History of Breast Conservation Therapy ( BCT)
The initial surgical treatment of breast cancer was typically wide excision but was associated with a high rate of local recurrence and poor survival. William Halsted popularized radical mastectomy in 1894. Radical mastectomy (RM) resulted in a significant drop in the local recurrence rate, but the curative potential remained limited.
Attempt with extended radical mastectomy, which included internal mammary node dissection, failed to improve survival. At different times, Modified Radical Mastectomy (MRM), Total (Simple) Mastectomy, and more recently, Skin sparing mastectomy (SSM) and Nipple-sparing mastectomy (NSM) were introduced.
Although MRM is a less morbid procedure compared to RM, the patient will still require a loss of the breast. The attempt to preserve the breast without compromising survival brought up the use of Breast-Conserving Therapy (BCT). This includes breast-conserving surgery and breast radiotherapy. Although BCT and breast-conserving surgery (BCS) is used interchangeably, strictly speaking, BCT includes both BCS and breast radiotherapy.
BCS is an important part of the breast-conserving therapy, which may be defined as a combination of conservative surgery for resection of the primary tumor with or without a surgical staging of the axilla, followed by radiotherapy for the eradication of the residual microscopic disease of the breast, with or without adjuvant systemic therapy.
The aim of this communication is to highlight the indications, contraindications, surgical techniques, and complications of BCT.
The National Surgical Adjuvant Breast and Bowel Project (NSABP) B 06 compared TM to lumpectomy, with or without radiation therapy, in the treatment of stages I and II breast cancer. After five- and eight-year follow-up periods, the disease-free, distant disease-free, and overall survival rates for a lumpectomy, with or without radiation therapy, were similar to those observed after TM. However, the incidence of ipsilateral breast cancer recurrence (in-breast recurrence) was higher in the lumpectomy group that did not receive radiation therapy.
In short, it is now proven that Breast conservation, when supplemented with adjuvant radiotherapy, is as effective in terms of locoregional recurrence, disease-free survival, and overall survival as total mastectomy
PATIENT’S SELECTION FOR BCT
The four critical elements in selecting patients for breast-conserving therapy are A history and physical examination, breast imaging, histological assessment of the resected breast, and assessment of the patient’s needs and expectations.
- If an attempt to preserve the breast is associated with high rates of in-breast recurrence, then BCT is absolutely contraindicated. These situations are: Extensive Multicentric disease ( cancer is detected at more than two sites in the same breast and is dispersed in distant quadrants)
- diffuse malignant-appearing mammographic microcalcifications (suggesting multicentricity)
- persistent positive resection margin at the time of breast conservation surgery
- prior radiotherapy to the breast or chest wall as we can’t reradiate breast
- pregnancy- I and II trimesters. The main reason for contraindication in pregnancy is the need for radiotherapy, which will be contraindicated in pregnancy. BCT can therefore be performed in the third trimester, deferring breast radiotherapy until after delivery.
- Hereditary Breast cancer syndromes- if genes are proven mutated, the conserved breast is at very high risk of second cancer / local recurrence.
Relative contraindications are
- connective tissue disease, especially scleroderma, and active systemic lupus erythematosus
- large tumor in a small breast.
Factors thought to be associated with the risk of breast cancer recurrence after BCT is now known to be unfounded as long as there is a negative margin on excision. Some of these are:
Positive family history of breast cancer
Skin or nipple retraction (not necessarily sign of locally advanced disease), Tumor location
Clinical or pathological axillary nodal metastases,
Aggressive histological subtypes like Triple-negative and HER2 enriched
Presence of an extensive intraductal component on biopsy
Margin Analysis during Breast Conservation Surgery –
During Breast conservation surgery,the most important goal as a surgeon to achieve is excision of the tumor in total adequately with no cancer left behind. It needs a thorough assessment of the excised specimen during or after surgery; the Specimen is assessed by routine Histopathology after surgery in many institutions in many countries and may warrant the need to re excise 9 redo surgery ) if the margins are positive for cancer in the final report. To reduce the chances of re-excision, we prefer to assess the specimen intraoperatively ( i.e. at the time the surgery only ) and analyse margins.
What constitutes adequate clearance of tumor at the surgical margin?
The majority of the general literature appears to consider 2 mm as the cut-off point for a negative margin with anything less than that being considered a close margin. We use 1 mm as a cut off for negative margins in its invasive carcinoma and 2 mm for non-invasive carcinoma in situ.
