Low-Kilovoltage, Single-Dose Intraoperative Radiation Therapy for Breast Cancer: Results and Impact on a Multidisciplinary Breast Cancer Program

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1 Low-Kilovoltage, Single-Dose Intraoperative Radiation Therapy for Breast Cancer: Results and Impact on a Multidisciplinary Breast Cancer Program Stephen R Grobmyer, MD, FACS, Judith L Lightsey, MD, Curtis M Bryant, MD, Christiana Shaw, MD, FACS, Anamaria Yeung, MD, Niranjan Bhandare, MS, Barbara Hitchingham, RN, BSN, Edward M Copeland III, MD, FACS BACKGROUND: The Intrabeam (Carl Zeiss) brachytherapy device (IB) is an electronic brachytherapy device that can be used to deliver low energy x-rays (50 kv) to a lumpectomy cavity at the time of lumpectomy for breast cancer. Reported experience with IB for breast cancer in the United States has been extremely limited. Here we describe our experience and analyze the impact of IB on our multidisciplinary breast cancer program. STUDY DESIGN: This is a retrospective review of a prospectively collected breast cancer database. Patient characteristics, treatment characteristics, recurrence, and cosmesis were analyzed. Cost data were also analyzed to determine the impact of IB on the breast cancer program. RESULTS: Seventy-eight patients underwent 80 IB treatments in this series between November 2010 and October Most patients had invasive ductal carcinoma. Mean total operative time for patients receiving lumpectomy, sentinel node biopsy, and IB was 132 minutes (range 79 to 243 minutes). Intrabeam brachytherapy was the only adjuvant radiation required in 81% of patients, and only 15% of patients required additional operation after the index lumpectomy procedure. At 12 months of follow-up, cosmesis was good to excellent in 92% of patients. There have been no local recurrences in patients treated in this series. Intrabeam brachytherapy is associated with considerably lower costs ($1,857) than conventional whole breast radiation therapy ($9,653). CONCLUSIONS: Implementation of IB impacts treatment planning and operating room use in a multidisciplinary breast cancer program. The safety profile, ease of administration, and reduced costs of IB favor its more widespread use in selected patients with early-stage breast cancer. (J Am Coll Surg 2013;216:617e624. Ó 2013 by the American College of Surgeons) Intraoperative radiation therapy using the Intrabeam brachytherapy (IB) device (Carl Zeiss) has been shown to be an effective treatment for patients with early-stage carcinoma of the breast. 1 The IB is an electronic brachytherapy device that can be used to deliver low-energy Disclosure Information: Nothing to disclose. This work was supported by a grant from the US Health Resources and Services Administration. Presented at the Southern Surgical Association 124th Annual Meeting, Palm Beach, FL, December Received December 12, 2012; Accepted December 12, From the Section of Surgical Oncology, Cleveland Clinic, Cleveland, OH (Grobmyer), Department of Radiation Oncology (Lightsey, Bryant, Yeung, Bhandare, Hitchingham), and Department of Surgery, Division of Surgical Oncology (Shaw, Copeland), University of Florida College of Medicine, Gainesville, FL. Correspondence address: Stephen R Grobmyer, MD, FACS, Section of Surgical Oncology, Cleveland Clinic, 9500 Euclid Ave A81, Cleveland, OH grobmys@ccf.org (50 kv) x-rays to the lumpectomy cavity at the time of operation. By delivering a tumoricidal dose of radiation at the time of surgery, most patients can be safely spared from any additional adjuvant radiation therapy. Some patients will require additional radiation therapy, but at a reduced dose. 1 Intrabeam brachytherapy has been directly compared with whole breast radiation therapy in low-risk breast cancer patients in a recently published randomized trial. 1 The TARGIT-A trial was a multicenter, international trial comparing whole breast radiation therapy with risk-adapted, intraoperative radiation therapy using IB. More than 2,000 patients were enrolled in the TARGIT-A trial. At a median follow-up of 4 years, there was no statistical difference in rates of local recurrence in those patients in the IB group (1.2%) and external beam radiotherapy group (0.95%; p ¼ 0.41). 1 An updated analysis of TARGIT-A local recurrence data confirmed the noninferiority of the TARGIT ª 2013 by the American College of Surgeons ISSN /12/$36.00 Published by Elsevier Inc

