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Tiloop® Bra Mesh Assisted Implant Based Breast Reconstruction (IBBR) and Post Mastectomy Radiotherapy (PMRT) – A single unit experience
S42
ABSTRACTS
Introduction: Idiopathic breast pain is common, but can be poorly managed e with a lack of up-to-date treatment reviews to guide management. Methods: Electronic literature searches of PUBMED, MEDLINE, Cochrane Database and Clinical Trials Registry were conducted (February, 2015) using the terms; mastalgia, mastodynia, cyclical and non-cyclical breast pain in accordance with PRISMA guidance. Manuscripts included RCTs, editorials, case reports and case series (with >20 subjects) between 1979e2015. Results: Treatment Method
Study design Evidence % patients with pain (no.) Level reduction (side effects)
Reassurance Brassiere
Cohort (1) RCT(1) Cohort (1) RCT (4) RCT (2) Cohort (1) Case Series (2) Cohort (1) RCT (6)
RCT (2)
EPO Topical NSAIDS Acupuncture Kinesiology Dopamine Agonists
Gonagotrophin suppressant (Danazol) GnRH agonist (Goserelin) Progesterone agonist Surgery
Relaxation Soya Tamoxifen SERMs: Ormeloxifene Toremifene)
III II
70% 49% 85%
II II
None 92%
IV
67% (36% dropout)
III II
II
60%; 18% resolution 80% (Bromocriptine); 90% (Lisuride); 71% (Agnus-Castus) (11% dizziness and nausea) 90% (Androgenic)
Cohort (1)
III
81% (Menopausal)
RCT (1) Cohort (1)
II V
33% (Androgenic in 41%) 42% pain-free post mastectomies (50% had post-op complications) 61% 56% 71% (10% intolerance) 90%
RCT RCT RCT RCT
(1) (2) (3) (5)
II II II II
64% (Hot flushes)
Conclusion: 70e85% of cases can be managed with reassurance and bra-fitting advice alone. Drug therapy should be balanced against side effects. NSAIDs and Ormeloxifene show greatest benefit with least side effects, however the latter has not been trialled or licensed in the UK. http://dx.doi.org/10.1016/j.ejso.2016.02.164
P112. Are National ABS/BAPRAS targets being met in the North West of England in implant based breast reconstruction? Saleem Mastan4, Rebecca L. Teasdale1,3, Matthew P. Rowland1,3, Sandhir K. Kandola1,7, Julia R. Henderson1,6, Cliona C. Kirwan2,5, James R. Harvey2,5 1 North West Breast Trainees Research Collaborative, North West, UK 2 University Hospital of South Manchester, Manchester, UK 3 Pennine Acute NHS Trust, Manchester, UK 4 Wrightington, Wigan & Leigh NHS Trust, Wigan, UK 5 Institute of Cancer, University of Manchester, Manchester, UK 6 The Royal Liverpool & Broadgreen University Hospitals NHS Trust, Liverpool, UK 7 Lancashire Teaching Hospitals NHS Trust, Preston, UK Introduction: Surgeons take precautions to prevent post-operative complications, however a recent covert surveillance audit of infection prophylaxis in implant surgery highlighted high inter-surgeon and intra-
surgeon variability in practice. We assessed rates of post-operative infection, unplanned return to theatre, readmission and implant loss at three months with a multi-centre study in North West England to compare with the quality criteria set in ABS/BAPRAS Oncoplastic Breast Reconstruction Guidelines for Best Practice. Methods: A retrospective review of implant based reconstructions, in 5 centres, between 01/01/12 and 31/12/12 was performed. Unplanned readmission, return to theatre, infection and implant loss at three months were assessed. Results: 191 patients underwent implant based breast reconstruction. 58 (30%) pedicle flap, 16 (8%) dermal sling, 48 (25%) ADM and 68 (36%) implant alone. Complication rates are largely comparable to Best Practice guidelines (table 1), however infection rates (determined by reference to clinical signs of infection or further use of antibiotics) are high at 29 (15%). Conclusion: Although our sample size is relatively small, the standard Table 1
Unplanned return to theatre Unplanned readmission Implant loss
Outcome at 3 months % (n)
Quality Criteria %
6 (12) 7 (14) 4 (7)
<5 <5 <5
set in the ABS/BAPRAS guidelines for implant loss appears achievable in unselected breast units. The high infection rate undoubtedly reflects our broad definition of infection and retrospectively collected data, however this represents an area where improvement is required. Standardising practice with an evidenced-based ‘Theatre Infection Checklist’ to ensure best practice recommendations are followed may improve outcomes. http://dx.doi.org/10.1016/j.ejso.2016.02.165
