Breast Cancer Spread?

It’s not related to seeding from Savi It was the biology of tumor

Doctors did not deviate from standard of care and care provided was correct

Case Summary: The patient presented with a palpable right breast abnormality. Imaging revealed a 1.4 cm irregular hypoechoic mass. Biopsy confirmed invasive ductal carcinoma, Grade 2, ER/PR positive, HER2 negative. She underwent lumpectomy with margin re-excision; axillary nodes were negative. Shortly after surgery, she developed a dermal/epidermal recurrence at the SAVI Scout placement site. Despite local re-excision, she was found to have widely metastatic disease (mediastinal adenopathy, pulmonary lesions, and multiple osseous metastases) by August 2024. ⸻ 1. Was the dermal recurrence due to biopsy or SAVI Scout seeding? Does this represent a deviation in standard of care? • Likelihood of seeding: Tumor seeding at sites of biopsy or localization device placement has been described in the literature but remains rare. Both core needle biopsies and SAVI Scout placements theoretically introduce a risk of dislodging tumor cells into the tract or dermis. The clinical course (tumor recurrence localized to the prior device/biopsy tract) is consistent with this possibility. • Standard of care: Importantly, use of image-guided core biopsy and SAVI Scout localization represents accepted standard of care in the diagnosis and surgical management of breast cancer. The occurrence of seeding is a recognized but rare complication, not a deviation. Opinion: The recurrence could plausibly have resulted from biopsy or SAVI Scout tract seeding, but this does not represent a breach of the standard of care. ⸻ 2. Was Stage IV metastatic disease caused by biopsy/SAVI seeding, or was it likely present at initial diagnosis? • Biopsy/SAVI as cause of systemic disease: There is no evidence that biopsy tract or SAVI seeding can account for the rapid development of diffuse mediastinal, pulmonary, and skeletal metastases. These reflect systemic disease biology rather than iatrogenic dissemination. • Bone scan interpretation: A negative bone scan in April does not exclude microscopic metastases. Standard staging for early breast cancer (node-negative, ~1.4 cm mass, ER/PR+) does not require systemic staging unless there are symptoms or abnormal labs. In fact, the bone scan performed was beyond standard requirements. • Timing: The rapid appearance of multiple metastases by August strongly suggests they were present but below detection thresholds at diagnosis, rather than arising from the local recurrence. Opinion: The Stage IV disease was most likely present at the time of initial diagnosis. It cannot be attributed to biopsy or SAVI seeding. ⸻ 3. If metastases were present, why were axillary nodes negative? Several possibilities explain this: 1. Alternative drainage pathways: Medial breast tumors may preferentially drain to the internal mammary chain, bypassing axillary nodes. 2. False negative rate: Sentinel lymph node biopsy carries a recognized false-negative rate (5–10%). A small number of micrometastatic deposits could have been missed. 3. Disease biology: Hematogenous spread can occur independently of nodal involvement, particularly in biologically aggressive tumors. Opinion: Negative axillary nodes do not preclude the presence of systemic disease, particularly with medial tumors or biologically aggressive variants. ⸻ Summary Opinion • The dermal recurrence may have been related to biopsy or SAVI tract seeding, a rare but recognized complication, not a deviation from standard of care. • The systemic metastases were almost certainly present at diagnosis and are not explained by local seeding events. • Negative axillary nodes are consistent with either alternative lymphatic drainage, limitations of sentinel node biopsy, or direct hematogenous dissemination. • Overall, the treating physicians’ approach—including biopsy, SAVI Scout localization, surgery, and staging—was consistent with the standard of care.

There is biological causation for the biopsy/localization procedure and the local recurrence, less likely the metastatic disease. There is no legal causation since biopsy procedures and localization are standard of care.

Answers: 1. I don't think the recurrence was a real recurrence. It sounds like the initial cancer was not totally removed. The answers about the margins were vague. The final pathology should have a T (tumor size), N (Nodal status), Grade, Margins. I would want to see the entire report. The Savi Scout came to the surface because it was most likely NOT removed at the initial surgery which can happen in up to 30% of cases. The details provided makes me think the index cancer was not removed and continued to grow "pushing" the Savi marker to the surface. 2. The Stage IV disease is very odd. Did they biopsy the metastatic lesion to confirm there was concordance with the index lesion? A sentinel lymph node biopsy has a positive predictive value of 98% with dual tracers. However, approximately 7.2% of metastatic breast cancers "bypass" the axillary lymph nodes. Which would be odd in a low grade, Oncotype tumor (13). The case was not appropriately "worked-up" before proceeding with surgery. A 30 year old most likely has dense breast, so an MRI would have been a better option to completely evaluate both breasts to ensure there was not a second lesion. The mammaprint is not the standard of care and is very limited. The time from biopsy to surgery was delayed, 80 days. Studies have demonstrated a delay of more than 40 days on a a low-grade tumor can decrease survival and recurrence. The SAVI didn't cause the tumor to invade the epidermis. Breast caners do not "spread' at the tract of surgery or biopsy. Only renal celI carcinomas, sarcoma or gallbladder cancers 'seed' the tract. This cancer was most likely not completely excised and grew to involve the epidermis. I suspect the index cancer was not removed at the time of the surgery on May 24th or a second tumor was not identified. Even though it appeared to be a slow growing tumor, they can spread over time. The work-up was incomplete and it appears the pathology was "lacking." I suspect the index tumor was not removed or a second tumor was not seen because of the dense tissue. The entire case is concerning.

As stated above, there appears to be a lack in the work-up of this patient. No genetics, MRI, Oncotype, US of the axilla and a complete metastatic work-up. I have a large number of questions about the treatment of this patient's breast cancer. From the initial information provided, there appears to be a deviation from the standard of care.