Indications for breast conserving surgery
Question
What are the indications for oncoplastic breast conserving surgery?
Recommendation
Consider oncoplastic surgery if:
- significant dead space remains after lumpectomy;
- a volume reduction greater than 20% is achieved;
- a full thickness defect to the pectoral muscle fascia exists.
Consider oncoplastic breast reduction techniques in patients:
- in whom breast conserving surgery would result in nipple malposition;
- with breast hypertrophy;
- with breast ptosis;
- with a tumor located primarily in the medial upper quadrant or the lower half of the breast.
Consider an oncoplastic volume replacement technique if:
- sufficient volume and shape retention cannot be achieved with a volume displacement technique;
- the patient does not want smaller breasts.
Preoperative joint assessment by a radiotherapist is preferred if oncoplastic surgery is chosen.
Considerations
Despite the limitations to the quality of the current literature, there appears to be no evidence that OPS has a negative effect on the occurrence of local recurrence, provided that the margins are tumor-free. The use of more extensive local displacement and rotation techniques may yield better options for conservative therapy with a good to acceptable cosmetic result, rather than moving to ablative surgery. Determining the indication and selecting the reconstruction technique depends on the personal preference and expertise within the multidisciplinary team, with multiple decision models being proposed (Noguchi et al, 1991; Audretsch, 1998; Losken et al, 2007; Kronowitz et al, 2007).
Radiation therapy is an important part of breast conserving therapy, with the excision cavity being considered a high-risk area and thus the target. The use of oncoplastic techniques can make this area more difficult to recognize for the radiation oncologist. Thus, if the indication for OPS is determined during the multidisciplinary meeting, preoperative consultation by a radiation oncologist is advisable.
The available literature examined cosmetic result or patient satisfaction using unstandardized and not always validated questionnaires (McIntosh et al, 2012) or general, validated questionnaires (e.g. Short Form-36 and Rosenberg Self–Esteem Scale) not specific to breast surgery (Veiga et al, 2010; Veiga et al, 2011). Recently, a standardized and validated patient questionnaire (BREAST-Q) with modules for only mastectomy and mastectomy followed by reconstruction was developed (Pusic et al, 2009; McIntosh et al, 2012). However, there are currently no published studies using this questionnaire specifically in patients with BCT and OPS.
If there is any uncertainty about tumor-free excision margins in breast conserving therapy, it has been suggested the lumpectomy cavity should be left intact and additional extensive oncoplastic surgery should be delayed for a number of days until the results of the pathology examination are available (‘delayed-immediate’ reconstruction). However, repeat surgery within a number of days to weeks, prior to radiation therapy, may be associated with an increased risk of postoperative wound healing and medical complications (Munhoz et al, 2011; Roughton et al, 2012).
Following a lumpectomy, the dead space may be closed by approximating the edges of the cavity, particularly if a full thickness gland excision down to the thoracic wall (m. pectoralis major) has been performed (Masetti et al, 2000; Anderson et al, 2005). This not only reduces the risk of seroma formation and infections, but also the risk of cosmetically unattractive deep adhesions of the skin to the underlying tissue following local radiation therapy. In most cases, the breast gland can be approximated using a dual plane dissection of adjacent parts of the remaining gland in the subcutaneous and/or pectoral plane (Clough et al, 2010). Approximation may be achieved using interrupted sutures in one or two layers. In order to optimize the cosmetic result, the wound and subcutis are closed in layers. To make the procedure technically easier and to improve cosmetic results of lumpectomy, the operation may be initiated using a single plane undermining of the subcutaneous plane around the portion of the breast gland to be removed.
The decision to perform additional oncoplastic surgical techniques depends on the assessment of the chance of a poor cosmetic result after a conventional lumpectomy. Ideally, this assessment should take place preoperatively in an outpatient setting.
The factors described below play a role in this decision:
- Excision volume: larger excision volumes, i.e. more than 20% of the breast gland, are associated with a greater risk of contour deformity (Taylor, et al, 1995; Bulstrode et al, 2001; Clough et al, 2010);
- Tumor localization: excisions in the medial upper quadrant are associated with the greatest risk of poor cosmetic results. The risk is reduced via the medial lower quadrant, lateral lower quadrant and then lateral upper quadrant (Clough et al, 1990; Kronowitz et al, 2007; Wang et al, 2008; Clough et al, 2010);
- Quality of breast gland tissue: firm/dense gland tissue is more easily transposed and sutured compared with fatty, loose gland tissue. In the latter case, techniques other than the simple rotation and displacement techniques are more appropriate (Clough et al, 2010);
- Breast contour: in case of ptosis of the breast, the cosmetic result may be improved if the lumpectomy is combined with mastopexy (Nos et al, 1998; Smith et al, 1998; Losken et al, 2007; Iwuchukwu et al, 2012);
- Breast size: in the event of breast hypertrophy, a concurrent breast reduction may be performed (Smith et al, 1998; Spear et al, 1998; Newman et al, 2001; Gulcelik et al, 2011).