P113. TiloopÒ Bra Mesh Assisted Implant Based Breast Reconstruction (IBBR) and Post Mastectomy Radiotherapy (PMRT) e A single unit experience Sonia Bathla, Chih Tan, Anupama Shrotri, Lee Martin University Hospital Aintree, Liverpool, UK Introduction: IBBR is the most common approach to breast reconstruction in the UK. Indications for PMRT are also increasing. PMRT is associated with increased complications in IBBR (40e68%), and a 30% implant loss rate. Limited data exists on the effects of radiotherapy in IBBR using TiLOOPÒ Bra mesh. Methods: Casenotes for patients undergoing TiLoop-assisted IBBR and PMRT in a single unit between January 2013eJune 2015 were reviewed. Patient factors, surgery, mastectomy weight, implant used, final histology, complications (minor e conservative management, major e requiring additional surgery) and aesthetic outcome were recorded. Results: 22/73 patients who underwent IBBR with Tiloop (3 bilateral) went on to have PMRT. 1/22 had previous radiotherapy. The median age was 51.5 (25e81), BMI 28.3 (19.2e40.3), all ASA 1 or 2, and 2 were smokers. Mean mastectomy weight was 655g (130e1272g). 14/22 had an axillary node clearance. 19/22 underwent a 2-stage procedure using an expander (300-800cc 133 SX Allergan), with on table fill volumes ranging from 100e600ml (29e77%). 7/22 (31.8% - 3 minor, 4 major) had a complication prior to radiotherapy, and 7/22 (31.8% - 7 minor) post radiotherapy. 4 implants were lost (18%), all prior to PMRT. Median follow up was 12 months (range 4e23). Aesthetic outcome was deemed satisfactory by the surgeon in 77% and patient in 72% at final followup. 8/22 were referred to plastics for corrective surgery or risk reduction mastectomy and reconstruction. Conclusions: Irradiation of TiLoop-assisted IBBR is not associated with increased early complications. Patient and tumour factors are more
ABSTRACTS likely to determine outcome. http://dx.doi.org/10.1016/j.ejso.2016.02.166
P114. Drainless Breast Reconstruction: Can it be safe when ADM are used? Kali Potiszil1,2, Sheikh Ahmad3 1 University of Exeter, Exeter, UK 2 Lifcell, England, UK 3 Royal Cornwall Hospital, Cornwall, UK Introduction: One of the most common reported side effects of acellular dermal matrix (ADM) use in breast reconstruction is seroma. Traditionally drains have been used post-operatively to reduce this. However, there is also evidence showing no increased rate of seroma with ADM use, no increased risk of infection with seroma and an increased risk of infection with drain use. This led us to think that there may be a degree of unnecessary drain use occurring in breast reconstructions Methods: A prospective study over 1 year of immediate breast reconstructions by one surgeon in a single institution. Surgical and patient characteristics were recorded, along with clinical follow-up and complications. Inclusion criteria involved: 1) BMI < 35/low breast volume 2) Non-smoking status 3) No high risk co-morbidities. Results: There were a total of 20 patients with 11 ADM / implant reconstructions. Clinical but asymptomatic seromas were seen in 6 cases (30%). None of these cases led to infection or implant loss, with 1 case needing a minor wound re-suture. Only one implant was lost and this was due to infection with USS confirming no seroma present at any point. Conclusion: We may be overusing drains in breast reconstruction. In a specific set of patients, not using drains in breast reconstructions with ADM appears safe and causes no permanent complications. Though clinically seromas may be seen, these have been small, asymptomatic and needed no intervention in our experience. This is a small set of patients and further investigation with larger numbers and longer follow up is needed to fully confirm these results. http://dx.doi.org/10.1016/j.ejso.2016.02.167