2 618 Grobmyer et al Intraoperative Radiation for Breast Cancer J Am Coll Surg risk-adapted approach compared with patients treated with whole breast irradiation. 2 Most patients treated in the TARGIT-A trial were treated outside the United States, and published experience with IB for early-stage breast cancer patients in the United States is very limited. 1,3,4 Based on the results of the TARGIT-A trial, the University of Florida began offering IB treatment for early-stage breast cancer patients in Here we analyze the institutional experience with this emerging technology in the context of its impact on our multidisciplinary breast cancer program. METHODS Data on patients treated with IB for breast cancer at University of Florida (Gainesville, FL) was collected prospectively in a breast cancer database approved by the University of Florida Institutional Review Board. The time period of the study was November 2010 to October Data collected included clinical presentation, diagnosis, stage, treatment details (surgical, pathological, radiation, and medical), and recurrence. Photographs of the treated breasts were obtained and stored at follow-up visits in radiation oncology after treatment for patients in the study. All patients in this series had a preoperative bilateral breast MRI to confirm the absence of multicentric breast cancer before surgery. 5 In all patients in this series, IB was planned initially as a single-dose intraoperative treatment immediately after lumpectomy. In patients who were found to have axillary lymph node metastasis, histologically positive lumpectomy margins, or lymphovascular invasion in the lumpectomy specimen, adjuvant whole breast radiation therapy was recommended and the IB was used as a boost replacement. 6 In these circumstances, some patients elected mastectomy in lieu of margin re-excision and whole breast radiation therapy. Specimen radiographs and gross pathologic specimen analysis after margin inking in consultation with the pathology service was performed intraoperatively in all cases. 7 Intraoperative margin directed re-excision was performed based on the gross specimen analysis to reduce the rate of margin-positive lumpectomies. 7 The prescribed dose was 20 Gy to the surface of the applicator in all patients. Dose at 1 cm from the surface of the applicator ranged from 5 Gy to 7 Gy (Table 1). Intraoperative ultrasound was performed with the applicator in place in the lumpectomy cavity to ensure adequate skin spacing between the applicator and the skin, defined as 1 cm. This was achieved in all patients. Intrabeam brachytherapy was performed in each case after insuring conformity of the treatment applicator to Table 1. Treatment Characteristics Characteristics n % Applicator size, cm Dose at 1 cm, Gy 5 to to Treatment time, min Additional surgery No Yes Additional radiation therapy No Yes Chemotherapy No Yes Unknown Hormonal therapy No Yes Unknown 2 3 lumpectomy cavity and complete hemostasis in the excision cavity. The course of IB treatment was monitored by the radiation oncologist. After completion of treatment, the surgeon returned to the operative suite to remove the applicator and close the surgical wound in layers. 8 Patients were evaluated beginning 1 week postoperatively and assessment for any acute toxicity and postoperative complications was made. Patients were then assessed every 6 months for ongoing monitoring of cosmetic results and disease status. Complications were evaluated using the Radiation Therapy Oncology Group toxicity scoring system based on Common Terminology Criteria for Adverse Events, version For the purposes of this study, post-treatment cosmesis was assessed based on the achieved patient photographs using the Harvard breast cosmesis score. 10 Available photographs were assessed and scored by 4 independent observers. Estimates of costs and reimbursement information related to radiation therapy were collected and analyzed

3 Vol. 216, No. 4, April 2013 Grobmyer et al Intraoperative Radiation for Breast Cancer 619 to provide insight into the financial impact of IB on the multidisciplinary breast cancer practice. RESULTS Seventy-eight patients received intraoperative radiation therapy using IB. Two patients had bilateral breast cancer, therefore, a total of 80 IBD treatments were given during this time period. Patient characteristics are listed in Table 2. The majority of patients were older than the age of 60 years (Table 2). The majority of patients had invasive ductal carcinoma. Four patients with ductal carcinoma in situ and 3 with invasive lobular carcinoma were also treated with IB (Table 2). The majority of patients had clinical and pathological stage I disease (Table 2). One patient in this series had a history of breast augmentation and was treated with lumpectomy, sentinel node biopsy, and IB with the implant in place. A variety of applicator sizes was used, ranging in diameter from 3.5 