LCA Breast Pathway 5 th Clinical Forum Immediate Breast Reconstruction 11 th March 2014

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1 LCA Breast Pathway 5 th Clinical Forum Immediate Breast Reconstruction 11 th March 2014

2 Welcome and LCA Breast Pathway Update Dr Will Teh, Chair - LCA Breast Pathway Group

3 LCA Breast 5 th Breast Pathway Clinical Forum Updates Pathway Group: Risk stratified pathways 23-hour discharge variability in screening pathways survivorship (treatment summaries and holistic needs assessment) implementation of subcut herceptin Cancer Registry Staging data low engagement of provider Trusts

4 LCA Breast 5 th Breast Pathway Clinical Forum Updates Commissioning to improve outcomes for cancer patients (21/01/14) & 5 year strategy for London eg Be clear on cancer campaign, 23 hour pathway, IBR, management of metastatic cancer, chemotherapy, patient experience (HNA, Treatment Summary, care plan, risk stratified pathways): Recommendation: End of 2 years 60% HNA, 75% TS, 70% stratified pathways Deterioration in 62 day performance

5 LCA Breast 5 th Breast Pathway Clinical Forum Updates New configuration of Members board and funding of LCA Long waits (>18 weeks) to be investigated with SI methodology 62 days worse at 82.7% (Q3) HNA now in contracts none received from 6 Trusts Discussion on CNS staffing levels and workload Breach allocation 6 month pilot (Oct 2013)

6 Feedback from Audits

7 ER and HER2 Status Audit Kalnisha Naidoo Sarah E. Pinder

8 Why audit proposed? Sherwood Forest incident Recognised technical issues Pre-emptive biomarker audit in LCA

9

10 Proposal

11 Proposed Method

12

13 Excel Form Provided to Units Only St George s and Kingston provided details of antibodies/methodology

14 Results Ten units responded Total 768 breast cancers Smallest centre - 28 cases Largest centre 165 cases

15 Primary Standard: Were 100% tested? ER - 13 not known (1.7%) HER2-34 not known (4.6%) - interesting questions raised as to streamlining HER2 audits in future

16 Reasons given for not testing HER2: - done on core - insufficient for DDISH - tumour too small - fixation issues - recurrence/met (NICE guidelines)

17

18 ER Scoring by Allred Score (0-8) Score for proportion Score for intensity 0 = no staining 0 = no staining 1 = < 1% nuclei staining 1 = weak staining 2 = 1 10% nuclei staining 2 = moderate staining 3 = 11 33% nuclei staining 3 = strong staining 4 = 34 66% nuclei staining 5 = % nuclei staining The scores are summed to give a maximum of 8 The cut off for positivity is score 3

19 ER Positivity ER Positive (Allred >2) Overall for LCA Lowest Unit Highest Unit 79.4% 60.5% 89.5% Average ER positivity rate from UK NEQAS ICC & ISH breast biomarker audit (over cancers) % overall % of primary tumours % of metastatic lesions

20 HER2 Testing Algorithm

21 Scoring HER2

22 HER2 Positivity HER2 Positive (3+ or amplified) Overall for LCA Lowest Unit Highest Unit 13.3% 4.9% 21.4%

23 HER2 Scores Frequency LCA /1+ or 1/2+ Overall positive Overall 40.1% 25.9% 17.3% 10.4% 2.0% 13.3% UK NEQAS Overall positive Overall 33.1% 33.6% 21.7% 11.6% 14.5% Primary 32.9% 34.0% 21.7% 11.5% 14.2% Met 36.6% 27.4% 21.1% 14.9% 18.0%

24 NHS BSP Guidelines (draft) It should be noted that the overall ER and PR positivity rates will vary, depending on whether the tumour is primary or metastatic and whether the patient presented with symptomatic disease or the breast cancer was identified through the breast screening programme.... Audits and benchmarking should take these factors into account

