- Email: [email protected]
The use of the MammoSite balloon applicator in re-irradiation of the breast
Brachytherapy 7 (2008) 316e319
The use of the MammoSite balloon applicator in re-irradiation of the breast Mark Trombetta1,*, Thomas Julian2, Moyed Miften1, Woodrow McWilliams1, Yongbok Kim1, David Parda1 1
Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA 2 Department of Human Oncology, Allegheny General Hospital, Pittsburgh, PA
ABSTRACT
PURPOSE: To examine the feasibility of using the MammoSite brachytherapy applicator in the retreatment of the previously irradiated breast. METHODS AND MATERIALS: Between March 2004 and March 2007, three patients previously treated with external beam radiotherapy were retreated using the MammoSite brachytherapy device. Two patients were treated for an ipsilateral breast tumor recurrence after breast conservation surgery and postoperative irradiation, whereas the third patient developed an in-field breast cancer likely associated with Hodgkin’s disease mantle irradiation 27 years before. The recurrent histology of two was ductal carcinoma in situ ([DCIS] one originally presenting as infiltrating ductal carcinoma [IDC] and the other as DCIS), whereas the Hodgkin’s disease patient presented with IDC. All patients received a twice-daily tumor dose of 3400 cGy at 340 cGy/fraction. The mean maximum skin dose was 53.4% (range, 49.5e60.3%) of the prescribed dose. RESULTS: With a mean followup of 32 months, no patient developed a local recurrence. Cosmesis in all three cases as graded by the National Surgical Adjuvant Breast and Bowel Project, cosmesis criteria was excellent (Grade I) in all cases. Dosimetric calculations demonstrated that the device allows for appropriate local irradiation while sparing the previously irradiated skin of the involved breast as defined by the protocol standard. CONCLUSIONS: Use of the MammoSite device in the treatment of the previously irradiated breast is feasible and may provide adequate local control as well as acceptable cosmesis in carefully selected patients. Ó 2008 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.
Keywords:
MammoSite; Brachytherapy; Breast cancer; Retreatment; Intracavitary
Introduction Breast cancer re-developing in a previously irradiated breast presents a therapeutic dilemma. To date, the standard of care is salvage mastectomy to obtain local control while avoiding the potential consequences of re-irradiation (1e4). With the desire of many women to attempt breast conservation after local recurrence in the previously irradiated breast, we have examined the feasibility of using the MammoSite brachytherapy applicator after lumpectomy in the retreatment of the previously irradiated breast as an alternative to salvage mastectomy. Received 2 February 2008; accepted 11 June 2008. * Corresponding author. Department of Radiation Oncology, Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15212. Tel.: þ1-412-359-3400; fax: þ1-412-359-3981. E-mail address: [email protected] (M. Trombetta).
High-dose-rate brachytherapy using the MammoSite balloon applicator has been used in partial breast irradiation (PBI) for the treatment of early stage breast cancer since its approval by the Food and Drug Administration in 2002 when the reproducibility and feasibility of the applicator were demonstrated (5). The device delivers a single Ir192 source to the lumpectomy cavity using a remote afterloader that allows for linear dwell position modulation only and produces a nearly spherical dose distribution. This accelerated PBI technique reduces the treatment time to one week in contrast to the 5e7 weeks typically associated with whole breast irradiation (WBI) (6). Although the overall time is significantly reduced, the treatment is delivered in twice-daily fractions separated by a minimum of 6 h between fractions. Clinical outcome results from MammoSite high dose rate brachytherapy studies have shown comparable local control to WBI with better normal tissue sparing
1538-4721/08/$ e see front matter Ó 2008 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.brachy.2008.06.001
M. Trombetta et al. / Brachytherapy 7 (2008) 316e319
(7e9). A number of studies have demonstrated the feasibility of retreatment brachytherapy (10e12) and retreatment external beam irradiation as well (13). To the best of our knowledge, this is the first reported use of the MammoSite device in the retreatment of the previously irradiated breast.
