In Hong Kong41 the use of material obtained from FNAC for evaluating multiple biologic indicators of prognosis (estrogen and progesterone receptor status,Her-2/neu, P53 and many others) has been reported. Reports from UK31, Australia30 and USA34 support the Hong Kong41 study.
Experience in India54 indicates that Robinson’s cytological grading correlates well with the modified Bloom-Richardson criteria for histopathological grading of breast cancers. Concordance of 63.0%, 65.6% and 82.9% were reported for grade I, II and III (modified Bloom-Richardson criteria) diagnosis respectively for a total of 59 cases studied54. The authors further emphasized that while lymph node metastasis was found in three cases of grade II group and 28 cases of grade III group, none was found in grade I group. It was concluded from the study that together with lymph node status, cytological grading may help determine the prognosis and may help guide the extent of resection54. In Korea38, similar results including a concordant diagnosis of 95% were reported.
The effectiveness of FNAC in typing breast tumours has been cited30,31,55. In a series of 200 cases of breast cancers, Young and coworkers55 found that the performance of FNAC in sub-classifying breast tumours was good for invasive ductal adenocarcinoma (65%), but low for the uncommon tumours such as mucinous (27%), lobular (20%) and medullary (12%) carcinomas. Therefore, in selected cases, cytological assessment can diagnose, type, prognosticate and grade breast cancers
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with a degree of accuracy that will allow the surgeon to make an informed decision on how best to approach management. This could be useful in selecting patients who are candidates for neoadjuvant chemotherapy or endocrine therapy.
FNAC has also been useful for therapeutic and monitoring purposes in breast diseases. In the Panchalingam28 series, ten cases of benign breast cysts encountered were managed by aspiration alone and none recurred. Similar experience was reported by Gukas56 who aspirated 12 benign cysts in his series without need for further treatment. However, no breast ultrasounds were done either before or after FNAC of the cysts to detect or rule out suspicious foci in both studies28,56. It is therefore particularly wise to apply triple test approach in breast cysts encountered in African patients before allowing a safe advice because follow-up may be difficult due to non-compliance. FNAC is a rapid means for confirmation of breast cancer recurrence during follow-up28,30,31,33,41,43. Sequential FNAC with cytometry has been found to be an effective method of monitoring the response of breast cancer to radiation therapy30,41,56.
2.11
: Summary of Literature Review:
The earliest reports on breast fine needle aspiration cytology in particular were written by Stewart46 and Martin and Ellis47, over two thirds of a century ago. Their studies were soon followed by a mixed reaction of skepticism and enthusiastic acceptance. With increasing experience, instrument modifications and establishment of FNAC clinics in major oncological centres, the diagnostic accuracy of the test improved remarkably leading to its world- wide acceptance28,30,31,41,43..
The principles underlying the practice of breast FNAC are the most important attributes of the test. The concept of triple test approach in a multidisciplinary manner is the acceptable gold standard for the conduct and interpretation of FNAC results30,41,43. In its classic form utilizing a dedicated ‘one stop’ breast clinic, the clinician sees the patient and requests radiological and cytopathological investigations at the first clinic visit30,31. This facilitated consultation among the specialists has a positive predictive value approaching 100%30,31,41,43. From the strength of different opinions on who performs FNAC, it is apparent that training, experience and motivation are the major denominators rather than specialty if desired outcomes are to be expected.
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Modifications of instruments originally used by earlier workers46,47 have contributed significantly to the success of the test. The use of thicker needles (18G), skin incisions and local infiltrative anesthesia practiced by Martin and Ellis47 have all been largely abandoned due to introduction of fine needles (21-25G) by modern workers30,31,35.
The technique of FNAC as practiced in modern time retains the basic principles used by the earlier workers with some modifications30,31,38,43. The stages of the procedure include specimen sampling, slide preparation or smearing, fixation of prepared slides, staining and finally cytological reporting30,31,38,41,47. Traditionally, fine needle aspiration (FNA) technique principally involves use of fine needle attached to a syringe to make ‘to and fro’ movements within the mass while maintaining a constant negative pressure with the dominant hand30,35,43. A modified technique called fine needle sampling (FNS) obviates the need for negative pressure with a syringe and operates by capillary action of the small luminal diameter of a fine needle to extract tissue cells for cytological preparation. There are five major cytological categories with corresponding numerical codes (C1-C5) recommended by UK NHSBSP62. The diagnostic accuracy of breast FNAC is affected by factors such as the experience of the aspirator and interpreter, nature of breast swelling and guidance technique used for specimen retrieval30,31,43. These factors either separately or in various combinations are responsible for diagnostic errors and pitfalls encountered while doing this test30,31,40. Inadequate samples(C1 ), equivocal specimens (C3 and C4 categories), false positive and false negative diagnosis all stem from the limitations engendered by these operational factors30,38,40.