After approximating the resection planes or the use of extensive volume displacement techniques, where interposition of gland tissue is sometimes performed to fill in the defect, accurate documentation and marking of the surgical excision cavity using MRI-compatible clips is critical to ensure the target volume for any boost radiation therapy can be determined adequately (Kirova et al, 2010; Kirova et al, 2011; Poortmans et al, 2012). This should be done according to the UK protocol (Coles et al, 2009), meaning: clips in five directions:
- At the medial edge of the tumor bed, between the thoracic wall and the skin.
- At the lateral edge of the tumor bed, between the thoracic wall and the skin.
- At the cranial edge of the tumor bed, between the thoracic wall and the skin.
- At the caudal edge of the tumor bed, between the thoracic wall and the skin.
- At the deepest point of the tumor bed.
When performing additional oncoplastic surgery, the patient should be informed that more and sometimes larger incisions will be made. Depending on the final result and the initial shape of the breast, a contralateral procedure to ensure symmetry may be required. This intervention is generally delayed until the ipsilateral breast has healed and recovered fully from radiation therapy (Kronowitz et al, 2007; Patel et al, 2011), but immediate symmetrization of the contralateral breast may be preferred for psychological reasons in selected cases, for example if obvious asymmetry is present (Munhoz, 2009). The latter strategy has the disadvantages that the ipsilateral breast contour may still change, resulting in asymmetry at a later point in time, and that immediate contralateral breast reduction results in longer surgery.
Evidence
Background
The primary goal of breast conserving surgery is an oncologically adequate resection, with tumor-free margins to reduce the chances of local recurrence. Additionally, striving for a good aesthetic result is a significant goal of breast conserving therapy (BCT). Interest in this aspect has been growing over the past years. However, it is estimated that about 30% to 40% of standard breast conserving surgery followed by radiation therapy leads to a disappointing aesthetic result due to contour abnormalities, breast asymmetry or nipple malposition (Matory et al, 1990; Clough et al, 2009). Correcting these abnormalities after local radiation therapy has been completed leads to an increased risk of wound healing problems. The dilemma is accurate preoperative assessment of which patients who qualify for BCT may benefit from immediate supplemental oncoplastic surgery (OPS). Secondly, it is unclear when which oncoplastic technique is most suitable, considering the variety of techniques described and the variable extent of their application.
Conclusions
|
Very low (GRADE) |
Patient satisfaction
Extending breast conserving therapy with oncoplastic surgery appears to result in improved patient satisfaction.
Sources (Haloua et al, 2013; Veiga et al, 2010, 2011) |
|
Very low (GRADE) |
Cosmetic result
Extending breast conserving therapy with oncoplastic surgery appears to result in improved cosmetic results.
Sources (Haloua et al, 2013; Veiga et al, 2010, 2011) |
|
Very low (GRADE) |
Quality of life
Extending breast conserving therapy with oncoplastic surgery appears to result in improved quality of life.
Sources (Haloua et al, 2013; Veiga et al, 2010, 2011) |
|
- |
Early and late postoperative complications, oncologic safety
Comparative studies do not allow conclusions to be drawn about the effect of additional oncoplastic surgery after breast conserving surgery on oncologic safety and early or late postoperative complications. |
Literature summary
The systematic review by Haloua et al, published in 2013, included 11 studies. Only three of these studies compared additional oncoplastic surgery to standard breast conserving therapy (Giacolone et al, 2007; Kaur et al, 2005; Veiga et al, 2010 and 2011). Since Kaur et al (2005) solely examined the outcome ‘tumor-free margins’, only the studies by Giacalone et al and Veiga et al fulfilled the selection criteria for this literature analysis. Some data in the evidence table are not presented in the review by Haloua et al, but are drawn from the individual publications of the three studies. Quadrantectomy was considered standard breast conserving surgery in these studies. Although the control groups in both studies by Veiga et al from 2010 and 2011 differed in terms of patient numbers (2010: 42 patients, 2011: 45 patients), both publications were considered one study, as both studies examined the same study population for different outcome measures.
