BCT - AIIMS Experience
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Transcript of BCT - AIIMS Experience
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Evolution of Surgery for BC
Ultra RadicalEarly 19 th Century
Conservation, Reconstruction
20 th century
RadicalLate 19 th Century
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Morbidity of Mastectomy
Breast - Symbol of Femininity,
Attractiveness and motherhood
Loss of feminine attractiveness Altered body image perceptionPsycho sexual problemsPainful reminder of cancerDepression
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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)
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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.
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
BCT - Multidisciplinary approach
Surgical OncologistRadiation OncologistMedical OncologistRadiologistPathologist
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Goals of Breast Conservation
Acceptable cosmetic outcome Minimal local recurrence Uncompromised - DFS and OS Good quality of life
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Breast Conservation TherapyPatient 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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Breast Conservation Surgery Indications for Re-excision
EIC & Margin + ve
> focal microscopic margin +ve
Uncertain resection margins
Residual microcalcification
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Breast Conservation TherapyTumor Bed Boost
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Breast Conservation TherapyTumor Bed Boost
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Breast Conservation Therapy:Radiotherapy
Meta analysis “ Vinh Hung et al”, JNCI, 2004 Pooled data from all trials on BCT with and with out RT8.6 % survival benefit apartDecreased local relapse
Definite role in eradicating microscopic tumor foci.
Group No. Local Failure (%) - RT + RTNSABP '92 1141 39 12Ontario '92 837 26 6Milan '93 567 9 0.3Sweden '94 381 20 3
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
BCT- Recent AdvancesSurgery - 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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Oncoplastic Techniques for BCS : Volume Displacement
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Mini Latissimus Dorsi flap (MLDF)
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Mini Latissimus Dorsi flap (MLDF)
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
BCT- Recent Advances MRI in BCT
• Dense Breast on Mammogram
• Post Surg & RT – Breast
• Unknown primary with Axillary node
• Indeterminate Mammogram
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
BCT- Recent Advances MRI in BCT
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
BCT- Recent Advances MRI in BCT
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
BCT – Pushing Frontiers
• Family H/O Breast cancer • Not a contraindication of BCT. Chabner et al 2004
• Lobular carcinoma • Not a contraindication for BCT. Carolin 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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Mammo guided wire localization and lumpectomy
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
BCT in LABC post NACT
• Better Chemotherapeutic drugs– Response rates in over 2/3rd patients– CR Rates –upto 1/3rd – Progression on chemotherapy – 2-3%
• Attempted in Non-inflammatory LABC
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
• 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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
• 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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
• 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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Breast Conservation Therapy: IRCH Treatment Protocol
SURGERY
• All patients - complete axillary lymph node dissection(level I-III)
• Incision - single or double - Single 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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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 ifInvolvement of >3 nodesExtra nodal spread
Breast Conservation Therapy: IRCH Treatment Protocol
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
SYSTEMIC THERAPY • Adjuvant Chemotherapy - All high-risk patients
Pre-menopausal statusTumor size >1 cm,Node positiveER/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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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%
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
IRCH –AIIMS Experience
50%
14.7%
20.5%
6.3%
6.8%
Site
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
IRCH –AIIMS Experience
• Post op Radiotherapy • EBRT - 92.6%• Brachytherapy – 44.2%
• Stage distribution• EBC – 93.7%• LABC – 6.3%
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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%
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
IRCH –AIIMS ExperienceSurvival Function
DFS
160140120100806040200
Cu
m S
urvi
val
1.0
.9
.8
.7
.6
.5
.4
.3
.2
.1
.0
Survival Function
Censored
5 yr DFS – 76%
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
IRCH –AIIMS ExperienceSurvival Function
OS
160140120100806040200
Cu
m S
urv
iva
l1.00
.80
.60
.40
.20
0.00
Survival Function
Censored
5 yr OS – 92%
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
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
TMH - 26th October 2007 Breast Conservation Therapy IRCH-AIIMS Experience
Thank YouDr. Manish Varma
MS, DNB, MNAMS
Department of Surgical OncologyBRA-IRCH,
All India Institute of Medical SciencesNew Delhi