Long-term results of phase ii ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial

Vicki Klimberg, Daniela Ochoa, Ronda Henry-Tillman, Matthew Hardee, Cristiano Boneti, Laura L. Adkins, Maureen McCarthy, Evan Tummel, Jeannette Lee, Sharp Malak, Issam Makhoul, Soheila Korourian

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Abstract

Background Excision followed by radiofrequency ablation (eRFA) is an intraoperative method that uses intracavitary hyperthermia to create an additional tumor-free zone around the lumpectomy cavity in breast cancer patients. We hypothesized that eRFA after lumpectomy for invasive breast cancer could reduce the need for re-excision for close margins as well as potentially maintain local control without the need for radiation. Study Design This prospective phase II institutional review board-approved study was conducted from March 2004 to April 2010. A standard lumpectomy was performed, then the RFA probe was deployed 1 cm circumferentially into the walls of the lumpectomy cavity and maintained at 100 C for 15 minutes. Validated Doppler sonography was used to intraoperatively determine adequacy of ablation. Results One hundred patients were accrued to the trial, with an average age of 65.02 years ± 10.0 years. The stages were Tis (n = 30); T1mic (n = 1); T1a (n = 9); T1b (n = 27); T1c (n = 22); T2 (n = 10); and T3 (n = 1). Grades were I (n = 48); II (n = 29); and III (n = 23). Seventy-eight subjects had margins >2 mm (negative), 22 patients had margins ≤ 2 mm, of which 12 were close and 3 focally positive, which, at our institution, would have required re-excision (only 1 patient in this group had re-excision). There were 6% postoperative complications, and 24 patients received radiation therapy (XRT). During the study mean follow-up period of 62 months ± 24 months (68-month median follow-up) in patients not treated with XRT, there were 2 in-site tumor recurrences treated with aromitase inhibitor, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy. Conclusions Long-term follow-up suggests that eRFA may reduce the need for re-excision for close or focally positive margins in breast cancer patients, and eRFA may be a valuable tool for treating favorable patients who desire lumpectomy and either cannot or do not want radiation. A multicenter trial has been initiated based on these results.

Original languageEnglish (US)
Pages (from-to)741-749
Number of pages9
JournalJournal of the American College of Surgeons
Volume218
Issue number4
DOIs
StatePublished - 2014
Externally publishedYes

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Segmental Mastectomy
Breast
Recurrence
Breast Neoplasms
Radiation
Doppler Ultrasonography
Research Ethics Committees
Mastectomy
Multicenter Studies
Neoplasms
Fever
Radiotherapy
Biopsy

ASJC Scopus subject areas

  • Surgery

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Long-term results of phase ii ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. / Klimberg, Vicki; Ochoa, Daniela; Henry-Tillman, Ronda; Hardee, Matthew; Boneti, Cristiano; Adkins, Laura L.; McCarthy, Maureen; Tummel, Evan; Lee, Jeannette; Malak, Sharp; Makhoul, Issam; Korourian, Soheila.

In: Journal of the American College of Surgeons, Vol. 218, No. 4, 2014, p. 741-749.

Research output: Contribution to journalArticle

Klimberg, V, Ochoa, D, Henry-Tillman, R, Hardee, M, Boneti, C, Adkins, LL, McCarthy, M, Tummel, E, Lee, J, Malak, S, Makhoul, I & Korourian, S 2014, 'Long-term results of phase ii ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial', Journal of the American College of Surgeons, vol. 218, no. 4, pp. 741-749. https://doi.org/10.1016/j.jamcollsurg.2013.12.032
Klimberg, Vicki ; Ochoa, Daniela ; Henry-Tillman, Ronda ; Hardee, Matthew ; Boneti, Cristiano ; Adkins, Laura L. ; McCarthy, Maureen ; Tummel, Evan ; Lee, Jeannette ; Malak, Sharp ; Makhoul, Issam ; Korourian, Soheila. / Long-term results of phase ii ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. In: Journal of the American College of Surgeons. 2014 ; Vol. 218, No. 4. pp. 741-749.
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abstract = "Background Excision followed by radiofrequency ablation (eRFA) is an intraoperative method that uses intracavitary hyperthermia to create an additional tumor-free zone around the lumpectomy cavity in breast cancer patients. We hypothesized that eRFA after lumpectomy for invasive breast cancer could reduce the need for re-excision for close margins as well as potentially maintain local control without the need for radiation. Study Design This prospective phase II institutional review board-approved study was conducted from March 2004 to April 2010. A standard lumpectomy was performed, then the RFA probe was deployed 1 cm circumferentially into the walls of the lumpectomy cavity and maintained at 100 C for 15 minutes. Validated Doppler sonography was used to intraoperatively determine adequacy of ablation. Results One hundred patients were accrued to the trial, with an average age of 65.02 years ± 10.0 years. The stages were Tis (n = 30); T1mic (n = 1); T1a (n = 9); T1b (n = 27); T1c (n = 22); T2 (n = 10); and T3 (n = 1). Grades were I (n = 48); II (n = 29); and III (n = 23). Seventy-eight subjects had margins >2 mm (negative), 22 patients had margins ≤ 2 mm, of which 12 were close and 3 focally positive, which, at our institution, would have required re-excision (only 1 patient in this group had re-excision). There were 6{\%} postoperative complications, and 24 patients received radiation therapy (XRT). During the study mean follow-up period of 62 months ± 24 months (68-month median follow-up) in patients not treated with XRT, there were 2 in-site tumor recurrences treated with aromitase inhibitor, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy. Conclusions Long-term follow-up suggests that eRFA may reduce the need for re-excision for close or focally positive margins in breast cancer patients, and eRFA may be a valuable tool for treating favorable patients who desire lumpectomy and either cannot or do not want radiation. A multicenter trial has been initiated based on these results.",
author = "Vicki Klimberg and Daniela Ochoa and Ronda Henry-Tillman and Matthew Hardee and Cristiano Boneti and Adkins, {Laura L.} and Maureen McCarthy and Evan Tummel and Jeannette Lee and Sharp Malak and Issam Makhoul and Soheila Korourian",
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T1 - Long-term results of phase ii ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial

AU - Klimberg, Vicki

AU - Ochoa, Daniela

AU - Henry-Tillman, Ronda

AU - Hardee, Matthew

AU - Boneti, Cristiano

AU - Adkins, Laura L.

AU - McCarthy, Maureen

AU - Tummel, Evan

AU - Lee, Jeannette

AU - Malak, Sharp

AU - Makhoul, Issam

AU - Korourian, Soheila

PY - 2014

Y1 - 2014

N2 - Background Excision followed by radiofrequency ablation (eRFA) is an intraoperative method that uses intracavitary hyperthermia to create an additional tumor-free zone around the lumpectomy cavity in breast cancer patients. We hypothesized that eRFA after lumpectomy for invasive breast cancer could reduce the need for re-excision for close margins as well as potentially maintain local control without the need for radiation. Study Design This prospective phase II institutional review board-approved study was conducted from March 2004 to April 2010. A standard lumpectomy was performed, then the RFA probe was deployed 1 cm circumferentially into the walls of the lumpectomy cavity and maintained at 100 C for 15 minutes. Validated Doppler sonography was used to intraoperatively determine adequacy of ablation. Results One hundred patients were accrued to the trial, with an average age of 65.02 years ± 10.0 years. The stages were Tis (n = 30); T1mic (n = 1); T1a (n = 9); T1b (n = 27); T1c (n = 22); T2 (n = 10); and T3 (n = 1). Grades were I (n = 48); II (n = 29); and III (n = 23). Seventy-eight subjects had margins >2 mm (negative), 22 patients had margins ≤ 2 mm, of which 12 were close and 3 focally positive, which, at our institution, would have required re-excision (only 1 patient in this group had re-excision). There were 6% postoperative complications, and 24 patients received radiation therapy (XRT). During the study mean follow-up period of 62 months ± 24 months (68-month median follow-up) in patients not treated with XRT, there were 2 in-site tumor recurrences treated with aromitase inhibitor, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy. Conclusions Long-term follow-up suggests that eRFA may reduce the need for re-excision for close or focally positive margins in breast cancer patients, and eRFA may be a valuable tool for treating favorable patients who desire lumpectomy and either cannot or do not want radiation. A multicenter trial has been initiated based on these results.

AB - Background Excision followed by radiofrequency ablation (eRFA) is an intraoperative method that uses intracavitary hyperthermia to create an additional tumor-free zone around the lumpectomy cavity in breast cancer patients. We hypothesized that eRFA after lumpectomy for invasive breast cancer could reduce the need for re-excision for close margins as well as potentially maintain local control without the need for radiation. Study Design This prospective phase II institutional review board-approved study was conducted from March 2004 to April 2010. A standard lumpectomy was performed, then the RFA probe was deployed 1 cm circumferentially into the walls of the lumpectomy cavity and maintained at 100 C for 15 minutes. Validated Doppler sonography was used to intraoperatively determine adequacy of ablation. Results One hundred patients were accrued to the trial, with an average age of 65.02 years ± 10.0 years. The stages were Tis (n = 30); T1mic (n = 1); T1a (n = 9); T1b (n = 27); T1c (n = 22); T2 (n = 10); and T3 (n = 1). Grades were I (n = 48); II (n = 29); and III (n = 23). Seventy-eight subjects had margins >2 mm (negative), 22 patients had margins ≤ 2 mm, of which 12 were close and 3 focally positive, which, at our institution, would have required re-excision (only 1 patient in this group had re-excision). There were 6% postoperative complications, and 24 patients received radiation therapy (XRT). During the study mean follow-up period of 62 months ± 24 months (68-month median follow-up) in patients not treated with XRT, there were 2 in-site tumor recurrences treated with aromitase inhibitor, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy. Conclusions Long-term follow-up suggests that eRFA may reduce the need for re-excision for close or focally positive margins in breast cancer patients, and eRFA may be a valuable tool for treating favorable patients who desire lumpectomy and either cannot or do not want radiation. A multicenter trial has been initiated based on these results.

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