Local recurrence
One study by Veiga et al (2010) compared rates of 1-year local recurrence in 45 patients who underwent additional oncoplastic surgery, with a control group of 42 patients who were operated at least one year previously (range 12 to 123 months, median 36 months). However, in a second publication using the same study population, the control group consisted of 45 patients (Veiga et al, 2011). For the oncoplastic group, the authors described two different results for the development of local recurrence, namely in two of 45 patients after four and nine months (Viega et al, 2010) versus one of 45 patients after nine months (Veiga et al, 2011). It is unclear which of these figures is correct. Data about the development of local recurrence in patients in the standard BCT group were not reported. This means the study is not comparative for this outcome measure, and cannot be used to draw a conclusion about the effect of OPS on local recurrence.
Patient satisfaction
One study with 87 patients examined the outcome measure patient satisfaction (Veiga et al 2010). This was assessed using the Rosenberg Self-Esteem Scale, with a score of 0 indicating the best self-esteem and 30 the worst. Patients in the oncoplastic group (n=45) scored better one year after surgery (median score 3.5) than women in the standard BCT group (n=42; median score 8.0; p=0.02).
Cosmetic result
One study with 90 patients examined aesthetic result, and found a better result for the oncoplastic surgery group (Veiga et al 2011). The results were not presented quantitatively.
Quality of life
One study with 87 patients examined the outcome measure quality of life using the Short Form-36 questionnaire, and found a better result for the oncoplastic surgery group one year after surgery (Veiga et al, 2011). After oncoplastic surgery, patients scored better on physical functioning (p<0.001), health perceptions (p=0.002), vitality (p=0.007), social role functioning (p=0.02), emotional role functioning (p=0.02) and mental health (0=0.0000) (Veiga et al 2010).
Postoperative complications:
One study with 74 patients examined the outcome measure early postoperative complications, defined by the authors as occurring within 2 months after surgery (Giacalone et al, 2007). In the oncoplastic group, 68% of patients suffered from partial skin necrosis. The authors did not report the percentage of patients with partial skin necrosis in the group of patients who underwent breast conserving therapy without additional OPS. This means the study is not comparative for this outcome measure and cannot be used to draw a conclusion for the outcome measure early postoperative complications.
Neither study examined late postoperative complications
Level of evidence of the literature
The level of evidence for the outcome measures cosmetic result, quality of life and patient satisfaction is very low, as the studies were not randomized (very serious limitations in study design) and due to the low number of patients (imprecision). Furthermore, a quadrantectomy is more extensive surgery than the lumpectomy which is more common in The Netherlands, so the question remains whether the results from the study can be extrapolated to Dutch clinical practice.
The level of evidence for the outcome measures oncologic safety and late postoperative complications cannot be assessed, as there are no comparative studies with these outcome measures.
Search and select
In order to answer the primary question, a systematic literature review was performed for the following question:
What is the effect of OPS on the aesthetic result, quality of life, patient satisfaction, oncologic safety and postoperative complications compared with conventional BCT?
Search and selection (Method)
Medline (OVID) and Embase databases were searched for immediate oncoplastic surgery during breast conserving surgery. The search justification is listed in the appendix to this chapter. The literature search yielded 22 results. Studies that met the following selection criteria were included in the literature summary: original studies; comparative studies; systematic review of comparative studies; comparison of OPS versus standard breast conserving therapy and at least one of the following outcome measures: aesthetic result, quality of life, patient satisfaction, oncologic safety or postoperative (major) complications.
One systematic review was included in the literature review (Haloua et al, 2013). The evidence tables and quality assessment from this study are presented in the appendix to this chapter.
Methods
Authorization date and validity
Last review : 01-03-2015
Last authorization : 01-03-2015
Planned reassessment : 01-01-2019
The Board of the Dutch Society for Plastic and Reconstructive Surgery (NVPC) will assess whether this guideline is still up-to-date in 2018 at the latest. If necessary, a new working group will be appointed to revise the guideline. The guideline’s validity may lapse earlier if new developments demand revision at an earlier date.
As the holder of this guideline, the NVPC is chiefly responsible for keeping the guideline up to date. Other scientific organizations participating in the guideline or users of the guideline share the responsibility to inform the chiefly responsible party about relevant developments within their fields.