25 Outliers Confidence intervals could be wide & reduction or addition of very small number of cases may make service no longer an outlier year on year data Review whether the data require risk adjustment (e.g. for age or grade) Review relevant laboratory procedures to ensure compliance with national guidelines - Poor fixation - Age of cut sections - Homebrews standardised kit recommended Engage with NEQAS Repeat/ongoing audit

26 Thank you!

27 Means of tumour bed localization for radiotherapy boost Dr Susan Cleator Dr Seema Dadhania 11 th March 2014

28 Boost why we do it? Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC trial. J Clin Oncol. 2007;25(22):3259 A significant reduction in the local recurrence rate compared with those not treated with a boost (6 vs 10 %; hazard ratio [HR] 0.59, 95% CI ). This proportional reduction in the risk of local recurrence was similar in all age groups. However, the absolute magnitude of the reduction was greatest in younger women: Age 40 years or younger (14 vs 24 %) Age 41 to 50 years (9 vs 12.5 %) Age 51 to 60 years (4.9 vs 8 %) Age over 60 years (3.8 vs 7 %) A 41% lower rate of subsequent mastectomies. No difference in overall survival, breast cancer mortality, or disease-free survival at 10 years. A higher rate of moderate or severe fibrosis (28 vs 13 %).

29 Current LCA guidelines All women under the age of 40 Those who have undergone resection with involved margins (no further surgery planned) Units may also choose to boost all women under the age of 50 A boost should be considered in women aged >51-60 with additional risk factors Lymphovascular invasion Grade 3 disease Lack of recommended systemic therapy ER negative, HER2 positivity, tight margins Patients > age 60 if considered at particular risk of local recurrence

30 Visualisation of tumour bed Why place clips? Helps coverage of tumour bed by boost Coverage of tumour bed by tangents for medial and lateral lesions

31 Standard measured & Aims 100% patients receiving tumour bed boost should undergo positioning of electron field or planned tangential field according to a PTV defined around clips on a planning CT scan

32 Methodology Prospective audit Inclusion criteria All breast cancer patients planned for a tumour bed boost in this time should be included Exclusions Mastectomy patients receiving a boost (uncommon) Time Frame 3 months: September to November (inclusive) 2013 Minimum acceptable: 95%

33 Radiotherapy centre Patient age Data collected Means of tumour bed definition for radiotherapy Clinical CT abnormality (e.g change in density, seroma) Clips Was there CT evidence of insertion of clips into the tumour bed? Y/N No. of clips Surgical unit where surgery was performed

34 Who took part? GSTT Mount Vernon RMH Sutton RMH Fulham Charing Cross QMS Northwick Park Guildford Lister WMH PRUH Hillingdon St George s Others Ealing QMH Kingston KCH East Surrey QEH CUH Gatwick park others

35 No. of patients according to RT provider CHARING CROSS GSTT MOUNT VERNON RMH SUTTON RMH FULHAM

36 Median age of patient =

37 Percentage of patients > 50 yrs old (%) >50 Age (years)

38 Means of tumour bed definition

39 Tumour Bed definition, using clips (clips present) GUYS & ST THOMAS TURKEY RMH SUTTON CUH QMH KCH QEH CXH QMS Northwick Park GSTT RMH FULHAM ST GEORGES Hillingdon PRUH WMH EALING Kingston Lister Hospital,Chelsea East Surrey London Breast Instintute Gatwick Park Guildford Overall 91.2% of patients had clips 0% 20% 40% 60% 80% 100% 120%

40 Median number of clips used GSTT QMH QMS PRUH East Surrey KCH QEH Lister Hospital,Chelsea RMH SUTTON CUH Northwick Park CXH EALING RMH FULHAM Lewisham TURKEY ST GEORGES Kingston Hillingdon WMH London Breast Instintute Gatwick Park Guildford Median = 5 Max = 24 Min =

41 Conclusions Small number to analyze by surgical unit Overall 1.1% cases used clinical assessment only 7.7% cases used CT abnormality e.g seroma or change in density 91.2% of cases used clips Minimum acceptable: 95% Median number of clips were 5 Maximum = 24 Minimum = 2

42 Conclusions Surgical units using clips in <95% of cases GSTT 93% RMH FULHAM 92% ST GEORGES 91% Hillingdon 89% PRUH 86% WMH 80% EALING 75% Kingston 60% Lister Hospital,Chelsea 50% East Surrey 33% London Breast Instintute 0% Gatwick Park 0% Guildford 0%

43 Comments Difficult to predict who needs a boost pre surgery therefore all BCS need clips What is the optimal number of clips?

