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 Table of Contents  
ORIGINAL ARTICLE
Year : 2015  |  Volume : 29  |  Issue : 1  |  Page : 26-30

Evaluation of modified triple test (clinical breast examination, ultrasonography, and fine-needle aspiration cytology) in the diagnosis of palpable breast lumps


Department of Surgery, Regional Institute of Medical Sciences, Imphal, Manipur, India

Date of Web Publication17-Jun-2015

Correspondence Address:
Dr. Lod Khoda
Department of Surgery, Regional Institute of Medical Sciences, Imphal - 795 004, Manipur
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-4958.158927

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  Abstract 

Objective: To find out the accuracy of the modified triple test in the diagnosis of palpable breast lumps. Materials and Methods: This was a cross-sectional study involving 50 female patients with palpable breast lumps attending the Surgical Out Patient Department of the Regional Institute of Medical Sciences, Imphal between October 2011 and September 2013, who underwent clinical breast examination (CBE), ultrasonography (USG), and fine-needle aspiration cytology (FNAC). All the cases irrespective of results underwent either excisional and or incisional biopsy for confirmation. The final histopathological report was considered the reference standard. Results: A total of 50 patients were included. The age range was 18-56 years. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of CBE were 66.6%, 100%, 100%, 90%, and 91.6% respectively; those of USG 91.6%, 100%, 100%, 97.3%, and 97.9% respectively; and those of FNAC 91.6%, 100%, 100%, 97.4%, and 98% respectively. Out of 50 patients, the three tests concurred in 42 (35 benign and 7 malignant) cases. When all the three tests concurred, there were no false positive or false negative cases, and sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were all 100%. Conclusion: The triple test is valid and reliable, with a high degree of accuracy for the diagnosis of breast lumps. Of all the three components of the triple test, FNAC is the most accurate. A patient with a concordant benign triple test report can be safely followed up without the need for biopsy.

Keywords: Breast lumps, Clinical breast examination (CBE), Fine-needle aspiration cytology (FNAC), Modified triple test, Ultrasonography (USG)


How to cite this article:
Khoda L, Kapa B, Singh KG, Gojendra T, Singh LR, Sharma KL. Evaluation of modified triple test (clinical breast examination, ultrasonography, and fine-needle aspiration cytology) in the diagnosis of palpable breast lumps. J Med Soc 2015;29:26-30

How to cite this URL:
Khoda L, Kapa B, Singh KG, Gojendra T, Singh LR, Sharma KL. Evaluation of modified triple test (clinical breast examination, ultrasonography, and fine-needle aspiration cytology) in the diagnosis of palpable breast lumps. J Med Soc [serial online] 2015 [cited 2019 Oct 17];29:26-30. Available from: http://www.jmedsoc.org/text.asp?2015/29/1/26/158927


  Introduction Top


The commonest mode of presentation of diseases of the breast is "lump." [1] A palpable mass in a woman's breast could be a benign or malignant lesion and it requires a prompt evaluation. Correct preoperative diagnosis of a breast lesion is essential for optimal treatment planning. The primary aim is to confirm or exclude cancer. A single-modality test is not accurate enough to make the correct diagnosis for a breast lesion. However, the accuracy of the diagnosis can be increased by employing multimodality tests. A number of modalities together are more accurate and reliable compared to a single-modality test, despite having their own technical limitations.

In the late 1970s, triple assessment for breast lumps was started in the UK, when fine-needle aspiration cytology (FNAC) was added to clinical breast examination (CBE) and mammography for the assessment of breast lumps. [2]

According to National Institute for Health and Clinical Excellence (NICE) guidelines, for patients with symptoms that could be caused by breast cancer, diagnosis is made by triple assessment (clinical assessment, mammography and/or ultrasound imaging, and core biopsy and/or FNAC). [3] Also, the Association of Breast Surgeons states that "wherever possible, a non-operative breast cancer diagnosis should be achieved by triple assessment, (clinical and radiological assessment followed by core biopsy and/or fine needle aspiration)." [4]

The aim of this study were to study the accuracy of triple assessment in the preoperative diagnosis of breast cancer and to find out the performance characteristics of CBE, ultrasonography (USG), and FNAC in isolation and when combined, keeping histopathological examination (HPE) as the reference standard.


  Materials and Methods Top


A total of 50 patients of clinically palpable breast lump(s) and age more than 18 years, attending the surgical Out Patient Department of Regional Institute of Medical Sciences Hospital, Imphal, from October 2011 to September 2013, were included in the study. Patients with a diagnosed case of breast cancer, those with inflammatory conditions of breast, and those with a previous history of operation on the same side of breast were excluded. Approval from the institution's Ethical Committee was obtained. Informed consent was taken for physical examination and investigations. A thorough history was taken for each subject, followed by CBE, USG, and FNAC.