P115. Does contralateral synchronous surgery delay adjuvant therapy for women undergoing immediate implant based reconstruction? Rebecca L. Teasdale1,2, Saleem Mastan3, Matthew P. Rowland1,2, Sandhir K. Kandola1,4, Julia R. Henderson1,5, Cliona C. Kirwan6,7, James R. Harvey6,7 1 North West Breast Trainees Research Collaborative, North West, UK 2 Pennine Acute NHS Trust, Manchester, UK 3 Wrightington, Wigan & Leigh NHS Trust, Wigan, UK 4 Lancashire Teaching Hospitals NHS Trust, Preston, UK 5 The Royal Liverpool & Broadgreen University Hospitals NHS Trust, Liverpool, UK 6 University of South Manchester NHS Trust, Manchester UK 7 Cancer Institute, University of Manchester, Manchester, UK Introduction: Many surgeons elect not to offer patients synchronous surgery on the contralateral breast when performing immediate reconstruction; one reason is to avoid possible delays to adjuvant treatment. We assessed the impact of synchronous surgery on delays to adjuvant chemotherapy/radiotherapy in implant-based reconstruction with a multicentre study in North West England. Methods: A retrospective review of implant based reconstructions, in 5 centres, between 01/01/12 and 31/12/12 was performed. Delay to adjuvant treatment, complications, further surgery and implant loss were assessed in those having and not having synchronous surgery with their reconstruction. Results: 103 patients underwent implant based immediate breast reconstructions for cancer, with minimum follow-up of 24 months. 17
S43 (17%) had synchronous surgery. 7 (41%) risk-reducing mastectomy and implant based immediate reconstruction, 6 (35%) reduction mammoplasty and 4(24%) implant based augmentation. For patients receiving adjuvant treatment (n¼40), in the contralateral surgery group 1 (10%) experienced a delay due to infection (in the index breast) compared to 3(10%) in the no synchronous surgery group. Conclusion:
Total Delay to adjuvant treatment Delayed wound healing Implant loss Unplanned procedures Unplanned for complications Unplanned for cosmesis
Synchronous Surgery n(%)
No Synchronous surgery n(%)
P Value
17 (17) 1 (10) 4 (24) 2 (12) 4 (24) 1 (6) 3 (18)
86 (83) 3 (10) 13 (15) 10 (12) 13 (15) 7 (8) 6 (7)
1 0.5 1 0.5 0.6 0.6
Although our numbers are small, surgery on the contralateral breast at the time of implant based reconstruction appears feasible with no significant delay to adjuvant treatment. http://dx.doi.org/10.1016/j.ejso.2016.02.168
P116. Response to vaccination via tumour draining lymph nodes does not demonstrate a tumour suppressive effect in patients with breast cancer: A peri-surgical window study David Layfield1, James Clarke1, Natalia Savelyeva1, Ramsey Cutress1,2, Christian Ottensmeier1,2 1 University of Southampton, Southampton, UK 2 University Hospital Southampton, Southampton, UK Introduction: Cancer modulates immune function via effects on draining lymphatics. Locoregional immune suppression through various mechanisms precedes establishment of lymphatic metastasis. Immunotherapeutic anti-cancer vaccines may prove useful adjuvants to current treatments however their efficacy depends on immunocompetence. Methods: 23 early breast cancer patients were recruited into a prospective peri-surgical window study (NRES:11/SC/0509) and randomised to receive tetanus/diphtheria vaccine either ipsilateral to their cancer (N¼11), contralateral (N¼6) or no vaccine (N¼6). Those vaccinated ipsilateraly received subcutaneous vaccination to the inner aspect of the upper arm to ensure axillary drainage. Vaccine response was assessed using a panel of 14 ELISA assays measuring Total IgG, IgM and IgG1-4 subtypes against vaccine components (Tetanus Toxoid (TTd), Diphtheria Toxoid (DTd)), as well as control protein (PPD). Results: Baseline immunoglobulin levels were equivalent across the three cohorts. Peak response was seen 3 weeks post vaccination (mean fold increase:TTd¼11.3,SEM 4.4. DTd¼8.3,SEM 3.6). Magnitude of response to each vaccine component was compared using two-sample T ak correction (alpha¼0.05): No differences in response test with Holm-Sid were detectable between ipsilateral and contralateral cohorts for either vaccine components, for any immunoglobulin subtypes at any time points analysed. Cluster analysis following data normalisation (mean¼0 (variance¼1)) using average linkage hierarchical clustering (Qlucore-omic explorer 3.1.1) failed to demonstrate differences between the two cohorts. Conclusion: Presence of locoregional breast cancer had no detectable effect on vaccine response compared to that seen when cancer is present at a site distant to vaccination. Patients with early breast cancer are immunereplete and may be good candidates for vaccine-based cancer therapeutics. http://dx.doi.org/10.1016/j.ejso.2016.02.169