cm to 5 cm; the most common applicator sizes used were 4.0 cm and 4.5 cm (Table 1). Actual IB treatment time ranged from 20 minutes to 53 minutes and varied with the size of the applicator used; this does not include lumpectomy cavity preparation time and device setup. Median total operative time (incision to wound closure) including lumpectomy with intraoperative margin analysis, node sampling and frozen section, IB setup, cavity preparation, and intraoperative ultrasound and treatment for patients in this series was 132 minutes (range 79 to 243 minutes). Most patients (n ¼ 68 [85%]) required no additional surgery after the initial procedure and IB. Twelve patients (15%) underwent additional surgery; mastectomy (n ¼ 4); and margin re-excision (n ¼ 8).Most patients were treated with adjuvant hormonal therapy, but not chemotherapy (Table 1). The majority of complications and acute toxicities were either grade 1 or 2 using the Radiation Therapy Oncology Group toxicity scoring system. There were no grade 3 complications and only 1 grade 4 complication (Table 3). Seromas developed in several patients during the early postoperative period. The majority of thesewereasymptomaticandresolvedwithin4to6 months. Only 4 (5%) patients required one aspiration of seroma for symptomatic relief. No patient required multiple aspirations of a breast seroma. There were 3 cases (4%) of breast cellulitis managed with antibiotics. Two patients had some mild erythema of the skin of the breast at their initial follow-up evaluation, which resolved without additional treatment within 6 weeks of their surgery. The grade 4 complication was a patient who was noted to have ulceration of the skin of the right Table 2. Patient Characteristics Characteristics n % Age, y Younger than to to or older Ethnicity White Black Hispanic Asian Other Laterality Left Right Histology DCIS 4 5 Invasive ductal Invasive lobular 3 4 Other 4 5 Clinical stage IA IIA Recurrent 1 1 Pathological stage IA IB 3 4 IIA 9 11 Other* 3 4 Hormone receptor status ER/PRþ ER/PR 7 9 NR 1 1 Her2/neu status Positive Negative NR 4 5 *Stage IIB, 1; IIIA, 2. DCIS, ductal carcinoma in situ; ER/PR, estrogen receptor/progesterone receptor; NR, not reported. breast 3 weeks after lumpectomy and IB treatment. This was an elderly patient who had been treated with breastconserving surgery and whole breast radiation therapy 16 years earlier and a small recurrent breast cancer developed in the ipsilateral breast. The ulceration resolved within 5 weeks post-ib treatment without additional intervention.

4 620 Grobmyer et al Intraoperative Radiation for Breast Cancer J Am Coll Surg Table 3. Complications (Radiation Therapy Oncology Group Toxicity Scoring) in Patients in Series Complications n % Seroma Grade Grade Dermatitis Grade Grade Infection Grade Grade Fibrosis grade Median follow-up interval is 12.5 months (range 6 weeks to 23 months). After a median follow-up of 12.5 months, there have been no local or regional recurrences. Metastatic disease to the bones developed in 1 patient within 1 year of diagnosis. This patient was found to have a positive sentinel lymph node and did receive an axillary lymph node dissection, which revealed an additional 3 of 8 lymph nodes positive for metastatic disease. She received additional radiation therapy in the form of whole breast radiation therapy and peripheral lymphatic irradiation. She refused chemotherapy but did receive hormonal therapy. She is currently alive with disease. All other patients are alive with no evidence of disease. Cosmesis was assessed at each follow-up visit and through the use of photographs. Thirty-one patients were eligible for cosmesis assessment by having photographs obtained from at least two different time periods. The photographs were scored using the Harvard Cosmesis Scale. 10 The majority of patients had good to excellent cosmesis at all time points (Table 4). Cosmesis tended to improve with increasing follow-up time from the lumpectomy and IB treatment (Table 4). The only factor associated with increased risk of having a fair or poor cosmesis was the addition of whole breast radiotherapy (data not shown). Intrabeam brachytherapy is associated with increased operating room time and its associated expenses. Estimated direct costs/collections (facility plus professional) for IB treatment are decreased substantially compared with other forms of adjuvant radiation therapy after lumpectomy for early-stage breast cancer: IB treatment, $1,857/$3,094; conventional whole breast irradiation, $9,653/$16,778; and interstitial balloon brachytherapy, $18,895/$25,011. The cost of the additional operating time and the opportunity cost of reduced operating room throughput is also a consideration. Actual operating room costs have been estimated to be $15 to $20 per minute, excluding physician professional fees for basic surgical cases, and are considerably higher for more complex surgical cases. 