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Management of Early Breast Cancer (by Dr. Akhil Kapoor)

Comprehensive discussion on Management of Early Breast Cancer along with NCCN guidelines.
Slides prepared by Dr. Akhil Kapoor
(Resident, Department of Radiation Oncology,
Acharya Tulsi Regional Cancer Treatment & Research Institute, Bikaner, Rajasthan, India

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Management of Early Breast Cancer (by Dr. Akhil Kapoor)

  1. 1. MANAGEMENT OF EARLY BREAST CANCER Dr. Akhil Kapoor Department of Radiation Oncology Acharya Tulsi Regional Cancer Treatment & Research Institute, Bikaner Acharya Tulsi Regional Cancer Center, Bikaner
  2. 2. STAGING Acharya Tulsi Regional Cancer Center, Bikaner
  3. 3. Acharya Tulsi Regional Cancer Center, Bikaner
  4. 4. Acharya Tulsi Regional Cancer Center, Bikaner
  5. 5. PATHOLOGIC N STAGE  pN1mi = Micrometastasis ≤ 2mm size (0.2-2mm) or, <200 cells Acharya Tulsi Regional Cancer Center, Bikaner
  6. 6. STAGES INCLUDED IN EARLY BREAST CANCER Acharya Tulsi Regional Cancer Center, Bikaner
  7. 7. LCIS  Multicentric in 90% of specimens  Bilateral in 35-59% cases  10% Invasive ca has associated LCIS. Must at diagnosis:  Bilateral Mammogram  Pathology Review Importance of Mammogram:  LCIS: A marker for increased risk for subsequent development of invasive (usually ductal carcinoma) Acharya Tulsi Regional Cancer Center, Bikaner
  8. 8.  Surgical Excision Biopsy is must to proceed for management.  Management is done according to associated DCIS or Invasive Ca disregarding the presence of LCIS.  If margins are positive for LCIS, additional surgery to obtain clear margins for LCIS is not required. Acharya Tulsi Regional Cancer Center, Bikaner
  9. 9. LCIS AS SOLE HISTOLOGIC DX  Most widely accepted approach: Close observation with mammographic surveillance  Patients with highest risk (Young; diffuse high grade lesion; Family history): Bilateral Prophylactic Mastectomy  Tamoxifen alone reduces the risk by 56%. Acharya Tulsi Regional Cancer Center, Bikaner
  10. 10. PAGET’S DISEASE  Rare entity: <5% of all Breast Ca cases; In fifth-sixth decade.  D/d: Eczema (B/L in Eczema)  Palpable mass present in 50% cases (Invasive Ca in 90%).  If no palpable mass, 66-86% underlying DCIS.  Prognosis and management according to underlying disease. Acharya Tulsi Regional Cancer Center, Bikaner
  11. 11. USUAL MANAGEMENT:  Complete excision of Nipple Areola Complex with microscopically clear margins for both Paget’s and associated malignancy. Followed by:  Whole Breast RT  5 Year Local Recurrence Rate of 5.2% (EORTC Study) Acharya Tulsi Regional Cancer Center, Bikaner
  12. 12. DCIS  Pure DCIS: No indication of Axillary dissection.  Apparent pure DCIS: Upto 25% cases turn out to be Invasive Ca in lumpectomy specimen.  Thus, if Mastectomy is performed: SLNB preferred.  If lumpectomy includes Axillary tail, SLNB preferred (as surgery compromises future SLNB in the rare event of associated Invasive Ca) Acharya Tulsi Regional Cancer Center, Bikaner
  13. 13. RECURRENCE  Recurrence is 50% DCIS and 50% Invasive Ca.  Risk Factors for Recurrence: 1) Age <50yrs 2) Palpable mass 3) Close (<1mm) or involved margins 4) High Grade 5) Diameter >1cm 6) Presence of Comedo Necrosis. Acharya Tulsi Regional Cancer Center, Bikaner
  14. 14. VAN NUYS INDEX more  Modified VNPI includes AGE as well. Acharya Tulsi Regional Cancer Center, Bikaner
  15. 15.  Whole Breast RT following lumpectomy reduces the recurrence rate by 50% in DCIS.  Boost to tumor bed by 10 Gy is recommended in cases with close margins and age <50yrs.  MRI may be advised in patients suspected to have multi centric disease. Acharya Tulsi Regional Cancer Center, Bikaner
