Cryoablation of Breast Tumors Successful in 69% of Patients With Early-Stage Disease in Phase II Trial
Cryoablation of breast tumors, which destroys lesions by exposing them to extremely low temperatures, may be a promising alternative to surgery in carefully selected women with early-stage disease, according to a study presented at the American Society of Breast Surgeons Annual Meeting in Las Vegas. In the multicenter phase II ACOSOG (Alliance) Z1072 trial of 99 patients with early-stage invasive ductal carcinoma, cryoablation resulted in complete ablation of tumor in 69% of patients overall and in 94% of patients with tumors < 1 cm, according to Rache Simmons, MD, Professor and Chief of Breast Surgery at Weill Cornell Breast Center, New York.
“A handful of studies have looked at cryoablation of breast tumors, but this is the first multicenter NIH-sponsored national trial,” Dr. Simmons said in a press briefing held in advance of the meeting.
Cryoablation is an established technique for the treatment of fibroadenomas. The modality involves the percutaneous insertion under ultrasound guidance of a cryoprobe, which destroys the lesion by means of a freeze-thaw-freeze cycle lasting about 20 minutes. Pilot studies have suggested it could also be an effective treatment for breast cancer.
Study Details
In the current study, patients underwent cryoablation and then underwent a resection so their surgical specimen could be examined for residual disease. Patients also underwent postablation magnetic resonance imaging (MRI) to evaluate its negative predictive value in determining residual disease. Successful tumor ablation was defined two ways: no remaining invasive cancer present on the pathologic examination of the targeted lesion or no residual invasive and no residual ductal carcinoma in situ present on the specimen.
Dr. Simmons reported that 69% of patients achieved complete ablation, as defined by no residual invasive ductal carcinoma or ductal carcinoma in situ. By the definition of no residual invasive disease only, the success rate was 80.5%, she reported.
Smaller Tumors, Greater Success Rate
“When we broke this down by tumor size, we showed something quite important,” Dr. Simmons added.
For tumors ≥ 1 cm, the success rate was 63%, but in those < 1 cm, it rose to 94%, “which we consider quite a success,” she said. Only one patient had some residual disease, but this was successfully revealed by MRI, indicating that the success rate is really 100%, she said.
For the whole group, MRI following the procedure predicted the disease status of 75% of patients with negative reports for both invasive ductal carcinoma or ductal carcinoma in situ and 85.9% of patients with negative pathology reports for invasive residual disease.
The findings indicated that MRI has an important role in evaluation the results after cryoablation, and could potentially be used in future trials as a surrogate for pathologic examination of the tissue, Dr. Simmons suggested.
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