Currently, a positive margin is generally interpreted to mean the presence of tumor, either invasive and/or ductal carcinoma in situ (DCIS), at the surgical resection line. However, lymphatic invasion at a margin is not considered a positive margin. Neither atypical ductal hyperplasia nor lobular carcinoma in situ at the margin is considered a positive margin
At the base of tumour, In the case of a pectoralis fascia margin, a single collagen strand separating tumour from the margin is considered adequate clearance
There are various methods to analyze margins of the resected specimen during surgery ( Intraoperative Margin Analysis Measures). E.g-
- Gross Examination
In theory, a mass is clearly identifiable and the distance to various resection margins measurable. In reality, often the mass is irregular with ill-defined tentacles cast out in different directions. An advantage of gross examination is that it is a rapid method of assessing margins and is useful in identifying grossly transacted tumour and close invasive tumours. In the setting of intraoperative consultation, a grossly close or positive margin can be rapidly communicated to the operating room while additional margin assessments are completed. A grossly negative margin has little predictive value unless the margin clearance is several centimetres and the patient does not have extensive DCIS, multifocal disease or invasive lobular carcinoma
- Image or Faxitron Analysis
Many institutions confirm resection of lesions using specimen imaging. Conventionally this is a single dimension X-ray with compression of the excision specimen . A smaller set of institutions incorporate 2-dimensional digital specimen mammography (Faxitron) without specimen compression. This may be followed with a second specimen mammogram of the serially sectioned specimen. The Faxitron appears to be better than conventional radiography at delineating microcalcifications and parenchymal distortions near margins, thereby enabling pathologists to select tissue for microscopic assessment. In the setting of intraoperative consultation, immediate reexcisions can be performed resulting in tumor-free resection margins at the time of the primary surgery. The sensitivity of the Faxitron appears to range from 78.6–85.6% for magnification of 1.0–2.0 : 1.0, with a specificity of 100%. However, if the Faxitron equipment and the ability to interpret the images is not housed within the pathology suite, there can be a significant time delay with its use in intraoperative consultation.
Specimen mammography- it’s the mammography of the transacted specimen. It’s especially useful to collude the complete excision of impalpable lesions like microcalcifications. The mammography images of excised tissue are compared with images of preoperative mammography.
- Touch Imprints or Smears of Margins
An imprint (touch) or a scraping of the specimen surface, placed on glass slides and stained using either hematoxylin and eosin or diffquick, can be used to evaluate for tumour cells in a specimen margin. This method is employed only in the setting of intraoperative consultation. The advantage of this method lies in the fact that it does not alter the specimen, which can be later imaged, fixed, and/or sectioned. The disadvantages are many: the requirement for multiple imprints, the associated time consumption, the dependency on close visual inspection of the specimen, the ability to only detect transacted disease, lower sensitivity, and the inability to measure the width of clearance. It is reported a sensitivity, and specificity of 100% for the use of touch preparation cytology in the evaluation of surgical margins in breast cancer. The sensitivity and specificity of the method in re-excision margin assessment, however, is reportedly only 75% and 82.8%, respectively, producing a PPV of 21.4% and a NPV of 98.2%
- Intraoperative Frozen Section (FS)
Mammary tissue is notoriously technically difficult to cryosection because of its adiposity. Freezing also introduces tissue artifact in the form of architectural distortion and resistance of adipose tissue to sectioning. In addition, if the tissue submitted for evaluation is more than one centimeter in largest dimension, there is the added risk of sampling error. This method therefore is not popular amongst most pathologists. Surgeons, however, like the method because it enables rapid microscopic examination of tissue during surgery and it can be used to determine the extent of surgery to be performed in a single operative setting. However, the use of frozen section for multiple margin assessment is time consumptive and adds significantly to operating time. In order to provide good turnaround for multiple margin assessments, a pathology frozen section suite would have to be equipped with multiple cryosectioning units and have reserves in both equipment and personnel so as not to impact other surgeries. More importantly frozen section alters the appearance of tumors, particularly ductal carcinoma in situ and infiltrating lobular carcinoma and benign lesions such as intraductal papillomas and sclerosing adenosis. The ability to read through the artifact and not call a benign lesion malignant or a malignant area benign is dependent on the skill and experience of both the pathologist and the entire frozen section staff.
Cendan and his group performed a retrospective analysis of FS margin accuracy compared to permanent sections and showed an 84% concordance per case, with 24% of the patients requiring immediate re-excision intraoperatively of the lesion and approximately 20% of patients needing second surgery due to false negative margins. Expectedly, invasive lobular carcinoma and DCIS cases had higher rates of false negative FS margins. In addition, 51.2% of all patients with positive margins had at least one false-negative margin on either the primary or secondary excision.
