European Journal of Cardiovascular Medicine

Benign breast diseases (BBDs) represent a diverse group of non-malignant conditions of the breast, constituting the majority of breast-related complaints among women attending surgical or outpatient departments worldwide. While non-life-threatening, BBDs are often associated with significant psychological distress, diagnostic uncertainty, and repeated clinical follow-up, particularly when presenting as palpable masses or imaging abnormalities [1].

Epidemiological studies have demonstrated that BBDs are more prevalent than breast cancer, especially among women in the reproductive age group [2]. Historical and regional data underscore the burden of benign conditions in both developed and developing healthcare systems. For instance, Ernster et al. highlighted the diverse histologic spectrum of BBDs in the U.S., while Fleming et al. noted similarities in presentation and risk factor profiles between benign lumps and malignancies in Western Australia [1,2].

The histopathologic classification of BBDs encompasses entities such as fibroadenoma, fibrocystic changes, mastitis, duct ectasia, and adenosis. Among these, fibroadenomas are reported as the most frequent diagnosis, particularly in women below the age of 30 [3]. Conversely, fibrocystic changes and duct ectasia become more prevalent with advancing age, particularly in perimenopausal women [4]. Importantly, certain subtypes of BBD—particularly those involving atypical hyperplasia—have been associated with a moderately elevated risk of subsequent breast malignancy [6].

A large-scale epidemiological review by Kumar et al. in North India documented fibroadenomas in nearly 45% of their 5965-case cohort, followed by fibrocystic changes and benign inflammatory lesions [3]. Regional variations have also been noted in African populations, where mastitis and duct ectasia were prominent contributors to benign breast presentations, as shown by Chalya et al. [5].

Despite the high prevalence and clinical overlap with malignancy, data from many tertiary care centres—especially in emerging health systems—remain limited. Therefore, this study was undertaken to evaluate the clinicopathological spectrum of BBDs in women attending TRR Institute of Medical Sciences. By correlating clinical parameters with histopathological findings, this analysis seeks to enhance diagnostic precision and guide evidence-based management of benign breast complaints.

Study Design and Setting

This cross-sectional observational study was conducted at the Department of General Surgery, TRR Institute of Medical Sciences, Telangana, India. The study was carried out over a 2-year period from June 2023 to June 2025 and received institutional ethics committee approval prior to data collection.

Participants

A total of 120 female patients presenting with palpable or radiologically suspicious breast lumps, clinically deemed benign and subsequently confirmed by histopathology, were enrolled consecutively. Inclusion criteria included adult women aged 15 years and above, presenting with breast masses without signs of malignancy. Patients with prior breast malignancy, incomplete diagnostic records, or refusal to undergo biopsy were excluded.

Data Collection

Clinical data were recorded using a standardized pro forma and included demographic variables (age, residence), clinical presentation (unilateral/bilateral involvement, duration of symptoms, lesion size), and family history. All patients underwent either excisional or core needle biopsy, and specimens were subjected to histopathological evaluation by a dedicated pathologist.

Histopathological Classification

Diagnoses were categorized based on World Health Organization (WHO) criteria into:

• Fibroadenoma
• Fibrocystic changes
• Duct ectasia
• Mastitis
• Other benign lesions (e.g., papilloma, adenosis)

Statistical Analysis

Data were entered using Microsoft Excel and analyzed with SPSS version 25.0. Continuous variables such as age and lesion size were summarized using means and standard deviations. Categorical variables—including histopathological subtypes, lesion laterality, and family history—were presented as frequencies and percentages.

Comparisons of age and lesion size across histopathological categories were made using one-way analysis of variance (ANOVA), followed by Tukey’s post hoc test for pairwise comparisons. Associations between categorical variables were assessed using the Chi-square test.

To identify independent predictors of fibroadenoma and fibrocystic changes, multivariate logistic regression analyses were conducted, adjusting for variables such as age, lesion size, and symptom duration. A p-value <0.05 was considered statistically significant.

