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Original Article |
1 Department of Surgical Oncology, Unit 444, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030
2 Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, Michigan 48073
3 Department of Surgery, Dallas Breast Center, Dallas, Texas 75235
4 Department of Radiology Oncology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901
5 Foundation for Cancer Research and Education, Arizona Oncology Services, Scottsdale, Arizona 85260
6 Department of Surgery, Breast Care Center of the Southwest, Phoenix, Arizona 85023
7 Department of Surgery, Western Pennsylvania Hospital, Pittsburgh, Pennsylvania 15224
8 Department of Radiation Oncology, St. Louis Cancer & Breast Center, St. Louis, Missouri 63141
9 Department of Surgery, Alabama Breast Center, Montgomery, Alabama 36106
10 Department of Surgery, Sacred Heart Hospital, Allentown, Pennsylvania 18103
11 Department of Surgery, The Breast Center of Southern Arizona, Tucson, Arizona 85712
12 Department of Surgery, Nashville Breast Center, Nashville, Tennessee 37203
13 Department of Surgery, The Breast Center, Marietta, Georgia 30060
14 Synergos, Inc., The Woodlands, Texas 77380
Correspondence: Address correspondence and reprint requests to: Henry M. Kuerer, MD, PhD, FACS; E-mail: hkuerer{at}mdanderson.org.
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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Methods: From 2002 to 2004, 191 patients with DCIS were enrolled in a registry trial to assess the MammoSite applicator. Fifteen patients were excluded from analysis because of device- or patient-related factors; 7 patients were excluded after receiving a radiotherapy boost, thus leaving 169 patients available for study. Follow-up information was available for 158 patients. The average length of follow-up was 7.35 months. Forty-three patients had at least 1 year of follow-up.
Results: Skin spacing for the MammoSite applicator was as follows: < 5 mm, 3 patients (1.78%); 5 to 7 mm, 18 patients (10.65%); and 
7 mm, 148 patients (87.57%). Patients with a device-to-skin distance of 7 mm had the best cosmetic result. Patients with a device-to-skin distance of 7 mm also had a lower incidence of radiation dermatitis. Data on 43 patients who were followed up for at least 1 year confirmed these findings. Additional adverse events were primarily related to skin changes, with breast infections occurring in five patients (3.16%). No patient in the study has experienced a recurrence.
Conclusions: APBI delivered via MammoSite is well tolerated in patients with DCIS, and the lowest toxicity was obtained in patients with the greatest device-to-skin distance. Long-term follow-up data regarding patient satisfaction, cosmesis, and efficacy are needed and will be determined from a recently opened large randomized study.
Key Words: MammoSite • Radiotherapy • Breast cancer • Cosmesis
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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Accelerated partial breast irradiation (APBI) delivered with the MammoSite (Cytcy Corp., Marlborough, MA) balloon brachytherapy applicator is one such alternative radiotherapy-delivery method that has recently gained favor. The MammoSite device is technically uncomplicated to use, permits a shorter overall treatment duration, and may also provide more consistent delivery of radiotherapy to the lumpectomy cavity.3,5–8 The initial recommended eligibility criteria for MammoSite insertion was centered on five criteria established by the American Society of Breast Surgeons (ASBS): (1) age 50 years, (2) DCIS or invasive ductal cancer, (3) tumor size of 
2 cm, (4) negative surgical margins, and (5) negative axillary nodal status.9 There are two sizes of MammoSite applicator, 70 and 125 cm3, and this may limit the applicability of this technique in certain patients whose cavity size does not conform to the available applicators.9 The device can be placed at the time of operation or afterward with the aid of ultrasound guidance. Although the ideal timing of placement has not been determined, a recent study recommended postoperative placement to facilitate more appropriate patient selection based mainly on the significance of the final pathologic analysis.10 At this point, results of studies examining the utility of the MammoSite applicator have been largely favorable. Complications have been primarily associated with radiation-induced skin changes and infection, and overall cosmetic results have been good.8,11 The MammoSite device received Food and Drug Administration (FDA) approval in 2002. The follow-up data needed to determine rates of local recurrence for this method of radiotherapy delivery are still being accumulated.
Thus far, the MammoSite device has been shown to be a safe and well-tolerated means of delivering radiotherapy in patients with invasive breast cancer. The ease of use and shorter treatment duration permitted by this device may ultimately allow a larger patient population to opt for lumpectomy rather than mastectomy. This is the first prospective registry study that examined the role of the MammoSite device in patients being treated specifically for DCIS. We hypothesized that APBI delivered with the MammoSite device would be well tolerated in this patient population, with minimal local toxicity and good cosmetic outcome.
