Should a palpable Breast Imaging-Reporting and Data System (BI-RADS) 3 breast lesion be biopsied?

Management of Palpable BI-RADS 3 Breast Lesions

Palpable BI-RADS 3 breast lesions should generally undergo biopsy rather than follow-up, especially if the lesion is new, enlarging, or present in high-risk patients. 1, 2

Decision Algorithm for Palpable BI-RADS 3 Lesions

Initial Assessment

• Complete diagnostic mammography/digital breast tomosynthesis (DBT) with targeted ultrasound is recommended for comprehensive evaluation 2
• Ultrasound is particularly valuable for differentiating solid masses from fluid collections (cysts) 2

Management Based on Imaging Characteristics:

1. Simple cyst on ultrasound:

   • No further workup needed 2

2. Solid mass with benign features:

   • Primary recommendation: Image-guided biopsy 1
   • Alternative (in select cases): Short-interval follow-up may be considered if ALL of the following criteria are met:
     • Mammography and clinical examination also suggest benign etiology
     • Definitive correlation between mammographic and sonographic findings
     • Not a new lesion
     • Not increasing in size (>20% in volume or diameter in 6 months)
     • Patient not high-risk
     • Patient not awaiting organ transplant
     • No synchronous cancers
     • Not trying to get pregnant
     • Patient does not have extreme anxiety 1

Evidence Supporting Biopsy for Palpable BI-RADS 3 Lesions

Historically, biopsy has been the standard recommendation for palpable solid masses, even with benign features 1. This approach is supported by several key considerations:

1. Malignancy rates in palpable BI-RADS 3 lesions:

   • While typical BI-RADS 3 lesions have <2% risk of malignancy, studies show that palpable lesions may carry higher risk 3
   • Synchronous BI-RADS 3 lesions in patients with known breast cancer have shown malignancy rates of 9.6%, significantly higher than the expected ≤2% 4

2. Special patient populations requiring biopsy:

   • High-risk patients
   • Patients awaiting organ transplant
   • Patients with known synchronous cancers
   • Patients trying to get pregnant 1

3. Imaging limitations:

   • Physical examination alone is insufficient for evaluating palpable breast masses 2
   • Inter-reader reliability of BI-RADS descriptors is only fair-moderate 5

Biopsy Technique Recommendations

• Image-guided core needle biopsy is preferred over fine needle aspiration (FNA) 2
  • Provides histologic diagnosis
  • Allows hormone-receptor testing
  • Differentiates between in situ and invasive disease
  • Sensitivity: 95-100%, Specificity: 90-100%

Follow-up After Biopsy

• If biopsy results are benign and concordant with imaging:
  • Follow-up imaging at 6-12 months to ensure stability 2
• If biopsy reveals atypia:
  • Surgical excision is recommended 2
• If biopsy reveals malignancy:
  • Proceed with definitive surgical management 1

Important Caveats

1. Pitfall to avoid: Relying solely on imaging follow-up for palpable BI-RADS 3 lesions can delay diagnosis of malignancy

2. Caution with microcalcifications: MRI has limited negative predictive value (76-97%) for evaluating mammographic microcalcifications and should not replace biopsy for these findings 6

3. Patient anxiety considerations: Biopsy may be appropriate even for probably benign lesions when it would alleviate extreme patient anxiety 1

4. Risk factors for malignancy in BI-RADS 3 lesions: Age ≥50 years, non-circumscribed margins, nonparallel orientation, and calcifications significantly increase malignancy risk 5

By following these guidelines, clinicians can ensure appropriate management of palpable BI-RADS 3 breast lesions while minimizing both unnecessary procedures and missed malignancies.