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Exeresis and brachytherapy as salvage treatment for local recurrence after conservative treatment for breast cancer: Results of a ten-year pilot study
covering >90% of the PTV_EVAL while limiting dose to the skin to #145% of the PD and with no limits on rib dose.2) Another improvement not mentioned in this article is the inclusion of vacuum ports on both the proximal and distal ends of the Contura MLB. The vacuum ports allow air and seroma that may be trapped between the balloon and the targeted breast tissue to be evacuated prior to treatment planning and delivery. The evacuation of air and seroma improves the dosimetric target coverage. The inability to achieve the ideal dosimetric goals in all cases with the Contura MLB demonstrates that 1 breast brachytherapy single-entry device cannot be the solution for all patient scenarios. Three single-entry
multilumen hybrid breast brachytherapy devices are now on the market: MammoSite ML, Contura MLB, and SAVI (Cianna Medical, Aliso Viejo, CA). The surgeon or radiation oncologist should not be limited to the use of a single device. Having the versatility to use any of the hybrid devices will provide the best chance of achieving optimal dosimetric coverage of the targeted breast tissue surrounding the lumpectomy cavity while minimizing the dose to normal tissues. Higher doses to the skin, chest wall, or breast tissue can result in long-term skin hyperpigmentation, telangiectasia, rib fracture, chest wall pain, or breast fibrosis. Long-term follow-up on the singleentry devices is still limited; we should try to preemptively reduce the poten-
tial risk of normal-tissue complications in the future.
Exeresis and brachytherapy as salvage treatment for local recurrence after conservative treatment for breast cancer: Results of a ten-year pilot study
sion followed by high–dose rate brachytherapy implants (30 Gy in 12 fractions over a period of 5 days). No patient was lost to follow-up. Special attention was paid to local, regional, or distant recurrences; survival; cosmesis; and early and late side effects. Results.—All patients completed treatment. During follow-up (range, 1–13 years), 8 patients presented metastases (2 regional and 6 distant) as their first site of failure, 1 had a differed local recurrence, and 1 died of the disease. Actuarial results at 10 years were as follows: local control, 89.4%; disease-free survival, 64.4%; and survival, 96.7%. Cosmetic results were satisfactory in 90.4%. No patient had Grade 3 or 4 early or late complications. Of the 11 patients followed up for at least 10 years, all but 1 still had their breast in place at the 10-year stage. Conclusions.—High–dose rate brachytherapy is a safe, effective treatment
for small-size, low-risk local recurrence after local excision in conservatively treated patients. The dose of 30 Gy of high–dose rate brachytherapy (12 fractions over a period of 5 days twice daily) was well tolerated. The excellent results support the use of breast preservation as salvage treatment in selected patients with local recurrence after conservative treatment for breast cancer.
Guix B, Lejrcegui JA, Tello JI, et al (IMOR Foundation, Barcelona, Spain; Universitat de Barcelona, Barcelona, Spain) Int J Radiat Oncol Biol Phys 78:804-810, 2010
Purpose.—To analyze the longterm results of a pilot study assessing excision and brachytherapy as salvage treatment for local recurrence after conservative treatment of breast cancer. Methods and Materials.—Between December 1990 and March 2001, 36 patients with breast-only recurrence less than 3 cm in diameter after conservative treatment for Stage I or II breast carcinoma were treated with local exci-
E. S. Bloom, MD
References 1. Brashears JH, Dragun AE, Jenrette JM. Late chest wall toxicity after MammoSite breast brachytherapy. Brachytherapy. 2009;8: 19-25. 2. NSABP Protocol B-39/RTOG Protocol 0413. A randomized phase III study of conventional Whole Breast Irradiation (WBI) versus Partial Breast Irradiation (PBI) for women with stage 0, I, or II breast cancer. http://www.rtog.org/members/ protocols/0413/0413.pdf. Accessed January 31, 2011.