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METHODS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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Patient Population
On November 17, 2003, the ASBS assumed complete management of the Registry Trial, at which time 882 patients had been enrolled. Since assumption of the trial, an additional 537 patients have been enrolled by the ASBS.
Clinical Research Participants/Organization
Synergos, Inc., an independent full-service contract research organization not affiliated with the ASBS, the manufacturer, or any of the institutions participating in this trial, was hired to collect, manage, and analyze data for the ASBS. Synergos provides regulatory, clinical trial management; monitoring; data management; statistical analysis; and report-writing services for numerous pharmaceutical and medical device companies. After assuming management of the trial, the ASBS asked Synergos to initiate an additional follow-up protocol to verify and collect more complete information about cosmetic results, adjuvant therapy, adverse events, radiation recall reactions, disease recurrence, and patient survival. The additional data collection began in July 2004 for 1051 patients with at least one follow-up visit and has been completed for 881 (84%) of these patients.
Registry Trial Design/Patient Enrollment
All centers trained in and currently using the MammoSite device clinically were encouraged to participate in the registry trial. Information about the registry trial program was incorporated into the regional training programs for the device. At each MammoSite training session, a presentation was given on the procedure for enrolling patients in the trial and the benefits of participating. Each center attending the training program was given a registry trial program disk and encouraged to participate. A registry trial program brochure was also produced and distributed by the manufacturer that described the process and benefits of participating. Finally, a one-page newsletter detailing some of the demographic data from the registry trial program was distributed monthly to all centers (this has been continued on a quarterly basis by the ASBS).
The recruitment goals were to include as many institutions as feasible to compile a large database of patients in various clinical settings (i.e., academic, private practice, and hospital based). No site with adequate resources to complete the required data forms was denied participation in the study. Patients could be enrolled on the trial at any time (before, during, or after treatment), although enrollment before treatment was strongly encouraged.
Because data entry and processing were a continuous process for this program, a data cutoff date was chosen for this article to allow for auditing and analysis. The cutoff date for the submission of patient data for analysis was January 31, 2005. A total of 191 patients enrolled in this study had DCIS as their primary pathologic diagnosis. Of these patients, 15 were not treated with the MammoSite applicator for the following reasons: problems with cavity conformance, 4 patients; suboptimal skin distance, 4 patients; positive resection margins, 4 patients; patient preference, 1 patient; infection, 1 patient; and balloon failure, 1 patient. An additional seven patients received a boost of radiotherapy and were excluded from analysis. Thus, a total of 22 patients were excluded, thus leaving a study population of 169 patients with DCIS who received primary MammoSite-delivered APBI (Table 1
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Technical Eligibility Criteria
Recommended technical guidelines were established in the protocol to exclude the treatment of patients with inadequate device-to-skin distances, excessive cavity size, or poor balloon-cavity conformance. Patients could be enrolled before final lumpectomy to allow device placement in an open fashion during that procedure; other patients were enrolled after lumpectomy and had device placement by using a closed technique.
The final determination of suitability for high-dose-rate brachytherapy treatment was made on the basis of computed tomography findings after device placement. The parameters measured included the applicator-to-skin distance (recommended minimum of 5 mm; preferably 7 mm), the prescribed radiation dose (to conform to 1 cm around the lumpectomy cavity), and symmetry of the central catheter shaft. Computed tomography and fluoroscopic simulation were advised for treatment planning, both to determine the single dwell position in the center of the balloon and for daily confirmation of the balloon diameter. Acceptable diameters ranged from 4 to 6 cm, corresponding to fill volumes of 35 to 125 mL. The recommended radiation dose fractionation scheme was 34 Gy delivered at a point 1 cm from the surface of the balloon in 3.4-Gy fractions (twice daily separated by a minimum of 6 hours) over 5 to 7 elapsed days, with various commercially available remote high-dose-rate afterloaders.
Recommended Implantation Techniques
Guidelines for proper device implantation were provided by the manufacturer and have been summarized in a previous article.11
Data Collection/Quality Assurance
Information on patient demographics, the technical reproducibility of radiation delivery, cosmetic results, toxicity, and overall efficacy were collected on the registry trial data forms supplied to investigators. After the ASBS assumed management of the trial, additional data were collected on cosmetic results, adjuvant therapy, adverse events, radiation recall reactions, disease recurrence, and patient survival. The Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART) coding dictionary was used to classify adverse events.