CBE

Each case was first subjected to CBE, including a systemic search for lymphadenopathy in the axilla and supraclavicular fossa on both sides in the Out Patient Department. Examination findings were recorded as benign, indeterminate, and suggestive of malignancy of breast lump.

USG

USG evaluation of breast was done using 7.5-10 MHz probe (SIEMENS, Sonoline Versa Plus, Department of Radio-Diagnosis, Regional Institute of Medical Sciences, Imphal, Manipur) with the patient lying supine and the ipsilateral hand raised above the head. Scanning of breast was done systemically by obtaining vertical and horizontal scans, and the findings were coded as benign, indeterminate, or suggestive of malignancy.

FNAC

Aspiration was done using a 21-22 gauge needle attached to a 20 mL syringe with the patient in supine position and the ipsilateral forearm resting behind the head. With the nondominant hand stabilizing and positioning the breast lump, the needle was placed in the mass; suction was applied while the needle was moved back and forth within the mass. Once cellular material was seen at the hub of the needle, the suction was released and the needle withdrawn. The cellular material was expressed on a slide, spread and air-dried, and sent to the pathology department for cytological examination. Reports were then coded as benign, indeterminate, or malignant.

HPE

All the cases irrespective of results underwent either excisional and or incisional biopsy and specimens were sent in 10% formalin solution to the pathology department for HPE. The final histopathological report was considered as the reference standard and reports were then grouped into "benign" and "malignant" for analysis.

Statistical analysis

Data were entered in a pro forma. Variables were cross-tabulated against the HPE report, the reference standard. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were determined for each modality separately and when combined.


  Results and Observation Top


A total of 50 female patients with clinically palpable breast lump(s) attending the surgical Out Patient Department were included for study. The age range was 18-56 years and the mean age was 32 years. The highest number of patients was in the age group of 18-25 years (32%), followed by the age group 36-45 years (30%). Of the 12 patients with malignant breast lumps, 11 patients were 37 years and older. Only one patient with malignant lesion was younger, at 28 years. The mean age of patients with breast cancer was 42.4 years. Of 50 patients, 10 (20%) were nulliparous and the remaining 40 (80%) were multiparous. However, malignant lesions were not detected in all the nulliparous patients.

The commonest site of lumps was the left upper outer quadrant (in 28% patients), followed by the right upper outer quadrant (24%), with the remaining patients' lumps in other quadrants. In each of the studied patients, only a single breast lump was detected.

On CBE, the lumps in 40 (80%) patients had benign and 8 (16%) had malignant features. However, 2 (4%) patients were found to be in the "suspicious" category. Of the 40 benign findings on CBE, 36 were benign and 4 had malignant reports confirmed on HPE. Of the 8 malignant findings on CBE, all of them were confirmed to be malignant on the final HPE reports. Two suspicious cases on CBE were found to have reactive lymphoid tissue and atypical ductal hyperplasia on HPE.

CBE when compared with histopathology had the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 66.6%, 100%, 100%, 90%, and 91.6%, respectively. Two suspicious cases on CBE were not included on final analysis [Table 1].
Table 1: CBE results compared to HPE report (reference standard)


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On USG examination, out of 50 patients, 38 (76%) had benign findings, 11 (22%) had malignant findings, and 1 (2%) had normal study results. Of the 38 benign findings, 37 were confirmed to be benign and one case was found to be infiltrating ductal carcinoma on HPE. All the 11 cases of malignant findings were confirmed to be malignant on HPE. However, one case of normal study result on USG was found to be fibroadenoma on HPE, and this case was excluded from the final calculation.

USG when compared with histopathology had the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 91.6%, 100%, 100%, 97.3%, and 97.9%, respectively. One case of normal study result on USG was excluded from final analysis [Table 2].
Table 2: USG findings as compared to HPE report (reference standard)


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Out of 50 patients examined by FNAC, 39 (78%) had benign and 11 (22%) had malignant findings. However, no patient was found to be in the "suspicious" category on FNAC. Of THE 39 benign findings on FNAC, 38 were confirmed as benign on HPE. The fibroadenoma reported on FNAC in 1 patient turn out to be ductal carcinoma in situ on HPE. Of the 11 malignant findings on FNAC, all were confirmed to be malignant on the final HPE.

