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Cryosurgery of Breast Cancer

Edgar D. Staren, MD, PhD; Michael S. Sabel, MD; Louis M. Gianakakis, MS; Gregory A. Wiener, MD; Vanessa M. Hart, MD; Marie Gorski, MD; Kambiz Dowlatshahi, MD; Brian F. Corning, DVM; Michael F. Haklin; George Koukoulis, MD
Arch Surg. 1997;132(1):28-33. doi:10.1001/archsurg.1997.01430250030005.
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Objective:  To determine the feasibility and efficacy of cryosurgery of breast cancer.

Design:  In phase 1, carcinogen-induced mammary adenocarcinomas in 13 Sprague-Dawley rats were treated by cryosurgery and were then examined for histopathologic change. In phase 2, transplantable mammary adenocarcinomas in 50 DBA/IJ mice were treated by cryosurgery to determine the effect of varying tumor temperatures, and duration and number of freeze-thaw cycles on tumor viability. In phase 3, 2- to 3-cm ultrasound-monitored cryolesions were formed in the breasts of 4 dogs and 4 sheep. These animals were followed up for procedure-related complications; the histopathologic necrosis of the cryolesions were correlated with the ultrasound images. Based on the results of these experiments, ultrasound-guided cryosurgery of breast cancer was initiated in a human clinical trial.

Results:  In phase 1, a single, short-term (<7 minutes) freeze killed only tumors smaller than 1.5 cm in diameter, despite an apparent decrease to −40°C at the periphery of each tumor. In phase 2, varying the peripheral tumor temperature to as low as −70°C, using a single, shortterm (<7 minutes) freeze did not alter the results from phase 1. If the ice ball fully encompassed the tumor, however, maintaining it for at least 15 minutes achieved 100% tumor kill independent of tumor size. In phase 3, creation of a reproducible ultrasound-monitored cryolesion was facilitated when 2 freeze-thaw cycles were performed. No procedure-related complications were noted. In the human trial, 2 invasive lobular carcinomas from 1 patient were treated by cryosurgery and were negative for persistent tumor by core needle biopsy performed 4 and 12 weeks after a well-tolerated procedure.

Conclusions:  In situ breast cryosurgery has been proved to be feasible and efficacious in small and large animal studies and has been successfully performed in 1 patient with breast cancer. The results of this study suggest that ultrasound-guided cryosurgery of breast cancer warrants further investigation.Arch Surg. 1997;132:28-33


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