11 DISCUSSION Accelerated partial breast irradiation is an emerging concept that is founded on the observation that most in-breast recurrences in patients with breast cancer occur at the site of the initial lumpectomy Partial breast irradiation is an attractive concept because it has the potential to reduce radiation to normal, nondiseased tissue and shorten the duration of treatment required without compromising outcomes. 15 Intrabeam brachytherapy is 1 of 2 primary types of intraoperative radiation therapy that have been investigated and reported in the adjuvant treatment of earlystage breast cancer. Electron intraoperative therapy is another approach to intraoperative radiation for earlystage breast cancer Both approaches reduce the need for postoperative irradiation, shortening the duration of treatment for most patients, and neither, importantly, requires CT for treatment planning. In comparison with electron intraoperative therapy, IB is easier to administer, does not require extensive tissue mobilization for treatment, and does not require room shielding. 4,18 Intrabeam brachytherapy treatment in this series was associated with no local recurrences with follow-up out to 23 months. This finding is consistent with findings reported in the international TARGIT-A trial. Intraoperative radiation therapy using IB is a welltolerated and safe technique for delivering radiation therapy to the tumor bed after breast-conserving surgery, as demonstrated in this series. Toxicity appears to be low, as demonstrated in the TARGIT-A trial. 1 Our own experience confirms the low complication rates seen in the TARGIT-A trial (Table 5). Seroma rates in this series Table 4. Cosmesis Assessment Assessment 1 Month, % (n ¼ 32) 6 Months, % (n ¼ 34) 12 Months, % (n ¼ 17) 18 Months, % (n ¼ 4) Excellent, n Good, n Fair, n Poor, n

5 Vol. 216, No. 4, April 2013 Grobmyer et al Intraoperative Radiation for Breast Cancer 621 Table 5. Comparison of Current Series with the Intraoperative Radiation Therapy Arm of TARGIT-A TARGIT-A IORT arm (n ¼ 1,113) Current series (n ¼ 80) n % n % Hematoma needing surgical evacuation Seroma needing 3 aspirations Infection needing IV antibiotics or surgical intervention Skin breakdown or delayed wound healing RTOG toxicity grade 3 or Major toxicity* *Major toxicity defined as skin breakdown or delayed wound healing and RTOG toxicity grade of 3 or 4. IORT, intraoperative radiation therapy; RTOG, Radiation Therapy Oncology Group. are very low, particularly compared with patients treated with balloon brachytherapy accelerated partial breast techniques, in which symptomatic seromas have been reported to occur in approximately 13% of cases. 19 This is likely related to the ability to reapproximate breast tissue after IB treatment. 8 The overall toxicity profile that was observed in this series of patients receiving IB treatment is in contrast to recently published data demonstrating increased complication rates with other forms of partial breast irradiation, specifically interstitial brachytherapy and balloon catheter brachytherapy. 20 It should also be noted, however, that there are several singleinstitution studies of balloon brachytherapy techniques showing acceptably low rates of acute toxicity and complications Long-term follow-up will be needed to determine if the rate of late complications in patients treated with IB treatment will be acceptably low. A study by Sperk and colleagues 24 analyzed the data from the TARGIT-A trial in terms of late toxicity. Patients receiving IB treatment only were noted to have less telangectasias and fibrosis compared with patients receiving whole breast radiation. 24 Intrabeam brachytherapy treatment is associated with reduced costs as shown in this report. To the extent that IB provides oncologic outcomes equivalent to other forms of breast irradiation, IB treatment represents an important value to the health care system. Greenup and colleagues 25 have also reported recently that accelerated partial breast irradiation is associated with substantially lower costs than whole breast irradiation. In addition, optimal application of accelerated partial breast radiation using a cost-minimization strategy would be associated with a cost savings of $5.69 million dollars per 1,000 patients treated for breast cancer. 