1. Demographic and Clinical Characteristics

A total of 120 women with clinically suspected benign breast lesions were enrolled in the study. The mean age of the cohort was 32.4 ± 9.1 years, with the highest proportion of cases observed in the 21–30-year age group (38.3%). The majority of patients (87.5%) presented with unilateral breast lesions, while bilateral involvement was noted in 12.5% of cases. The median duration of symptoms prior to presentation was 6 weeks (interquartile range: 4–10 weeks). The average lesion size recorded was 2.7 ± 1.1 cm. A positive family history of breast disease was reported in 18 patients, accounting for 15% of the study population. Table 1 summarizes the demographic and clinical characteristics of the study cohort.

Table 1. Demographic and Clinical Characteristics of the Study Cohort (n = 120)

2. Histopathological Distribution

Histopathological examination confirmed benign pathology in all 120 cases. The most frequently diagnosed lesion was fibroadenoma, observed in 54 patients (45%), followed by fibrocystic changes in 28 patients (23.3%), duct ectasia in 16 patients (13.3%), and mastitis in 12 patients (10%). Less common lesions included intraductal papilloma (6 cases, 5%) and adenosis (4 cases, 3.3%).

The distribution aligns with expected epidemiological trends, with fibroadenoma being most prevalent among younger women, while fibrocystic change and duct ectasia appeared more commonly in older age groups. Figure 1 illustrates the relative distribution of histopathological subtypes.

Figure 1. Relative Distribution of Histopathological Subtypes (n = 120)

Table 2. Histopathological Diagnosis of Benign Breast Lesions (n = 120)

3. Correlation Between Age and Lesion Type

An analysis of patient age distribution across histopathological subtypes revealed significant differences. The mean age for patients diagnosed with fibroadenoma was 27.5 ± 5.4 years, significantly lower than those diagnosed with fibrocystic changes (38.6 ± 6.9 years) and duct ectasia (41.2 ± 7.3 years). Patients with mastitis and intraductal papilloma had intermediate age distributions, averaging 33.4 ± 6.1 years and 35.2 ± 5.7 years, respectively. The few cases of adenosis were seen in women with a mean age of 39.0 ± 6.3 years.

Statistical comparison using one-way ANOVA showed a significant difference in mean age between the lesion groups (F = 19.87, p < 0.001). A post hoc Tukey test confirmed that the age of fibroadenoma patients was significantly lower than those with fibrocystic changes (p < 0.001) and duct ectasia (p = 0.002).

Table 3. Mean Age Across Histopathological Subtypes

4. Association Between Clinical Features and Histological Diagnosis

We examined the association between key clinical features—laterality, lesion size, and family history—and the histopathological subtypes of benign breast disease.

Lesion Laterality

Unilateral lesions were more frequently associated with fibroadenoma (94.4%) and mastitis (91.7%), while bilateral lesions were relatively more common in patients with fibrocystic changes (21.4%). Chi-square analysis revealed a significant association between laterality and lesion type (χ² = 10.32, p = 0.035).

Lesion Size

The mean lesion size varied across subtypes: it was highest in patients with fibroadenoma (3.1 ± 1.0 cm) and lowest in those with adenosis (1.5 ± 0.6 cm). One-way ANOVA confirmed a statistically significant difference in lesion size among subtypes (F = 4.67, p = 0.001).

Family History

A positive family history was observed in 22.2% of patients with fibrocystic changes and 12.9% with fibroadenoma. However, no statistically significant association was found between family history and lesion type (p = 0.216).

Table 4. Association Between Clinical Features and Histopathological Diagnosis

* Statistically significant (p < 0.05)

5. Predictors of Common Benign Lesions: A Multivariate Analysis

A binary logistic regression model was employed to identify independent clinical predictors for the two most prevalent histopathological diagnoses—fibroadenoma and fibrocystic changes—using age, lesion size, symptom duration, and family history as covariates.

Fibroadenoma

After adjustment, younger age (adjusted OR: 1.14; 95% CI: 1.06–1.23; p < 0.001) and larger lesion size (adjusted OR: 1.52; 95% CI: 1.10–2.10; p = 0.013) were significantly associated with a higher likelihood of fibroadenoma diagnosis. Family history and symptom duration did not show statistical significance in the model.