ABSTRACTS
Introduction: Idiopathic breast pain is common, but can be poorly managed e with a lack of up-to-date treatment reviews to guide management. Methods: Electronic literature searches of PUBMED, MEDLINE, Cochrane Database and Clinical Trials Registry were conducted (February, 2015) using the terms; mastalgia, mastodynia, cyclical and non-cyclical breast pain in accordance with PRISMA guidance. Manuscripts included RCTs, editorials, case reports and case series (with >20 subjects) between 1979e2015. Results: Treatment Method
Study design Evidence % patients with pain (no.) Level reduction (side effects)
Reassurance Brassiere
Cohort (1) RCT(1) Cohort (1) RCT (4) RCT (2) Cohort (1) Case Series (2) Cohort (1) RCT (6)
RCT (2)
EPO Topical NSAIDS Acupuncture Kinesiology Dopamine Agonists
Gonagotrophin suppressant (Danazol) GnRH agonist (Goserelin) Progesterone agonist Surgery
Relaxation Soya Tamoxifen SERMs: Ormeloxifene Toremifene)
III II
70% 49% 85%
II II
None 92%
IV
67% (36% dropout)
III II
II
60%; 18% resolution 80% (Bromocriptine); 90% (Lisuride); 71% (Agnus-Castus) (11% dizziness and nausea) 90% (Androgenic)
Cohort (1)
III
81% (Menopausal)
RCT (1) Cohort (1)
II V
33% (Androgenic in 41%) 42% pain-free post mastectomies (50% had post-op complications) 61% 56% 71% (10% intolerance) 90%
RCT RCT RCT RCT
(1) (2) (3) (5)
II II II II
64% (Hot flushes)
Conclusion: 70e85% of cases can be managed with reassurance and bra-fitting advice alone. Drug therapy should be balanced against side effects. NSAIDs and Ormeloxifene show greatest benefit with least side effects, however the latter has not been trialled or licensed in the UK. http://dx.doi.org/10.1016/j.ejso.2016.02.164
P112. Are National ABS/BAPRAS targets being met in the North West of England in implant based breast reconstruction? Saleem Mastan4, Rebecca L. Teasdale1,3, Matthew P. Rowland1,3, Sandhir K. Kandola1,7, Julia R. Henderson1,6, Cliona C. Kirwan2,5, James R. Harvey2,5 1 North West Breast Trainees Research Collaborative, North West, UK 2 University Hospital of South Manchester, Manchester, UK 3 Pennine Acute NHS Trust, Manchester, UK 4 Wrightington, Wigan & Leigh NHS Trust, Wigan, UK 5 Institute of Cancer, University of Manchester, Manchester, UK 6 The Royal Liverpool & Broadgreen University Hospitals NHS Trust, Liverpool, UK 7 Lancashire Teaching Hospitals NHS Trust, Preston, UK Introduction: Surgeons take precautions to prevent post-operative complications, however a recent covert surveillance audit of infection prophylaxis in implant surgery highlighted high inter-surgeon and intra-
surgeon variability in practice. We assessed rates of post-operative infection, unplanned return to theatre, readmission and implant loss at three months with a multi-centre study in North West England to compare with the quality criteria set in ABS/BAPRAS Oncoplastic Breast Reconstruction Guidelines for Best Practice. Methods: A retrospective review of implant based reconstructions, in 5 centres, between 01/01/12 and 31/12/12 was performed. Unplanned readmission, return to theatre, infection and implant loss at three months were assessed. Results: 191 patients underwent implant based breast reconstruction. 58 (30%) pedicle flap, 16 (8%) dermal sling, 48 (25%) ADM and 68 (36%) implant alone. Complication rates are largely comparable to Best Practice guidelines (table 1), however infection rates (determined by reference to clinical signs of infection or further use of antibiotics) are high at 29 (15%). Conclusion: Although our sample size is relatively small, the standard Table 1
Unplanned return to theatre Unplanned readmission Implant loss
Outcome at 3 months % (n)
Quality Criteria %
6 (12) 7 (14) 4 (7)
<5 <5 <5
set in the ABS/BAPRAS guidelines for implant loss appears achievable in unselected breast units. The high infection rate undoubtedly reflects our broad definition of infection and retrospectively collected data, however this represents an area where improvement is required. Standardising practice with an evidenced-based ‘Theatre Infection Checklist’ to ensure best practice recommendations are followed may improve outcomes. http://dx.doi.org/10.1016/j.ejso.2016.02.165
