1. Enhanced MR guided Focused Ultrasound Surgery (MRgFUS) Guidelines Demonstrates Improved Efficacy and Durability for the Treatment of Uterine Myoma Phyllis J. Gee, M.D., FACOG North Texas Uterine Fibroid Institute, Plano, Texas Presented at ACOG's 2007 Annual Clinical Meeting (ACM) San Diego, CA, May 5-9, 2007 Purpose Results Conclusions 44in high Background Brigham and Women’s Hospital, John Hopkins Hospital, Mayo Clinic, Lahey Clinic, Radnet, North Texas Uterine Fibroid Institute, Sightline-Houston, University MRI, Virtua Hospital The purpose of this multi-center study trial is to compare the clinical outcomes of MRgFUS patients treated using expanded and commercial treatment guidelines with those patients treated using the pivotal treatment guidelines. Data were collected to confirm improved safety and efficacy of MRgFUS treatment of uterine leiomyoma with these expanded guidelines. Hypothesis 1.Expanded and commercial treatment guidelines allow more efficacious treatments that are durable (greater symptom relief) with as good a safety profile as the pivotal treatment guidelines. 2.Secondary outcomes included the relationship between symptom severity score (SSS) improvement versus non-perfused leiomyoma volume and the percentage of patients requiring alternative treatments post-MRgFUS. –Similar to how a magnifying glass focuses light energy, ultrasound can be focused to a spot the size of a jelly bean. –The high energy density at the focus results in tissue heating and thermal injury. –As depicted below: During MRgFUS treatment, the physician uses MR images to aid in planning treatment location (1), visualizing where the ultrasound will be delivered (2), monitoring temperature changes inside the body (3), and evaluating the treatment outcome (4). Water Bath Focused Ultrasound Beam Tumor Transducer MR Guided… - Real Time 3D imaging - MRI Thermal monitoring Methods 12 34 Pivotal Study GuidelinesExpanded Tx GuidelinesCommercial Guidelines Volume restriction as a percentage of fibroid Prescribed volume limited to 33% of all fibroids Treated Vol. limited to 50% of all fibroids except submucosal - 33% Treated volume limited to 50% of all fibroids Volume restrictionMax Tx of 100 cc per fibroid or 150 cc if more than 1 Fibroid Max Tx 150 cc regardless of number of treatments None Time restriction first to last sonication 120 minutes180 minutes Minimum distance to the endometrium 1.5 cmNone Minimum distance to the serosa 1.5 cm Restricted distance to fibroid capsule 0.5 cm on side closest to serosa None Second treatment session NoYes – limited to 2 within a 2 week period Group AGroup CGroup B Limited Tx Volume Expanded Tx Volume Treatment Guidelines and Patient Population Symptom Severity Score (SSS) - a validated tool to compare symptom severity among women suffering from uterine leiomyoma - MRgFUS patients in the study were highly symptomatic and had a much greater SSS than an average patient with uterine leiomyoma Group A patients: Pivotal study guidelines Group B patients: Expanded treatment guidelines Group C patients: Commercial treatment guidelines UF005-B1Continued access study group 1 patientsN= 96 UF005-B2Continued access study group 2 patientsN= 64 UF014African American study patientsN= 73 Symptom improvement was greatest under commercial treatment guidelines. 86% of patients treated with commercial treatment guidelines sustained a 10-point or greater improvement in SSS by 12 months compared to 84% of patients treated with expanded guidelines and 71% of patients treated with pivotal guidelines. 84% of all patients had some form of symptom improvement Percent of patients exhibiting >10 points SSS improvement Expanded and commercial treatment guidelines (UF005-B2 and UF014) resulted in greater reduction in symptom severity score at 3,6,12 and 24 months Majority of symptom relief was experienced at 3 months (first data point) Durable / sustained symptom relief up to 36 months Reduction in Patient Symptoms Over Time Patients treated under the expanded and commercial treatment guidelines (UF005-B2 and UF014) required fewer alternative treatments than those treated under the pivotal study guidelines. Rate of Alternative Treatments This data confirms improved efficacy and durability of MR-guided Focused Ultrasound Surgery of uterine leiomyoma with expanded commercial guidelines. These enhanced treatments result in greater symptom relief and less need for alternative treatments. References 1.Stewart, E.A., et al. “Clinical Outcomes of Focused Ultrasound Surgery for the Treatment of Uterine Fibroids.” Fertility and Sterility 2006;85 (1):22-29. 2.Spies, J. B., Coyne, K., et.al. “The UFS-QOL, A New Disease-specific Symptom and Health-related Quality of Life Questionnaire for Leiomyomata. Obstet Gynecol 2002; 99(2):290-300 92in wide Participating Sites UFS-QOL Validation Study Objective: Data were collected to confirm improved efficacy of Magnetic Resonance-guided focused ultrasound surgery (MRgFUS) treatment of uterine leiomyomata with expanded guidelines. Methods: From April 2003 to March 2006, 160 patients were treated in a continued access study (UF005), and 73 were treated in a study involving African-American patients exclusively (UF014). MRgFUS was performed using three different sets of treatment guidelines: 96 patients in UF005 were treated under pivotal study guidelines with limited treatment times and volumes (Group A), 64 patients in UF005 were treated with expanded guidelines (Group B), and the UF014 patients were treated using current commercial treatment guidelines (Group C). Results: Outcomes confirmed that patients treated under expanded and commercial treatment guidelines achieved greater nonperfused myoma volumes and greater symptom relief than those treated under the pivotal study guidelines. The symptom severity score, a component of the validated uterine leiomyoma quality of life questionnaire, was used to quantify these results. Approximately 85% of Group B patients achieved a greater than 10-point improvement in symptom severity score compared with 74% of Group A patients, which represents a 15% improvement in results. The number of alternative treatments for Group B patients at 12 and 24 months was also much less than that for Group A patients. Of the Group C patients, 43 have crossed the 3-month follow-up. Ninety-three percent (93%) of these patients have achieved symptom severity score improvement of 10 points or greater. Conclusions: These findings demonstrate that larger leiomyoma treatment volumes result in larger nonperfused tumor volumes after MR-guided focused ultrasound surgery. These enhanced treatments result in greater symptom relief and less need for alternative treatment. MRgFUS is a non-invasive outpatient treatment for uterine leiomyoma that enables women to go home immediately, returning to normal activities and to work within 1-2 days Abstract