Abstract  Introduction:Triple test (mammography, Fine needle aspiration cytology and physical examination) can be used accurately in patients presenting with palpable breast masses. We studied the sensitivity, specificity and predictive values of the three components.Aims and Objectives:This study aimed at the assessment of palpable breast masses in north Indian women using triple test.Materials and Methods: Prospectively for one year 52 female patients who presented with a palpable breast lump were assessed using all three components of the triple test.Results:Physical examination showed 57.14% sensitivity, 100% specificity and 100% positive predictive value. Fine needle aspiration cytology (FNAC) showed 71.43% sensitivity, 96.97% specificity and 90.91% positive predictive value whereas mammography revealed 50% sensitivity, 100% specificity and 100% positive predictive value. The overall predictive value of the triple test score was 94.87%Conclusions:Triple Test i.e. combined physical, radiologic and cytological diagnosis is more sensitive and specific than any procedure used alone. The study shows that when TT is concordant i.e. TTS score is more than 6, the final treatment may be ensued without confirmatory biopsy.

 Introduction:

‘Triple test’ (physical examination, mammography and fine needle aspiration cytology) can be employed to provide an accurate diagnosis in patients presenting with a palpable breast mass. [1]. Initial studies of this procedure showed that it enhanced the diagnostic accuracy [2],[3]. Subsequently, a large Danish study showed a high sensitivity of the triple test when all three components were concordant or in agreement [4]. Similar studies in the early 1990s found100% accuracy when all three components of the test were concordant and similar accuracy when the elements were non-concordant [5]. However, it was found that approximately 40% of cases had non-concordant tests, thus requiring biopsy. Hence the triple test was improved with the concept of the triple test score (TTS), in which each component of the triple test was rated as benign, suspicious or malignant and assigned 1, 2 or 3 points respectively.

 

Aims and Objectives:

This study aimed at the assessment of palpable breast masses in north Indian women using triple test.

 

Materials and Methods:

This study is based upon observation and analysis of fifty two female patients who presented with lump in the breast in the Department of Surgery, Christian Medical College and Hospital, Ludhiana for a period of one year.

Patients with breast abscess were excluded from the study.

The clinical history and examination of the breast and axilla were carried out in a standardized method.

FNAC was done with a 22 gauge needle. Half of the smears prepared by aspiration technique were immediately placed in 95% ethyl alcohol while wet, to be taken out only at the time of staining by papanicolaou stain. The other smears were air dried and kept for staining with May GrunwaldGiemsa stain.

Mammography was performed with standard planes of imaging (craniocaudal and mediolateral oblique).The mediolateral oblique view is obtained with the x-rays film holder between and parallel to the pectoralis major and lattissimusdorsi muscles. The craniocaudal view places the x-rays film underneath the breast .The breast is held against the image receptor with a compression. All mammograms were done with a Siemens Mammomet 3000 machine. With comparative study of mammograms of the two breasts, various mammographic features were analyzed.

Results of all three methods were tabulated as malignant, benign or suspicious.

The triple test was considered concordant when the three elements had either all malignant or benign results. The negative predictive value of the triple test was defined as the percentage of cases in which the results of the TT components were concordant and scored as benign, and subsequently the biopsy also showed a benign lesion.

Positive predictive value was defined as the percentage of cases in which results of the triple test component were all malignant and the biopsy confirmed the lesion to be malignant. Sensitivity was defined as the percentage of cases in which biopsy proven cancer was correctly diagnosed by the triple test whereas specificity was diagnosed as percentage of cases in which the biopsy proven benign lesions were correctly diagnosed as benign by the triple test.

 

 

Results and analysis:

Fifty two female patients (mean age was 43.8 years, range 30 to 70 years) were included in the study.In all the patients, chief complaint was breast lump. The mass was painless in 28 patients (53.8%) and 4.2% had associated nipple discharge. In our study, 88.5% women were multiparous.Histopathologically, 63.5% of the study patients were proven to have benign disease while 36.5% patients had a malignant disease.The incidence of benign disease was higher (63.0%) in multiparous,educated (77.8%) women and those with history of oral contraceptive use (81.8%), breast pain (70.8%) and nipple discharge (75%). On the contrary, tenderness was more common in benign disease.

Patients who attained menarche before 13 years of age had higher incidence of malignant disease (57.14%) and so did patients with advancing menopausal age.The mean age of patients with benign disease was 41.33 ± 10.18 years while that of malignant disease was 48.10 ± 11.52 years.Mean size of malignant mass (36.05±34.03mm) was higher than benign breast mass (12.98±19.83mm).Patients with axillary lymphadenopathy had higher incidence of malignant disease (66.7%). Features like nodular surface, irregular margins, hard consistency and skin changes had higher association with malignant disease.

The sensitivity patterns of individual components of triple test and the overall sensitivities are depicted in Table 1 and 2 respectively. All the patients with Triple Test Score (TTS) of 3 had benign breast disease and all the patients with TTS more than 6 had malignant breast disease.All the patients with TTS of 3 to 6 underwent excision biopsy of which 75.6% had benign breast disease. Patients with TTS of more than 6 underwent mastectomy.