Methods and materials Between March 2004 and March 2007, three patients previously treated with external beam radiotherapy were retreated using the MammoSite brachytherapy device (Hologic Corporation, Marlborough, MA) for early stage carcinoma of the breast. Two patients were treated for an ipsilateral breast tumor recurrence (IBTR) after breast conservation surgery and postoperative irradiation, whereas the third patient developed an in-field breast cancer likely associated with mantle irradiation and chemotherapy for stage IIA nodular sclerosing Hodgkin’s disease (NSHD) treated 27 years before. The initial course of therapy was delivered in 1976 and consisted of five cycles of MOPP (nitrogen mustard, vincristine, procarbazine, and prednisone) chemotherapy followed by full mantle field irradiation which delivered 4500 cGy at 180 cGy/fraction to the axillae and upper outer quadrants of the bilateral breasts. This patient had presented with right supraclavicular and right axillary adenopathy and developed significant right upper extremity edema and bilateral trapezial atrophy as permanent sequelae from the irradiation. The decision to offer partial breast irradiation in this woman as an alternative to mastectomy or WBI was made largely in an effort to avoid further worsening of the chronic lymphedema. The recurrent histology of the two breast cancer patients was ductal carcinoma in situ (DCIS). One patient originally presented as infiltrating ductal carcinoma (IDC), whereas the other presented as DCIS. The patient originally diagnosed with NSHD developed IDC which was suspected to be radiation and chemotherapy induced (14). One of the patients initially diagnosed with breast cancer developed an IBTR in the lower inner quadrant of the breast which was an ‘‘elsewhere’’ failure as the original site of presentation was the upper outer quadrant. The second original breast cancer patient developed an IBTR immediately adjacent to the prior tumor bed. The patient treated for Hodgkin’s disease developed breast carcinoma in the upper outer quadrant of the breast which was verified as clearly within the previously irradiated mantle field by a review of the portal images and inspection of the permanent tattoo markings given to her at the time of her NSHD radiotherapy. All patients were advised that salvage mastectomy was the standard of care; however, all expressed strong desire for breast preservation. Brachytherapy was delivered in accordance with the original MammoSite registry study parameters (9) in patients 1 and 2 (Tables 1 and 2). Patient 3 (Tables 1 and 2) was treated in accordance with the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39 protocol
317
Table 1 Patient data Patient 1 Patient 2 Patient 3 Original histology NSHD Retreatment histology IDC Previous radiotherapy dose at the 45 site of retreatment (Gy) Time from original radiotherapy (months) 328 Follow up (months) 46
DCIS DCIS 55
IDC DCIS 50.6
72 42
115 8
NSHD, nodular sclerosing Hodgkin’s disease; DCIS, ductal carcinoma in situ ; IDC, infiltrating ductal carcinoma.
guidelines for application of the MammoSite balloon (15). All patients received a tumor dose of 3400 cGy at 340 cGy per fraction with each fraction delivered twice daily separated by a minimum 6-h interval and calculated at 1.0 cm from the balloon surface. The treatment planning was performed on a commercial treatment planning system (Plato V 13.7, Nucletron B.V., Veenendaal, The Netherlands) for patients 1 and 2 using two orthogonal radiographic films. For Patient 3, a CTbased plan was generated on a different treatment planning system (BrachyVision V6.5, Varian Medical Systems, Inc., Palo Alto, CA). A single-dwell position method was used for the plan of patients 1 and 2, whereas a multiple-dwell position method was used for the plan of Patient 3. For each patient, the volume and diameter of the implanted MammoSite balloon were reported together with the minimum ballooneskin distance and the maximum skin dose.
Results With a mean follow-up of 32 months (range, 8e46 months), no patient has developed a local recurrence. Additionally, no patient developed any degree of acute reaction as scored by the Common Terminology Criteria for Adverse Events scale (CTCAE v3.0) (16). To date, there have been no chronic adverse events in any patient. All patients fit the required prescription constraints. The average minimum ballooneskin distance was 5.0 cm (range, 4.8e5.1). The mean maximum point skin dose was 181.5 cGy per fraction (range, 168.2e205.0 cGy), corresponding to a mean of 53.4% (range, 49.5e60.3%) of the prescribed dose (Table 2). Dosimetric calculations demonstrated that the device allows for appropriate local irradiation while sparing the previously irradiated skin of the involved breast as defined by the protocol standard (15). Cosmesis in all Table 2 Applicator data
Balloon volume (cc) Axial balloon diameter (cm) Minimum ballooneskin distance (cm) Maximum skin dose/fraction (Gy)
Patient 1
Patient 2
Patient 3
70 5.1 2.7 1.71
70 5.0 1.6 2.05
56.7 4.8 2.9 1.68
318
M. Trombetta et al. / Brachytherapy 7 (2008) 316e319
three cases as graded by the NSABP cosmesis criteria was grade I (Appendix 1) in all cases. Cosmesis was graded by both an attending radiation oncologist and a breast surgical oncologist (Fig. 1). Patient satisfaction was uniformly high in our study group for the device, treatment methodology, and cosmetic outcome.