With the continued success of accelerated partial breast irradiation and improvements in other partial breast treatment techniques, several groups have now reported on repeat lumpectomy followed by partial breast irradiation as an approach to continued breast preservation for patients with in-breast recurrence following initial breast conservation therapy with whole breast irradiation. The concept for this treatment approach has emerged from patients’ desire to
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avoid mastectomy (the current standard of care), data that show that the in-breast recurrence rate following repeat lumpectomy alone is excessive (19%-50%),1,2 and the concern about unacceptable toxicity following repeat whole breast irradiation. Studies of repeat lumpectomy followed by partial breast brachytherapy reveal mastectomy-free survival rates that range from 73% to 94%.1,2 Such a range in results is not unexpected, as these are small experiences from single institutions where patients were treated with various techniques over long periods of time. In this prospective, nonrandomized trial, Guix and colleagues applied appropriately conservative patient selection criteria, clear surgical principles (pathologic margin of $5 mm), target definitions, and consistent dosimetric guidelines. As a result, in-breast control rates and overall outcome were excellent and consistent with those previously published in studies that applied similar selection and treatment guidelines. This article further supports the hypothesis that repeat lumpectomy followed by partial breast irradiation may be an appropriate alternative for women who want to avoid mastectomy. Despite the excellent results presented in this article, the small numbers reported force us to hold to mastectomy as the appropriate standard of care for in-breast recurrence following breast conservation therapy as we await further study. However, the hypothesis that repeat breast conservation can be successfully delivered is now further supported and should be further studied. Stan-
190
dards of patient selection, workup, and the specifics of treatment delivery remain to be defined so as to optimize in-breast control and cosmetic outcome. Since in-breast recurrence following breast-conserving therapy is an infrequent event, a long enrollment time is required for a single-institution study; therefore, a multi-institutional protocol may provide a vehicle to accumulate necessary data in a timelier manner so this hypothesis can be fully investigated. In response, the Radiation Therapy Oncology Group recently opened RTOG 1014 ‘‘A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma.’’ The aim of this new prospective study is to answer the question of whether partial breast irradiation following repeat lumpectomy in patients with recurrence after conservative surgery and previous whole breast irradiation is effective and can provide an acceptable cosmetic outcome. For this study, the treatment technique and dose delivery scheme were chosen so that many centers could participate and toxicity would be maximally reduced through optimal dose homogeneity in association with a less-accelerated dose delivery scheme that cannot be easily achieved with brachytherapy. Therefore, patients will receive 3-dimensional conformal externalbeam partial breast radiotherapy at a dose of 1.5 Gy twice daily, for a total of 30 treatments and 45 Gy. Patients who are eligible for the study have inbreast local recurrence after previous breast-conserving surgery, have not
Breast Diseases: A Year BookÒ Quarterly Vol 22 No 2 2011
had whole breast irradiation for at least 1 year, have a recurrent tumor no larger than 3 cm, have mammographic and MRI results that reveal no evidence of multicentric disease, have undergone resection of the recurrent tumor with negative surgical margins defined as no tumor on the inked surface, and have no more than 3 positive lymph nodes, with no extracapsular extension, on axillary evaluation (if needed). The primary end points of the study are skin, breast, and chest wall toxicity. The secondary end points of the study include the in-breast control rate, rate at which mastectomy is avoided, and overall survival. We anticipate that the results of this phase II study will lead to a better understanding of this treatment approach and techniques of dose delivery that will allow further consideration of a phase III study of the management of in-breast local recurrences. D. W. Arthur, MD H. M. Kuerer, MD, PhD
References 1. Kuerer HM, Arthur DW, Haffty BG. Repeat breast-conserving surgery for in-breast local breast carcinoma recurrence: the potential role of partial breast irradiation. Cancer. 2004;100:2269-2280. 2. Chadha M, Trombetta M, Boobol S, Osborne MP. Managing a small recurrence in the previously irradiated breast. Is there a second chance for breast conservation? Oncology (Williston Park). 2009;23:933-940.
multilumen hybrid breast brachytherapy devices are now on the market: MammoSite ML, Contura MLB, and SAVI (Cianna Medical, Aliso Viejo, CA). The surgeon or radiation oncologist should not be limited to the use of a single device. Having the versatility to use any of the hybrid devices will provide the best chance of achieving optimal dosimetric coverage of the targeted breast tissue surrounding the lumpectomy cavity while minimizing the dose to normal tissues. Higher doses to the skin, chest wall, or breast tissue can result in long-term skin hyperpigmentation, telangiectasia, rib fracture, chest wall pain, or breast fibrosis. Long-term follow-up on the singleentry devices is still limited; we should try to preemptively reduce the poten-
tial risk of normal-tissue complications in the future.
Exeresis and brachytherapy as salvage treatment for local recurrence after conservative treatment for breast cancer: Results of a ten-year pilot study
sion followed by high–dose rate brachytherapy implants (30 Gy in 12 fractions over a period of 5 days). No patient was lost to follow-up. Special attention was paid to local, regional, or distant recurrences; survival; cosmesis; and early and late side effects. Results.—All patients completed treatment. During follow-up (range, 1–13 years), 8 patients presented metastases (2 regional and 6 distant) as their first site of failure, 1 had a differed local recurrence, and 1 died of the disease. Actuarial results at 10 years were as follows: local control, 89.4%; disease-free survival, 64.4%; and survival, 96.7%. Cosmetic results were satisfactory in 90.4%. No patient had Grade 3 or 4 early or late complications. Of the 11 patients followed up for at least 10 years, all but 1 still had their breast in place at the 10-year stage. Conclusions.—High–dose rate brachytherapy is a safe, effective treatment
for small-size, low-risk local recurrence after local excision in conservatively treated patients. The dose of 30 Gy of high–dose rate brachytherapy (12 fractions over a period of 5 days twice daily) was well tolerated. The excellent results support the use of breast preservation as salvage treatment in selected patients with local recurrence after conservative treatment for breast cancer.
