A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma

Results from ACOSOG (Alliance) Z1072

Rache M. Simmons, Karla V. Ballman, Charles Cox, Ned Carp, Jennifer Sabol, Rosa F. Hwang, Deanna Attai, Michael Sabel, David Nathanson, Andrew Kenler, Linsey Gold, Cary Kaufman, Linda Han, Aaron Bleznak, J. Stanley Smith, Dennis Holmes, Bruno Fornage, Carisa Le-Petross, Syed Hoda, Linda McCall & 1 others Kelly K. Hunt

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Background: Cryoablation is a well-established technique to treat fibroadenomas. Pilot studies suggest this could be an effective non-surgical treatment for breast cancer. American College of Surgeons Oncology Group Z1072 is a phase II trial exploring the effectiveness of cryoablation in the treatment of breast cancers. Methods: The primary endpoint of Z1072 was the rate of complete tumor ablation, defined as no remaining invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) on pathologic examination of the targeted lesion. A secondary objective was to evaluate the negative predictive value of magnetic resonance imaging (MRI) to determine residual IBC or DCIS. Eligible patients included those with unifocal invasive ductal breast cancer ≤2 cm, with <25 % intraductal component and tumor enhancement on MRI. A total of 19 centers contributed 99 patients, of which 86 patients (87 breast cancers) were evaluable for data analysis. Results: Final pathology results, regardless of whether residual IBC/DCIS was in the targeted ablation zone or elsewhere in the breast, showed successful ablation in 66/87 (75.9 %) cancers. The 90 % confidence interval for the estimate of successful cryoablation was 67.1–83.2, with the one-sided lower-sided 90 % CI of 69.0. The negative predictive value of MRI was 81.2 % (90 % CI 71.4–88.8). When multifocal disease outside of the targeted cryoablation zone was not defined as an ablation failure, 80/87 (92 %) of the treated cancers had a successful cryoablation. Conclusion: Further studies with modifications on the Z1072 protocol could be considered to evaluate the role for cryoablation as a non-surgical treatment of early-stage breast cancer.

Original languageEnglish (US)
Pages (from-to)2438-2445
Number of pages8
JournalAnnals of Surgical Oncology
Volume23
Issue number8
DOIs
StatePublished - Aug 1 2016

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Cryosurgery
Breast Neoplasms
Carcinoma, Intraductal, Noninfiltrating
Magnetic Resonance Imaging
Therapeutics
Neoplasms
Fibroadenoma
Breast
Confidence Intervals
Pathology

All Science Journal Classification (ASJC) codes

  • Surgery
  • Oncology

Cite this

Simmons, Rache M. ; Ballman, Karla V. ; Cox, Charles ; Carp, Ned ; Sabol, Jennifer ; Hwang, Rosa F. ; Attai, Deanna ; Sabel, Michael ; Nathanson, David ; Kenler, Andrew ; Gold, Linsey ; Kaufman, Cary ; Han, Linda ; Bleznak, Aaron ; Smith, J. Stanley ; Holmes, Dennis ; Fornage, Bruno ; Le-Petross, Carisa ; Hoda, Syed ; McCall, Linda ; Hunt, Kelly K. / A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma : Results from ACOSOG (Alliance) Z1072. In: Annals of Surgical Oncology. 2016 ; Vol. 23, No. 8. pp. 2438-2445.
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title = "A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072",
abstract = "Background: Cryoablation is a well-established technique to treat fibroadenomas. Pilot studies suggest this could be an effective non-surgical treatment for breast cancer. American College of Surgeons Oncology Group Z1072 is a phase II trial exploring the effectiveness of cryoablation in the treatment of breast cancers. Methods: The primary endpoint of Z1072 was the rate of complete tumor ablation, defined as no remaining invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) on pathologic examination of the targeted lesion. A secondary objective was to evaluate the negative predictive value of magnetic resonance imaging (MRI) to determine residual IBC or DCIS. Eligible patients included those with unifocal invasive ductal breast cancer ≤2 cm, with <25 {\%} intraductal component and tumor enhancement on MRI. A total of 19 centers contributed 99 patients, of which 86 patients (87 breast cancers) were evaluable for data analysis. Results: Final pathology results, regardless of whether residual IBC/DCIS was in the targeted ablation zone or elsewhere in the breast, showed successful ablation in 66/87 (75.9 {\%}) cancers. The 90 {\%} confidence interval for the estimate of successful cryoablation was 67.1–83.2, with the one-sided lower-sided 90 {\%} CI of 69.0. The negative predictive value of MRI was 81.2 {\%} (90 {\%} CI 71.4–88.8). When multifocal disease outside of the targeted cryoablation zone was not defined as an ablation failure, 80/87 (92 {\%}) of the treated cancers had a successful cryoablation. Conclusion: Further studies with modifications on the Z1072 protocol could be considered to evaluate the role for cryoablation as a non-surgical treatment of early-stage breast cancer.",
author = "Simmons, {Rache M.} and Ballman, {Karla V.} and Charles Cox and Ned Carp and Jennifer Sabol and Hwang, {Rosa F.} and Deanna Attai and Michael Sabel and David Nathanson and Andrew Kenler and Linsey Gold and Cary Kaufman and Linda Han and Aaron Bleznak and Smith, {J. Stanley} and Dennis Holmes and Bruno Fornage and Carisa Le-Petross and Syed Hoda and Linda McCall and Hunt, {Kelly K.}",
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Simmons, RM, Ballman, KV, Cox, C, Carp, N, Sabol, J, Hwang, RF, Attai, D, Sabel, M, Nathanson, D, Kenler, A, Gold, L, Kaufman, C, Han, L, Bleznak, A, Smith, JS, Holmes, D, Fornage, B, Le-Petross, C, Hoda, S, McCall, L & Hunt, KK 2016, 'A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072', Annals of Surgical Oncology, vol. 23, no. 8, pp. 2438-2445. https://doi.org/10.1245/s10434-016-5275-3