  16. 16.  Patients without any high risk feature: Surgical Excision alone is sufficient.  Tamoxifen addition for 5 years (NSABP B-24 trial):  Reduces the recurrence rate by 3.4% (HR 0.30, p<0.001) in ipsilateral IBTR.  Absolute reduction in Contra lateral Breast Ca by 3.2% (HR 0.68, p=0.02). Thus, Tamoxifen is added in ER+ DCIS after Lumpectomy and Radiation. Acharya Tulsi Regional Cancer Center, Bikaner
  17. 17.  Her 2 status in pure DCIS: No significance. Indications of Simple Mastectomy in DCIS:  Multicentric Disease  Diffuse Microcalcifications  Family History Acharya Tulsi Regional Cancer Center, Bikaner
  18. 18. Acharya Tulsi Regional Cancer Center, Bikaner
  19. 19. WORK UP FOR EARLY BREAST CA Hematological Tests  Baseline CBC, RFT, LFT (as Surgery and Chemotherapy are to be given)  Serum Alkaline phosphatase: Raised in patients with Bone Mets "bone burns, liver lasts" : Heat Unstable ALP in Bone diseases. Acharya Tulsi Regional Cancer Center, Bikaner
  20. 20. PATHOLOGY  Pathology Review  Determination of ER, PR and Her-2-neu Status Acharya Tulsi Regional Cancer Center, Bikaner
  21. 21. IMAGING STUDIES o Bilateral Mammogram ± USG o Bone Scan: Indicated in  Localised bone pain  Elevated ALP o Chest CT: If pulmonary symptoms o Baseline Echo/ MUGA Scan (MultiGated Acquistion- Tc99m) Acharya Tulsi Regional Cancer Center, Bikaner
  22. 22. ABDOMINAL ± PELVIC CT: Indications:  Abnormal Physical Examination of abdomen or pelvis  Abdominal Symptoms  Abnormal LFT  Raised ALP Acharya Tulsi Regional Cancer Center, Bikaner
  23. 23. BREAST MRI Requirements:  Expert Breast Imaging Team  Dedicated Breast Coils  Facility for MRI guided Needle Sampling or wire localisation of MRI detected abnormalities. Indications:  To evaluate dense breasts (young)  Breast Ca in Pregnancy  In patients with Positive Axilla with Occult primary (not identified with Mammogram).  To determine Multicentric Disease in I/L Breast  Screening of C/L Breast in high risk patients Acharya Tulsi Regional Cancer Center, Bikaner
  24. 24. PET-CT  Not usually indicated.  Indicated in situations when standard imaging is equivocal/suspicious especially in locally advanced/metastatic breast cancer. Acharya Tulsi Regional Cancer Center, Bikaner
  25. 25. FOR T3N1MO Usually Part of the Initial Work up:  Chest CT  Abdominal CT  Bone Scan Acharya Tulsi Regional Cancer Center, Bikaner
  26. 26. BCS Acharya Tulsi Regional Cancer Center, Bikaner (in absence of Extensive Intraductal Component-Boost Required)
  27. 27. PRE OPERATIVE SYSTEMIC THERAPY  Indicated if patient desires BCS and fulfills the criteria for BCS except for size.  Core Biopsy with placement of image-detectable marker to demarcate the tumor bed for post-CT surgical management.  Clinically negative axilla should be checked by USG, suspicious nodes should be sampled by FNAC or core needle and clipped with image detectable marker. Acharya Tulsi Regional Cancer Center, Bikaner
  28. 28.  Similarly, clinically positive nodes must be sampled and clipped.  Clipped Nodes that are positive on histology must be removed at the time of Surgery. Acharya Tulsi Regional Cancer Center, Bikaner
  29. 29.  CT regimes are similar in neo-adjuvant and adjuvant settings.  Endocrine therapy alone may be considered in Post-menopausal patients with receptor positive disease (Aromatase inhibitor).  Her-2 + disease treated with systemic therapy along with at least 9 weeks of trastuzumab. Acharya Tulsi Regional Cancer Center, Bikaner
  30. 30. DEFINITION OF MENOPAUSE  PM Range: FSH >25 IU/l; E2 <200pmol/l Acharya Tulsi Regional Cancer Center, Bikaner
  31. 31. HER 2 NEGATIVE Acharya Tulsi Regional Cancer Center, Bikaner
  32. 32. HER 2 NEGATIVE Acharya Tulsi Regional Cancer Center, Bikaner
  33. 33. Acharya Tulsi Regional Cancer Center, Bikaner
  34. 34. HER 2 POSITIVE Acharya Tulsi Regional Cancer Center, Bikaner
