World Journal of Surgical Oncology - Journal of Surgical Oncology Technical innovations Open Access Intraoperative radiation therapy in the treatment of early-stage ... cc of saline (Figure 1)

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    World Journal of Surgical Oncology

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    Open AcceTechnical innovationsIntraoperative radiation therapy in the treatment of early-stage breast cancer utilizing xoft axxent electronic brachytherapyAdam Dickler*1, Olga Ivanov2 and Darius Francescatti3

    Address: 1Department of Radiation Oncology, Little Company of Mary Hospital, Evergreen Park, IL 60805, USA, 2Department of General Surgery, Little Company of Mary Hospital, Evergreen Park, IL 60805, USA and 3Department of General Surgery, Rush University Medical Center, Chicago, IL 60612, USA

    Email: Adam Dickler* - atd22_99@yahoo.com; Olga Ivanov - olgaivanovmd@yahoo.com; Darius Francescatti - Dfrancescatti@gmail.com

    * Corresponding author

    AbstractBackground: In an effort to overcome the barriers to BCT, alternative methods of deliveringradiation therapy have been explored. APBI allows the radiation treatment to be accomplished inone week or less. XB is a form of balloon-based APBI that uses an electronic source generated bya mobile controller unit. Investigators have also explored IORT treatment that delivers a singlefraction of radiation in the operating suite at the time of surgery.

    Methods: We report on the first patient treated with XB to deliver IORT.

    Results: IORT treatment utilizing XB is feasible and can be accomplished with a total proceduretime of approximately 2 hours.

    Conclusion: Further research on XB and other methods of IORT is needed to establish clinicalefficacy and safety for patients with early-stage breast cancer.

    BackgroundSeveral large randomized trials with extended follow-uphave shown that breast conserving therapy (BCT) offersequivalent overall survival to modified radical mastec-tomy in patients with early stage breast cancer [1,2]. Stud-ies have also shown that in certain parts of the UnitedStates, as few as 10% of eligible patients receive BCT [3,4].Instead, some women are treated with mastectomy andothers receive lumpectomy alone. This is especially com-mon for women who live at an increased distance fromradiation centers [5,6]. The logistical difficulties thataccompany a 67 week course of whole breast externalbeam radiation (EBRT) are believed to be the main deter-rent to patients receiving radiation therapy. Althoughradiation therapy is burdensome, it is an important com-ponent of BCT that cannot be safely omitted. EBRT has

    been shown to both decrease the risk of local recurrenceand also to improve overall survival compared to surgeryalone [7].

    In an effort to overcome the barriers to BCT, alternativemethods of delivering radiation therapy have beenexplored. In contrast to standard EBRT, which treats thewhole breast, accelerated partial breast irradiation (APBI)delivers radiation to the lumpectomy bed plus a 12 cmmargin only. By decreasing the volume of treatment andincreasing the daily fraction size of the radiation, treat-ment can be accomplished in one week rather than thestandard 67 weeks.

    The method of APBI with the longest published experi-ence is multi-catheter interstitial brachytherapy. In this

    Published: 2 March 2009

    World Journal of Surgical Oncology 2009, 7:24 doi:10.1186/1477-7819-7-24

    Received: 17 December 2008Accepted: 2 March 2009

    This article is available from: http://www.wjso.com/content/7/1/24

    2009 Dickler et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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    technique, several rows of catheter needles are placedaround the lumpectomy bed and loaded with radiationsources. Multi-catheter interstitial brachytherapy has beenassociated with local recurrence rates of less than 5% atover 5-years follow-up and favorable cosmesis [8,9].Unfortunately, this technique is difficult and requires sig-nificant expertise. As a result, multi-catheter interstitialbreast brachytherapy is performed at relatively few centersin the U.S.

    Balloon-based APBI methods were developed to simplifythe brachytherapy procedure. The MammoSite (MS)brachytherapy applicator was the first balloon catheter tobe developed for APBI. The catheter contains an inflationchannel and a channel for the passage of an Iridium-192(Ir-192) radiation source. It can be inserted through a sin-gle incision at the time of surgery or post-lumpectomyusing ultrasound guidance. Initial results regarding cos-mesis and local control using the MS catheter have beencomparable to multi-catheter interstitial brachytherapy[10,11].