General details
Guideline development was funded by the Quality Fund for Medical Specialists (SKMS) and The Netherlands Organization for Health Research and Development (ZonMw).
Scope and target group
Guideline goal
To develop a multidisciplinary, evidence-based guideline for breast reconstruction in women undergoing breast conserving therapy or mastectomy for breast cancer, or following prophylactic mastectomy.
Guideline scope
The guideline focuses on all patients with an indication for breast reconstruction following breast conserving therapy or mastectomy. Additionally, the guideline may be applied to breast reconstruction in patients who have undergone surgical treatment for a benign breast condition. The guideline does not comment on the treatment of breast cancer. We refer the reader to the NABON guideline for the treatment of breast cancer (www.richtlijnendatabase.nl), which this guideline complements.
Unfortunately, circumstances did not permit a medical oncologist representing the NVMO to participate in the working group. Thus, the current version lacks a module on chemotherapy and breast reconstruction. The working group strives to create such a module for this guideline in the near future.
Intended audience for the guideline
The guideline aims to provide practical guidance for plastic surgeons and members of the multidisciplinary breast cancer team (surgical oncologist, medical oncologist, radiation oncologist, radiologist, pathologist, psychologist, breast care nurse specialist). A version for patients has recently been developed (https://www.b-bewust.nl/pif_borstreconstructie).
Samenstelling werkgroep
A multidisciplinary working group was appointed to develop the guideline in October 2011, consisting of representatives from all relevant specialties involved in the care for patients with breast reconstruction (see above for working group membership). Working group members were mandated by their professional organizations. The working group worked on developing the guideline for 2 years. The working group is responsible for the full text of this guideline.
- Dr. M.A.M. Mureau (President), MD, PhD, plastic surgeon, Erasmus MC Cancer Institute, Erasmus University Medical Center Rotterdam
- Professor Dr. R.R.W.J. van der Hulst, MD, PhD, plastic surgeon, Maastricht University Medical Center/Orbis Medical Center/Viecuri Medical Center, Maastricht
- Dr. L. A.E. Woerdeman, MD, PhD, plastic surgeon, Antoni van Leeuwenhoek / Netherlands Cancer Institute, Amsterdam
- Drs. A.A.W.M van Turnhout, MD, plastic surgeon, Tergooi Hospital, Hilversum Site
- N.A.S. Posch, MD, plastic surgeon, Haga Hospital, The Hague
- Dr. M.B.E. Menke-Pluijmers, MD, PhD, oncologic surgeon, Albert Schweitzer Hospital, Dordrecht
- Dr. E.J.T. Luiten, MD, PhD, oncologic surgeon, Amphia Hospital, Breda
- Drs. A.H. Westenberg, MD, radiotherapist/oncologist, Arnhem Radiotherapy Institute, Arnhem
- Dr. J.P. Gopie, PhD, psychologist, Leiden University Medical Center, Leiden
- Dr. H.M. Zonderland, MD, PhD, radiologist, Academic Medical Center, Amsterdam
- Drs. M. Westerhof, MSc, Netherlands Breast Cancer Association, Utrecht
- E.M.M. Krol-Warmerdam MA, V&VN Nurse Specialists, Leiden University Medical Center, Leiden
With support from
- Drs. B.S. Niël-Weise, MD, microbiologist / epidemiologist, senior advisor, Knowledge Institute for Medical Specialists
Declaration of interest
Working group members declared any (financial) ties with commercial companies, organizations or institutions involved in the field covered by the guideline for the past five years in writing. An overview is available on request from the office of the Knowledge Institute for Medical Specialists (KIMS).
Patient involvement
Patients are represented by a delegate from the Netherlands Breast Cancer Association in this guideline.
Method of development
Implementation
Guideline implementation and practical applicability of the recommendations was taken into consideration during various stages of guideline development. Factors that may promote or hinder implementation of the guideline in daily practice were given specific attention.
The guideline is distributed digitally among all relevant professional groups. The guideline can also be downloaded from the Dutch Society for Plastic and Reconstructive Surgery website: www.nvpc.nl, the guideline website: www.richtlijnendatabase.nl and the Quality Organization for Medical Specialists.
Methods and proces
AGREE
The guideline has been drafted in accordance with the requirements outlined in the ‘Guidelines 2.0’ report of the Guideline Advisory Committee of the Council on Science, Education and Quality (WOK). This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreecollaboration.org), an instrument designed to assess the quality of guidelines with broad international support.