Discussion Since clinical equivalence in the areas of local control and overall survival was established (17, 18), breast conservation has largely replaced mastectomy in the management of early stage carcinoma of the breast. Those patients developing a breast carcinoma in a previously irradiated breast have generally been managed by salvage mastectomy. However, in our experience, most patients faced with salvage mastectomy have retained their desire for breast preservation if at all possible. A growing body of literature suggests that salvage mastectomy may not always be required in the previously irradiated breast (10, 12, 13); however, further investigation is required before a change in the standard of care can become the norm. Issues related to body self-image and functional
sequelae have caused physicians to investigate breast preservation with lumpectomy and retreatment irradiation (10). Although interstitial multicatheter brachytherapy has been used in the retreatment of breast cancers (10e12), the literature is silent on the use of an intracavitary device such as MammoSite. Due to its unique dosimetric characteristics, high degree of patient acceptance and relative ease of use, the MammoSite system presents an attractive possible alternative to mastectomy. Furthermore, the growing body of literature surrounding the preliminary therapeutic results related to this device (6e9) further supports this exploration of feasibility. In this study, no patient suffered any short-term sequelae as measured by CTCAE v. 3.0 (16). This compares quite favorably with patients in every other interstitial or external beam cohort who were shown to develop acute sequelae ranging from Grade I through Grade III (10e13). No patient has suffered fat necrosis as documented by ultrasonography or mammography postprocedure. Additionally, no patient scored lower than NSABP Grade I (Appendix 1; Fig. 1) when long-term cosmesis was evaluated, although additional follow-up time and larger subject numbers are required. In addition, these results compare favorably to those patients treated with multicatheter therapy (10). Inherent in these data is the fact that the skin sparing requirements (5e7 mm minimum skin distance from the balloon surface) established by the original trial (6e9) and used in NSABP B-39 (15) demand strict attention to skin dose. When one considers that each of these patients had received a prior minimum dose of 4500 cGy (range, 4500e5500 cGy) skin sparing becomes even more critical.
Conclusions Use of the MammoSite applicator in the treatment of the previously irradiated breast is feasible and may provide adequate local control as well as acceptable cosmesis in carefully selected patients. Additional patient followup is necessary as are larger patient numbers before definitive conclusions can be drawn.
Appendix 1 NSABP Breast Cosmesis Grading Scale (NSABP Protocol B-39 Form COS)
Fig. 1. Patient 2 at 40 months post-retreatment. The implant site was the lower outer quadrant of the left breast just inferolateral to the nipple.
I. Excellent: when compared with the untreated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or fluid accumulation within the breast but not enough to change the appearance. II. Good: there is a slight difference in the size or shape of the treated breast compared with the opposite breast or the original appearance of the treated breast.
M. Trombetta et al. / Brachytherapy 7 (2008) 316e319
There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes only a mild change in the shape or size. III. Fair: obvious difference in the size and shape of the treated breast. This change involves one quarter or less of the breast. There can be moderate thickening or scar tissue of the skin and the breast, and there may be obvious color changes. IV. Poor: marked change in the appearance of the treated breast involving more than one quarter of the breast tissue. The skin changes may be obvious and detract from the appearance of the breast. Severe scarring and thickening of the breast, which clearly alters the appearance of the breast, may be found.