25 Broader application of IB treatment (and other selected forms of accelerated partial breast irradiation) should be considered in efforts to increase value in delivery of breast cancer treatment. Advantages of Intrabeam intraoperative radiotherapy include its ease of use, proof of efficacy, and improved breast symptoms scores in patients treated with IB compared with conventional whole breast irradiation. 26 The radiation source emits soft x-ray radiation (maximum 50 kv) in an isotropic distribution so that, in combination with the spherical applicator, the target tissue is irradiated homogeneously. 1 Intrabeam brachytherapy requires no special shielding and can be used in any operating room, as the device is mobile. This is in contrast to the mobile linear accelerator devices that require extensive shielding and are not portable. 16 Avoidance of daily trips to a radiation oncology center is very attractive to patients, particularly those who live far from a radiation therapy facility. Distance from radiation facility has been shown to correlate with increasing rates of mastectomy compared with lumpectomy. 27,28 In this context, wider application of IB for single-dose adjuvant radiation for early-stage breast cancer has the potential to increase the use of partial mastectomy for early-stage breast cancer without compromising oncologic outcomes. Establishing an IB program for treatment of patients for early-stage breast cancer requires some special considerations. There is a need for all patients to be seen and evaluated by radiation oncology for treatment considerations before operation. Intrabeam brachytherapy treatment requires more personnel, including radiation oncology and physicists, in the operating room and their availability must be considered when scheduling cases. Additional operating time must be accounted for in treatment planning and operative scheduling. In addition, our institutional protocol requires pathology services support for intraoperative gross margin analysis to minimize the rate of margin-positive excision and subsequent need for re-excision and additional radiation therapy. 7 Our results find that IB is associated with good to excellent cosmetic results in a large majority of cases and that cosmesis improves with time. Elliot and colleagues similarly found that IB treatment was associated with good to excellent cosmesis. 4 This is likely

6 622 Grobmyer et al Intraoperative Radiation for Breast Cancer J Am Coll Surg related to minimal exposure of normal breast tissue to irradiation when IB treatment is used as a single-dose treatment after lumpectomy. CONCLUSIONS This series, which to our knowledge is the largest US single-center reported experience to date with IB, confirms the safety of IB treatment as a component of breast-conserving therapy for early-stage breast cancer. Although follow-up for patients in this series is relatively short (up to 23 months), there have been no local recurrences to date. We have demonstrated good to excellent cosmetic results associated with the use of IB. Use of IB in a multidisciplinary breast cancer program does require re-engineering of perioperative processes and operating room use, given the association with increased operating room times and requirement for additional personnel in the operating room. Costs are considerably lower with IB treatment compared with other forms of adjuvant radiotherapy for early-stage breast cancer, suggesting that IB is a valuable component of treatment for earlystage breast cancer. This report supports the continued use of IB treatment for early-stage breast cancer in the United States, particularly if long-term follow-up from the international TARGIT-A trial demonstrates IB to be equivalent to or better than whole breast irradiation for early-stage breast cancer. Author Contributions Study conception and design: Grobmyer, Lightsey, Shaw, Yeung, Copeland Acquisition of data: Grobmyer, Lightsey, Bryant, Shaw, Bhandare Analysis and interpretation of data: Grobmyer, Lightsey, Yeung, Bhandare, Hitchingham, Copeland Drafting of manuscript: Grobmyer, Lightsey, Bryant, Shaw Critical revision: Bryant, Yeung, Bhandare, Hitchingham, Copeland REFERENCES 1. Vaidya JS, Joseph DJ, Tobias JS, et al. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet 2010;376:91e Vaidya JS, Wenz F, Bulsara M, et al. Targeted intraoperative radiotherapy for early breast cancer: TARGIT-A trialdupdated analysis of local recurrence and first analysis of survival. Cancer Res Suppl 2012;72:100se101s. 3. Deneve JL, Hoefer RA Jr, Harris EE, Laronga C. Accelerated partial breast irradiation: a review and description of an early North American surgical experience with the Intrabeam delivery system. Cancer Control 2012;19:295e Elliott RL, DeLand M, Head JF, Elliott MC. Accelerated partial breast irradiation: initial experience with the Intrabeam System. Surg Oncol 2011;20:73e Grobmyer SR, Mortellaro VE, Marshall J, et al. Is there a role for routine use of MRI in selection of patients for breast-conserving cancer therapy? J Am Coll Surg 2008;206:1045e Vaidya JS, Baum M, Tobias JS, et al. Long-term results of targeted intraoperative radiotherapy (Targit) boost during breastconserving surgery. Int J Radiat Oncol Biol Phys 2011;81: 1091e Cabioglu N, Hunt KK, Sahin AA, et al. Role for intraoperative margin assessment in patients undergoing breast-conserving surgery. Ann Surg Oncol 2007;14:1458e Indelicato D, Grobmyer SR, Newlin H, et al. Association between operative closure type and acute infection, local recurrence, and disease surveillance in patients undergoing breast conserving therapy for early-stage breast cancer. Surgery 2007;141:645e Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Available at: electronic_applications/docs/ctcaev3.pdf. Accessed December 1, Rose MA, Olivotto I, Cady B, et al. Conservative surgery and radiation therapy for early breast cancer. Long-term cosmetic results. Arch Surg 1989;124:153e Macario A. What does one minute of operating room time cost? J Clin Anesth 2010;22:233e Fisher B, Anderson S, Bryant J, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med 2002;347:1233e Veronesi U, Marubini E, Mariani L, et al. Radiotherapy after breast-conserving surgery in small breast carcinoma: long-term results of a randomized trial. Ann Oncol 2001;12:997e Clark RM, Whelan T, Levine M, et al. Randomized clinical trial of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer: an update. Ontario Clinical Oncology Group. J Natl Cancer Inst 1996;88: 1659e McCormick B. Partial breast radiation for early-stage breast cancer. Curr Opinion Obstet Gynecol 2012;24:31e Orecchia R, Ciocca M, Lazzari R, et al. Intraoperative radiation therapy with electrons (ELIOT) in early-stage breast cancer. Breast 2003;12:483e Veronesi U, Orecchia R, Luini A, et al. Intraoperative radiotherapy during breast conserving surgery: a study on 1,822 cases treated with electrons. Breast Cancer Res Treat 2010;124:141e Kimple RJ, Klauber-DeMore N, Kuzmiak CM, et al. Local control following single-dose intraoperative radiotherapy prior to surgical excision of early-stage breast cancer. Ann Surg Oncol 2011;18:939e Nelson JC, Beitsch PD, Vicini FA, et al. Four-year clinical update from the American Society of Breast Surgeons MammoSite brachytherapy trial. Am J Surg 2009;198:83e Presley CJ, Soulos PR, Herrin J, et al. Patterns of use and short-term complications of breast brachytherapy in the national Medicare population from J Clin Oncol 2012;30:4302e Dragun AE, Harper JL, Jenrette JM, et al. Predictors of cosmetic outcome following MammoSite breast brachytherapy: a single-institution experience of 100 patients with two years of follow-up. Int J Radiat Oncol Biol Phys 2007;68: 354e358.

7 Vol. 216, No. 4, April 2013 Grobmyer et al Discussion Keisch M, Vicini F, Kuske RR, et al. Initial clinical experience with the MammoSite breast brachytherapy applicator in women with early-stage breast cancer treated with breastconserving therapy. Int J Radiat Oncol Biol Phys 2003;55: 289e Chao KK, Vicini FA, Wallace M, et al. Analysis of treatment efficacy, cosmesis, and toxicity using the MammoSite breast brachytherapy catheter to deliver accelerated partial-breast irradiation: the William Beaumont Hospital experience. Int J Radiat Oncol Biol Phys 2007;69:32e Sperk E, Welzel G, Keller A, et al. Late radiation toxicity after intraoperative radiotherapy (IORT) for breast cancer: results from the randomized phase III trial TARGIT A. Breast Cancer Res Treat 2012;135:253e Greenup RA, Camp MS, Taghian AG, et al. Cost comparison of radiation treatment options after lumpectomy for breast cancer. Ann Surg Oncol 2012;19:3275e Welzel G, Hofmann F, Blank E, et al. Health-related quality of life after breast-conserving surgery and intraoperative radiotherapy for breast cancer using low-kilovoltage x-rays. Ann Surg Oncol 2010;17:359e Schroen AT, Brenin DR, Kelly MD, et al. Impact of patient distance to radiation therapy on mastectomy use in earlystage breast cancer patients. J Clin Oncol 2005;23: 7074e Greenberg CC, Lipsitz SR, Hughes ME, et al. Institutional variation in the surgical treatment of breast cancer: a study of the NCCN. Ann Surg 2011;254:339e345. Discussion DR KELLY McMASTERS (Louisville, KY): I congratulate Dr Grobmyer, Dr Copeland, and colleagues for sharing with us their initial experience with intraoperative radiation therapy for breast cancer. Although the median follow-up of 12.5 months is too short to