Shayna L Showalter1, Gina Petroni2, Daniel M Trifiletti3, Bruce Libby3, Anneke T Schroen4, David R Brenin4, Parchayi Dalal3, Mark Smolkin2, Kelli A Reardon3, Timothy N Showalter3. 1. Division of Surgical Oncology, Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia. Electronic address: snl2t@virginia.edu. 2. Division of Translation Research and Applied Statistics, Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia. 3. Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia. 4. Division of Surgical Oncology, Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia.
Abstract
PURPOSE: Existing intraoperative radiation therapy (IORT) techniques are criticized for the lack of image guided treatment planning and energy deposition with, at times, poor resultant dosimetry and low radiation dose. We pioneered a novel method of IORT that incorporates customized, computed tomography (CT)-based treatment planning and high-dose-rate (HDR) brachytherapy to overcome these drawbacks: CT-HDR-IORT. METHODS AND MATERIALS: A phase 1 study was conducted to demonstrate the feasibility and safety of CT-HDR-IORT. Eligibility criteria included age ≥50 years, invasive or in situ breast cancer, tumor size <3 cm, and N0 disease. Patients were eligible before or within 30 days of breast-conserving surgery (BCS). BCS was performed, and a multilumen balloon catheter was placed. CT images were obtained, a customized HDR brachytherapy plan was created, and a dose of 12.5 Gy was delivered to 1-cm depth from the balloon surface. The catheter was removed, and the skin was closed. The primary endpoints were feasibility and acute toxicity. Feasibility was defined as IORT treatment interval (time from CT acquisition until IORT completion) ≤90 minutes. The secondary endpoints included dosimetry, cosmetic outcome, quality of life, and late toxicity. RESULTS: Twenty-eight patients were enrolled. The 6-month follow-up assessments were completed by 93% of enrollees. The median IORT treatment interval was 67.2 minutes (range, 50-108 minutes). The treatment met feasibility criteria in 26 women (93%). The dosimetric goals were met in 22 patients (79%). There were no Radiation Therapy Oncology Group grade 3+ toxicities; 6 patients (21%) experienced grade 2 events. Most patients (93%) had good/excellent cosmetic outcomes at the last follow-up visit. CONCLUSIONS: CT-HDR-IORT is feasible and safe. This promising approach for a conformal, image-based, higher-dose breast IORT is being evaluated in a phase 2 trial.
PURPOSE: Existing intraoperative radiation therapy (IORT) techniques are criticized for the lack of image guided treatment planning and energy deposition with, at times, poor resultant dosimetry and low radiation dose. We pioneered a novel method of IORT that incorporates customized, computed tomography (CT)-based treatment planning and high-dose-rate (HDR) brachytherapy to overcome these drawbacks: CT-HDR-IORT. METHODS AND MATERIALS: A phase 1 study was conducted to demonstrate the feasibility and safety of CT-HDR-IORT. Eligibility criteria included age ≥50 years, invasive or in situ breast cancer, tumor size <3 cm, and N0 disease. Patients were eligible before or within 30 days of breast-conserving surgery (BCS). BCS was performed, and a multilumen balloon catheter was placed. CT images were obtained, a customized HDR brachytherapy plan was created, and a dose of 12.5 Gy was delivered to 1-cm depth from the balloon surface. The catheter was removed, and the skin was closed. The primary endpoints were feasibility and acute toxicity. Feasibility was defined as IORT treatment interval (time from CT acquisition until IORT completion) ≤90 minutes. The secondary endpoints included dosimetry, cosmetic outcome, quality of life, and late toxicity. RESULTS: Twenty-eight patients were enrolled. The 6-month follow-up assessments were completed by 93% of enrollees. The median IORT treatment interval was 67.2 minutes (range, 50-108 minutes). The treatment met feasibility criteria in 26 women (93%). The dosimetric goals were met in 22 patients (79%). There were no Radiation Therapy Oncology Group grade 3+ toxicities; 6 patients (21%) experienced grade 2 events. Most patients (93%) had good/excellent cosmetic outcomes at the last follow-up visit. CONCLUSIONS: CT-HDR-IORT is feasible and safe. This promising approach for a conformal, image-based, higher-dose breast IORT is being evaluated in a phase 2 trial.
Authors: Chirag Shah; Martin Keisch; Atif Khan; Douglas Arthur; David Wazer; Frank Vicini Journal: Ann Surg Oncol Date: 2021-01-13 Impact factor: 5.344
Authors: Max O Meneveau; Gina R Petroni; Nikole E Varhegyi; John C Hulse; Anneke T Schroen; David R Brenin; Einsley M Janowski; Adam C Berger; Melissa A Lazar; Nicole L Simone; Timothy N Showalter; Shayna L Showalter Journal: Brachytherapy Date: 2020-06-20 Impact factor: 2.362
Authors: Courtney M Lattimore; Max O Meneveau; Gina R Petroni; Nikole E Varhegyi; Gabriella C Squeo; Timothy N Showalter; Shayna L Showalter Journal: Brachytherapy Date: 2022-02-02 Impact factor: 2.441
Authors: Gabriella C Squeo; Courtney M Lattimore; Nicole L Simone; Greg Suralik; Sunil W Dutta; Michael D Schad; Lucy Su; Bruce Libby; Einsley-Marie Janowski; Shayna L Showalter; Jennifer M Lobo; Timothy N Showalter Journal: Brachytherapy Date: 2022-02-04 Impact factor: 2.441
Authors: Greg Suralik; Sonali Rudra; Sunil W Dutta; Jialu Yu; Jason C Sanders; Michael D Schad; Einsley-Marie Janowski; Lucy Su; Bruce Libby; Shayna L Showalter; Jennifer M Lobo; Timothy N Showalter Journal: Brachytherapy Date: 2020-03-28 Impact factor: 2.362
Authors: Taryn E Hassinger; Timothy N Showalter; Anneke T Schroen; David R Brenin; Adam C Berger; Bruce Libby; Shayna L Showalter Journal: J Med Imaging Radiat Oncol Date: 2018-08-13 Impact factor: 1.735
Authors: E Marinetto; A Uneri; T De Silva; S Reaungamornrat; W Zbijewski; A Sisniega; S Vogt; G Kleinszig; J Pascau; J H Siewerdsen Journal: Comput Med Imaging Graph Date: 2017-04-03 Impact factor: 7.422
Authors: Sunil W Dutta; Shayna L Showalter; Timothy N Showalter; Bruce Libby; Daniel M Trifiletti Journal: Breast Cancer (Dove Med Press) Date: 2017-04-18
Authors: Roberto Ivan López; Jenny Lissette Castro; Heidy Cedeño; Dagoberto Cisneros; Luis Corrales; Ileana González-Herrera; Mayté Lima-Pérez; Rogelio Prestol; Roberto Salinas; Jorge Luis Soriano-García; Alejandra T Zavala; Luis Miguel Zetina; Carlos Eduardo Zúñiga-Orlich Journal: ESMO Open Date: 2018-03-15