[8]
[9]
[10]
[11]
[12]
References [1] Abner AL, Recht A, Eberlein T, et al. Prognosis following salvage mastectomy for recurrence in the breast after conservative surgery and radiation therapy for early-stage breast cancer. J Clin Oncol 1993;11:44e48. [2] Salvadori B, Marubini E, Miceli R, et al. Reoperation for locally recurrent breast cancer in patients previously treated with conservative surgery. Br J Surg 1999;86:84e87. [3] Huang E, Bucholz T, Meric F, et al. Classifying local disease recurrences after breast conservation therapy based on location and histology. Cancer 2002;95:2059e2067. [4] Doyle T, Schultz D, Peters C, et al. Long-term results of local recurrence after breast conservation treatment for invasive breast cancer. Int J Radiat Oncol Biol Phys 2001;51:74e80. [5] Edmundson GK, Vicini FA, Chen PY, et al. Dosimetric characteristics of the MammoSite RTS, a new breast brachytherapy applicator. Int J Radiat Oncol Biol Phys 2002;52:1132e1139. [6] Tsai PI, Ryan M, Meek K, et al. Accelerated partial breast irradiation using the MammoSite device: early technical experience and shortterm clinical follow-up. Am Surg 2006;72:929e934. [7] Keisch M, Vicini F, Kuske RR, et al. Initial clinical experience with the MammoSite breast brachytherapy applicator in women with
[13]
[14]
[15]
[16]
[17]
[18]
319
early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys 2003;55:289e293. Benitez PR, Streeter O, Vicini F, et al. Preliminary results and evaluation of MammoSite balloon brachytherapy for partial breast irradiation for pure ductal carcinoma in situ: a phase II clinical study. Am J Surg 2006;192:427e433. Jeruss JS, Vicini FA, Beitsch PD, et al. Initial outcomes for patients treated on the American Society of Breast Surgeons MammoSite clinical trial for ductal carcinoma-in-situ of the breast. Ann Surg Oncol 2006;13:967e976. Trombetta M, Julian T, Bhandari T, et al. Breast conservation brachytherapy and interstitial radiation in the management of locally recurrent carcinoma of the breast: The Allegheny General Hospital experience. Brachytherapy 2008;7:29e36. Petrovich Z, Langholz B, Lam K, et al. Interstitial microwave hyperthermia combined with Iridium-192 radiotherapy for recurrent tumors. Am J Clin Oncol 1989;12:264e268. Hannoun-Levi JM, Houvenaeghel G, Ellis S, et al. Partial breast irradiation as second conservative treatment for local breast cancer recurrence. Int J Radiat Oncol Biol Phys 2004;60:1385e1392. Deutsch M. Repeat high-dose external beam irradiation for in-breast tumor recurrence after previous lumpectomy and whole breast irradiation. Int J Radiat Oncol Biol Phys 2002;53:687e691. Hodgson D, Koh E, Tran T, et al. Individualized estimates of second cancer risks after contemporary radiation therapy for Hodgkin’s lymphoma. Cancer 2007;110:2576e2586. Vicini FA, White J, Arthur D, et al. NSABP B-39/RTOG 0413 protocol, 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. Available at: http://www.rtog.org. Cancer Therapy Evaluation Program. Common terminology criteria for adverse events. Version 3.0, DCTD, NCI, NIH, DHHS; March 31, 2003. Available at: http://ctep.cancer.gov, Aug 9, 2006. Fisher B, Bauer M, Margolese R, et al. Five year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med 1985;312:665e673. Veronesi U, Saccozzi R, Del Vecchio M, et al. Comparing radical mastectomy with quadrantectomy, axillary dissection, and radiotherapy in patients with small cancers of the breast. N Engl J Med 1981; 305:6e11.
The use of the MammoSite balloon applicator in re-irradiation of the breast Mark Trombetta1,*, Thomas Julian2, Moyed Miften1, Woodrow McWilliams1, Yongbok Kim1, David Parda1 1
Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA 2 Department of Human Oncology, Allegheny General Hospital, Pittsburgh, PA
ABSTRACT
PURPOSE: To examine the feasibility of using the MammoSite brachytherapy applicator in the retreatment of the previously irradiated breast. METHODS AND MATERIALS: Between March 2004 and March 2007, three patients previously treated with external beam radiotherapy were retreated using the MammoSite brachytherapy device. Two patients were treated for an ipsilateral breast tumor recurrence after breast conservation surgery and postoperative irradiation, whereas the third patient developed an in-field breast cancer likely associated with Hodgkin’s disease mantle irradiation 27 years before. The recurrent histology of two was ductal carcinoma in situ ([DCIS] one originally presenting as infiltrating ductal carcinoma [IDC] and the other as DCIS), whereas the Hodgkin’s disease patient presented with IDC. All patients received a twice-daily tumor dose of 3400 cGy at 340 cGy/fraction. The mean maximum skin dose was 53.4% (range, 49.5e60.3%) of the prescribed dose. RESULTS: With a mean followup of 32 months, no patient developed a local recurrence. Cosmesis in all three cases as graded by the National Surgical Adjuvant Breast and Bowel Project, cosmesis criteria was excellent (Grade I) in all cases. Dosimetric calculations demonstrated that the device allows for appropriate local irradiation while sparing the previously irradiated skin of the involved breast as defined by the protocol standard. CONCLUSIONS: Use of the MammoSite device in the treatment of the previously irradiated breast is feasible and may provide adequate local control as well as acceptable cosmesis in carefully selected patients. Ó 2008 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.