    Additional methods of balloon-based APBI are also beingexplored. A modified form of balloon-based brachyther-apy called Xoft Axxent Electronic Brachytherapy (XB)received FDA clearance for the treatment of breast cancerin January, 2006. This device uses a mobile controller,which generates kilovoltage (kV) x-rays. This approach toAPBI requires minimal shielding and thus has the poten-tial to increase the number of settings in which radiationtreatments can be offered. In addition, XB is not limitedby rigorous radiation source regulations associated withother methods of APBI, which utilize radioisotopesources. The early results of a clinical trial to evaluate theperformance and safety of XB in the outpatient treatmentof early-stage breast cancer patients were recently pre-sented at the American Society of Clinical Oncology(ASCO) Breast Cancer Symposium. Treatment with XBwas found to be feasible and associated with minimalacute side effects [12].

    Investigators have also explored delivering APBI in theoperating room immediately after lumpectomy. Intraop-erative radiation therapy (IORT) allows the patient toreceive all her radiation in a single fraction before sheawakens from surgery. Additional potential advantagesinclude delivering the radiation before tumor cells have achance to proliferate, performing the radiation underdirect visualization at the time of surgery, and decreasinghealthcare costs. Published results using IORT both as atumor bed boost in conjunction with EBRT and as a pri-mary treatment in APBI have shown favorable outcomes[13-15].

    To date, XB has been utilized only in an outpatient settingto deliver APBI in 10 fractions over 5 days. We report onthe first patient treated using XB to deliver IORT as part ofan IRB approved single-institution trial.

    Patients and methodsThe patient is a 61-year-old woman who presented withan abnormal screening mammogram. It revealed an 8-mm mass in the lower inner quadrant of the left breast.She had a core biopsy performed that showed a Grade 1,infiltrating ductal cancer that was estrogen and progester-one receptor positive.

    The patient was seen in consultation by her surgeon andradiation oncologist. Radiation treatment options wereexplained to the patient, including the standard of care, 67 weeks of whole breast radiation therapy, and one weekof outpatient APBI. An IRB approved protocol utilizing XBto deliver IORT was also discussed. The patient opted toenroll in the IORT protocol.

    On September 3rd, 2008, the patient underwent a lumpec-tomy and sentinel lymph node biopsy. The tumor massand margins of excision were sent for permanent section,and the identified sentinel lymph node was sent for fro-zen section. The pathology department reviewed thelymph node specimen at the time of surgery and informedthe treating physicians that it was uninvolved by cancer.

    At that point, additional breast tissue was removed poste-rior to the lumpectomy cavity down to the depth of thesuperficial pectoralis fascia to accommodate the chest wallshield. A pliable piece of lead was then temporarily placedover the chest wall to shield the ribs, lung, and heart, fromscatter radiation. A cavity evaluation device (CED) wasthen inserted into the lumpectomy cavity through a smallincision in the lateral breast and inflated with exactly 40cc of saline (Figure 1). The conformity of the CED to thesurrounding breast tissue was then evaluated under directvisualization. Conformance was considered to be accept-able if less than 10% of the tissue immediately surround-ing the breast tissue was composed of fluid or air and theballoon was tightly opposed to the lumpectomy cavity.Conformance was found to be inadequate, so an addi-tional 10 cc of saline was inserted into the balloon. It wasfound that conformance was still less than ideal, so anadditional 10 cc, or at total of 60 cc, was inserted into theballoon.

    Since a CED inflated to 60 cc was found to be the propersize, a 4 5 cm XB balloon catheter kit was then openedby the OR staff. The CED was then deflated and removedand a XB was then inserted in place of the CED. If a 40 ccballoon were to be used, a 3 4 cm catheter kit wouldhave been opened. The physicist then began calibration of

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    the XB controller. Radiation plans for a 40 cc, 50 cc, 60 cc,and 70 cc balloon were previously developed by CT scan-ning the XB catheter inflated with saline to the 4 sizes in awater phantom. These plans were then loaded onto USBdrives. At the completion of calibration, which typicallytakes approximately 15 minutes, the physicist then loadedthe corresponding radiation plan onto the controller unit.

    Du