Journal of Pharmacy And Bioallied Sciences
Journal of Pharmacy And Bioallied Sciences Login  | Users Online: 2731  Print this pageEmail this pageSmall font sizeDefault font sizeIncrease font size 
    Home | About us | Editorial board | Search | Ahead of print | Current Issue | Past Issues | Instructions | Online submission




 
 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 13  |  Issue : 6  |  Page : 1381-1385  

Quadruple score: A novel scoring system for diagnosing breast lump – A retrospective pilot study


1 Departments of General Surgery, AIIMS, Bhopal, Madhya Pradesh, India
2 Department of General Surgery, AIIMS, Bhopal, Madhya Pradesh, India
3 Department Obstetrics and Gynecology, AIIMS, Bhopal, Madhya Pradesh, India
4 Department of Radiodiagnosis, AIIMS, Bhopal, Madhya Pradesh, India

Date of Submission23-Mar-2021
Date of Decision12-Apr-2021
Date of Acceptance09-May-2021
Date of Web Publication10-Nov-2021

Correspondence Address:
Soma Mukherjee
HIG 142, Amarnath Colony, Kolar, Bhopal - 462 042, Madhya Pradesh
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpbs.jpbs_219_21

Rights and Permissions
   Abstract 


Background: Triple test was a breakthrough in the initial screening of breast cancer due to its high sensitivity, but it has few limitations. To overcome those limitations, we developed a novel quadruple score which included physical examination, ultrasound, mammography, and fine-needle aspiration cytology (FNAC). Aim: The aim of this study was to test the sensitivity, specificity, negative predictive value (NPV), and positive predictive value of a novel quadruple score for the initial screening of breast cancer. Methodology: This retrospective study was conducted on 320 patients having breast lump to the Breast Cancer Outpatient Department of AIIMS, Bhopal. The physical examination findings, breast sonography findings, mammography, and FNAC findings were recorded in the set pro forma, these were later analyzed, and a cumulative scoring was done categorizing patients in the benign, dubious, and malignant category according to the QTS score. These findings were then validated and compared by histopathology. Results: Statistical results show a positive covariance σ suggesting the positive relation between them; also, the correlation coefficient was 0.9996 suggesting a strong linear correlation. On comparing the accuracy of all four variables as physical examination, USG, mammography and FNAC individually and QTS, the accuracy of QTS was highest i.e 99.44%. Conclusion: QTS is accurate and reliable diagnostic approach for evaluation of breast lumps. By using the quadruple scoring system, management of palpable breast lump will become more streamlined, providing a platform for managing discordant results, which can be followed universally.

Keywords: Breast cancer, fine-needle aspiration cytology, mammography, quadruple test score, breast sonography, breast lump, triple test assessment


How to cite this article:
Brahmachari S, Vasuniya V, Mukherjee S, Chaurasia A. Quadruple score: A novel scoring system for diagnosing breast lump – A retrospective pilot study. J Pharm Bioall Sci 2021;13, Suppl S2:1381-5

How to cite this URL:
Brahmachari S, Vasuniya V, Mukherjee S, Chaurasia A. Quadruple score: A novel scoring system for diagnosing breast lump – A retrospective pilot study. J Pharm Bioall Sci [serial online] 2021 [cited 2022 Aug 19];13, Suppl S2:1381-5. Available from: https://www.jpbsonline.org/text.asp?2021/13/6/1381/330016




   Introduction Top


Breast lump is the most common presentation of breast diseases which can be of various etiologies, benign or malignant, management and prognosis of which depends on early diagnosis and treatment. Although benign breast lump is more common, malignant breast lump is more dreaded as cancer of the breast, and is one of the most frequently encountered cancers recognized in 2.58 per million women taking mortality to 1.27 per million women.[1] Thirteen percent will have encroaching breast cancer in total life span, and the death rate due to carcinoma breast will be 1 woman out of 39 (3%) women.[1]

The diagnostic approach of triple assessment of palpable breast lumps to evaluate and distinguish between benign and malignant lumps in outpatient clinics, is a quick, cost-effective, least invasive method with accuracy comparable to open biopsy.[2]