FNAC when compared with histopathology had the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 91.6%, 100%, 100%, 97.4%, and 98% respectively [Table 3].
Table 3: FNAC report as compared to HPE report (reference standard)


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On HPE, out of 50 breast lumps, 34 (68%) were fibroadenoma, 11 (22%) infiltrating ductal carcinoma, 2 (4%) fibroadenosis, 1 (2%) ductal carcinoma in situ, 1 (2%) atypical ductal hyperplasia, and 1 (2%) reactive lymphoid tissue. The total number of malignant lesions detected on HPE was 12 (24%) and that of benign lesions was 38 (76%) [Table 4].
Table 4: Result of HPE of breast lumps


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Degree of concurrence of triple test

When the combined results of CBE, FNAC, and USG were analyzed together, concurrence was observed in 35 (70%) benign and 7 (14%) malignant cases. Therefore, out of 50 patients, the three tests concurred in 42 (84%) patients. When all the modalities of THE triple test concurred, there were no false positive OR false negative cases. The triple test had 100% sensitivity, specificity, positive predictive value, negative predictive value, and accuracy [Table 5].
Table 5: Triple test as compared to HPE report (reference standard)


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  Discussion Top


Breast cancer is the most common cancer in women worldwide. The employment of multimodality tests preoperatively for diagnosis helps in differentiating benign from malignant lesions. The primary goal of the triple test is to make the correct preoperative diagnosis, avoiding open biopsy in case of a benign breast lump. The present study tries to evaluate the accuracy of multimodality tests, that is, CBE, USG, and FNAC together, keeping HPE of breast lump(s) as the reference standard.

In the present series, among 50 patients, in 26 (52%) patients a lump was detected in the upper outer quadrant of breast, followed by 12 (24%) in the upper inner quadrant and the remaining 12(24%) in other quadrants of breast. Similar observations were made by Khemka et al. and Hussain et al., in whose studies the majority of breast lumps were found in the upper outer quadrant. [5],[6] The relative higher occurrence of breast lump in the upper outer quadrant of breast compared to the other quadrants is because much of the epithelial tissue of breast is present in this quadrant. [7]

On physical examination, of 50 patients, in 36 (72%) the lump was benign, in 12 (24%) the lump was malignant, and 2 (4%) patients were placed in the "suspicious" category. On HPE, these two cases turned out to be a case each of reactive lymphoid tissue and atypical ductal hyperplasia. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the CBE were 66.6%, 100%, 100%, 90%, and 91.6% respectively. On review of the literature, various studies show the sensitivity of the CBE ranging from 21% to as high as 100% and the specificity from 50% to 97.8%. In the present study, the high sensitivity could be because only patients with symptoms of breast lump(s) either self-detected or by a physician were included.

USG is the recommended initial imaging modality in women younger than 35 years for characterizing breast lumps because of dense breast tissue. Mammography is recommended for women over 35 years of age. In our study, USG favored malignant diagnosis in 11 patients, all of which cases turned out to be malignant on histopathology. Out of 38 benign cases, 1 turned out to be malignant on histopathology. However, one case of normal study on USG was found to be fibroadenoma on HPE. Thus, for USG, sensitivity was 91.6%, specificity was 100%, positive predictive value was 100%, negative predictive value was 97.3%, and accuracy was 97.9%. When we compared these results with the available literature, we found that our results correlated with other studies. Pande et al. had found that sensitivity, specificity, positive predictive value, and negative predictive value were 95%, 94.1%, 95.5%, and 93.7%, respectively. [8] In another study by Jan et al., USG of breast lumps showed sensitivity, specificity, positive predictive value, and negative predictive value of 100%, 96.4%, 66.7%, and 100%, respectively. [9]

The present study showing a sensitivity of 91.6% means that 8.4 malignant lesions would be missed out of 100 malignant lesions. Thus, a benign result on USG does not completely rule out the possibility of malignancy. In case of a benign report, additional testing modalities should be used to rule out malignancy. A specificity of 100% and a positive predictive value of 100% means that a USG report can be relied upon for treatment decisions when a malignant result is reported.

However, cautious interpretation of a USG report should be made, as one case of fibroadenoma was reported as a normal study result. The wide variation of observation seen in various studies could be partly because of variation in case selection and partly due to the operator dependency of USG.