P113. TiloopÒ Bra Mesh Assisted Implant Based Breast Reconstruction (IBBR) and Post Mastectomy Radiotherapy (PMRT) e A single unit experience Sonia Bathla, Chih Tan, Anupama Shrotri, Lee Martin University Hospital Aintree, Liverpool, UK Introduction: IBBR is the most common approach to breast reconstruction in the UK. Indications for PMRT are also increasing. PMRT is associated with increased complications in IBBR (40e68%), and a 30% implant loss rate. Limited data exists on the effects of radiotherapy in IBBR using TiLOOPÒ Bra mesh. Methods: Casenotes for patients undergoing TiLoop-assisted IBBR and PMRT in a single unit between January 2013eJune 2015 were reviewed. Patient factors, surgery, mastectomy weight, implant used, final histology, complications (minor e conservative management, major e requiring additional surgery) and aesthetic outcome were recorded. Results: 22/73 patients who underwent IBBR with Tiloop (3 bilateral) went on to have PMRT. 1/22 had previous radiotherapy. The median age was 51.5 (25e81), BMI 28.3 (19.2e40.3), all ASA 1 or 2, and 2 were smokers. Mean mastectomy weight was 655g (130e1272g). 14/22 had an axillary node clearance. 19/22 underwent a 2-stage procedure using an expander (300-800cc 133 SX Allergan), with on table fill volumes ranging from 100e600ml (29e77%). 7/22 (31.8% - 3 minor, 4 major) had a complication prior to radiotherapy, and 7/22 (31.8% - 7 minor) post radiotherapy. 4 implants were lost (18%), all prior to PMRT. Median follow up was 12 months (range 4e23). Aesthetic outcome was deemed satisfactory by the surgeon in 77% and patient in 72% at final followup. 8/22 were referred to plastics for corrective surgery or risk reduction mastectomy and reconstruction. Conclusions: Irradiation of TiLoop-assisted IBBR is not associated with increased early complications. Patient and tumour factors are more
ABSTRACTS likely to determine outcome. http://dx.doi.org/10.1016/j.ejso.2016.02.166
P114. Drainless Breast Reconstruction: Can it be safe when ADM are used? Kali Potiszil1,2, Sheikh Ahmad3 1 University of Exeter, Exeter, UK 2 Lifcell, England, UK 3 Royal Cornwall Hospital, Cornwall, UK Introduction: One of the most common reported side effects of acellular dermal matrix (ADM) use in breast reconstruction is seroma. Traditionally drains have been used post-operatively to reduce this. However, there is also evidence showing no increased rate of seroma with ADM use, no increased risk of infection with seroma and an increased risk of infection with drain use. This led us to think that there may be a degree of unnecessary drain use occurring in breast reconstructions Methods: A prospective study over 1 year of immediate breast reconstructions by one surgeon in a single institution. Surgical and patient characteristics were recorded, along with clinical follow-up and complications. Inclusion criteria involved: 1) BMI < 35/low breast volume 2) Non-smoking status 3) No high risk co-morbidities. Results: There were a total of 20 patients with 11 ADM / implant reconstructions. Clinical but asymptomatic seromas were seen in 6 cases (30%). None of these cases led to infection or implant loss, with 1 case needing a minor wound re-suture. Only one implant was lost and this was due to infection with USS confirming no seroma present at any point. Conclusion: We may be overusing drains in breast reconstruction. In a specific set of patients, not using drains in breast reconstructions with ADM appears safe and causes no permanent complications. Though clinically seromas may be seen, these have been small, asymptomatic and needed no intervention in our experience. This is a small set of patients and further investigation with larger numbers and longer follow up is needed to fully confirm these results. http://dx.doi.org/10.1016/j.ejso.2016.02.167