Keywords:
MammoSite; Brachytherapy; Breast cancer; Retreatment; Intracavitary
Introduction Breast cancer re-developing in a previously irradiated breast presents a therapeutic dilemma. To date, the standard of care is salvage mastectomy to obtain local control while avoiding the potential consequences of re-irradiation (1e4). With the desire of many women to attempt breast conservation after local recurrence in the previously irradiated breast, we have examined the feasibility of using the MammoSite brachytherapy applicator after lumpectomy in the retreatment of the previously irradiated breast as an alternative to salvage mastectomy. Received 2 February 2008; accepted 11 June 2008. * Corresponding author. Department of Radiation Oncology, Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15212. Tel.: þ1-412-359-3400; fax: þ1-412-359-3981. E-mail address: [email protected] (M. Trombetta).
High-dose-rate brachytherapy using the MammoSite balloon applicator has been used in partial breast irradiation (PBI) for the treatment of early stage breast cancer since its approval by the Food and Drug Administration in 2002 when the reproducibility and feasibility of the applicator were demonstrated (5). The device delivers a single Ir192 source to the lumpectomy cavity using a remote afterloader that allows for linear dwell position modulation only and produces a nearly spherical dose distribution. This accelerated PBI technique reduces the treatment time to one week in contrast to the 5e7 weeks typically associated with whole breast irradiation (WBI) (6). Although the overall time is significantly reduced, the treatment is delivered in twice-daily fractions separated by a minimum of 6 h between fractions. Clinical outcome results from MammoSite high dose rate brachytherapy studies have shown comparable local control to WBI with better normal tissue sparing
1538-4721/08/$ e see front matter Ó 2008 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.brachy.2008.06.001
M. Trombetta et al. / Brachytherapy 7 (2008) 316e319
(7e9). A number of studies have demonstrated the feasibility of retreatment brachytherapy (10e12) and retreatment external beam irradiation as well (13). To the best of our knowledge, this is the first reported use of the MammoSite device in the retreatment of the previously irradiated breast.
Methods and materials Between March 2004 and March 2007, three patients previously treated with external beam radiotherapy were retreated using the MammoSite brachytherapy device (Hologic Corporation, Marlborough, MA) for early stage carcinoma of the breast. Two patients were treated for an ipsilateral breast tumor recurrence (IBTR) after breast conservation surgery and postoperative irradiation, whereas the third patient developed an in-field breast cancer likely associated with mantle irradiation and chemotherapy for stage IIA nodular sclerosing Hodgkin’s disease (NSHD) treated 27 years before. The initial course of therapy was delivered in 1976 and consisted of five cycles of MOPP (nitrogen mustard, vincristine, procarbazine, and prednisone) chemotherapy followed by full mantle field irradiation which delivered 4500 cGy at 180 cGy/fraction to the axillae and upper outer quadrants of the bilateral breasts. This patient had presented with right supraclavicular and right axillary adenopathy and developed significant right upper extremity edema and bilateral trapezial atrophy as permanent sequelae from the irradiation. The decision to offer partial breast irradiation in this woman as an alternative to mastectomy or WBI was made largely in an effort to avoid further worsening of the chronic lymphedema. The recurrent histology of the two breast cancer patients was ductal carcinoma in situ (DCIS). One patient originally presented as infiltrating ductal carcinoma (IDC), whereas the other presented as DCIS. The patient originally