International Journal of Scientific Research and Engineering Studies (IJSRES)

Volume 1 Issue 3, September 2014

ISSN: 2349-8862

www.ijsres.com Page 1

Analysis Of Unsatisfactory Category Of 1601 Cases Of Breast
Cytology An Institutional Study









Abstract: With ever increasing dependence on cytology
reports for management of breast masses, audit of breast
cytology and analysis of unsatisfactory cytology cases have
become necessary.
This study was undertaken to evaluate various diagnostic
parameters for cytology diagnosis of breast lesions in our
cytology set-up. Clinico-cytological findings in 1601 cases
and details of unsatisfactory cytology category were studied.
All patients coming with complaints related to breast and
referred for cytology were included in the study. Material for
cytology study was obtained by smears made from fine
needle aspiration/non-aspiration biopsies of breast lump,
lymph nodes or nipple discharge.
Breast cytology formed about 15 % of total FNAC workload
of our cytology section. Conclusive cytological diagnosis
could be offered in 84.14% cases of breast cytology. None of
the patients had any post-procedure complication. For
analysis cytological smears from these cases were
categorized into standard I to V categories. The largest
category was that of benign lesions(category I ) 66.02%
followed by malignant lesions (category I V)
14.68%.Category I I & I I I taken together included cases
reported as atypical, indeterminate or suspicious and formed
3.44% of the total number. Unsatisfactory (category V)
included inadequate and inconclusive reports and formed
15.86% cases .The study revealed sensitivity, specificity and
diagnostic accuracy of 95.28%, 96.17% and 95.92%
respectively.

Keyword: Breast cytology, audit, unsatisfactory category


I. INTRODUCTION

From being a rapid, reliable and cost-effective method of
diagnosis cytological study of breast lesions has now become
an established and indispensable pre-operative assessment tool
along with clinical and imaging work up at many cytology
centers.

FNAB is utilized as a first line diagnostic procedure for
patients coming with complaints related to breast, in our setup.
Important management decisions of operative Vs conservative
treatment are based on the cytology reports for patients
coming with palpable or non-palpable breast abnormalities.
This necessitates the need for regular audit studies of breast
cytology to be undertaken in order to evaluate diagnostic
parameters and to know areas where errors commonly occur.
II. PATIENTS AND METHODS

1601 consecutive patients presenting to surgical
outpatient department with complaints of lump in breast,
increased or asymmetrical nodularity or nipple discharge were
referred for cytological study from January 2006 to September
2010. Complete clinical details were obtained, thorough
clinical examination was done and written consent was taken
after explaining the procedure. Total 1595 patients were
subjected to fine needle aspiration or non-aspiration
(FNAB/FNC) biopsy of breast lump/lumps and palpable
lymph nodes when present, using conventional procedure.
FNABs were carried out by Pathology residents with
rotational Cytology OPD posting under supervision of cyto-
pathologist.
23 or 24 gauge needle and 10 ml plastic syringe attached
to syringe holder were used. Grossly vascular lumps were
subjected to fine needle capillary sampling without attaching
syringe and holder. In cystic lumps, reaspiration from the cyst
wall was done in same sitting. Ultrasound guided FNAB was
done in deep seated lump not accessible by routine method.
Six patients presented with nipple discharge without
breast lump and smears for cytology were made from the
expressed nipple secretion. In each case on an average 3-4
smears were made from the aspirated material and were wet
fixed in 95% alcohol and air dried. Wet fixed smears were
stained with HE and PAP stain and air dried ones with MGG
stain in all cases. Ziehl-Nelsen staining was carried out in
cases that were diagnosed as abscess or granulomatous
mastitis on initial cytological examination.
The analysis included prospective and retrospective cases
over equally divided study period. Cytological diagnoses were
categorized into five standard categories for purpose of
analysis. Histological diagnoses were available in 501 cases
and were based on either excision of lump or mastectomy
specimens from the same breast subjected to routine paraffin
sectioning and HE staining. Calculation of various diagnostic
parameters of this study was based on these 501 cases.