The accuracy of diagnosis of breast cancer even in the most experienced hands-on physical examination is only 70%;[3] for mammography alone, it is 82%,[4] and for fine-needle aspiration cytology (FNAC); it is 78%.[4] Later on, a new score called modified triple score incorporating breast sonography, instead of mammography, was made, taking into consideration that mammography has low specificity in the young female population owing to dense breast and 30% of breast carcinoma is present in younger population. When all the components of triple test assessment (TTS) or modified TTS point to one possibility (are concordant), then the diagnosis is almost certain and management can be confidently planned in such a situation. However, about 30% of cases were still discordant that is differing in their interpretation of the breast lump.[4] In QTS, sonography and mammography are taken as separate investigating modalities to improve upon the diagnostic accuracy of the score.

In QTS, sonography when used in conjunction with physical, mammographic examination and FNAC is a more accurate diagnostic tool even in younger females. By bringing in the quadruple scoring system, management of palpable breast lump will become more streamlined, providing a platform for managing discordant results, which can be followed universally, thus empowering surgeon to go ahead in managing breast lump effectively and confidently. The present study was performed to determine the role of quadruple test in palpable breast lesions for providing one-stop diagnostic tool and to evaluate performance characteristics of its components individually and combined keeping histopathological examination as a reference standard for streamlining the diagnostic protocol for palpable breast lump.


   Methodology Top


The present study was undertaken as a retrospective pilot study with the aim to estimate quadruple score in preoperative diagnosis of perceptible breast lesions for developing a standard protocol for management of breast lump and to test the validity of the Quadruple Score in making a pre-procedural diagnosis of palpable breast lumps so that an prospective trial can be done.

Medical records of patients aged 20 years or above with clinically palpable breast lump from September 1, 2017, to August 31, 2018, including history/physical examination, ultrasonography (USG), mammography, and FNAC in association with tru-cut or excisional pathology results, were retrospectively analyzed.

Inclusion criteria

  1. All patients of age >20 years with palpable breast lump who underwent triple assessment were selected to participate in the present trial.


Criteria for exclusion

  1. Patients with the known presence of breast carcinoma before attending breast clinic
  2. Patients whose results of all three elements of triple test were not clearly recorded.


Scoring background

The scoring was done by keeping the following scoring criteria's for physical examination, USG, mammography, and biopsy of the specimen. As per Best practice guidelines for patients presenting with breast symptoms and American College of Radiology Breast Imaging Reporting and Data System (BI-RADS). [5,6] The malignancy level will be recorded using 1–5 scale.[5] The scoring of each of the component of QTS score was done separately which was later added to achieve the designed cumulative QTS score which could finally classify the lump as benign, dubious, or malignant. The histopathology report of specimens obtained by core-cut or excisional biopsy of the breast mass was correlated with quadruple assessment of breast lump.[6] All the scores are mentioned in [Table 1].
Table 1: Proposed quadruple test screening score

Click here to view


Statistical analysis

The results of the study were then analyzed individually and as a combination using standard statistical software. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of quadruple score are calculated according to histopathologic results. A positive covariance means that the two variables are positively related and they have the same direction, and a correlation coefficient uses values from − 1 to 1; correlation with greater absolute value shows a stronger linear correlation. Comparison between the age groups was done by Tukey's honestly significant difference test.


   Results Top


Totally 320 patients were included in the study, out of which 7 were males and 313 were females. All the patients were divided into 6 (A–F): 5 (A–E) groups according to the age [Table 2].
Table 2: The demographic data for the study participants

Click here to view


In our study, individuals were divided into six groups according to the age and demographic data were recorded. [Table 3] shows the clinical examination scoring in the studied age groups.
Table 3: The clinical examination scoring in the studied age groups

Click here to view


[Table 4] shows the scores of USG. It was found that 81, 106, 88, 23, and 22 patients were categorized in U1, U2, U3, U4, and U5, respectively.
Table 4: The ultrasonography scores