All data forms were collected and reviewed by Synergos for inaccuracies, omissions, and conflicting information. Upon receipt of the data forms, a medical review was performed to ensure that none of the pertinent data were omitted or contained conflicting information. Patient data were not included in the Registry Trial until all of the information that was deemed critical was provided. Additionally, a random audit of 10% of the patient data was performed (at the request of the ASBS) to verify data accuracy. During the course of the audit, source documents (when available) were used to verify as much of the data as possible.
All patients enrolled in the study were required to give informed consent, and patients treated on or after April 14, 2003, were required to sign a Health Insurance Portability and Accountability Act agreement allowing the release of their data. Patient data submitted without an informed consent form and/or HIPAA agreement were excluded from this analysis.
Study End Points
Cosmetic Outcome
Cosmetic outcome was evaluated at each follow-up visit by the treating radiation oncologist or surgeon by using the Harvard criteria (provided in the registry trial data forms).13 The Harvard criteria used in the study compared the treated breast with the opposite (untreated) breast. An excellent cosmetic result score was assigned when the treated breast looked essentially the same as the contralateral breast (as related to radiation effects). A good cosmetic score was assigned when the treated breast had minimal but identifiable radiation effects. A fair score meant significant radiation effects were readily observable. A poor score was given for severe sequelae of breast tissue secondary to radiation effects.
Radiation Dermatitis
Radiation dermatitis events were broken down by grade and included the following: grade 1, faint erythema and dry desquamation; grade 2, brisk erythema, moist desquamation, and moderate erythema; grade 3, moist desquamation other than skin folds and bleeding from abrasion; and grade 4, necrosis or ulceration of full-thickness dermis or spontaneous bleeding from involved spot.
Infections
Events considered to be infectious included breast infection, mastitis, cellulitis, or abscess occurring at any point during follow-up. Device-related infections were those that the investigator believed to be secondary to the use of the MammoSite (no stringent criteria were established).
Late Radiation Skin Changes
Late radiation skin changes were defined as changes to the subcutaneous tissue: grade 1, slight induration (fibrosis) and loss of subcutaneous fat; grade 2, moderate fibrosis but asymptomatic, with a slight contracture, and < 10% linear reduction; grade 3, severe induration and loss of subcutaneous tissue and a field contracture > 10% of the linear measurement; and grade 4, necrosis. Regarding changes to the skin, grades were as follows: grade 1, atrophy, pigmentation, and some hair loss; grade 2, patchy atrophy and moderate telangiectasis; grade 3, marked atrophy and gross telangiectasis; and grade 4, ulceration.
Local Recurrence
A local recurrence was defined as a pathologically confirmed reappearance of cancer in the treated breast.
Statistical Methods
Standard statistical methods were used to analyze all data. The following techniques were used: descriptive statistics, Fisher’s exact test, Kruskal-Wallis test, and analysis of variance. All tests were declared statistically significant if the calculated P value was .05. All tests appear as two-sided P values. Descriptive statistics consist of numbers and percentages of responses in each category for discrete measures and of medians, minimum, and maximum values for continuous measures. Version 8.0 or higher of the SAS statistical software package (SAS Institute, Cary, NC) was used to provide all statistical analyses.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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). A total of 13 (7.69%) patients were premenopausal, 11 (6.51%) were perimenopausal, and 145 (85.80%) were post-menopausal. One hundred sixty-six (98.22%) patients had pure DCIS, whereas three (1.78%) patients had mixed DCIS/lobular carcinoma-in-situ pathology. The median DCIS size was .80 cm (range, .10–4.50 cm) according to mammography. A size determination based on mammography could not be established in 33 patients. Breast cup size was A in 7 patients (4.90%), B in 42 patients (29.37%), C in 50 patients (34.96%), and D or larger in 44 patients (30.77%). Breast cup size was unknown for 26 patients. Three patients (1.78%) had a level I axillary node dissection, and 29 patients (17.16%) had a sentinel lymph node biopsy; most patients, 137 (81.07%), had no axillary intervention. Final surgical margins were negative for 149 (88.17%) of the study patients, whereas the margins were close (<2 mm) for 17 patients (10.06%). Margins were ultimately found to be positive in three patients (1.78%). Forty-two patients (24.85%) had grade 1 DCIS, 54 patients (31.95%) had grade 2 DCIS, and 50 patients (29.59%) had grade 3 DCIS (pathologic grade could not be assessed for 23 patients [13.61%]). Thirty-two (18.93%) patients received hormonal therapy (hormonal treatment was unknown for three patients; Table 2). Follow-up information was available for 158 patients, and the average length of follow-up was 7.35 months (range, 9 days to 24 months). A subset of 43 patients had follow-up of at least 1 year. At the time of last follow-up for all 158 patients, no patient had experienced a recurrence.