III. RESULTS

A total number of 1601 cases of breast lesions referred for
cytology were evaluated .Breast cytology formed 15% of total
FNABs carried out during January 2006 to September 2010.
Patients belonged to age range of 11 to 80 years. Maximum
number 32.42% were between 21 to 30 years of age.98.38%
Bhushan M. Warpe
MD Pathology, Department of Pathology, IGGMC,
Nagpur city, Maharashtra state, India
International Journal of Scientific Research and Engineering Studies (IJSRES)
Volume 1 Issue 3, September 2014
ISSN: 2349-8862

www.ijsres.com Page 2

were females and 1.62% were males.
Painless breast lump was the most common presenting
symptom in 75.52% followed by lump with pain in
24.48%.Other symptoms were lump associated with either
cyclical mastalgia, palpable lymph nodes, skin changes or
nipple discharge. Only ten patients gave history of trauma and
nipple discharge without lump was present in six patients.
Symptom duration varied from 15 days to 90 days in
51.03% and more than 90 days to one year in 31.86%
patients.90.88% patients presented with single breast lump
.Two or more lumps were present in 8.69%patients.
Conclusive cytological diagnosis was possible in 84.14%
cases. None of the patients complained of any post procedural
complication.
Descriptive reports mentioning salient cytological
features of the lesion and a definitive diagnosis were given
when possible .For purpose of analysis cytological disease
categorization of breast lesions was done in five categories as:
I-Benign, II-Atypical/Indeterminate, III-Suspicious ,IV-
Malignant, V-Unsatisfactory .For sake of convenience
category II and III were clubbed together.
Cytological disease categorization in our study was as under-
Category I-Benign= 66.02%
Category II+III-Atypical/Indeterminate/Suspicious=
3.44%
Category IV-Malignant = 14.68%
Category V Unsatisfactory =15.86%
Cases where aspirators yielded material but a definite
diagnosis could not be given were considered inconclusive
.These cases were included in unsatisfactory category V for
statistical analysis in the present study.
Out of total 1601 cases, histopathological diagnoses were
available in 531 cases giving an overall biopsy rate of 31.29%
cases. Out of total satisfactory cytology samples,
histopathology was available in 466 cases .Cytological and
histological diagnoses correlated in 98.19% cases of benign
and 97.37% of malignant category.
Out of total 254 unsatisfactory aspirates on cytology,
histopathological diagnoses were available in 45 cases -37
turned out to be benign and 08 were malignant .Out of 37
benign histopathology diagnoses final definitive diagnoses
were fibroadenomas-20,inflammatory lesions(acute and
chronic)-09,fibrocystic disease-06 and one case each of
tubular adenoma and lactational adenoma.
Sensitivity, specificity and diagnostic accuracy were
calculated by comparison of cytological data with
histopathological findings. Thus this study had sensitivity of
95.28%, specificity of 96.17% and diagnostic accuracy of
95.92%.


IV. DISCUSSION

Diagnostic parameters namely sensitivity, specificity and
diagnostic accuracy in the present study on breast cytology
carried out at Cytology centre of a Teaching Institute and
Tertiary care centre compare favourably with other studies on
breast cytology carried out at hospital based cytology centers
and published during last fifteen years.
[1,5-9]
Inadequacy rate
varies from 5.4% to 18.4% between these studies.
In our study, the rate of unsatisfactory samples varied
between 9.44% to 28.86%, with an average of 15.86% over
the study period of four years and nine months. This includes
material that was either inconclusive or inadequate for
interpretation on reaspiration. Out of total 1601 breast
cytology samples, 254 were found to be unsatisfactory and
included 210 inadequate and 44 inconclusive reports.
Fine needle aspiration biopsies (FNABs)/ fine needle
capillary sampling (FNC) performed by multiple aspirators,
inclusion of patients with palpable as well as non-palpable
breast lesions in the study and categorization of inconclusive
and inadequate aspirates into unsatisfactory category are
important contributors for this number of unsatisfactory
samples in our study.
On further analysis reasons and remedies for
unsatisfactory category could be detailed out as

A. INADEQUACY RESULTING FROM IMPROPER
TECHNIQUE

Factors like delay in fixation resulting in partial drying of
smears, crush artifacts due to firm pressure applied during
smearing and lot of blood due to overzealous negative
pressure are responsible for yield of fine needle aspiration
cytology (FNAC) samples unsatisfactory for cytological
assessment.
It has been shown that best results for FNAC are obtained
in centers with a small selected group of well motivated
aspirators. Unsatisfactory samples are less if the technique is
carried out by one experienced person preferably a pathologist
as compared to when many persons-clinicians were involved.
Initial inexperience of aspirators (registered pathology
residents) due to rotational posting in cytology OPD where
FNABs are carried out was responsible to some extent for
obtaining unsatisfactory material for cytology study at our
center. In a Teaching Institute new residents have to be trained
every six months .However in order to minimize inadequacy
resulting from improper aspiration technique ,smear
preparation and preservation, new aspirators are trained by
senior residents and a reporting cytopathologist in cytology
OPD for six months period without interruption.
It was noted that fine needle aspiration biopsy (FNAB)
was most suitable for deep seated, sclerotic, necrotic tumors,
fatty breasts and vague breast lumps while fine needle
capillary sampling (FNC) proved to be better for superficial
and highly vascular masses as aspiration of large quantity of
fresh blood due to negative pressure was avoided.
[14]
Proper
technique was selected by the aspirator after local examination
of the lump.

