Max O Meneveau1, Gina R Petroni2, Nikole E Varhegyi2, John C Hulse3, Anneke T Schroen3, David R Brenin3, Einsley M Janowski4, Adam C Berger5, Melissa A Lazar6, Nicole L Simone7, Timothy N Showalter4, Shayna L Showalter3. 1. Department of Surgery, University of Virginia School of Medicine, Charlottesville, VA. Electronic address: mom4u@hscmail.mcc.virginia.edu. 2. Division of Translational Research and Applied Statistics, Department of Public Health Sciences, University of Virginia Health System, Charlottesville, VA. 3. Department of Surgery, University of Virginia School of Medicine, Charlottesville, VA. 4. Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, VA. 5. Department of Surgery, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ. 6. Department of Surgery, Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA. 7. Department of Radiation Oncology, Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA.
Abstract
PURPOSE: Intraoperative radiation therapy (IORT), a form of accelerated partial breast irradiation (APBI), is an appealing alternative to postoperative whole breast irradiation for early-stage breast cancer. The purpose of this study was to examine the toxicity and cosmetic outcomes of patients treated with a novel form of breast IORT (precision breast IORT; PB-IORT), that delivers a targeted, higher dose of radiation than conventional IORT. METHODS AND MATERIALS: The first 204 patients treated with PB-IORT in a Phase II clinical trial (NCT02400658) with 12 months of followup were included. Trial inclusion criteria were age ≥45 years, invasive or in situ breast cancer, tumor size ≤3 cm, and node negative. Toxicity and cosmetic scoring were performed at 6 and 12 months. RESULTS: 98 patients (48%; 95% CI, 41-55%) experienced toxicity. Seven Grade 3 toxicities occurred (3.4%; 95% CI, 1.4-6.9%). Most patients (95%) had excellent or good cosmetic outcomes (95% CI, 91-98%) at 12 months. Most patients (94%) had little or no pigmentation change (95% CI, 90-97%), 88% little to no size change (95% CI, 82-92%), and 87% experienced minimal shape change (95% CI, 82-92%). CONCLUSIONS: Overall, Grade 3+ toxicity was rare and cosmetic outcomes were excellent. Severe toxicity with PB-IORT is similar to that reported in the TARGIT trial (3.3% rate of major toxicity) but lower than APBI (NSABP-39, 10.1% Grade 3/4 toxicities). We propose that the toxicity of PB-IORT compared with TARGIT and NSABP-39 is related to the radiation dose and delivery schedule. PB-IORT offers low-toxicity and good cosmetic outcomes when compared with other forms of APBI.
PURPOSE: Intraoperative radiation therapy (IORT), a form of accelerated partial breast irradiation (APBI), is an appealing alternative to postoperative whole breast irradiation for early-stage breast cancer. The purpose of this study was to examine the toxicity and cosmetic outcomes of patients treated with a novel form of breast IORT (precision breast IORT; PB-IORT), that delivers a targeted, higher dose of radiation than conventional IORT. METHODS AND MATERIALS: The first 204 patients treated with PB-IORT in a Phase II clinical trial (NCT02400658) with 12 months of followup were included. Trial inclusion criteria were age ≥45 years, invasive or in situ breast cancer, tumor size ≤3 cm, and node negative. Toxicity and cosmetic scoring were performed at 6 and 12 months. RESULTS: 98 patients (48%; 95% CI, 41-55%) experienced toxicity. Seven Grade 3 toxicities occurred (3.4%; 95% CI, 1.4-6.9%). Most patients (95%) had excellent or good cosmetic outcomes (95% CI, 91-98%) at 12 months. Most patients (94%) had little or no pigmentation change (95% CI, 90-97%), 88% little to no size change (95% CI, 82-92%), and 87% experienced minimal shape change (95% CI, 82-92%). CONCLUSIONS: Overall, Grade 3+ toxicity was rare and cosmetic outcomes were excellent. Severe toxicity with PB-IORT is similar to that reported in the TARGIT trial (3.3% rate of major toxicity) but lower than APBI (NSABP-39, 10.1% Grade 3/4 toxicities). We propose that the toxicity of PB-IORT compared with TARGIT and NSABP-39 is related to the radiation dose and delivery schedule. PB-IORT offers low-toxicity and good cosmetic outcomes when compared with other forms of APBI.
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