TY - JOUR
T1 - Uterine leiomyomas
T2 - MR imaging-guided focused ultrasound surgery - Results of different treatment protocols
AU - Fennessy, Fiona M.
AU - Tempany, Clare M.
AU - McDannold, Nathan J.
AU - So, Minna J.
AU - Hesley, Gina
AU - Gostout, Bobbie
AU - Kim, Hyun S.
AU - Holland, George A.
AU - Sarti, Dennis A.
AU - Hynynen, Kullervo
AU - Jolesz, Ferenc A.
AU - Stewart, Elizabeth A.
PY - 2007/6
Y1 - 2007/6
N2 - Purpose: To prospectively assess patient response (after 12 months) to magnetic resonance (MR) imaging-guided focused ultrasound surgery in treatment of uterine leiomyomas by using two treatment protocols. Materials and Methods: This prospective clinical trial was approved by institutional review boards and was HIPAA compliant. After giving informed consent, patients with symptomatic leiomyomas were consecutively enrolled and treated at one of five U.S. centers by using an original or a modified protocol. Outcomes were assessed with the symptom severity score (SSS) obtained at baseline and 3, 6, and 12 months after treatment. Adverse events (AEs) were recorded. Statistical analysis included Student t test, Fisher exact test, analysis of covariance, Spearman correlation, and logistic regression. Results: One hundred sixty patients had a mean SSS of 62.1 ± 16.3 (standard deviation) at baseline, which decreased to 35.5 ± 19.5 at 3 months (P < .001) and to 32.3 ± 19.8 at 6 months (P < .001) and was 32.7 ± 21.0 at 12 months (P < .001). Ninety-six patients (mean age, 46.0 years ± 4.6) were treated with an original protocol, and 64 (mean age, 45.9 years ± 3.9) were treated with a modified protocol. Patients in the modified group had a significantly greater SSS decrease at 3 months (P = .037) than those in the original group, and 73% of those in the original group and 91% of those in the modified group reported a significant decrease in SSS (of 10 points or greater) at 12 months. No serious AEs were recorded. Fewer AEs were reported in the modified group than in the original group (25% vs 13% reporting no event). Of evaluable patients, fewer in the modified group chose alternative treatment (28%) than in the original group (37%). Conclusion: MR imaging-guided focused ultrasound surgery results in symptomatic improvement, sustained to 12 months after treatment. Treatment with a modified protocol results in greater clinical effectiveness and fewer AEs.
AB - Purpose: To prospectively assess patient response (after 12 months) to magnetic resonance (MR) imaging-guided focused ultrasound surgery in treatment of uterine leiomyomas by using two treatment protocols. Materials and Methods: This prospective clinical trial was approved by institutional review boards and was HIPAA compliant. After giving informed consent, patients with symptomatic leiomyomas were consecutively enrolled and treated at one of five U.S. centers by using an original or a modified protocol. Outcomes were assessed with the symptom severity score (SSS) obtained at baseline and 3, 6, and 12 months after treatment. Adverse events (AEs) were recorded. Statistical analysis included Student t test, Fisher exact test, analysis of covariance, Spearman correlation, and logistic regression. Results: One hundred sixty patients had a mean SSS of 62.1 ± 16.3 (standard deviation) at baseline, which decreased to 35.5 ± 19.5 at 3 months (P < .001) and to 32.3 ± 19.8 at 6 months (P < .001) and was 32.7 ± 21.0 at 12 months (P < .001). Ninety-six patients (mean age, 46.0 years ± 4.6) were treated with an original protocol, and 64 (mean age, 45.9 years ± 3.9) were treated with a modified protocol. Patients in the modified group had a significantly greater SSS decrease at 3 months (P = .037) than those in the original group, and 73% of those in the original group and 91% of those in the modified group reported a significant decrease in SSS (of 10 points or greater) at 12 months. No serious AEs were recorded. Fewer AEs were reported in the modified group than in the original group (25% vs 13% reporting no event). Of evaluable patients, fewer in the modified group chose alternative treatment (28%) than in the original group (37%). Conclusion: MR imaging-guided focused ultrasound surgery results in symptomatic improvement, sustained to 12 months after treatment. Treatment with a modified protocol results in greater clinical effectiveness and fewer AEs.
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U2 - 10.1148/radiol.2433060267
DO - 10.1148/radiol.2433060267
M3 - Article
C2 - 17446521
AN - SCOPUS:34249011527
SN - 0033-8419
VL - 243
SP - 885
EP - 893
JO - Radiology
JF - Radiology
IS - 3
ER -