Primary questions and outcome measures
Based on the outcomes of the bottleneck analysis, the president and advisor formulated draft primary questions. These were discussed and defined together with the working group. Subsequently, the working group determined which outcome measures were relevant for the patient for each primary question, examining both desired and undesirable effects. The working group valuated these outcomes based on their relative importance as crucial, important and unimportant.
Literature search and selection strategy
Specific search terms were used to identify published scientific studies related to each individual primary question in Medline, Cochrane and, where necessary, Embase. Additionally, the references of the selected articles were screened for additional relevant studies. Studies offering the highest level of evidence were sought out first. Working group members selected articles identified by the search based on predetermined criteria. The selected articles were used to answer the primary question. The searched databases, the search string or terms used during the search and selection criteria applied are listed in the chapter for each individual primary question.
Quality assessment of individual studies
Individual studies were assessed systematically based on predefined methodological quality criteria in order to assess the risk of biased study results. These assessments may be found in the column ‘Study quality assessment’ in an evidence table.
Literature summary
The relevant study results from all selected articles were presented clearly in evidence tables. The key findings from the literature are described in the literature summary. If studies were sufficiently similar in design, data were also summarized quantitatively (meta-analysis) using Review Manager 5.
Assessment of the level of scientific evidence
A) With regard to intervention questions:
The level of scientific evidence was determined using the GRADE method. GRADE is short for ‘Grading Recommendations Assessment, Development and Evaluation’ (see http://www.gradeworkinggroup.org/) (Atkins et al, 2004).
B) With regard to questions about the value of diagnostic tests, harm or adverse effects, etiology and prognosis:
GRADE cannot be used (yet) for these types of questions. The level of evidence of the conclusion was determined based on the accepted EBRO method (van Everdingen et al, 2004).
Formulation of conclusions
With regard to questions about the value of diagnostic tests, harm or adverse effects, etiology and prognosis, the scientific evidence is summarized in one or more conclusions, listing the level of evidence for the most relevant data.
For interventions, the conclusion does not refer to one or more articles, but is drawn based on the body of evidence. The working group looked at the net benefits of each intervention. This was done by determining the balance between favorable and unfavorable effects for the patient.
Considerations
When making recommendations, scientific evidence was considered together with other key aspects, such as working group member expertise, patient preferences, costs, availability of facilities and/or organizational aspects. Insofar as they are not part of the systematic literature review, these aspects are listed under ‘Considerations’.
Formulation of recommendations
Recommendations provide an answer to the primary question, and are based on the best scientific evidence available and the most important considerations. The level of scientific evidence and the importance given to considerations by the working group jointly determine the strength of the recommendation. In accordance with the GRADE method, a low level of evidence for conclusions in the systematic literature review does not rule out a strong recommendation, while a high level of evidence may be accompanied by weak recommendations. The strength of the recommendation is always determined by weighing all relevant arguments.
Development of indicators
Along with developing a draft guideline, internal quality indicators were developed to allow monitoring of the implementation of the guideline in daily practice. More information about the method for indicator development may be requested from KIMS.
Knowledge gaps
During the development of this guideline, systematic searches were conducted for research contributing to answering the primary questions. For each primary question, the working group determined whether (additional) scientific research is desirable.
Commentary and authorization phase
The draft guideline was submitted to the (scientific) organizations involved for comment. The guideline was also submitted to the following organizations for comment: Netherlands Breast Cancer Association (BVN), Netherlands Society for Medical Oncology (NVMO), Dutch College of General Practitioners (NHG), Healthcare Insurers Netherlands (ZN), The Dutch Healthcare Authority (NZA), Health Care Insurance Board (CvZ), the Health Care Inspectorate (IGZ), Achmea, CZ, Menzis and VGZ. Comments were collected and discussed with the working group. The draft guideline was updated and finalized by the working group based on the comments. The final guideline was submitted for authorization to the (scientific) organizations involved and authorized by them.
Legal standing of guidelines
Guidelines are not legal prescriptions, but contain evidence-based insights and recommendations that care providers must meet in order to provide high quality care. As these recommendations are primarily based on ‘general evidence for optimal care for the average patient’, care providers may deviate from the guideline based on their professional autonomy when they deem it necessary for individual cases. Deviating from the guideline may even be necessary in some situations. If care providers choose to deviate from the guideline, this should be done in consultation with the patient, where relevant. Deviation from the guideline must always be justified and documented.