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). The MammoSite was inserted via the lumpectomy scar in 23 (13.61%) patients, whereas an alternative insertion location was used in 144 patients (85.21%), and the insertion location was unknown in 2 patients (1.18%). With regard to timing of enrollment, 93 patients (55.03%) were entered in the MammoSite registry before treatment, and 69 patients (40.83%) were entered after treatment had begun; enrollment timing was not recorded for 7 patients (4.14%). The 4- to 5-cm-diameter MammoSite sphere was implanted in 153 patients (90.53%), whereas the larger 5- to 6-cm-diameter sphere was implanted in 16 patients (9.47%). Skin spacing for the device was as follows: 7 mm in 148 patients (87.57%), 5 to 7 mm in 18 patients (10.65%), and < 5 mm in 3 patients (1.78%; range, <5 to 20 mm). The median device-to-skin distance for all patients was 1.0 cm (range, .30–6.0 cm). Radiotherapy treatment regimens were delivered as follows: 165 patients (97.63%) received 34 Gy/10 fractions, 2 patients (1.18%) received 32 Gy/8 fractions, and other regimens were used for 2 patients (1.18%). With regard to removal of the MammoSite applicator, 3 patients (1.78%) required general anesthesia, 26 patients (15.38%) required local anesthesia, 3 patients (1.78%) were given oral pain medications, and 23 patients (13.61%) used an alternative form of analgesia. Most patients, 114 (67.46%), required no analgesia during MammoSite removal.
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). Out of 115 patients surveyed at 1 month after MammoSite placement, 107 patients (93.04%) had an excellent or good cosmetic result, whereas 8 patients (6.96%) were rated as having a fair or poor result. Out of 45 patients surveyed at 2 months of follow-up, 39 patients (86.67%) were rated as having an excellent or good result, whereas 6 patients (13.33%) were found to have a fair or poor result. At the last assessment (2–24 months), for each patient, from 104 patients surveyed, 98 (94.23%) had an excellent or good result, and only 6 (5.77%) were rated as having a fair or poor result.
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7-mm group, 128 patients (96.97%) were found to have excellent or good cosmetic results, whereas 4 (3.03%) patients were rated as having fair or poor outcomes. Cosmesis by skin distance was statistically significantly different between the 5- to 7-mm and 7-mm patient groups (P = .0162; patients in the <5-mm group excluded). Data available for 39 of the 43 patients who had been followed up for at least 1 year and had cosmetic-outcome data available showed the same trend for superior cosmetic results in the 7-mm patient group, although statistical significance was not achieved. Overall, these results suggest that a greater device-to-skin distance facilitates improved cosmetic outcome.
Adverse Events
A correlation between skin spacing and radiation dermatitis was noted (Table 5). In the 5- to 7-mm patient group, 9 patients (64.29%) out of 14 total experienced radiation dermatitis. Conversely, of the 142 patients with a device-to-skin distance of 7 mm, 28 patients (19.72%) experienced this complication. The incidence of radiation dermatitis between the 5- to 7-mm and 7-mm patient groups was statistically significantly different (P = .0001; patients in the < 5-mm group excluded). The same pattern of findings was seen after MammoSite treatment in the subgroup of 43 patients with at least 1 year of follow-up: rates of radiation dermatitis were 100% (6 of 6 patients) in the 5- to 7-mm patient group and 27% (10 of 37 patients) in the 7-mm patient group, (P = .0013).