44 Thank you

45 Pathway audit of women undergoing mastectomy Initial findings February data Miss Nicola Roche Liz Chart

46 Pathway audit of women undergoing mastectomy Monthly audit returns collecting data for women undergoing mastectomy Data collected included patient age type of mastectomy / type of reconstruction (if any) axillary procedures number of out patients prior to surgery whether patient breached or not.

47

48 Options for Breast Reconstruction Mr Stuart James The Royal Marsden NHS Foundation Trust Consultant Plastic surgeon

49 Coffee Break

50 Breast Imaging Aspects of the Reconstructed Breast Dr Sarah McWilliams Guy s and St Thomas NHS Foundation Trust

51 Objectives Review normal imaging appearance of different reconstruction techniques Lipofilling or autologous fat transfer Surveillance of the reconstructed breast

52 Breast reconstruction Increase in breast reconstruction due to NICE guidelines : 5 patients had immediate reconstruction Advanced techniques: skin sparing, nipple sparing, dermal slings, acellular dermal matrices

53 Oncoplastic Breast Reconstruction tissue expander or fixed volume implant implant plus flap Autologous pedicle = TRAM or latissimus dorsi myocutaneous flap Autologous free flap from distant donor site DIEP =Deep inferior epigastric artery perforator flap

54 Implant type Saline Silicone Silicone / saline After mastectomy subpectoral implant Single lumen silicone Becker + inferior dermal sling

55 Imaging inflatable implants Becker implants = outer lumen with a fixed volume of silicone saline-filled internal lumen, which can be added to via a port

56 Becker Dual Chamber SILICONE BRIGHT FAT FLUID SUPPRESSED FAT SUPPRESSED FLUID SILICONE BRIGHT

57 MRI breast reconstruction- implants Single lumen right Double lumen left different implants if unilateral mastectomy and contralateral augmentation or prophylactic mastectomy

58 Autologous pedicle- Latissimus dorsi flap

59 BRCA carrier, Right mastectomy, LD flap, implant

60 Autologous pedicle -Latissimus dorsi plus implant- ultrasound

61 Autologous pedicle -TRAM flap Atrophied rectus muscle anterior to pectoralis denuded dermal layer of abdominal tissue seen parallel to breast skin

62 Autologous free flap - DIEP free flap Deep Inferior epigastric perforator Anastamosis of left internal mammary artery If unilateral, can make contralateral breast appear abnormal

63 CT reconstruction Bilateral mastectomies +DIEP

64 Nipple tattoo Age 57 TRAM flap reconstruction and nipple tattoo: T1W fat-sat contrastenhanced T2W non fat signal void along the nipple areola complex due to pigments = blooming artifact

65 Unilateral reconstruction causes asymmetry normal glandular parenchyma on contralateral side appears abnormal

66 Autologous fat transfer- lipofillers Indications To correct deformities after flap reconstruction To improve coverage of implants and mask rippling deformities fat grafting to the reconstructed post mastectomy breast does not delay cancer detection or increase local recurrence rates complications of fat necrosis distinguishable from suspicious lesions 2012 ASPS Guidance Delay, Aesthet.Surg. J, 29, 2009

67 Autologous fat transfer Fat easy to harvest No foreign body problems Corrects contour deformities Fat necrosis, calcification, disfigurement complications Mu et al. Ann Plast Surg 2009; 63:

68 Complications of breast reconstruction fibrosis fat necrosis implant rupture recurrence clinical examination mammography ultrasound MR

