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Title: A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial

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 wasmore » 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.« less

Authors:
 [1];  [2]; ;  [3]; ;  [1];  [3];  [2]; ;  [3]
  1. Division of Surgical Oncology, Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia (United States)
  2. Division of Translation Research and Applied Statistics, Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia (United States)
  3. Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia (United States)
Publication Date:
OSTI Identifier:
22648779
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 96; Journal Issue: 1; Other Information: Copyright (c) 2016 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BRACHYTHERAPY; CLINICAL TRIALS; COMPUTERIZED TOMOGRAPHY; CONSUMER PRODUCTS; CT-GUIDED RADIOTHERAPY; DOSE RATES; DOSIMETRY; GY RANGE 10-100; IMAGES; MAMMARY GLANDS; NEOPLASMS; PATIENTS; RADIATION DOSES; STANDARD OF LIVING; TOXICITY

Citation Formats

Showalter, Shayna L., E-mail: snl2t@virginia.edu, Petroni, Gina, Trifiletti, Daniel M., Libby, Bruce, Schroen, Anneke T., Brenin, David R., Dalal, Parchayi, Smolkin, Mark, Reardon, Kelli A., and Showalter, Timothy N. A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial. United States: N. p., 2016. Web. doi:10.1016/J.IJROBP.2016.04.035.
Showalter, Shayna L., E-mail: snl2t@virginia.edu, Petroni, Gina, Trifiletti, Daniel M., Libby, Bruce, Schroen, Anneke T., Brenin, David R., Dalal, Parchayi, Smolkin, Mark, Reardon, Kelli A., & Showalter, Timothy N. A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial. United States. doi:10.1016/J.IJROBP.2016.04.035.
Showalter, Shayna L., E-mail: snl2t@virginia.edu, Petroni, Gina, Trifiletti, Daniel M., Libby, Bruce, Schroen, Anneke T., Brenin, David R., Dalal, Parchayi, Smolkin, Mark, Reardon, Kelli A., and Showalter, Timothy N. Thu . "A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial". United States. doi:10.1016/J.IJROBP.2016.04.035.
@article{osti_22648779,
title = {A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial},
author = {Showalter, Shayna L., E-mail: snl2t@virginia.edu and Petroni, Gina and Trifiletti, Daniel M. and Libby, Bruce and Schroen, Anneke T. and Brenin, David R. and Dalal, Parchayi and Smolkin, Mark and Reardon, Kelli A. and Showalter, Timothy N.},
abstractNote = {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.},
doi = {10.1016/J.IJROBP.2016.04.035},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 1,
volume = 96,
place = {United States},
year = {Thu Sep 01 00:00:00 EDT 2016},
month = {Thu Sep 01 00:00:00 EDT 2016}
}