A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma : Results from ACOSOG (Alliance) Z1072. / Simmons, Rache M.; Ballman, Karla V.; Cox, Charles; Carp, Ned; Sabol, Jennifer; Hwang, Rosa F.; Attai, Deanna; Sabel, Michael; Nathanson, David; Kenler, Andrew; Gold, Linsey; Kaufman, Cary; Han, Linda; Bleznak, Aaron; Smith, J. Stanley; Holmes, Dennis; Fornage, Bruno; Le-Petross, Carisa; Hoda, Syed; McCall, Linda; Hunt, Kelly K.

In: Annals of Surgical Oncology, Vol. 23, No. 8, 01.08.2016, p. 2438-2445.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma

T2 - Results from ACOSOG (Alliance) Z1072

AU - Simmons, Rache M.

AU - Ballman, Karla V.

AU - Cox, Charles

AU - Carp, Ned

AU - Sabol, Jennifer

AU - Hwang, Rosa F.

AU - Attai, Deanna

AU - Sabel, Michael

AU - Nathanson, David

AU - Kenler, Andrew

AU - Gold, Linsey

AU - Kaufman, Cary

AU - Han, Linda

AU - Bleznak, Aaron

AU - Smith, J. Stanley

AU - Holmes, Dennis

AU - Fornage, Bruno

AU - Le-Petross, Carisa

AU - Hoda, Syed

AU - McCall, Linda

AU - Hunt, Kelly K.

PY - 2016/8/1

Y1 - 2016/8/1

N2 - Background: Cryoablation is a well-established technique to treat fibroadenomas. Pilot studies suggest this could be an effective non-surgical treatment for breast cancer. American College of Surgeons Oncology Group Z1072 is a phase II trial exploring the effectiveness of cryoablation in the treatment of breast cancers. Methods: The primary endpoint of Z1072 was the rate of complete tumor ablation, defined as no remaining invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) on pathologic examination of the targeted lesion. A secondary objective was to evaluate the negative predictive value of magnetic resonance imaging (MRI) to determine residual IBC or DCIS. Eligible patients included those with unifocal invasive ductal breast cancer ≤2 cm, with <25 % intraductal component and tumor enhancement on MRI. A total of 19 centers contributed 99 patients, of which 86 patients (87 breast cancers) were evaluable for data analysis. Results: Final pathology results, regardless of whether residual IBC/DCIS was in the targeted ablation zone or elsewhere in the breast, showed successful ablation in 66/87 (75.9 %) cancers. The 90 % confidence interval for the estimate of successful cryoablation was 67.1–83.2, with the one-sided lower-sided 90 % CI of 69.0. The negative predictive value of MRI was 81.2 % (90 % CI 71.4–88.8). When multifocal disease outside of the targeted cryoablation zone was not defined as an ablation failure, 80/87 (92 %) of the treated cancers had a successful cryoablation. Conclusion: Further studies with modifications on the Z1072 protocol could be considered to evaluate the role for cryoablation as a non-surgical treatment of early-stage breast cancer.

AB - Background: Cryoablation is a well-established technique to treat fibroadenomas. Pilot studies suggest this could be an effective non-surgical treatment for breast cancer. American College of Surgeons Oncology Group Z1072 is a phase II trial exploring the effectiveness of cryoablation in the treatment of breast cancers. Methods: The primary endpoint of Z1072 was the rate of complete tumor ablation, defined as no remaining invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) on pathologic examination of the targeted lesion. A secondary objective was to evaluate the negative predictive value of magnetic resonance imaging (MRI) to determine residual IBC or DCIS. Eligible patients included those with unifocal invasive ductal breast cancer ≤2 cm, with <25 % intraductal component and tumor enhancement on MRI. A total of 19 centers contributed 99 patients, of which 86 patients (87 breast cancers) were evaluable for data analysis. Results: Final pathology results, regardless of whether residual IBC/DCIS was in the targeted ablation zone or elsewhere in the breast, showed successful ablation in 66/87 (75.9 %) cancers. The 90 % confidence interval for the estimate of successful cryoablation was 67.1–83.2, with the one-sided lower-sided 90 % CI of 69.0. The negative predictive value of MRI was 81.2 % (90 % CI 71.4–88.8). When multifocal disease outside of the targeted cryoablation zone was not defined as an ablation failure, 80/87 (92 %) of the treated cancers had a successful cryoablation. Conclusion: Further studies with modifications on the Z1072 protocol could be considered to evaluate the role for cryoablation as a non-surgical treatment of early-stage breast cancer.

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