B. INHERENT PROBLEMS IN THE LESION ASPIRATED,
RESPONSIBLE FOR UNSATISFACTORY SAMPLES

Predominantly cystic or small and deep seated or ill-
defined lesion
Fatty pendulous breast
Lesion with prominant desmoplastic reaction
Lesions with lot of necrosis and inflammation

International Journal of Scientific Research and Engineering Studies (IJSRES)
Volume 1 Issue 3, September 2014
ISSN: 2349-8862

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To keep sample inadequacy to minimum repeat FNABs
were performed under radiological guidance in these cases.
After aspirating full contents from a breast cyst
reaspiration was done from the cyst wall. Aspirated fluid was
centrifuged and smears were made from the sediment.
It is known that well defined lumps yield best material by
FNAB and it is more difficult to obtain adequate aspirates in
benign lesions and certain histological types of malignancies.
Studies on breast cytology in which patients with advanced
tumors form majority of cases and patients who have non-
palpable breast lesions are excluded show reduced inadequacy
rate and significantly higher sensitivity.
In our study aspirators had no choice of patient selection
as patients were referred for cytology by clinicians and
patients with vague breast lumps were also included. In our
experience patients having vague breast lumps often do not
co-operate or turn up for repeat aspiration .Uncertainty on
palpation and ultrasonography and lack of follow-up in these
cases contribute further to increased percentage of cases in
unsatisfactory category .Mammographic examination was not
available for our patients.

C. ERRORS IN INTERPRETATION

Diagnostic accuracy of cytology report is highly
dependent on the training and experience of the
cytopathologist.
[2]
Inexperience of cytopathologist who cannot
confidently convey a meaningful report to the treating
clinician is responsible for inconclusive reports that are finally
included in unsatisfactory category. Periodic training and
refresher courses for cytopathologists will surely help to
reduce inconclusive reports.
Because of lack of architectural information, the
interpretation of FNAC requires more training and experience
than does the reading of a needle core biopsy.

Definite criteria
of cell groups seen in the smears as a measure of adequacy are
established.

However now-a-days adequacy of cytology
sample is judged by whether it leads to resolution of the
problem presented by the lesion in a particular patients breast
FNAC aspirate is to be assessed in its clinical context.

It is
equally important to know limitations of needle aspiration
biopsy and decide the future course of action in a particular
patient on the basis of findings in smears.

Good cytology
reporting is a matter of experience .This is taken care of by
posting an experienced cytopathologist with a less experienced
one.
Choi et al have categorized causes of interpretive errors into
three groups -
Overlooking atypical cells in the background of
benign changes
mis- interpretation of atypical cells as degenerative
histology and
true interpretive errors where malignant cells are
interpreted as benign
All these errors have occured in aspirates labelled as
unsatisfactory in this study. In our analysis when available
histopathology reports were correlated with those reported as
unsatisfactory on cytology, it was noted that ,20 inconclusive
and 17 inadequate on cytology were benign lesions on
histopathology. For 8 malignant histopathology reports, 4
were reported as inconclusive and 4 were inadequate on
cytology. Histopathology of unsatisfactory category has
shown that either carcinoma or benign lesions may exist in
this group and unsatisfactory category has no diagnostic or
prognostic significance as was observed also by Rocha et al. It
thus becomes necessary to evaluate reasons for unsatisfactory
cytology material at a particular cytology centre in order to
take pertinent corrective measures.
Methods of statistical analysis vary considerably. In some
studies calculation of statistical test parameters is based only
on those cases with definitive cytological diagnoses and cases
that remain inadequate on re-aspiration are not reported as
inadequate.

We have included the inadequate on reaspiration
cases into unsatisfactory category. In our study, in few cases
cytological and histological diagnoses could not be verified
because of inadequate records or unavailability of original
slides or tissue blocks. Some workers prefer to exclude such
cases from analysis.

Collection of data for analysis becomes time consuming
and tedious in absence of computerization. Computerization of
patient data will be of help for regular statistical analysis
studies and evaluation of clinical effectiveness of the
procedure by long term follow-up .Availability of ancillary
techniques will further increase efficacy of breast cytology
reports.
In conclusion regular audits of breast cytology are needed
in cytology centre with significant cytology workload and
clinical setup that uses cytology reports as the basis for patient
management. Yearly or half yearly audits will help to
maximize diagnostic accuracy and reliability of breast
cytodiagnosis and to reduce number of unsatisfactory samples.
Audits should be submitted to Expert committee of
cytopathologists. Feedback by the cytology laboratories
should be made obligatory. Frequent interdepartmental
multidisciplinary audits are equally essential.


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