  35. 35. Acharya Tulsi Regional Cancer Center, Bikaner
  36. 36. MOA PERTUZUMAB  PERJETA targets a different domain on the HER2 receptor than trastuzumab, allowing the combination to provide a more comprehensive blockade of HER2-driven signaling pathways. Acharya Tulsi Regional Cancer Center, Bikaner
  37. 37. PERTUZUMAB  The pCR rates were 39.3% in patients who received pertuzumab plus trastuzumab and docetaxel  and 21.5 % in patients who received trastuzumab plus docetaxel.  (adjusted p-value = 0.0063).  The pCR rates and magnitude of improvement with the addition of pertuzumab were lower in the subgroup of patients with hormone receptor-positive tumors compared to patients with hormone receptor-negative tumors. Acharya Tulsi Regional Cancer Center, Bikaner
  38. 38. PREOP SYSTEMIC THERAPY  Confirmed Progressive disease anytime: Proceed to MRM  If CR/PR with possible BCS: Proceed to Lumpectomy Acharya Tulsi Regional Cancer Center, Bikaner
  39. 39. BASELINE DOCUMENTATION OF “TARGET” AND “NON-TARGET” LESIONS  All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline.  Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). Acharya Tulsi Regional Cancer Center, Bikaner
  40. 40.  A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response.  All other lesions should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout follow-up. Acharya Tulsi Regional Cancer Center, Bikaner
  41. 41. EVALUATION OF TARGET LESIONS  Complete Response (CR): Disappearance of all target lesions  Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD  Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started  Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Acharya Tulsi Regional Cancer Center, Bikaner
  42. 42. EVALUATION OF NON-TARGET LESIONS  Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level  Incomplete Response/ Stable Disease (SD): Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits  Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions Acharya Tulsi Regional Cancer Center, Bikaner
  43. 43. BCS WITH SURGICAL AXILLARY STAGING  No Axillary Node: RT to Whole Breast ± Boost APBI in selected patients  +ve Axillary Node: RT to whole breast ± Boost + Nodal RT ± IMN RT Acharya Tulsi Regional Cancer Center, Bikaner
  44. 44. Acharya Tulsi Regional Cancer Center, Bikaner
  45. 45. TUMOR BED BOOST  Rationale: 65%-80% of breast recurrences after BCS + RT occur around the primary tumor site.  Clark et al. noted in 1,504 patients a greater incidence of failures at 10 years of 17% in those to whom no boost was delivered, compared with 11% in those who received doses of 5 to 15 Gy at the primary excision site (P = .03) Acharya Tulsi Regional Cancer Center, Bikaner
  46. 46. Currently, most institutions prefer electron beam boost because  of its relative ease in setup,  outpatient setting,  lower cost,  decreased time demands on the physician,  and excellent results compared with 192Ir implants. Acharya Tulsi Regional Cancer Center, Bikaner
  47. 47. EORTC TRIAL  Bartelink et al. after BCS and axillary dissection, stage I or II, received 50 Gy of radiation to the whole breast in 2-Gy fractions over a 5-week period  Randomly assigned to receive either no further local treatment (2,657 patients) or a boost of 16 Gy, usually given in 8 fractions by electron beam (2,661 patients).  The 5-year actuarial rates of local recurrence were 7.3% and 4.3%, respectively (P <.001). Acharya Tulsi Regional Cancer Center, Bikaner
  48. 48. INTERNATIONAL BREAST CANCER STUDY GROUP TRIALS  Premenopausal with 1-3+LN: LRR 19-27% if G2-3 disease with vascular invasion but that risk was <15% if they had G1 disease with no vascular invasion.  Postmenopausal with 1-3+LN: G3 disease and T>2 cm LRR 24% as compared with <15% for those with G1–2 disease with T<2 cm. Acharya Tulsi Regional Cancer Center, Bikaner
