Interim results from the FibroAdenoma Cryoablation Treatment Registry

Jacobo Nurko, Charles D. Mabry, Pat Whitworth, Daleela Dodge, Lori Oetting, Theodore Potruch, Linda Han, Michael J. Edwards

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Abstract

Objective: The aim of this prospective study was to assess the intermediate- (6 months) and longer-term (12 months) follow-up of patients with breast fibroadenomas treated by cryoablation in community-based practice settings. Methods: The FibroAdenoma Cryoablation Treatment (FACT) registry was created to systematically collect procedural and follow-up data for patients with fibroadenomas treated by cryoablation without subsequent excision. This report summarizes the experience from 55 different practice settings across the United States. Baseline and follow-up clinical data at 6 months and 12 months were tabulated for all patients. Results: Data from 444 treated fibroadenomas were analyzed. The mean tumor diameter was 1.8 cm. Before cryoablation, 75% of fibroadenomas were palpable by the patient. Follow-up at 6- and 12-month intervals revealed palpability of the treated site in 46% and 35%, respectively. When fibroadenomas were grouped by size, for lesions ≤2 cm, residual cryoablation induce changes were visible by ultrasound in 35% of patients at 6 months. The treatment area was palpable in 31% of cases at this time. Visibility by ultrasound was 27%, and palpability was 28% at 12 months follow-up in these patients with smaller fibroadenomas. For lesions >2 cm, residual cryoablation induce changes were visible by ultrasound in 39% of the patients at 6 months. The treatment area was palpable in 78% of the cases at the same time. Visibility by ultrasound was 32%, and palpability was 59% at 12 months follow-up. Patient satisfaction with the procedure was rated as high at 91% and 88% at 6 and 12 months follow-up, respectively. Conclusions: Before implementing this technique, patients should be apprised of the likely persistence of a palpable mass of the treated site for a prolonged period that will reabsorb over time. Palpability of the treated site persists for a substantially longer period of time for lesions greater than 2 cm in diameter. For patients with a fibroadenoma smaller than 2 cm, complete resolution can be expected in two thirds and three quarters of the patients at 6 and 12 months, respectively. We will continue to follow these patients to better define the length of time and factors influencing the resolution of the treatment induced physical and radiographic findings.

Original languageEnglish (US)
Pages (from-to)647-652
Number of pages6
JournalAmerican Journal of Surgery
Volume190
Issue number4
DOIs
StatePublished - Oct 1 2005

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Fibroadenoma
Cryosurgery
Registries
Therapeutics
Patient Satisfaction
Breast

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Nurko, J., Mabry, C. D., Whitworth, P., Dodge, D., Oetting, L., Potruch, T., ... Edwards, M. J. (2005). Interim results from the FibroAdenoma Cryoablation Treatment Registry. American Journal of Surgery, 190(4), 647-652. https://doi.org/10.1016/j.amjsurg.2005.06.033
Nurko, Jacobo ; Mabry, Charles D. ; Whitworth, Pat ; Dodge, Daleela ; Oetting, Lori ; Potruch, Theodore ; Han, Linda ; Edwards, Michael J. / Interim results from the FibroAdenoma Cryoablation Treatment Registry. In: American Journal of Surgery. 2005 ; Vol. 190, No. 4. pp. 647-652.
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abstract = "Objective: The aim of this prospective study was to assess the intermediate- (6 months) and longer-term (12 months) follow-up of patients with breast fibroadenomas treated by cryoablation in community-based practice settings. Methods: The FibroAdenoma Cryoablation Treatment (FACT) registry was created to systematically collect procedural and follow-up data for patients with fibroadenomas treated by cryoablation without subsequent excision. This report summarizes the experience from 55 different practice settings across the United States. Baseline and follow-up clinical data at 6 months and 12 months were tabulated for all patients. Results: Data from 444 treated fibroadenomas were analyzed. The mean tumor diameter was 1.8 cm. Before cryoablation, 75{\%} of fibroadenomas were palpable by the patient. Follow-up at 6- and 12-month intervals revealed palpability of the treated site in 46{\%} and 35{\%}, respectively. When fibroadenomas were grouped by size, for lesions ≤2 cm, residual cryoablation induce changes were visible by ultrasound in 35{\%} of patients at 6 months. The treatment area was palpable in 31{\%} of cases at this time. Visibility by ultrasound was 27{\%}, and palpability was 28{\%} at 12 months follow-up in these patients with smaller fibroadenomas. For lesions >2 cm, residual cryoablation induce changes were visible by ultrasound in 39{\%} of the patients at 6 months. The treatment area was palpable in 78{\%} of the cases at the same time. Visibility by ultrasound was 32{\%}, and palpability was 59{\%} at 12 months follow-up. Patient satisfaction with the procedure was rated as high at 91{\%} and 88{\%} at 6 and 12 months follow-up, respectively. Conclusions: Before implementing this technique, patients should be apprised of the likely persistence of a palpable mass of the treated site for a prolonged period that will reabsorb over time. Palpability of the treated site persists for a substantially longer period of time for lesions greater than 2 cm in diameter. For patients with a fibroadenoma smaller than 2 cm, complete resolution can be expected in two thirds and three quarters of the patients at 6 and 12 months, respectively. We will continue to follow these patients to better define the length of time and factors influencing the resolution of the treatment induced physical and radiographic findings.",
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Nurko, J, Mabry, CD, Whitworth, P, Dodge, D, Oetting, L, Potruch, T, Han, L & Edwards, MJ 2005, 'Interim results from the FibroAdenoma Cryoablation Treatment Registry', American Journal of Surgery, vol. 190, no. 4, pp. 647-652. https://doi.org/10.1016/j.amjsurg.2005.06.033

Interim results from the FibroAdenoma Cryoablation Treatment Registry. / Nurko, Jacobo; Mabry, Charles D.; Whitworth, Pat; Dodge, Daleela; Oetting, Lori; Potruch, Theodore; Han, Linda; Edwards, Michael J.