diagnosed with NSHD developed IDC which was suspected to be radiation and chemotherapy induced (14). One of the patients initially diagnosed with breast cancer developed an IBTR in the lower inner quadrant of the breast which was an ‘‘elsewhere’’ failure as the original site of presentation was the upper outer quadrant. The second original breast cancer patient developed an IBTR immediately adjacent to the prior tumor bed. The patient treated for Hodgkin’s disease developed breast carcinoma in the upper outer quadrant of the breast which was verified as clearly within the previously irradiated mantle field by a review of the portal images and inspection of the permanent tattoo markings given to her at the time of her NSHD radiotherapy. All patients were advised that salvage mastectomy was the standard of care; however, all expressed strong desire for breast preservation. Brachytherapy was delivered in accordance with the original MammoSite registry study parameters (9) in patients 1 and 2 (Tables 1 and 2). Patient 3 (Tables 1 and 2) was treated in accordance with the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39 protocol
317
Table 1 Patient data Patient 1 Patient 2 Patient 3 Original histology NSHD Retreatment histology IDC Previous radiotherapy dose at the 45 site of retreatment (Gy) Time from original radiotherapy (months) 328 Follow up (months) 46
DCIS DCIS 55
IDC DCIS 50.6
72 42
115 8
NSHD, nodular sclerosing Hodgkin’s disease; DCIS, ductal carcinoma in situ ; IDC, infiltrating ductal carcinoma.
guidelines for application of the MammoSite balloon (15). All patients received a tumor dose of 3400 cGy at 340 cGy per fraction with each fraction delivered twice daily separated by a minimum 6-h interval and calculated at 1.0 cm from the balloon surface. The treatment planning was performed on a commercial treatment planning system (Plato V 13.7, Nucletron B.V., Veenendaal, The Netherlands) for patients 1 and 2 using two orthogonal radiographic films. For Patient 3, a CTbased plan was generated on a different treatment planning system (BrachyVision V6.5, Varian Medical Systems, Inc., Palo Alto, CA). A single-dwell position method was used for the plan of patients 1 and 2, whereas a multiple-dwell position method was used for the plan of Patient 3. For each patient, the volume and diameter of the implanted MammoSite balloon were reported together with the minimum ballooneskin distance and the maximum skin dose.
Results With a mean follow-up of 32 months (range, 8e46 months), no patient has developed a local recurrence. Additionally, no patient developed any degree of acute reaction as scored by the Common Terminology Criteria for Adverse Events scale (CTCAE v3.0) (16). To date, there have been no chronic adverse events in any patient. All patients fit the required prescription constraints. The average minimum ballooneskin distance was 5.0 cm (range, 4.8e5.1). The mean maximum point skin dose was 181.5 cGy per fraction (range, 168.2e205.0 cGy), corresponding to a mean of 53.4% (range, 49.5e60.3%) of the prescribed dose (Table 2). Dosimetric calculations demonstrated that the device allows for appropriate local irradiation while sparing the previously irradiated skin of the involved breast as defined by the protocol standard (15). Cosmesis in all Table 2 Applicator data
Balloon volume (cc) Axial balloon diameter (cm) Minimum ballooneskin distance (cm) Maximum skin dose/fraction (Gy)
Patient 1
Patient 2
Patient 3
70 5.1 2.7 1.71
70 5.0 1.6 2.05
56.7 4.8 2.9 1.68
318
M. Trombetta et al. / Brachytherapy 7 (2008) 316e319
three cases as graded by the NSABP cosmesis criteria was grade I (Appendix 1) in all cases. Cosmesis was graded by both an attending radiation oncologist and a breast surgical oncologist (Fig. 1). Patient satisfaction was uniformly high in our study group for the device, treatment methodology, and cosmetic outcome.
