Mammo Site and the FDA Trial

Between May 2000 and October of 2001, 70 patients were enrolled in a multi-institution prospective phase I/II trial approved by the investigational review board (IRB) designed to test the MammoSite device's safety and performance in preparation for attempted FDA approval either as the sole modality of irradiation (PBI) or as a boost dose after whole-breast irradiation (Keisch et al. 2004). However, all patients entered on the trial were enrolled in the PBI arm at the treating physician's choice.

Eligibility requirements included: age >45 years, tumor <2 cm, invasive ductal histology, negative nodal status, negative marginal status (National Surgical Adjuvant Breast and Bowel Project definition), applicator placement within 10 weeks of final lumpec-tomy procedure, and a cavity post-lumpectomy with one dimension of at least 3.0 cm. Ineligibility criteria included: an extensive intraductal component, pure intraductal cancers, lobular histology, or collagen vascular disease. Additionally, patients were deemed ineligible for technical issues including inadequate balloon-skin distance, excessive cavity size, or poor balloon-cavity conformance. Patients could be enrolled prior to final lumpectomy to allow device placement in an open fashion during that procedure; other patients were enrolled post-lumpectomy and implanted using a closed technique (typically under ultrasound guidance).

Final determination of suitability for HDR brachytherapy treatment was made after device placement using computed tomography (CT) imaging in all patients to measure the applicator-skin distance (minimum requirement 5 mm). Conformance was assessed by CT imaging after device placement, and was deemed acceptable if the balloon was in contact with the lumpectomy margin uniformly, without air or fluid-filled gaps. CT and fluoroscopic simulation were used for treatment planning, both to determine the single dwell position in the center of the balloon and for daily confirmation of balloon diameter. Acceptable diameters ranged from 4 to 5 cm, corresponding to a fill volume of 35-70 ml. In all cases, 34 Gy was delivered at a point 1 cm from the surface of the balloon in fractions of 3.4 Gy twice daily over 5-7 elapsed days with various commercially available remote afterloaders. Interfraction separation was a minimum of 6 hours.

A total of 70 patients were enrolled, 54 patients were implanted, and 43 patients were ultimately eligible for and received brachytherapy as the sole radiation modality after lumpectomy. Figure 10.2 shows the distribution of patients from enrollment through treatment and the reasons for not being implanted or treated. In most patients not treated, failure to treat was due to either technical or pathologic features. Patients implanted after lumpectomy were more likely to be treated than those implanted at the time of lumpectomy due to knowledge regarding final pathology. The patients tolerated therapy well. The most commonly reported radiation effects were limited to mild or moderate erythema without desquamation. In addition, other less common but significant events included moist desquamation in three patients, two infections including an abscess requiring drainage, and three seromas requiring drainage due to patient discomfort. No definite serious device-related events were reported. In four patients, serious adverse events were noted that were potentially related to the device; these were the previously mentioned abscess and seromas. The trial led to United States FDA approval of the device in May 2002 (Keisch et al. 2003).

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