Osborn et al. compared the cost-effectiveness of routine FS analysis of breast margins against reoperation for positive margins assessed by routine examination of the resected specimen. Their experience has shown that the use of FS for margin assessment with the attendant increased operative time provide cost savings only when the re-excision rates are greater than 36% . The use of intraoperative assessment of margins is driven in part by patient demographics. Institutions which have a large patient population that travels long distances for surgical treatment will spend more resources in attempting to achieve tumour-free margins at primary excision to avoid second surgeries than medical centres whose patients are local and who can readily return for a second procedure if needed. The expense and inconvenience of patients having to return from great distances is balanced against the greater expenditure of operating room time. Besides in the community like ours in India, cost is always a factor driving the decisions. If you consider second surgery , it is definitely costlier than the added cost of increased operation theatre time during first surgery and intraoperative frozen analysis.
Surgically, a shave margin is a thin piece of tissue obtained by shaving the surface of a lumpectomy cavity or other excision surface. This tissue will have two surfaces of interest: the original margin and the new margin surface. These two surfaces are differentially inked to maintain the identification of the two margins. Most shave margins are large enough to require serial sectioning with the submission of multiple tissue sections for microscopy to completely assess for presence or absence of disease. The pathologist can trace disease, if present, from the original margin to the new margin. Any disease present can be measured for distance from the “final” margin.
A shave margin taken by a pathologist is a very thin slice of tissue from a margin surface in question and is usually a size that can be frozen for microscopic intraoperative examination or placed directly in a tissue-processing cassette. Any tumor present in the section examined would indicate a positive margin. In the intraoperative setting, relatively larger surface areas can thus be examined compared to that of a perpendicular section through a margin, providing a yes or no answer. Disadvantages of a shave margin include difficulty in obtaining a shave of a soft surface and in maintaining tissue orientation. The nature of the section also precludes measurement of the clearance of a tumor from a margin. Pathologic shave margins for the permanent sections are most commonly used to assess margins that are distant from a tumor and are required for completeness of reporting margin status.
Alternative methodologies for margin assessment have emerged recently.
Intraoperative Optical Coherence Tomography (OCT) is a high-resolution imaging technique involving real-time exvivo microscopic images and another one is Margin Index. But these are not yet widely accepted /used.
Breast Conservation Surgery
breast-conserving surgery ( BCS) is also known as wide local excision / partial mastectomy because — unlike a mastectomy — only a portion of the breast is removed. Surgeons may call it a Lumpectomy too.
During BCS, a small amount of normal tissue around the lump (also described as clean or normal margins of breast tissue) is also taken to help ensure that all cancer or other abnormal tissue is removed. There are various methods to assess the completion of tumor removal We prefer specimens to be examined for instant histopathological analysis, called a Frozen section, to confirm free margins and the complete removal of cancer. Your surgeon gets the result of the findings of the pathologist in real-time during surgery. If there are chances of cancer left behind, your surgeon re-excises that portion till he gets optimum negative margins.
Axilla ( armpit) is treated as per status of Lymph node metastasis , proven before surgery. i.e. axillary clearance for proven lymph node metastasis and if not, then it is subjected to sentinel lymph node biopsy and analysis of nodes by frozen section. If frozen section shows lymph node involvement by cancer, you will be subjected to full axillary clearance. ( see for more details; Sentinel Lymph Node biopsy and axillary staging )
If there is loss of less than 20 % of breast volume during cancer resection, the breast shape is not usually distorted nor would there be disparity in shape and symmetry. Its may not be necessary to reconstruct the defect and the incision would be closed primarily.
If the volume loss is between 20 – 30 % of original breast volume, it needs to be reconstructed to maintain shape an symmetry. It can be achieved by simple displacement techniques (see for more details :Breast Oncoplastic Surgery Type I)
If the volume loss is 30- 50%, It needs to be replaced by the tissue in order to maintain the volume, shape and symmetry of breast after resection. The Tissues can be to be borrowed from surrounding area of body in the form of perforator flaps ( See for more details ; Volume Replacement Techniques : Breast Oncoplastic Surgery Type II: chest wall perforator flaps). Sometimes the breast are Large and ptotic. In such cases, the tumor is excised by Reduction Mammoplasty techniques, to reduce the breast size and give them better contour. The opposite breasts are operated to maintain symmetry.
If the volume loss is more than 50% , it needs a major replacement to maintain volume and shape. It can be achieved by mobilizing major volume of your body tissue in the form of pedicelled / free microvascular flaps ( for more details, see: Pedicelled flaps: Free Microvascular Flaps)
Incision of Breast Conservation Surgery –
There are various incisions for Breast conservation surgery. Incision is designed by your surgeon before you being taken into the operation theater and its discussed with you beforehand.
The incision is designed by taking into account of various factors like
tumor size, Its distance from Nipple areolar complex, its adherence to overlying skin, Biopsy site, the choice of reconstruction procedures etc.