In: American Journal of Surgery, Vol. 190, No. 4, 01.10.2005, p. 647-652.

Research output: Contribution to journalArticle

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T1 - Interim results from the FibroAdenoma Cryoablation Treatment Registry

AU - Nurko, Jacobo

AU - Mabry, Charles D.

AU - Whitworth, Pat

AU - Dodge, Daleela

AU - Oetting, Lori

AU - Potruch, Theodore

AU - Han, Linda

AU - Edwards, Michael J.

PY - 2005/10/1

Y1 - 2005/10/1

N2 - Objective: The aim of this prospective study was to assess the intermediate- (6 months) and longer-term (12 months) follow-up of patients with breast fibroadenomas treated by cryoablation in community-based practice settings. Methods: The FibroAdenoma Cryoablation Treatment (FACT) registry was created to systematically collect procedural and follow-up data for patients with fibroadenomas treated by cryoablation without subsequent excision. This report summarizes the experience from 55 different practice settings across the United States. Baseline and follow-up clinical data at 6 months and 12 months were tabulated for all patients. Results: Data from 444 treated fibroadenomas were analyzed. The mean tumor diameter was 1.8 cm. Before cryoablation, 75% of fibroadenomas were palpable by the patient. Follow-up at 6- and 12-month intervals revealed palpability of the treated site in 46% and 35%, respectively. When fibroadenomas were grouped by size, for lesions ≤2 cm, residual cryoablation induce changes were visible by ultrasound in 35% of patients at 6 months. The treatment area was palpable in 31% of cases at this time. Visibility by ultrasound was 27%, and palpability was 28% at 12 months follow-up in these patients with smaller fibroadenomas. For lesions >2 cm, residual cryoablation induce changes were visible by ultrasound in 39% of the patients at 6 months. The treatment area was palpable in 78% of the cases at the same time. Visibility by ultrasound was 32%, and palpability was 59% at 12 months follow-up. Patient satisfaction with the procedure was rated as high at 91% and 88% at 6 and 12 months follow-up, respectively. Conclusions: Before implementing this technique, patients should be apprised of the likely persistence of a palpable mass of the treated site for a prolonged period that will reabsorb over time. Palpability of the treated site persists for a substantially longer period of time for lesions greater than 2 cm in diameter. For patients with a fibroadenoma smaller than 2 cm, complete resolution can be expected in two thirds and three quarters of the patients at 6 and 12 months, respectively. We will continue to follow these patients to better define the length of time and factors influencing the resolution of the treatment induced physical and radiographic findings.

AB - Objective: The aim of this prospective study was to assess the intermediate- (6 months) and longer-term (12 months) follow-up of patients with breast fibroadenomas treated by cryoablation in community-based practice settings. Methods: The FibroAdenoma Cryoablation Treatment (FACT) registry was created to systematically collect procedural and follow-up data for patients with fibroadenomas treated by cryoablation without subsequent excision. This report summarizes the experience from 55 different practice settings across the United States. Baseline and follow-up clinical data at 6 months and 12 months were tabulated for all patients. Results: Data from 444 treated fibroadenomas were analyzed. The mean tumor diameter was 1.8 cm. Before cryoablation, 75% of fibroadenomas were palpable by the patient. Follow-up at 6- and 12-month intervals revealed palpability of the treated site in 46% and 35%, respectively. When fibroadenomas were grouped by size, for lesions ≤2 cm, residual cryoablation induce changes were visible by ultrasound in 35% of patients at 6 months. The treatment area was palpable in 31% of cases at this time. Visibility by ultrasound was 27%, and palpability was 28% at 12 months follow-up in these patients with smaller fibroadenomas. For lesions >2 cm, residual cryoablation induce changes were visible by ultrasound in 39% of the patients at 6 months. The treatment area was palpable in 78% of the cases at the same time. Visibility by ultrasound was 32%, and palpability was 59% at 12 months follow-up. Patient satisfaction with the procedure was rated as high at 91% and 88% at 6 and 12 months follow-up, respectively. Conclusions: Before implementing this technique, patients should be apprised of the likely persistence of a palpable mass of the treated site for a prolonged period that will reabsorb over time. Palpability of the treated site persists for a substantially longer period of time for lesions greater than 2 cm in diameter. For patients with a fibroadenoma smaller than 2 cm, complete resolution can be expected in two thirds and three quarters of the patients at 6 and 12 months, respectively. We will continue to follow these patients to better define the length of time and factors influencing the resolution of the treatment induced physical and radiographic findings.

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