69 RCR guidelines : Imaging of mastectomy flaps and ipsilateral axilla before reconstruction Routine imaging of asymptomatic mastectomy flaps with mammography and/or ultrasound is not recommended Routine ultrasound of the asymptomatic ipsilateral axilla following BC treatment is not recommended Early detection of axillary recurrence has not been shown to improve outcomes

70 Local recurrence Incidence of locoregional recurrence post mastectomy is low 2.3% to 10.2% 93 /1057 recurrence post mastectomy 28 isolated local recurrence 22 were rendered disease free with Px early detection of local recurrence could improve outcome Buchanan et al, 2006 J Am Coll Surg 203

71 Surveillance Imaging of the Reconstructed Breast Autologous breast reconstruction and skin sparing mastectomy have not increased the local recurrence rate Howard et al, Plast Reconstr Surg Vaughan,2007 Am J Surg 194 The likely site for local recurrence- Implant based reconstruction subpectoral therefore recurrence palpable Autologous reconstruction half of recurrences impalpable as deeper

72 Local recurrence in a reconstructed breast. - superior gluteal flap reconstruction last year.

73 Local recurrence reconstructed breast TRAM Flap 419 TRAM flaps Sloane Kettering Follow up 4.9 years 16 local recurrences[ 3.8%] site 50% skin flap clinically visible site 50% chest wall- pain discomfort mean time 1.6 years Howard et al,2006 Plast Reconstr Surg 117

74 Local recurrence rate TRAM reconstruction RT reconstruction autologous flap, local recurrence 2 studies 265 TRAM flaps BM follow up 4.9 years cancer detection rate 0% Lee at al Radiology TRAM flaps local recurrence detection rate 1.9% Helvie 2002, Radiology 224

75 RCR guidelines: Imaging of autologous breast reconstruction- June 2013, 3 rd edition Impalpable local recurrence following autologous breast reconstructions is rare Mammographic surveillance of these is only justified if a woman is thought to be at high risk of local recurrence no evidence for MR screening Zakireh et al JCO 2010 Jan 28 Lee et al, Radiology 2008

76 Mammograms following skin sparing mastectomy If modified radical mastectomy, and reconstruction no follow mammography required If nipple sparing mastectomy, subcutaneous mastectomy, also called skin-sparing mastectomy,no increase in local recurrence rate follow up mammography not warranted Zakireh et al JCO 2010 Jan 28

77 Left mastectomy, reconstruction, LD flap. Prophylactic mastectomy right. L pain-ic rupture rupture

78 Summary Screening of reconstructed breast not recommended appreciate different imaging appearances of implants and the reconstructed breast

79 Thank you Thank Dr Will Teh

80 The Impact of Radiotherapy on Breast Reconstruction Dr Susan Cleator, Imperial College Healthcare NHS Trust

81 Indications for Mastectomy Risk reducing Extensive DCIS/ in situ component Large cancers Many will require radiotherapy Cancers >5cm 3 or 4 involved lymph nodes

82 Potential sequences +/- chemo Mastectomy +/- chemo Mastectomy Immediate reconstruction +/- chemo Radiotherapy to chest wall +/- chemo Radiotherapy to reconstruction Delayed reconstruction PROS No flat chest Avoid radiotherapy to Skin can be conserved reconstruction One op (!) Smaller initial procedure Implant only Minimize delay to chemo/ reconstruction permissible RT (usually temporizing) CONS Risk of delay in radiotherapy +/- chemo RT to reconstruction Flat chest Can t preserve skin Complex reconstruction needed

83 Potential sequences +/- chemo Mastectomy +/- chemo Mastectomy chem o Radiotherapy Immediate reconstruction +/- chemo Radiotherapy to chest wall Mastectomy +/- chemo Radiotherapy to reconstruction Delayed reconstruction Immediate reconstruction PROS No flat chest Avoid radiotherapy to Skin can be conserved reconstruction One op (!) Smaller initial Implant only reconstruction procedure permissible (usually Minimize delay to temporizing) chemo/ RT CONS Risk of delay in radiotherapy +/- chemo RT to reconstruction Flat chest Can t preserve skin Complex reconstruction needed No flat chest Skin can be conserved Avoid radiotherapy to reconstruction No data on op complications Loss of prognostic information