 

Discussion:

The goals of the triple test are to avoid expensive, potentially morbid negative open biopsies when no malignancy is present. It also allows the patient and the clinician to proceed directly to definitive therapy. Safely reducing the number of breast biopsies can save patients the discomfort associated with open biopsies and eliminate unnecessary expenditure. [6]

In examining the triple test components individually we noted that FNAC is more accurate than mammography but has the same overall predictive value as physical examination (table 1). This agrees with the study of Morris and Vetto [6], [5]. In our study physical examination showed a sensitivity of 57.14%, a specificity of 100% and a positive predictive value of 100% with and overall predictive value of 92.1% (Table1). Other studies showed that physical examination could diagnose upto 70% of cases of carcinoma [7]

The wide spread use of mammography has radically changed the diagnostic approach to breast cancer[8]. In our study mammography alone had a sensitivity of 50% , a specificity of 100% and a positive predictive value of 100% for malignancy and 88.94% for benign lesions. In a Dutch study of breast cancer screening, Romback found that if mammography alone has been used the sensitivity of breast cancer diagnosis would have been 95% [9]. While our study specifically excluded ultrasonography, increasing use of this modality to facilitate either FNAC or core needle biopsy is proving effective in reports from institutions that are comfortable with the use of this technique [10].

In our study the sensitivity of FNAC was 71.43%. It has a specificity of 96.9% and a positive predictive value of 90.91%. The overall predictive value of this diagnostic modality was 92.1%. These results are in accordance with Morris et al and veto et al who reported a sensitivity of 96% for FNAC with a specificity of 100% and a positive predictive value of 100%. Rubin and Joy concluded that FNAC is the first reliable diagnostic step in detection of breast carcinoma [10]. They reported a positive predictive value of 100%, a specificity of 1005, a sensitivity of 87% and a negative predictive value of 89%. Morris 1998 in their study of 259 patients with 261 palpable breast mass lesions have reported 152 masses with TTS of 4, with all benign characteristics on open biopsy or clinical follow up.88 patients had a TTS of 6 points or more; all had malignant histopathological characteristics on subsequent open biopsy. 21 patients had a TTS of 5, of these 13(62%) were found to have benign histopathologic characteristics, while 8(38%) had malignant lesion on subsequent open biopsy. They reported a diagnostic accuracy and positive and negative predictive value of TTS were 100% with p<0.001.

In this study, 29 patients had TTS of 3 out of which only 6.90% had a malignant mass. 13 patients had TTS between 4 to 6 of which 53.85% patients were in malignant group, whereas, there were 10 patients with TTS more than 6 and 100% of them were found to be malignant. The sensitivity of TTS in this study was 83.33%, specificity of 100%, positive predictive value of 100%, negative predictive value of 93.10 % and an overall predictive value of 94.87%. These observations were found to be statistically significant (p<0.01).

In conclusion, the TTS reliably guides the evaluation and treatment of palpable breast masses in North Indian women by enhancing the value of the triple test. Masses that score 6 or more should be treated as malignant while those with a score of 4 or less are benign and may be clinically followed up. The masses that score 5, need to be further evaluated with open biopsy before definitive treatment plans are drawn.

 

 

 

 

 

 

 

References:

1.            Al-Mulhim AS, Sultan M , Mohammed AM, Al-Wehdey A, Ali AM, Al-Suwaigh A et al, Accuracy of the “triple test” in the diagnosis of palpable breast masses in Saudi Females : Ann Saudi Med. 2003 May-Jul;23(3-4):158-61.

2.            Johansen C. Breast disease: a clinical study with special reference to diagnostic procedures. ActaClinScand (Suppl.) 1975; 451: 1-70.

3.            Kreuzen G, Boquoi E. Aspiration biopsy cytology, mammography and clinical exploration: A modern setup in diagnosis of tumors the breast. ActaCytol 1976; 20: 319-323.

4.            Hermansen C, Paulsen HS Jensen J, et al. Diagnostic reliability of combined physical examination, mammography and fine needle puncture (“triple tests”) in breast tumors: a prospective study. Cancer 1987; 60: 1866-1871.

5.            Vetto J., Pommier R, Schmidt W, et al. Use of “Triple Test” for palpable breast lesions yields high diagnostic accuracy and cost saving. Am JSurg 1995; 169: 519-522.

6.            Morris A, Prommier RF, Schmidt WA, et al. Accurate evaluation of palpable breast mass by the triple test score. Arch Surg.1998; 133: 930-934.

7.            Wolson RE. The breast: The biological basis of modern surgical practice. In: Text book of surgery. 13th ed. Edited by David C S. W.B Saunders, 1986: 530-552.

8.            Rosait J. Breast clinical examination. In : Ackermann Surgical Pathology, 8th ed. St. Louis, Mosby 1996; 1591-2001.

9.            RombackJJ. Breast cancer screening.Br Med J 1986; 292:233-236.

10.          Parker SH. Percutaneous large core breast biopsy. Cancer 1994; 74:694-6Table 1: Sensitivity analysis of individual components of triple test

Test Biopsy positive Biopsy negative Sensitivity

(%)

Specificity

(%)

PPV (%) NPV (%) OPV (%)

 

PE Positive 04 00 57.14 100 100 91.18 92.11
PE Negative 03 45          
Mammogram Positive 05 00 50 100 100 88.24 89.4
Mammogram Negative 14 33          
FNAC Positive 11 01 71.43 96.97 90.9 88.89 92.11
FNAC Negative 09 31          

 

 

 

Table 2  Overall sensitivity analysis of Triple test score

Particulars Percentage (%)
Sensitivity 83.33
Specificity 100
+ve predictive value 100
-ve predictive value 93.10
Overall predictive value 94.87

 

 

Assessment of palpable breast masses in north Indian women using triple test

ShekharUpadhyay*, Rajesh Chakravarty**, NaliniCalton***, William Bhatti#

*Department of General Surgery, Christian Medical College and Hospital, Ludhiana

**Department of Radio diagnosis, Christian Medical College and Hospital, Ludhiana

***Department of Pathology, Christian Medical College and Hospital, Ludhiana

#Department of Pediatric Surgery, Christian Medical College and Hospital, Ludhiana

 

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