Click here to view


As per [Table 5], a statistically nonsignificant difference was found when the different age groups were compared as per the clinical examination scoring, suggesting that no age group was more inclined toward any category.
Table 5: The scoring of proposed quadruple test screening

Click here to view


[Table 6] shows the histopathology of all the studied patients. According to this 301 were benign and 5 were malignant 14 were of uncertain malignant potential
Table 6: The scores of histopathology

Click here to view


[Table 7] shows the correlation of QTS score with histopathology. Statistical results show a positive covariance σ suggesting the positive relation between them, and also, the correlation coefficient was 0.9996 suggesting a strong linear correlation.
Table 7: Correlation between quadruple test screening and histopathology

Click here to view


[Table 8] shows the comparisons of the variables and accuracy of physical examination score, USG, mammography, FNAC, and QTS. We found that the accuracy of QTS was highest among all four, i.e. 99.44%.
Table 8: The comparison of specificity, sensitivity, positive predictive value and negative predictive value of physical examination score, ultrasonography, mammography, fine-needle aspiration cytology, and quadruple test score

Click here to view



   Discussion Top


The breakthrough in breast cancer screening came with the introduction of triple assessment, but still, this system had some drawbacks and so a modified triple assessment was introduced, even with this modified system about 30% of cases remained discordant, hence the need for improvising leads us to introduce this quadruple test score (QTS).[7]

In our study also, the patients presenting with lump in breast were more from urban areas as compared to the rural population.

It is evident by many studies that mammography screening[8] can early diagnose and hence it is helpful to reduce mortality in postmenopausal women. FNAC is a reliable tool with a good sensitivity and positive predictive value (PPV) but again dependent upon the experience of a cytopathologist. The accuracy of triple assessment can be increased if it is modified to QTS as shown in our study.

As per our clinical examination scoring, 110, 25, and 19 patients were in P3, P4, and P5 categories, respectively, although when comparing the age groups, no significant difference was observed, suggesting that the clinical examination score was independent of age although the malignancy was detected in the 30 years and above age group in histopathology. As per a study conducted by Anders et al.,[9] approximately 7% of the patients diagnosed with breast cancer are below 40 years of age, hence validating our study. This suggests that diagnosis only on the basis of physical examination has poor value.

In the USG examination, 88, 23, and 22 patients were in U3, U4, and U5 categories, respectively. As per the American Cancer Society, mammography in addition with the USG in comparison to only mammography can be more fruitful than alone. As per Rebolj et al.,[10] supplementary ultrasound screening increased detection of breast cancer.

As per our QTS score, 301 cases were benign, 14 were dubious, and 5 were malignant. When this result was compared with the histopathology, it showed that our QTS did not miss a single case. When the histopathology results were compared to the QTS results, we found that both the results were in a linear and positive relation validating our scoring system.

All 301 cases which were tested benign by QTS were benign in the histopathology as well. According to this 301 were benign and 2 were malignant 12 were of uncertain malignant potential. Five cases were reported malignant by QTS; out of them three were malignant in histopathology report.

The sensitivity of our score was 100%, suggesting that not even single potentially malignant case was missed, but the specificity was low 96.2%, suggesting that those tested positive for malignancy should be confirmed by histopathology because likelihood of false positivity is high with this score. The purpose of developing this score was for initial screening. The diagnostic tools for initial screening are required to be more sensitive rather than specific and our QTS was successful in that. The PPV of this proposed QTS tool was 26.23, but the negative predictive value (NPV) was 100%. These results are in consistent with the triple test score in breast carcinoma, a study conducted by Kharkwal et al.[11] to test the validity of triple test score, suggesting the diagnostic value of our tool.

A previous study conducted by Khalid[12] discovered QTS accuracy up to 99.44%, whereas the accuracy of triple score was only 83.3%. Our study also implicates similar results, suggesting that QTS provides a user-friendly and objective evaluation tool for screening breast cancer.