Guix B, Lejrcegui JA, Tello JI, et al (IMOR Foundation, Barcelona, Spain; Universitat de Barcelona, Barcelona, Spain) Int J Radiat Oncol Biol Phys 78:804-810, 2010
Purpose.—To analyze the longterm results of a pilot study assessing excision and brachytherapy as salvage treatment for local recurrence after conservative treatment of breast cancer. Methods and Materials.—Between December 1990 and March 2001, 36 patients with breast-only recurrence less than 3 cm in diameter after conservative treatment for Stage I or II breast carcinoma were treated with local exci-
E. S. Bloom, MD
References 1. Brashears JH, Dragun AE, Jenrette JM. Late chest wall toxicity after MammoSite breast brachytherapy. Brachytherapy. 2009;8: 19-25. 2. NSABP Protocol B-39/RTOG Protocol 0413. A randomized phase III study of conventional Whole Breast Irradiation (WBI) versus Partial Breast Irradiation (PBI) for women with stage 0, I, or II breast cancer. http://www.rtog.org/members/ protocols/0413/0413.pdf. Accessed January 31, 2011.
With the continued success of accelerated partial breast irradiation and improvements in other partial breast treatment techniques, several groups have now reported on repeat lumpectomy followed by partial breast irradiation as an approach to continued breast preservation for patients with in-breast recurrence following initial breast conservation therapy with whole breast irradiation. The concept for this treatment approach has emerged from patients’ desire to
Breast Diseases: A Year BookÒ Quarterly Vol 22 No 2 2011
189
avoid mastectomy (the current standard of care), data that show that the in-breast recurrence rate following repeat lumpectomy alone is excessive (19%-50%),1,2 and the concern about unacceptable toxicity following repeat whole breast irradiation. Studies of repeat lumpectomy followed by partial breast brachytherapy reveal mastectomy-free survival rates that range from 73% to 94%.1,2 Such a range in results is not unexpected, as these are small experiences from single institutions where patients were treated with various techniques over long periods of time. In this prospective, nonrandomized trial, Guix and colleagues applied appropriately conservative patient selection criteria, clear surgical principles (pathologic margin of $5 mm), target definitions, and consistent dosimetric guidelines. As a result, in-breast control rates and overall outcome were excellent and consistent with those previously published in studies that applied similar selection and treatment guidelines. This article further supports the hypothesis that repeat lumpectomy followed by partial breast irradiation may be an appropriate alternative for women who want to avoid mastectomy. Despite the excellent results presented in this article, the small numbers reported force us to hold to mastectomy as the appropriate standard of care for in-breast recurrence following breast conservation therapy as we await further study. However, the hypothesis that repeat breast conservation can be successfully delivered is now further supported and should be further studied. Stan-
190
dards of patient selection, workup, and the specifics of treatment delivery remain to be defined so as to optimize in-breast control and cosmetic outcome. Since in-breast recurrence following breast-conserving therapy is an infrequent event, a long enrollment time is required for a single-institution study; therefore, a multi-institutional protocol may provide a vehicle to accumulate necessary data in a timelier manner so this hypothesis can be fully investigated. In response, the Radiation Therapy Oncology Group recently opened RTOG 1014 ‘‘A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma.’’ The aim of this new prospective study is to answer the question of whether partial breast irradiation following repeat lumpectomy in patients with recurrence after conservative surgery and previous whole breast irradiation is effective and can provide an acceptable cosmetic outcome. For this study, the treatment technique and dose delivery scheme were chosen so that many centers could participate and toxicity would be maximally reduced through optimal dose homogeneity in association with a less-accelerated dose delivery scheme that cannot be easily achieved with brachytherapy. Therefore, patients will receive 3-dimensional conformal externalbeam partial breast radiotherapy at a dose of 1.5 Gy twice daily, for a total of 30 treatments and 45 Gy. Patients who are eligible for the study have inbreast local recurrence after previous breast-conserving surgery, have not
Breast Diseases: A Year BookÒ Quarterly Vol 22 No 2 2011
had whole breast irradiation for at least 1 year, have a recurrent tumor no larger than 3 cm, have mammographic and MRI results that reveal no evidence of multicentric disease, have undergone resection of the recurrent tumor with negative surgical margins defined as no tumor on the inked surface, and have no more than 3 positive lymph nodes, with no extracapsular extension, on axillary evaluation (if needed). The primary end points of the study are skin, breast, and chest wall toxicity. The secondary end points of the study include the in-breast control rate, rate at which mastectomy is avoided, and overall survival. We anticipate that the results of this phase II study will lead to a better understanding of this treatment approach and techniques of dose delivery that will allow further consideration of a phase III study of the management of in-breast local recurrences. D. W. Arthur, MD H. M. Kuerer, MD, PhD
References 1. Kuerer HM, Arthur DW, Haffty BG. Repeat breast-conserving surgery for in-breast local breast carcinoma recurrence: the potential role of partial breast irradiation. Cancer. 2004;100:2269-2280. 2. Chadha M, Trombetta M, Boobol S, Osborne MP. Managing a small recurrence in the previously irradiated breast. Is there a second chance for breast conservation? Oncology (Williston Park). 2009;23:933-940.