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. A total of 37 (23.42%) patients seen in follow-up reported having breast pain due to radiation treatment (Table 6). Five (3.16%) patients developed a breast abscess, and 24 (15.19%) patients developed a breast seroma. Additional adverse events associated with MammoSite therapy were primarily related to breast skin changes (Table 6). These outcomes included subcutaneous tissue changes in 29 (18.35%) patients, skin contour changes in 18 (11.39%) patients, skin erythema in 17 (10.76%) patients, skin discoloration in 14 (8.86%) patients, and late radiation skin changes in 14 (8.86%) patients (13 patients had a grade 1 event reported, and 1 patient had a grade 3 event reported).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONREFERENCES |
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7 mm). APBI, given through the MammoSite device, may ultimately facilitate the potential for lumpectomy as a treatment option in appropriately selected patients with DCIS, and it may help to decrease the percentage of lumpectomy patients who are undertreated secondary to the obstacles inherent to standard radiotherapy regimens. Although more than 55,000 new cases of DCIS are diagnosed each year in the United States, there is considerable controversy regarding the appropriate algorithm for care of this disease.14 The use of radiotherapy, sentinel node biopsy, and adjuvant therapy are issues of active investigation. A major challenge to the standardization of treatment for DCIS lies in the extremely heterogeneous nature of this breast pathology.15 Although most DCIS lesions have an indolent course, certain pathologic features, such as comedo necrosis, may be harbingers of a more malignant trajectory.4 Consequently, multiple patient and tumor factors must be considered when DCIS treatment regimens are designed.2 Historically, DCIS was managed primarily by mastectomy. Over time, however, the broad implementation of mammography has permitted a greater anatomical understanding of DCIS. This has led to the use of lumpectomy, with or without radiotherapy, as an alternative treatment for the management of appropriate DCIS cases.2 Currently, there are several factors that can make standard radiotherapy regimens inaccessible to patients who may be candidates for this treatment. APBI provides an alterative means for delivering radiotherapy that could circumvent these obstacles to patient care.
The National Surgical Adjuvant Breast and Bowel Program B-17 trial demonstrated that radiotherapy after lumpectomy reduced both invasive and noninvasive breast cancer recurrence in patients initially treated for DCIS.1 Although the presence and severity of comedo necrosis was found to contribute to an increased local recurrence risk in this trial, all patient groups with DCIS who underwent lumpectomy were shown to benefit from radiotherapy.16 Nevertheless, ongoing trials continue to assess the curability of small, margin-negative DCIS lesions by primary excision alone.17 Issues with accessibility of radiotherapy, the prolonged duration of the therapeutic regimen, the cost, and the associated comorbidities of this treatment will continue to drive the need for further patient substratification regarding a rational approach to radiation treatment recommendations for patients with DCIS.18 Simultaneously, less cumbersome radiation treatment regimens may provide a more feasible, yet medically equivalent, alternative treatment for patients with DCIS who are appropriate candidates for radiotherapy.
The biological rationale for APBI stems from the observation that most in-breast recurrences are found within the region of the previous lumpectomy site. More distant in-breast recurrences are much rarer, occurring only 3% of the time.3,5,19 These findings have been consistent, despite the use of whole-breast radiotherapy, thus implying that whole-breast irradiation may essentially be overtreatment of the disease.19 Thus far, techniques for delivering partial breast irradiation include interstitial catheter-based brachytherapy, brachytherapy via implants with beads or seeds, external-beam radiotherapy, high-dose intraoperative radiotherapy, and balloon catheter–based brachytherapy. A major advantage of APBI lies in the shortened treatment time of 4 to 5 days as opposed to 5 to 6 weeks.20 Looking at patients with infiltrating ductal carcinoma, long-term follow-up data from several studies comparing high-dose catheter-based brachytherapy with standard whole-breast radiotherapy have revealed similar outcomes with regard to local recurrence and cosmesis.9 However, the difficulty of actualizing catheter-based brachytherapy, primarily as a consequence of technical intricacies, has limited the widespread use of this technique.11 Therefore, the use of alternative balloon-catheter–based treatment, specifically, MammoSite balloon brachytherapy, has been implemented.11
The controversy regarding APBI for the treatment of DCIS is centered around the variable distribution of this disease. DCIS can be extensive, and the limited circumferential cavitary delivery of approximately 1 cm of radiation treatment facilitated through APBI may not be considered sufficient in this disease setting.3 Studies of mastectomy specimens, evaluating the feasibility of lumpectomy for DCIS, indicate that the characteristic large size of these lesions would necessitate quadrantectomy for complete excision.21 Furthermore, studies of mastectomy specimens from patients with infiltrating ductal cancer and an extensive intraductal component were found to have significant amounts of additional intraductal disease when compared with patients without an extensive intraductal component.22 A recent study examining patterns of recurrence in patients with stage 0 to II disease has shown that, after 15 years of follow-up, patients treated with whole-breast radiotherapy had a significantly lower incidence of recurrence in the irradiated breast as compared with the contralateral breast. After long-term follow-up, this finding supports a benefit of whole-breast irradiation in patients with early-stage disease.23
