCT in LABC post NACT
  • 41. BCT Rates
    • Recent survey 2002 USA - NCDB
    • BCT- Grossly underutilized option
    • BCT rates – 10 to 45 % in USA in EBC
    • Factors for low BCT
      • Age - young age > BCT
      • Place of treatment- Urban vs Rural, North & east USA
      • Socioeconomic factors
      • ? Low reimbursement for BCT
  • 42. Breast conservation therapy
    • IRCH –AIIMS
      • Current BCT rate – 30 % of EBC
      • Reasons for refusing BCT
        • Fear of recurrence in residual breast
        • Family members not keen for BCT
        • Second opinion- Physician bias
  • 43. Breast Conservation Therapy: IRCH Treatment Protocol
    • SURGERY
    • Initial phase - Quadrantectomy
    • Subsequently - Wide excision - 1.5 cm, 3 dimensional tumor free margins
    • Previous lumpectomy patients - Re-excision of scar and lumpectomy cavity
    • Re-excision of tumor bed after lumpectomy - specimens sent separately as medial, lateral, superior, inferior and deep margins
    • Titanium clips placed in tumor bed
  • 44. Breast Conservation Therapy: IRCH Treatment Protocol
    • SURGERY
    • All patients - complete axillary lymph node dissection
    • (level I-III)
    • Incision - single or double
    • - S ingle incision for selected UOQ tumors
    • - two incisions in remaining tumors - one for lumpectomy and other for axillary dissection
    • A single drain in axilla and no drains in the tumor bed
  • 45.
    • RADIOTHERAPY
    • Whole breast radiotherapy (WBRT)
      • 45 Gy EBRT - 25 #, 5weeks
      • 3-4 weeks after surgery
    • Tumor bed boost
      • Using Electrons or low dose rate peri-operative brachytherapy
    • Peri-operative brachytherapy
      • Single or two plane nylon catheters implant in tumor bed after lumpectomy
      • Inter-catheter distance 1 cm
    Breast Conservation Therapy: IRCH Treatment Protocol
  • 46.
    • RADIOTHERAPY
    • Boost delivered through nylon catheters using iridium-192 wires or seeds by remote controlled after loading technique
    • 2-3 days after surgery
    • Electron boost
      • After completion of WBRT
      • Using a linear accelerator
      • The boost dose - 15 to 20 Gy
    • RT to axilla – EBRT if
    • Involvement of >3 nodes
    • Extra nodal spread
    Breast Conservation Therapy: IRCH Treatment Protocol
  • 47.
    • SYSTEMIC THERAPY
    • Adjuvant Chemotherapy - All high-risk patients
    • Pre-menopausal status
    • Tumor size >1 cm,
    • Node positive
    • ER/PR negative
    • High grade tumors
    • Lymphovascular invasion
    • Six cycles of DEC/CEF/CMF - depending upon the risk factors and economic status
    Breast Conservation Therapy: IRCH Treatment Protocol
  • 48.
    • SYSTEMIC THERAPY
    • No adjuvant chemotherapy –
    • Post menopausal women with < 1 cm ER/ PR positive tumor
    • Neo-adjuvant chemotherapy - 3 cycles anthracycline based for patients with > 4 cm tumor keen for BCT
    • Hormonal therapy - ER/PR positive
    • Tamoxifen/ AIs for 5 years
    Breast Conservation Therapy: IRCH Treatment Protocol
  • 49.
    • FOLLOW UP
    • After completion of treatment in breast cancer clinic
    • First 2 years - every 3 monthly and thereafter 6 monthly
    • Clinical examination and SAP at each follow up
    • Chest X-ray – 6 monthly
    • Annual bilateral mammogram
    • Cosmesis
    • Assessed at the end of one year
    • Graded - good, average and poor - JCRT criteria
    Breast Conservation Therapy: IRCH Treatment Protocol
  • 50. IRCH –AIIMS Experience
    • Study period - 1998 -2007
    • No. of BCT - 272
    • Mean Age – 44.2 yrs (23-66 yrs)
    • Premenopausal- 37.4%
    • Receptor
        • +ve – 33%
        • -ve – 45%
        • Unknown – 22%
    • Positive family history– 8.9%
  • 51. IRCH –AIIMS Experience 50% 14.7% 20.5% 6.3% 6.8% Site
  • 52. IRCH –AIIMS Experience
    • Post op Radiotherapy
        • EBRT - 92.6%
        • Brachytherapy – 44.2%
    • Stage distribution
        • EBC – 93.7%
        • LABC – 6.3%
  • 53. IRCH –AIIMS Experience
    • Histo-pathology
        • Margin +ve – 2.1%
        • Pathological Node +ve - 29%
        • Extranodal spread – 7.9%
    • Recurrence (Total 33 patients, 12%)
      • Local - 2.6%
      • Systemic – 8.4%
      • Local+Systemic – 1.1%
  • 54. IRCH –AIIMS Experience 5 yr DFS – 76%
  • 55. IRCH –AIIMS Experience 5 yr OS – 92%
  • 56. Conclusions
    • BCT most scientifically evaluated surgical treatment modality for EBC
    • Cosmetic and psychological advantages
    • Grossly under-utilized treatment option
    • Need to educate patients and physicians
    • Recent advances – Expand indications for BCT
    • NACT increases the BCT rates in LABC, but may have a higher risk of local recurrence
  • 57. Thank You
    • Dr. Manish Varma
        • MS, DNB, MNAMS
        • Department of Surgical Oncology
        • BRA-IRCH,
        • All India Institute of Medical Sciences
        • New Delhi

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