84 Potential radiotherapy induced complications long term Capsular fibrosis Fat necrosis Fibrosis (hardening/ shrinkage/ distortion/ swelling) of autologous skin Reduced patient satisfaction/ Q of L Loss of capacity to gain/lose weight in line with contralateral breast (DIEP) These can all happen in the absence of radiotherapy Radiotherapy can alleviate keloid scars

85 How can the impact of radiotherapy be measured? Randomized trials TRAM +/-RT DIEP +/-RT LD and implant +/-RT strattice and implant +/-RT and 5 TRAM + RT v DIEP s + RT v LD and s implant + RT v strattice s and implant + RT SUPREMO? N=..

86 Challenges of Randomized Trial Many patient and tumour characteristics restrict options and preclude randomization Cannot compare reconstruction type A versus reconstruction type A +RT readily (e.g in same pt undergoing risk reducing contralateral surgery): surgery to a large cancer requiring RT may differ from surgery to small cancer not requiring RT Metrics not simple: 4D photos compressibility grading of capsule (Baker; clinical, 4 levels, simple) revision rates patient assessment most important, least objective, but validated tools exist

87 PROMS Systemic review of 34 papers that include HR QoL measures in breast construction (Winters Z et al Annals Surgery, 2010) Poor methodology Under-powered 6 included pts who had received RT 1 prospective (Brandberg Y et al. Plastic and Reconstr Surgery, 2000: RT no impact in autologous reconstructions 28 pts out of 75 received RT) Novel breast reconstruction (BRR)-specific questionnaire QLQ-BRR26 Prospective study in 6 UK centres (Winters Z et al, BJC, 2012) 182 pts 82 implant assisted LD 100 (LDI) Autologous LD (ALD) 30% RT 53% RT No difference in health related Q of L EORTC QLQ-C30 and -BR23

88 Literature reporting on impact of radiotherapy in outcome from reconstruction Mainly retrospective Contradictory Small numbers Different types of reconstruction often pooled Timing of radiotherapy wrt surgery not consistently described Of 39 studies looking at impact on immediate DIEP/TRAM, 21/39 studies concluded no significant impact, 11/ 39 concluded impact Some studies document patients reporting improved appearance of reconstruction post RT (?? Relative to reconstruction on other side)

89 Some but not all studies suggestive of adverse outcome on autologous reconstruction e.g: Rogers and Allen et al, point scoring of photos for 1) symmetry 2) aesthetic proportion and 3) appearance of upper pole breast, of 20 DIEP reconstructions, 10 of which were irradiated All 3 measurements scored worse in irradiated arm (stat sig) BUT Only 10 patients Was surgery really equivalent (e.g. wrt axillary surgery)

90 What do we know? Capsular contracture more common if RT delivered post implant only reconstruction Gui et al, patients implant alone, 72 implant-assisted LD. 44 breasts received RT. Capsule formation in 13/92 (14.1%) reconstructed breasts with no RT and in 17/44 (38.6%) reconstructed breasts with RT mean photo score 8 (95% CI 8, 8.5) in capsule group (worse) versus no capsule group 6.5 (95% CI 5, 7.5), p<0.001 more than 60% of patients do not get capsules despite RT at four years implant-assisted tissue expansion techniques is a viable breast reconstructive option in selected cases

91 Impact of radiotherapy on acellular matrix + implant reconstruction Very little data Early days

92 Advice to patients? Avoid implant only reconstruction if subsequent RT planned (unless temporizing) Radiotherapy probably has potential to adversely affect outcome from autologous reconstruction (as it does to natural breast), although this is very poorly documented in the scientific literature An excellent result (as judged by patient and/ or doctor) still possible Professionals can t always tell if radiotherapy has been delivered to a reconstruction what are the CNS s advising the patients..

93 Summary and Close Chair Miss Nicola Roche

94 Thank you for coming today Presentations will be available on the website shortly.

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