P115. Does contralateral synchronous surgery delay adjuvant therapy for women undergoing immediate implant based reconstruction? Rebecca L. Teasdale1,2, Saleem Mastan3, Matthew P. Rowland1,2, Sandhir K. Kandola1,4, Julia R. Henderson1,5, Cliona C. Kirwan6,7, James R. Harvey6,7 1 North West Breast Trainees Research Collaborative, North West, UK 2 Pennine Acute NHS Trust, Manchester, UK 3 Wrightington, Wigan & Leigh NHS Trust, Wigan, UK 4 Lancashire Teaching Hospitals NHS Trust, Preston, UK 5 The Royal Liverpool & Broadgreen University Hospitals NHS Trust, Liverpool, UK 6 University of South Manchester NHS Trust, Manchester UK 7 Cancer Institute, University of Manchester, Manchester, UK Introduction: Many surgeons elect not to offer patients synchronous surgery on the contralateral breast when performing immediate reconstruction; one reason is to avoid possible delays to adjuvant treatment. We assessed the impact of synchronous surgery on delays to adjuvant chemotherapy/radiotherapy in implant-based reconstruction with a multicentre study in North West England. Methods: A retrospective review of implant based reconstructions, in 5 centres, between 01/01/12 and 31/12/12 was performed. Delay to adjuvant treatment, complications, further surgery and implant loss were assessed in those having and not having synchronous surgery with their reconstruction. Results: 103 patients underwent implant based immediate breast reconstructions for cancer, with minimum follow-up of 24 months. 17
S43 (17%) had synchronous surgery. 7 (41%) risk-reducing mastectomy and implant based immediate reconstruction, 6 (35%) reduction mammoplasty and 4(24%) implant based augmentation. For patients receiving adjuvant treatment (n¼40), in the contralateral surgery group 1 (10%) experienced a delay due to infection (in the index breast) compared to 3(10%) in the no synchronous surgery group. Conclusion:
Total Delay to adjuvant treatment Delayed wound healing Implant loss Unplanned procedures Unplanned for complications Unplanned for cosmesis
Synchronous Surgery n(%)
No Synchronous surgery n(%)
P Value
17 (17) 1 (10) 4 (24) 2 (12) 4 (24) 1 (6) 3 (18)
86 (83) 3 (10) 13 (15) 10 (12) 13 (15) 7 (8) 6 (7)
1 0.5 1 0.5 0.6 0.6
Although our numbers are small, surgery on the contralateral breast at the time of implant based reconstruction appears feasible with no significant delay to adjuvant treatment. http://dx.doi.org/10.1016/j.ejso.2016.02.168
P116. Response to vaccination via tumour draining lymph nodes does not demonstrate a tumour suppressive effect in patients with breast cancer: A peri-surgical window study David Layfield1, James Clarke1, Natalia Savelyeva1, Ramsey Cutress1,2, Christian Ottensmeier1,2 1 University of Southampton, Southampton, UK 2 University Hospital Southampton, Southampton, UK Introduction: Cancer modulates immune function via effects on draining lymphatics. Locoregional immune suppression through various mechanisms precedes establishment of lymphatic metastasis. Immunotherapeutic anti-cancer vaccines may prove useful adjuvants to current treatments however their efficacy depends on immunocompetence. Methods: 23 early breast cancer patients were recruited into a prospective peri-surgical window study (NRES:11/SC/0509) and randomised to receive tetanus/diphtheria vaccine either ipsilateral to their cancer (N¼11), contralateral (N¼6) or no vaccine (N¼6). Those vaccinated ipsilateraly received subcutaneous vaccination to the inner aspect of the upper arm to ensure axillary drainage. Vaccine response was assessed using a panel of 14 ELISA assays measuring Total IgG, IgM and IgG1-4 subtypes against vaccine components (Tetanus Toxoid (TTd), Diphtheria Toxoid (DTd)), as well as control protein (PPD). Results: Baseline immunoglobulin levels were equivalent across the three cohorts. Peak response was seen 3 weeks post vaccination (mean fold increase:TTd¼11.3,SEM 4.4. DTd¼8.3,SEM 3.6). Magnitude of response to each vaccine component was compared using two-sample T ak correction (alpha¼0.05): No differences in response test with Holm-Sid were detectable between ipsilateral and contralateral cohorts for either vaccine components, for any immunoglobulin subtypes at any time points analysed. Cluster analysis following data normalisation (mean¼0 (variance¼1)) using average linkage hierarchical clustering (Qlucore-omic explorer 3.1.1) failed to demonstrate differences between the two cohorts. Conclusion: Presence of locoregional breast cancer had no detectable effect on vaccine response compared to that seen when cancer is present at a site distant to vaccination. Patients with early breast cancer are immunereplete and may be good candidates for vaccine-based cancer therapeutics. http://dx.doi.org/10.1016/j.ejso.2016.02.169