  49. 49. DOSE OF RADIATION  Dose of 45-50Gy at 1.8-2Gy per fraction given 5 fractions per week.  Another dose schedule: 42.5 Gy at 2.66Gy per fraction in 16 fractions  Boost to tumor bed in patients at high risk (Age<50 years, high grade disease) with 10-16Gy at 2 Gy per fraction.  Dose to regional nodes: 50-50.4Gy at 1.8-2Gy per fraction (±Scar Boost to 60Gy at 2Gy per fraction). Acharya Tulsi Regional Cancer Center, Bikaner
  50. 50. HYPOFRACTIONATION IN BREAST Acharya Tulsi Regional Cancer Center, Bikaner
  51. 51. START TRIAL A  Criteria: Early breast cancer (pT1-3, pN0-1 M0); BCS or Mastectomy  50 Gy in 25 fractions over 5 weeks  41.6 Gy/3.2Gy per fraction in 13 fractions over 5 weeks, or  39 Gy/3Gy per fraction in 13 fractions over 5 weeks  The overall treatment time was kept constant in all three arms  Allowed treatment of regional lymph nodes (supraclavicular and axillary), used in 20%. Acharya Tulsi Regional Cancer Center, Bikaner
  52. 52. RESULTS  Median follow-up was 9·3 years.  10-year rates of local-regional relapse:  50 Gy: 7.4%  41.6 Gy: 6.3% (p=0.65)  39 Gy: 8.8% (p=0.41) Acharya Tulsi Regional Cancer Center, Bikaner
  53. 53. START TRIAL B  Criteria: Early breast cancer (pT1-3, pN0-1 M0)  50 Gy/2 Gy per fraction, 25 fractions over 5 wks,  40 Gy/2.67 Gy per fraction,15 fractions over 3 wks.  Results:  10-year rates of local-regional relapse:  50 Gy: 5.5%  40 Gy: 4.3% (p=0.21) Acharya Tulsi Regional Cancer Center, Bikaner
  54. 54. COSMESIS Acharya Tulsi Regional Cancer Center, Bikaner
  55. 55. COSMESIS  Breast induration, telangiectasia, and breast oedema were significantly less common normal tissue effects in the Hypofractionated group than in the 50 Gy group. Acharya Tulsi Regional Cancer Center, Bikaner
  56. 56. DFS IN START A & B Acharya Tulsi Regional Cancer Center, Bikaner
  57. 57. SUBGROUP ANALYSIS Acharya Tulsi Regional Cancer Center, Bikaner
  58. 58.  Inclusion Criteria: Invasive Breast Ca, BCS, Margins clear, N0  Control group: 50.0 Gy in 25 fractions over a period of 35 days  Hypofractionated group: 42.5 Gy in 16 fractions over a period of 22 days. Acharya Tulsi Regional Cancer Center, Bikaner
  59. 59.  No Nodal radiation; No Boost RESULTS The risk of local recurrence at 10 years:  6.7% standard irradiation  6.2% hypofractionated regimen Good or excellent cosmetic outcome at 10 years:  71.3% in control group  69.8% in hypofractionated Acharya Tulsi Regional Cancer Center, Bikaner
  60. 60. Acharya Tulsi Regional Cancer Center, Bikaner
  61. 61. HAZARD RATIO FOR SUBGROUPS Acharya Tulsi Regional Cancer Center, Bikaner
  62. 62. SELECTION CRITERIA FOR APBI (ASTRO)  Age>60 yrs  pT1N0, ER +  Margins Negative by at least 2mm  BRCA 1, 2 Negative  LVSI Absent  DCIS Absent  Ext Intraductal Component Absent  Unicentric  Unifocal (same quadrant)  Histology: IDC/Mucinous/Tubular/Colloid  No previous NACT  Asso. LCIS allowed Acharya Tulsi Regional Cancer Center, Bikaner
  63. 63. DOSE IN APBI  34Gy/3.4Gy per fraction/2 fractions per day 6 hrs apart for 5 days  For APBI by EBRT, 38.5Gy/3.85Gy per fraction/2 fractions per day 6 hrs apart for 5 days Acharya Tulsi Regional Cancer Center, Bikaner
  64. 64. FOLLOWING TOTAL MASTECTOMY
  65. 65.  The finding comes from a meta-analysis of individual data for a total of 8135 women participating in clinical trials who were followed for an average of 11 years; 1314 of these women were found to have 1 to 3 positive nodes. Acharya Tulsi Regional Cancer Center, Bikaner
  66. 66. EBCTCG STUDY  In women who had 1-3+ nodes, PMRT reduced the RR by 32% and reduced the breast cancer mortality rate by 20%.  The benefit was similar whether women had only 1+ node or whether they had 2 or 3+ nodes.  For women with ≥4 + nodes (n = 1772), RT reduced overall recurrence by 21% and breast cancer mortality by 13%. Acharya Tulsi Regional Cancer Center, Bikaner