draw any conclusions about efficacy, the authors have shown that this technique is feasible and leads to cosmetically acceptable results. I have a few questions. First, it appears that your patient population consisted mainly of elderly women with small estrogen receptor-positive breast cancersd the same population that CALGB study 9343 demonstrated can be treated with tamoxifen alone and no radiation therapy. A skeptic might say that the best patients for intraoperative radiation therapy are those who don t need radiation at all. Convince us otherwise. Second, do you feel comfortable treating patients with DCIS using intraoperative radiation therapy outside of a clinical trial? Although you suggest that intraoperative radiation therapy may save money for the health care system overall, it certainly seems that it would decrease operating room efficiency and surgeon productivity. In the abstract, you say that intraoperative radiation therapy adds 1 hour to the operating room time. Do you have data on length of the operation compared with standard lumpectomy and sentinel lymph node (SLN) biopsy? Finally, based on ACOSOG trial Z11 results, the current practice for many is to perform lumpectomy, SLN biopsy, and perform no frozen section analysis of the SLN because the node-positive patients will get whole-breast radiation therapy in lieu of axillary dissection. How do you handle the node-positive patients? Do you do intraoperative SLN frozen sections or touch preparations? Do these patients get whole-breast radiation therapy? Why give intraoperative radiation therapy? DR SUZANNE KLIMBERG (Little Rock, AR): This paper paves the way for the surgeon to take control of the patient s treatment and make sure that patients get all of their treatment and decreases the overtreatment of patients with radiation, increases cosmetic outcomes, and lowers cost. Lumpectomy followed by radiation is widely used for the treatment of breast cancer. At least 75% to 90% of recurrences are at the previous lumpectomy site. Radiation effectively lowers the risk of recurrence at the site of lumpectomy but is not as important in reducing ipsilateral recurrences in the breast, giving rise to the concept of brachytherapy that treats approximately a centimeter around the tumor bed with 100% radiation dose. Excision followed by IntraBeam radiation in this way is used to destroy any undetectable residual disease. This process is designed to treat a zone at greatest risk of recurrence without damaging the normal tissue. Recent data from Whelan and colleagues demonstrated that, by 5 years after whole breast irradiation, 50% of patients had a moderate to greater change in their breast size, ie, shrinkage, with whole breast radiation. IntraBeam minimizes the risk to other tissues, which I think is one of its many benefits. Did you measure or get a sense of the size differences in breasts and how they compared with whole breast irradiation in your experience? Perhaps a greater benefit, and not really given its due in your paper, is the fact that 15% to 20% of patients undergoing breast conservation therapy don t receive their prearranged radiation dose. In treating patients at the time of surgery, 100% of patients will receive the prescribed radiotherapy. And I would expect that, over time, one might even see a survival advantage with interoperative therapy, simply based on patients actually receiving all their therapy. I did wonder why the intraoperative times of radiation delivery varied so much. I know you didn t include the set up time in your times listed, but how much additional time did it cost you in setting up in the operating room? Also, can you give us some practical sense about the scheduling difficulties created by teaming up with radiation oncologists? You didn t really discuss in your paper which patients you considered eligible for IntraBeam. Can you give us some guidelines? For example, how close can the lesion be to the skin? Did you resect skin? And if I knew I had to get negative margins, I would take a bigger piece of tissue. Can you tell me what that looked like? Did you close the wound in multiple layers? Did you resect fascia, which could lead to seromas? Can you discuss what the mammograms looked like after Intra- Beam? And did they interfere with anything? Was there more necrosis or calcifications, as seen in other studies? Finally, what are your plans to make intraoperative radiation standard of care? DR PHILLIP BURNS (Chattanooga, TN): Oncoplastic closure for breast-conserving treatment has become increasingly popular. Can you apply oncoplastic closure and use this technique?

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