   Conclusion Top


QTS, a novel scoring tool for breast cancer, was developed which is based on physical examination, ultrasound, mammography, and FNAC. This retrospective pilot study was conducted to test the validity of this score as an initial screening tool. We found that the sensitivity and NPV was 100%, emphasizing that the error or limitation of one modality was compensated by the other elements. When clinical signs and symptoms, USG and mammography and FNAC were combined which when correlated with true cut findings, diagnostic accuracy was 99.4%. This study shows that QTS is accurate and reliable diagnostic approach for evaluation of breast lumps.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Sanders ME, Schuyler PA, Simpson JF, Page DL, Dupont WD. Continued observation of the natural history of low-grade ductal carcinoma in situ reaffirms proclivity for local recurrence even after more than 30 years of follow-up. Mod Pathol 2015;28:662-9.  Back to cited text no. 1
    
2.
Ghafouri A, Attarian S, Tavangar M, Sedighi N. Modified Triple Test Score (MTTS) for evaluation of palpable breast masses in women under age 40. MJIRI 2006;20:115-8.  Back to cited text no. 2
    
3.
Barton MB, Harris R, Fletcher SW. The rational clinical examination. Does this patient have breast cancer? The screening clinical breast examination: Should it be done? How? JAMA 1999;282:1270-80.  Back to cited text no. 3
    
4.
Malik AS. Role of fine needle aspiration biopsy and cytology in breast lump. J Cole Physicians Surg Pak 1995;5:75-7.  Back to cited text no. 4
    
5.
Willett AM, MIchell MJ, Lee MJR, edotors. Best Practice Guidelines for Patients Presenting with Breast Symptoms London Department of Health; 2010. Available from: https://associationofbreastsurgery.org.uk/media/1416/best-practice-diagnostic-guidelines-for-patients-presenting-with-breast-symptoms.pdf. [Last accessed on 2017 Sep 04].  Back to cited text no. 5
    
6.
Yoon JH, Kim MJ, Lee HS, Kim SH, Youk JH, Jeong SH, et al. Validation of the fifth edition BI-RADS ultrasound lexicon with comparison of fourth and fifth edition diagnostic performance using video clips. Ultrasonography 2016;35:318-26.  Back to cited text no. 6
    
7.
Rangarajan B, Shet T, Wadasadawala T, Nair NS, Sairam RM, Hingmire SS, et al. Breast cancer: An overview of published Indian data. South Asian J Cancer 2016;5:86-92.  Back to cited text no. 7
[PUBMED]  [Full text]  
8.
Sankatsing VD, van Ravesteyn NT, Heijnsdijk EA, Looman CW, van Luijt PA, Fracheboud J, et al. The effect of population-based mammography screening in Dutch municipalities on breast cancer mortality: 20 years of followup. Int J Cancer 2017;141:671-7.  Back to cited text no. 8
    
9.
Anders CK, Johnson R, Litton J, Phillips M, Bleyer A. Breast cancer before age 40 years. Semin Oncol 2009;36:237-49.  Back to cited text no. 9
    
10.
Rebolj M, Assi V, Brentnall A, Parmar D, Duffy SW. Addition of ultrasound to mammography in the case of dense breast tissue: Systematic review and meta-analysis. Br J Cancer 2018;118:1559-70.  Back to cited text no. 10
    
11.
Kharkwal S, Sameer, Mukherjee A. Triple test in carcinoma breast. J Clin Diagn Res 2014;8:NC09-11. doi: 10.7860/JCDR/2014/9237.4971.  Back to cited text no. 11
    
12.
Khalid S. Evaluation of triple assessment modalities in the management of palpable breast lumps. Iraqi Postgrad Med J 2010;9:48-56.  Back to cited text no. 12
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]



 

Top
 
 
  Search
 
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
    Access Statistics
    Email Alert *
    Add to My List *
* Registration required (free)  

 
  In this article
    Abstract
   Introduction
   Methodology
   Results
   Discussion
   Conclusion
    References
    Article Tables

 Article Access Statistics
    Viewed369    
    Printed6    
    Emailed0    
    PDF Downloaded46    
    Comments [Add]    

Recommend this journal