Conversely, The Van Nuys Prognostic Index (VNPI) has been developed to aid in delineating the resectability of patients with DCIS through treatment with lumpectomy, with or without postoperative radiotherapy. The VNPI takes into account disease size and distribution within the breast, nuclear grade, presence of comedo necrosis, patient age, and margin status.24,25 By using these criteria, patients can be substratified according to their risk of local recurrence, thus guiding surgical and radiation treatment. The utility of the VNPI was recently confirmed in a study examining the relevance of additional disease biomarkers and local recurrence risk.26 Until the outcomes of long-term trials comparing local recurrence rates in patients with DCIS treated with APBI versus whole-breast radiotherapy are available, surgical and radiation treatment decisions for DCIS management should be predicated on the established histopathologic markers of the disease. Whole-breast radiotherapy is not used to eradicate gross residual disease, but primarily to control microscopic disease within the tumor bed.27 Therefore, APBI should be effectively implemented in the same scenarios as those in which standard radiotherapy is considered appropriate. Furthermore, patients with extensive DCIS or high-risk DCIS patient or tumor factors are ultimately poor candidates for lumpectomy and any radiation treatment and are best treated with mastectomy.
With regard to cosmesis and associated radiation-induced toxicity, this analysis indicated that a greater device-to-skin distance promoted improved outcomes. At the time of last follow-up, cosmetic results were considered to be excellent or good in 95.24% of patients in whom the MammoSite device was used. To date, all MammoSite studies have generally shown excellent cosmetic results associated with the device.8,11 Patients who had the greatest device-to-skin distance, 7 mm, were found to have the best cosmetic result; 96.97% of these patients had excellent or good outcomes, compared with 76.92% of patients in the 5-to 7-mm group. Although device-to- skin distance has not consistently been found to directly affect cosmesis, adequate skin spacing is imperative to ensuring proper, nontoxic radiation dose delivery to the overlying skin.8,11 It follows that adequate skin spacing in this study was also found to affect toxicity, as 64.29% of patients in the 5- to 7-mm group developed radiation dermatitis, compared with 19.72% of patients in the 7-mm group. Ultimately, these findings underscore the significance of appropriate patient selection for MammoSite treatment; patients with a device-to-skin distance of 7 mm were the best candidates for this delivery system. The remaining adverse events reported were self-limiting, and no patient required explantation of the device. One important limitation of this analysis is that only very early results regarding cosmesis and efficacy were available.
Taken together, this study demonstrated that radiotherapy delivered via the MammoSite device was well tolerated, with good cosmetic results and minimal toxicity. Optimal patients for this treatment are those with a device-to-skin distance of 7 mm. Patients with DCIS who are candidates for lumpectomy and who are selected appropriately should benefit from this treatment option as it may facilitate considerable benefits in terms of cost, convenience, and, ultimately, compliance. Given these benefits, APBI with the MammoSite device may make lumpectomy possible for some women who would otherwise have to choose mastectomy because of radiation therapy–associated barriers. Certainly, long-term follow-up of this technique in patients with DCIS will be necessary to ascertain the comparative local recurrence risk in relation to the recurrence risk after whole-breast radiation. APBI using three-dimensional conformal radiation and brachytherapy is currently being tested in a randomized trial by the National Surgical Adjuvant Breast and Bowel Project and the Radiation Therapy Oncology Group.3 As patients with DCIS, and invasive breast cancer 3 cm of all age groups are eligible to participate in this randomized study, more definitive data will be forthcoming.
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ACKNOWLEDGMENTS |
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Received for publication August 26, 2005. Accepted for publication December 20, 2005.
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  J. Godinez, E. C. Gombos, S. A. Chikarmane, G. K. Griffin, and R. L. Birdwell Breast MRI in the Evaluation of Eligibility for Accelerated Partial Breast Irradiation Am. J. Roentgenol., July 1, 2008; 191(1): 272 - 277. [Abstract] [Full Text] [PDF]
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 J. C. Boughey, R. J. Gonzalez, E. Bonner, and H. M. Kuerer Current Treatment and Clinical Trial Developments for Ductal Carcinoma In Situ of the Breast Oncologist, November 1, 2007; 12(11): 1276 - 1287. [Abstract] [Full Text] [PDF]
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