Here are few examples of incisions-
Radial and circumareolar
Round block / doughnut mastopexy
After the procedure
After your surgery, you can expect to:
- Be taken to a recovery room where your blood pressure, pulse and breathing are monitored
- Have a dressing (bandage) over the surgery site
- Feel some pain, numbness and a pinching sensation in your underarm area
- Usually ICU is not needed unless you have a serious comorbidities like uncontrolled diabetes, heart disease, serious hypertension etc.
- You will be infused Intarvenous fluids for hydration for the day of surgery
- You will be given antibiotics, pain killers, antacids either orally or through venous access
- You will be kept fasting for 6 hrs after surgery and then allowed to eat completely
- You will be mobilised out of bed next day of surgery
- If you have undergone armpit surgery too , you will be instructed not to use your upper limb of operated site for ant injections and will instructed to protect it from any injuries and abrasions. You will be given a pressure garment to apply on that limb for initial few months of surgery
- You will be taught and instructed few breathing exercises and exercises: massage techniques of the upper limb of operated side.
- You will be having a tube inserted at your operated site to withdraw the collected fluids from operated site. It may stay with you beyond your discharge from hospital. Its usually removed once the daily output gets reduced to safe value. You will be instructed and taught how to take care of the drain tube.
- The check dressing is done usually on post Day 3. If the wound is healing well, its not necessary to keep wound dressed beyond this time. Its advised to keep your conserved/reconstructed breast nicely supported with sports bra of proper size. ( for more details see: Know your Breast Bra Cup Size)
- Receive instructions on how to care for yourself at home, including taking care of your incision and drains, recognizing signs of infection, and understanding activity restrictions
- Talk with your health care team about when to resume wearing a bra or wearing a breast prosthesis
- Be given prescriptions for pain medication and possibly an antibiotic
- Your excised tissue is sent to histopathology examination. The report gets ready in 4 to 10 days of time after your surgery. This report guides your doctor for further adjuvant therapies. So its mandatory to collect this report and visits your Surgeon during your follow ups
- If the period is uneventful, you will be discharged from hospital after 3 to 5 days
- You need to continue all your previous medications for your comorbidities by consulting your respective specialties for the changes in prescription .
There are chances of
- Skin flap necrosis – its due to poor blood supply to the skin conserved during surgery. Skin discolours from bluish to black. It needs re excision of that part of skin and resuturing. If the necrosis is extensive, it might require wider excision and flap reconstruction for closure.
- Wound infection – its common in diabetic patients. Its self-limiting with daily dressing and antibiotics. But if its uncontrollable it may need surgical debridement
- Seroma– it’s a collection of body fluid ( lymph ) at operated site. Its major morbidity after axillary ( armpit ) surgery. Its extensive in overweight patients and in those where there is extensive nodal involvement requiring thorough Lymph node clearance.
- Pyoma– the collected fluid ( seroma) can get infected and turn into pus. It needs to be drained and debrided. Its curable with antibiotic cover.
- Haematoma– there are chances of bleeding at operated site and blood gets accumulated at site to present as haematoma. The presentation is usually with blood in the tube inserted at time of surgery, drop in blood pressure due to blood loss and drop in haemoglobin ( HB) percent. It needs reexplanation and finding out the bleeding points and taking care of it wither by ligating or coagulating . It usually occur in patients on anticoagulants ( blood thinners ) and uncontrolled hypertension.
- Heaviness and numbness in armpit and inner upper arm– Its due t armpit dissection. The numbness and heaviness is due to sacrifice of cutaneous nerves of sensations. Its called hypoesthesia or anaesthesia . It can’t be recovered completely but can get reduced over a long time
- Burning – Its due to handling of nerves of sensation during armpit dissection. It may get worse especially at night time or at rest. If its extreme , you need to consult your surgeon to modify pain killers and add neuromodulators.
- Deep seated aching sensation in armpit – Its again due to handling of nerves during armpit dissection.
- Swelling of upper limb of operated site – Its lymph oedema . it’s one of the common long term complication of axillary clearance ( armpit dissection ) The nodes are excised from armpit as a part of cancer clearance , there is tendency of accumulation of lymph in the soft tissue of upper limb of operated side. It can start and evident even after 2 years of your surgery. It’s called Lymphedema of upper limb. Though its not curable effectively , Its preventable. A vigorous upper limb exercises , lymph massage, physiotherapy and use pressure garments during initial postoperative phase prevents future Lymph oedema.
Next therapy –
Once the drain tube & sutures are removed and wound is healed completely, You will be guided for your next adjuvant therapy. It’s usually decided in a tumour board consisting of all the subspecialties by discussing your final histopathology report of surgical specimen, your cancer stage, type of cancer, comorbidities and your general health status.
A mastectomy is a surgery to remove all breast tissue from a breast as a way to treat or prevent breast cancer.
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