Fibrocystic Changes

In contrast, older age (adjusted OR: 1.08; 95% CI: 1.01–1.16; p = 0.027) was an independent predictor of fibrocystic changes, while lesion size and other variables were not significantly associated.

Table 5. Logistic Regression Model for Predicting Fibroadenoma and Fibrocystic Changes

Figure 2. Forest Plot of Multivariate Predictors for Benign Breast Lesions

Forest plot illustrating the adjusted odds ratios (aORs) with 95% confidence intervals for key clinical predictors of fibroadenoma and fibrocystic changes. Age and lesion size were independently associated with fibroadenoma, while age was the only significant predictor for fibrocystic changes. The vertical dashed line represents the null value (OR = 1.0).

This prospective observational study explored the clinicopathological spectrum of benign breast diseases (BBDs) in 120 women over two years at TRR Institute of Medical Sciences. Consistent with global epidemiological data, fibroadenoma (45%) was the most common lesion, followed by fibrocystic changes (23.3%) and duct ectasia. These findings are consistent with earlier studies by Goehring and Morabia [6], Kotepui et al. [7], and Cheng et al. [8], which collectively highlight the predominance of fibroadenoma in younger women and the diversity of BBD presentations across populations.

We observed clear age-related trends: fibroadenoma was most prevalent among women in their 20s, whereas fibrocystic changes and duct ectasia appeared more frequently in older age groups. These findings parallel those by Kapoor et al. [9] and Olu-Eddo & Ugiagbe [10], who emphasized the youth-skewed distribution of fibroadenoma. Kotepui et al. [7] notably quantified this age disparity, attributing an 8.6-fold higher odds of breast cancer in women over 40, further reinforcing the age-stratified risk landscape of breast lesions.

Statistical analyses supported these clinical trends. The mean age differed significantly among lesion types (ANOVA F = 19.87; p < 0.001), with post hoc analysis confirming younger age in fibroadenoma patients (Tukey p < 0.001 vs. fibrocystic change; p = 0.002 vs. duct ectasia). Lesion laterality was significantly associated with histopathological subtype (χ² = 10.32; p = 0.035), with fibroadenoma and mastitis more often presenting unilaterally. Lesion size also varied significantly by subtype (ANOVA F = 4.67; p = 0.001), while family history did not show a statistically significant association (p = 0.216).

Multivariate logistic regression confirmed that younger age (adjusted OR: 1.14; 95% CI: 1.06–1.23; p < 0.001) and larger lesion size (adjusted OR: 1.52; 95% CI: 1.10–2.10; p = 0.013) independently predicted fibroadenoma diagnosis. Conversely, age alone was a significant predictor of fibrocystic change (adjusted OR: 1.08; 95% CI: 1.01–1.16; p = 0.027). These findings support the concept that clinical-demographic parameters can effectively stratify lesion type without immediate need for invasive diagnostics, particularly relevant in resource-limited settings.

Our results affirm the established progression models in breast pathology, including the multistep carcinogenesis hypothesis described by Shaaban et al. [11], which emphasizes the need to classify high-risk benign lesions for long-term monitoring. Additionally, epidemiological reviews by Boyd et al. [12] and Sangma et al. [13] highlight how lesion type correlates with mammographic features and future risk—adding relevance to our findings for primary care and radiological triage. Finally, Guray and Sahin [14] provide a valuable clinical framework for classification and management, aligning with our approach to distinguishing benign subtypes via symptomatology and basic clinical parameters.

Limitations

This study was conducted at a single tertiary care centre, which may limit its generalizability. The sample size, while adequate for identifying common benign breast lesions, constrained analysis of rarer subtypes. Additionally, factors such as ethnicity, imaging characteristics, and long-term outcomes were not evaluated, warranting further multicentre and longitudinal research.

Benign breast diseases present with diverse histopathological and clinical profiles, with fibroadenoma and fibrocystic changes being the most prevalent subtypes. Younger age and larger lesion size emerged as strong independent predictors for fibroadenoma, while fibrocystic changes were more common in older patients. Integrating age and lesion size into diagnostic workflows may aid in early stratification, especially in resource-limited settings, facilitating targeted diagnostic and therapeutic decisions

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