Discussion Since clinical equivalence in the areas of local control and overall survival was established (17, 18), breast conservation has largely replaced mastectomy in the management of early stage carcinoma of the breast. Those patients developing a breast carcinoma in a previously irradiated breast have generally been managed by salvage mastectomy. However, in our experience, most patients faced with salvage mastectomy have retained their desire for breast preservation if at all possible. A growing body of literature suggests that salvage mastectomy may not always be required in the previously irradiated breast (10, 12, 13); however, further investigation is required before a change in the standard of care can become the norm. Issues related to body self-image and functional
sequelae have caused physicians to investigate breast preservation with lumpectomy and retreatment irradiation (10). Although interstitial multicatheter brachytherapy has been used in the retreatment of breast cancers (10e12), the literature is silent on the use of an intracavitary device such as MammoSite. Due to its unique dosimetric characteristics, high degree of patient acceptance and relative ease of use, the MammoSite system presents an attractive possible alternative to mastectomy. Furthermore, the growing body of literature surrounding the preliminary therapeutic results related to this device (6e9) further supports this exploration of feasibility. In this study, no patient suffered any short-term sequelae as measured by CTCAE v. 3.0 (16). This compares quite favorably with patients in every other interstitial or external beam cohort who were shown to develop acute sequelae ranging from Grade I through Grade III (10e13). No patient has suffered fat necrosis as documented by ultrasonography or mammography postprocedure. Additionally, no patient scored lower than NSABP Grade I (Appendix 1; Fig. 1) when long-term cosmesis was evaluated, although additional follow-up time and larger subject numbers are required. In addition, these results compare favorably to those patients treated with multicatheter therapy (10). Inherent in these data is the fact that the skin sparing requirements (5e7 mm minimum skin distance from the balloon surface) established by the original trial (6e9) and used in NSABP B-39 (15) demand strict attention to skin dose. When one considers that each of these patients had received a prior minimum dose of 4500 cGy (range, 4500e5500 cGy) skin sparing becomes even more critical.
Conclusions Use of the MammoSite applicator in the treatment of the previously irradiated breast is feasible and may provide adequate local control as well as acceptable cosmesis in carefully selected patients. Additional patient followup is necessary as are larger patient numbers before definitive conclusions can be drawn.
Appendix 1 NSABP Breast Cosmesis Grading Scale (NSABP Protocol B-39 Form COS)
Fig. 1. Patient 2 at 40 months post-retreatment. The implant site was the lower outer quadrant of the left breast just inferolateral to the nipple.
I. Excellent: when compared with the untreated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or fluid accumulation within the breast but not enough to change the appearance. II. Good: there is a slight difference in the size or shape of the treated breast compared with the opposite breast or the original appearance of the treated breast.
M. Trombetta et al. / Brachytherapy 7 (2008) 316e319
There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes only a mild change in the shape or size. III. Fair: obvious difference in the size and shape of the treated breast. This change involves one quarter or less of the breast. There can be moderate thickening or scar tissue of the skin and the breast, and there may be obvious color changes. IV. Poor: marked change in the appearance of the treated breast involving more than one quarter of the breast tissue. The skin changes may be obvious and detract from the appearance of the breast. Severe scarring and thickening of the breast, which clearly alters the appearance of the breast, may be found.
[8]
[9]
[10]
[11]
[12]
References [1] Abner AL, Recht A, Eberlein T, et al. Prognosis following salvage mastectomy for recurrence in the breast after conservative surgery and radiation therapy for early-stage breast cancer. J Clin Oncol 1993;11:44e48. [2] Salvadori B, Marubini E, Miceli R, et al. Reoperation for locally recurrent breast cancer in patients previously treated with conservative surgery. Br J Surg 1999;86:84e87. [3] Huang E, Bucholz T, Meric F, et al. Classifying local disease recurrences after breast conservation therapy based on location and histology. Cancer 2002;95:2059e2067. [4] Doyle T, Schultz D, Peters C, et al. Long-term results of local recurrence after breast conservation treatment for invasive breast cancer. Int J Radiat Oncol Biol Phys 2001;51:74e80. [5] Edmundson GK, Vicini FA, Chen PY, et al. Dosimetric characteristics of the MammoSite RTS, a new breast brachytherapy applicator. Int J Radiat Oncol Biol Phys 2002;52:1132e1139. [6] Tsai PI, Ryan M, Meek K, et al. Accelerated partial breast irradiation using the MammoSite device: early technical experience and shortterm clinical follow-up. Am Surg 2006;72:929e934. [7] Keisch M, Vicini F, Kuske RR, et al. Initial clinical experience with the MammoSite breast brachytherapy applicator in women with
[13]
[14]
[15]
[16]
[17]
[18]
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