The policy of immediate slide assessment and repetition of unsatisfactory samples was an important aspect that this study evaluated to determine how it improves accuracy of the test. Indeed, immediate slide assessment positively impacted on the overall success of this study by reducing unsatisfactory smears to a manageable level. The sensitivity ranges from 84-98% and specificity 90-100% in various series28,30,31,35,41. The diagnostic accuracy ranges between 80-98% while false positive and false negative rates lie between 0-2% and 0.7-10% respectively in many series,30,31,33,37,40. Inadequate sample rates of 0.7-28% have been documented28,30,33,34,37,54.
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The complications of breast FNAC are uncommon and rarely serious30,31,43. This is largely due to the introduction of fine needles rather than bigger needles used by earlier workers. The merits of FNAC are numerous. To mention a few, it is cheap, accurate, reproducible, rapid, simple, minimally invasive, but maximally diagnostic and obviates the need for skin incision and anesthesia28,30,31,35,38. The major advances in the application of FNAC are use in assessing multiple biologic indicators of prognosis and prediction of response to chemotherapy, endocrine and radiation therapies30,31,38,41,43,57. When all these advantages are considered, FNAC offers the best option for pre-operative diagnosis of breast lesions in most instances31,30,31,35,37,38.
CHAPTER THREE 3.0. Materials and methods:
The study was a nine-month prospective study of all the consecutive patients with palpable breast lumps presenting at the general surgery out-patient clinics of the hospital from March 2012 to November 2012. However, initial three months (December 2011 to February 2012) were designated for pilot study before the nine-month study. Approval for this study was obtained from the hospital ethics and research committee. The nurses and doctors in histopathology and surgery departments of the hospital were informed about the objective of the study to enable them cooperate with the author. In our centre, patients with palpable breast lumps routinely do open biopsy for tissue diagnosis. Consent (Appendix III) from the patients to do FNAC before the open biopsy was routinely obtained.
The procedure of FNAC, benefits and possible complications of FNAC were clearly explained to the patients before obtaining such consent. Additionally, consent was obtained from relations of patients who were not able to give consent themselves (mentally impaired or critically ill patients). An information sheet detailing the FNAC procedure, benefits and possible complications is shown in appendix II and this was also given to the patients to aid clarification. Those that refuse to give consent were excluded from the study, but this refusal did not affect their care. Open biopsy was used as the standard reference test for histological confirmation of the breast swellings previously subjected to FNACs.
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Excision biopsies for histological confirmation were done for mobile, palpable swellings with no clinical evidence of fixity to the chest wall or extensive breast skin involvement. Multiple mobile swellings were similarly managed. This approach was adopted because the breast swellings that were confirmed benign after histology did not require second stage procedures. This is preferred by many surgeons. Histology of all locally advanced lesions with either chest wall or skin involvement or both were confirmed by incision biopsy (edge biopsy for fungating ulcers).
3.1
Patient selection:
All the consecutive patients with palpable breast swellings attending general surgery clinics within the one year period of study were selected after obtaining informed written consent (Appendix III). Patients were interviewed by the author using the observer-administered Pro-forma (Appendix I) where all relevant patients’ data were recorded. Details of socio-demographic data of patients were noted. Detailed clinical history was obtained.
A thorough breast examination commencing with the normal side for unilateral pathology was conducted. Emphasis was laid on the characteristics of the lump, changes on the breast, nipple-areolar complex, nipple discharge, axilla with axillary tail and evidence of metastasis. However, clinical measurements of the sizes of the lumps were done with a tape as there was no dedicated ultrasound machine or caliper in the breast clinic in our centre. This may affect the representativeness of the values obtained due to errors from manual measurements. A clinical diagnosis was made and this was explained to the patient. The plan of management including FNAC was made known to the patient. The procedure of FNAC was carried out and arrangement for open biopsy made on a later appointment. Majority (88.7%) of the patients had open biopsy one to six days after FNAC test while only 13 (11.3%) patients had open biopsied between one to two weeks following FNAC procedure.
The results of FNAC and histology when ready were entered into the Pro-forma and made known to the patients.