Whither surgical quality assurance of breast cancer surgery (surgical margins and local recurrence) after paterson
Whither surgical quality assurance of breast cancer surgery (surgical margins and local recurrence) after paterson
N. J. Bundred 0 1 2 3
J. Thomas 0 1 2 3
J. M. J. Dixon 0 1 2 3
0 Western General Hospital , Edinburgh EH4 2 XU , UK
1 Department of Surgery, Education and Research Centre, University Hospital of South Manchester , 2nd Floor, Southmoor Road, Manchester M23 9LT , UK
2 & N. J. Bundred
3 Edinburgh Breast Unit, Western General Hospital , Edinburgh EH4 2XU , UK
Purpose The Kennedy report into the actions of the disgraced Breast Surgeon, Paterson focussed on issues of informed consent for mastectomy, management of surgical margins and raised concerns about local recurrence rates and the increasing emphasis on cosmesis after mastectomy for breast cancer. This article assesses whether Kennedy's recommendations apply to the UK as a whole and how to address these issues. New GMC advice on consent and newer nonevidenced innovations in immediate reconstruction have altered the level of informed consent required. Patients deserve a better understanding of the issues of oncological versus cosmetic outcomes on which to base their decisions. Involvement of the whole multidisciplinary team including Oncologists is necessary in surgical planning. Failure to obtain clear microscopic margins at mastectomy leads to an increased local recurrence, yet has received little attention in the UK. Whereas, other countries have used surgical quality assurance audits to reduce local recurrence; local recurrence rates are not available and the extent of variation across the UK in margin involvement after surgery, its management and relationship to local recurrence needs auditing prospectively to reduce unnecessary morbidity. To reassure public, patients and the NHS management, an accreditation system with more rigour than NHSBSP QA and peer review is now required. Resource and efforts to support its introduction will be necessary from the Royal College of Surgeons and the Association of Breast Surgeons. New innovations require careful evaluation before their backdoor introduction to the NHS. Private Hospitals need to have the same standards imposed.
Breast Cancer; Local recurrence; Mastectomy; Involved margins
-
The UK Breast Surgeon, Ian Paterson received a 15 year
jail sentence last month after being convicted of
intentionally wounding his patients in Private hospitals. He
misled vulnerable concerned patients worried about having
a breast cancer and persuaded them to undergo unnecessary
major surgical procedures rather than reassuring them they
had no evidence of cancer.
The Kennedy report [
1
] into the actions of Paterson in
NHS practice focussed on several themes but crucially
questioned issues of informed consent, management of
surgical margins and raised concerns about local
recurrence rates and his emphasis on cosmesis after mastectomy
for breast cancer. The report noted a premise widely
accepted that ‘‘if you cut a cancer out and it is present at the
edges (of the cut) there is an increased risk that it will come
back at the edge’’. Kennedy reported that the West
Midlands had an overall 1.4% local recurrence rate following
mastectomy, but Paterson had an overall 3% local
recurrence at 5 years, although after Cleavage Sparing
Mastectomy (CSM) or following mastectomy and immediate
reconstruction, it was 5.7% after 5 years rising to 9% by
10 years. Paterson’s high rate of local recurrence was
explained by Kennedy as due to his nonevidence based
‘‘CSM’’ technique which left breast tissue behind and
produced a high microscopic margin involvement after
mastectomy, despite oncologists mitigating risk with
adjuvant radiotherapy [
1
]. Paterson’s prioritisation of
cosmesis over complete cancer removal, left margins
involved with cancer in 10-37% of cases undergoing CSM
and resulted in a 9–18% local recurrence rate at 5 years
after Mastectomy and Reconstruction [
1
].
Following local recurrence in the breast there is a 1 in 4
risk of dying from cancer [
2
]. Internationally, local
recurrence rates (LRR) after mastectomy have fallen from 20%
in the 1990s to 3% or less, in part due to the increased use
of Adjuvant Systemic Therapy. Local recurrence varies
with Tumour Phenotype (higher rate in Oestrogen Receptor
Negative and HER2 positive cancers), node status and
microscopic margin involvement (not type of
Mastectomy). The only factor the Surgeon can influence is Margin
Status [
2, 3
].
After Mastectomy for DCIS (when adjuvant therapy is
not indicated), Fitzsullivan [
4
] reported on 810 patients
with DCIS, of whom 66% had Immediate Breast
Reconstruction with an overall LRR of 1% at 5 years.
Intraoperative margin assessment by Frozen Section reduced the
margin involvement rate from 14% to a final rate of 7.3%.
Margin involvement was associated with a significantly
higher 5% local recurrence rate (which was not affected by
post-mastectomy radiotherapy), and was the only
independent predictor of local recurrenc (...truncated)