On FNAC examination, out of 39 benign diagnoses, 38 were confirmed benign and one malignant on HPE. All the 11 malignant cases were confirmed on HPE. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of FNAC were 91.6%, 100%, 100%, 97.4%, and 98%, respectively. Our results were in agreement with other studies. Muhammed et al. in their study found that the sensitivity, specificity, positive predictive value, and negative predictive value of FNAC were 90.6%, 100%, 100%, and 99% respectively. [10] Khemka et al. found that FNAC had the sensitivity, specificity, positive predictive value, and negative predictive value of 96%, 100%, 100%, and 95.12%, respectively. [5]

When triple assessment was compared with the results of histopathology, we found that the three tests concurred in 35 benign and 7 malignant cases, i.e., 42 (84%) patients. When all the three tests concurred, there were no false positive or false negative cases. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were all 100%. Our results compared favorably with the available literature. Ghafouri et al. found that when suspicious results were excluded, the diagnostic accuracy of the modified triple test was 100%. [11] In another study by Jan et al., the sensitivity and specificity of triple assessment was 100% and 99.3%, respectively. The concordance for the triple assessment was 99.3%, positive predictive value was 93.3%, and negative predictive value was 100%. [9]

Similar findings were noted by Vaithianathan et al. in their study. The diagnostic accuracy rate of the modified triple test in concordant cases (benign and malignant) was 100%. The sensitivity, specificity, positive predictive value, and negative predictive value were found to be 100%, 82%, 76.9%, and 100% respectively. [12]


  Conclusion Top


The modified triple test is valid and reliable, with a high degree of accuracy for the diagnosis of breast lumps. Of all the three components of the triple test, FNAC is the most accurate. A patient with a concordant benign triple test report can be safely followed up without the need for biopsy. The aim of the modified triple test is to allow the clinician to avoid unnecessary open biopsy and to proceed to definitive therapy if a malignant breast lump is present. In summary, the modified triple test can reliably guide the evaluation and treatment of breast lumps.

 
  References Top

1.
Das S. A manual on clinical surgery. 4 th ed. Kolkata: Dr. S. Das′s Publications; 1996. p. 308.  Back to cited text no. 1
    
2.
Thomas JM, Fitzharris BM, Redding WH, Williams JE, Trott PA, Powles TJ, et al. Clinical examination, xeromammography, and fine-needle aspiration Cytology in diagnosis of breast tumor. Br Med J 1978;2:1139-41.  Back to cited text no. 2
    
3.
National Institute for Health and Clinical Excellence. Early and Locally Advanced Breast Cancer: Diagnosis and Treatment. NICE clinical guideline 80, 2009. Available from: http://www.nice.org.uk.   Back to cited text no. 3
    
4.
Association of Breast Surgery at Baso 2009. Surgical guidelines for the management of breast cancer. Eur J Surg Oncol 2009;35 (Suppl 1): 1-22.   Back to cited text no. 4
    
5.
Khemka A, Chakrabati N, Shah S, Patel V. Palpable breast lumps: Fine-needle aspiration cytology versus histopathology: A correlation of diagnostic accuracy. Internet J Surg 2009;18.  Back to cited text no. 5
    
6.
Hussain MT. Comparison of fine needle aspiration cytology with excisional biopsy of breast lump. J Coll Physicians Surg Pak 2005;15:211-4.  Back to cited text no. 6
    
7.
Tari AK, Monica M. The Breast. Greenfield′s Surgery, Scientific Priniciples and Practice. 5 th ed. Philadelphia: Lippincott Williams & Wilkins; 2011. p. 1241-81.  Back to cited text no. 7
    
8.
Pande AR, Lohani B, Sayami P, Pradhan S. Predictive value of ultrasonography in the diagnosis of palpable breast lump. Kathmandu Univ Med J (KUMJ) 2003;1:78-84.  Back to cited text no. 8
    
9.
Jan M, Matto JA, Salroo NA, Ahangar S. Triple assessment in the diagnosis of breast cancer in Kashmir. Indian J Surg 2010;72:97-103.  Back to cited text no. 9
    
10.
Muhammed AZ, Edino ST, Ochicha O, Alhasan SU. The value of fine needle aspiration biopsy in preoperative diagnosis of palpable breast lumps in resource poor countries: A Nigerian experience. Ann Afr Med 2005;4:19-22.  Back to cited text no. 10
    
11.
Ghafouri A, Attarian SH, Tavangar M, Sedighi N. Modified Triple Test Score (MTTS) for evaluation of palpable breast masses in women under age 40. Med J Islam Repub Iran 2006;20:115-8.  Back to cited text no. 11
    
12.
Vaithianathan R, Sundaresan V, Santhanam R. Vlaue of modified triple test in the diagnosis of palpable breast lumps. Int J Cur Res Rev 2013;5:125-34.  Back to cited text no. 12
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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