  67. 67.  Woodward et al. found that the risk of LRR after mastectomy and anthracycline-based chemotherapy was only 13% for patients with stage II disease and one to three positive lymph nodes.  However, at the same institution, patients with similarly staged disease treated with PMRT had a LRR risk of only 3%. Acharya Tulsi Regional Cancer Center, Bikaner
  68. 68. COFACTORS FOR >15% LRR AFTER MASTECTOMY + CT WITH 1-3 +LN Acharya Tulsi Regional Cancer Center, Bikaner
  69. 69. CLINICAL CASE  A 40 year lady with lump in upper outer quadrant of breast underwent MRM with final HPR as follows: pT1N0 (T=0.4 cm), Metaplastic histology, ER+, PR-, Her 2+; other parameters favorable. Acharya Tulsi Regional Cancer Center, Bikaner
  70. 70. QUESTION  What next in management? Ans: Adjuvant endocrine therapy is sufficient. Acharya Tulsi Regional Cancer Center, Bikaner
  71. 71. DECISION CHART Acharya Tulsi Regional Cancer Center, Bikaner
  72. 72. QUESTION  What if the same patient was ER, PR Negative? Ans: No adjuvant therapy Acharya Tulsi Regional Cancer Center, Bikaner
  73. 73. DECISION TREE
  74. 74. CLINICAL CASE  A 40 year lady with lump in upper outer quadrant of breast underwent MRM with final HPR as follows: pT1N0 (T=1 cm), Ductal histology, ER+, PR-, Her 2- ; other parameters favorable. Ques: Next Management? Acharya Tulsi Regional Cancer Center, Bikaner
  75. 75. ONCOTYPE DX  Analyzes a panel of 21 genes within a tumor to determine a Recurrence Score.  The RS is a number between 0 and 100 that corresponds to a specific likelihood of breast cancer recurrence within 10 years of the initial diagnosis. Acharya Tulsi Regional Cancer Center, Bikaner
  76. 76. GENES ANALYZED IN ONCOTYPE DX Acharya Tulsi Regional Cancer Center, Bikaner
  77. 77. USE Oncotype DX demonstrated both  Prognostic significance (the capability of predicting distant recurrence)  Predictive significance (the capability of the test to assess the potential benefit of additional adjuvant chemotherapy). Acharya Tulsi Regional Cancer Center, Bikaner
  78. 78. Acharya Tulsi Regional Cancer Center, Bikaner
  79. 79. Kaplan-Meier plots for distant recurrence comparing treatment with tamoxifen (Tam) alone versus treatment with tamoxifen plus chemotherapy (Tam + chemo). Paik S et al. JCO 2006;24:3726-3734 ©2006 by American Society of Clinical Oncology Acharya Tulsi Regional Cancer Center, Bikaner
  80. 80. Relative and absolute risks of chemotherapy (chemo) benefit as a function of recurrence score (RS) risk category. Paik S et al. JCO 2006;24:3726-3734 ©2006 by American Society of Clinical Oncology Acharya Tulsi Regional Cancer Center, Bikaner
  81. 81. Acharya Tulsi Regional Cancer Center, Bikaner
  82. 82. CLINICAL CASE  A 40 year lady with lump in upper outer quadrant of breast underwent MRM with final HPR as follows: pT1N0 (T=0.8 cm), Mucinous histology, ER+, PR-, other parameters favorable. Next Management? Ans: No adjuvant therapy Acharya Tulsi Regional Cancer Center, Bikaner
  83. 83. DECISION TREE
  84. 84. FOLLOW UP Acharya Tulsi Regional Cancer Center, Bikaner
  85. 85. Acharya Tulsi Regional Cancer Center, Bikaner
  86. 86. THANKS Acharya Tulsi Regional Cancer Center, Bikaner
  87. 87. NEXT PRESENTATION Management of Locally Advanced Breast Cancer Dr. Satya Narayan Acharya Tulsi Regional Cancer Center, Bikaner

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Comprehensive discussion on Management of Early Breast Cancer along with NCCN guidelines. Slides prepared by Dr. Akhil Kapoor (Resident, Department of Radiation Oncology, Acharya Tulsi Regional Cancer Treatment & Research Institute, Bikaner, Rajasthan, India

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