PurposeAccelerated partial breast irradiation (APBI) is an increasingly popular treatment choice for patients with early stage breast cancer following breast conserving surgery. The Strut-Adjusted Volume Implant (SAVI) is a multi-channel brachytherapy apparatus that has been implemented for APBI. The purpose of this analysis was to evaluate the toxicity and efficacy of APBI in patients treated with the SAVI device.Materials and MethodsAn IRB approved review was done of patients treated from January 2013 through July 2015 with APBI using SAVI. Patients were treated in 10 twice daily fractions of 3.4 Gy each for a total dose of 34 Gy. Clinical, tumor, and dosimetric information were collected. Acute and late toxicities were prospectively collected on patients in follow-up. Patients were evaluated for rates of acute toxicity, late toxicity, and local control at the end of last follow-up. Toxicity was graded by the Common Terminology Criteria for Adverse Events, version 4.0, except for pain which was scored from 0 to 10 (0 = no pain; 10 = worst pain) and fatigue which was scored from 0 to 4 (0 = none, able to perform daily activities; 4 = confined to bed).Results132 patients were included in this analysis, with one patient having synchronous early stage breast cancer diagnosed in each breast. Median follow up time was 14.5 months (range, 1.1 - 33.5 months). The median age at diagnosis was 61 years (range 41-83 years old), with 80% of patients being post-menopausal. Forty-two lesions (32%) were in-situ (stage 0), 88 lesions (66%) were stage 1, and 3 (2%) lesions were stage 2, with 86% being estrogen receptor positive. Fifteen (11%) patients received adjuvant chemotherapy and 100 (76%) patients initiated adjuvant hormonal therapy. The median planning target volume was 58.2 cc (range, 24.2 - 109.9 cc). The median volume receiving 150% of the prescription or more was 26.3 cc (range, 11.5 - 47.5 cc) and the median volume receiving 200% of the prescription or more was 13.0 cc (range, 6.3 - 26.1 cc). One patient discontinued treatment after the first day of treatment (2 fractions). The pain was worst on day #2 of treatment, with an average score of 0.46 (mode =0). The fatigue was worst on day #5 of treatment, with an average score of 0.22 (mode =0). One patient developed an acute skin infection; two patients developed late skin infections possibly related to the radiation treatment, one of which was grade 3. Other late toxicities were all grade 1 or 2: hyperpigmentation (43%), telangiectasia (0.8%), seroma (8%), fat necrosis (5%), and fibrosis (11%). Crude local recurrence rate was 4% (n=5).ConclusionsSAVI is a safe and effective treatment option for patients who are candidates for APBI. It is a well-tolerated technique that is convenient for patients due to the shorter overall treatment duration. Only one grade 3 toxicity reported that may have been related to radiation therapy; the remainder of toxicities was either grade 1 or 2. Local control appears to be excellent, but longer follow-up will be needed. PurposeAccelerated partial breast irradiation (APBI) is an increasingly popular treatment choice for patients with early stage breast cancer following breast conserving surgery. The Strut-Adjusted Volume Implant (SAVI) is a multi-channel brachytherapy apparatus that has been implemented for APBI. The purpose of this analysis was to evaluate the toxicity and efficacy of APBI in patients treated with the SAVI device. Accelerated partial breast irradiation (APBI) is an increasingly popular treatment choice for patients with early stage breast cancer following breast conserving surgery. The Strut-Adjusted Volume Implant (SAVI) is a multi-channel brachytherapy apparatus that has been implemented for APBI. The purpose of this analysis was to evaluate the toxicity and efficacy of APBI in patients treated with the SAVI device. Materials and MethodsAn IRB approved review was done of patients treated from January 2013 through July 2015 with APBI using SAVI. Patients were treated in 10 twice daily fractions of 3.4 Gy each for a total dose of 34 Gy. Clinical, tumor, and dosimetric information were collected. Acute and late toxicities were prospectively collected on patients in follow-up. Patients were evaluated for rates of acute toxicity, late toxicity, and local control at the end of last follow-up. Toxicity was graded by the Common Terminology Criteria for Adverse Events, version 4.0, except for pain which was scored from 0 to 10 (0 = no pain; 10 = worst pain) and fatigue which was scored from 0 to 4 (0 = none, able to perform daily activities; 4 = confined to bed). An IRB approved review was done of patients treated from January 2013 through July 2015 with APBI using SAVI. Patients were treated in 10 twice daily fractions of 3.4 Gy each for a total dose of 34 Gy. Clinical, tumor, and dosimetric information were collected. Acute and late toxicities were prospectively collected on patients in follow-up. Patients were evaluated for rates of acute toxicity, late toxicity, and local control at the end of last follow-up. Toxicity was graded by the Common Terminology Criteria for Adverse Events, version 4.0, except for pain which was scored from 0 to 10 (0 = no pain; 10 = worst pain) and fatigue which was scored from 0 to 4 (0 = none, able to perform daily activities; 4 = confined to bed). Results132 patients were included in this analysis, with one patient having synchronous early stage breast cancer diagnosed in each breast. Median follow up time was 14.5 months (range, 1.1 - 33.5 months). The median age at diagnosis was 61 years (range 41-83 years old), with 80% of patients being post-menopausal. Forty-two lesions (32%) were in-situ (stage 0), 88 lesions (66%) were stage 1, and 3 (2%) lesions were stage 2, with 86% being estrogen receptor positive. Fifteen (11%) patients received adjuvant chemotherapy and 100 (76%) patients initiated adjuvant hormonal therapy. The median planning target volume was 58.2 cc (range, 24.2 - 109.9 cc). The median volume receiving 150% of the prescription or more was 26.3 cc (range, 11.5 - 47.5 cc) and the median volume receiving 200% of the prescription or more was 13.0 cc (range, 6.3 - 26.1 cc). One patient discontinued treatment after the first day of treatment (2 fractions). The pain was worst on day #2 of treatment, with an average score of 0.46 (mode =0). The fatigue was worst on day #5 of treatment, with an average score of 0.22 (mode =0). One patient developed an acute skin infection; two patients developed late skin infections possibly related to the radiation treatment, one of which was grade 3. Other late toxicities were all grade 1 or 2: hyperpigmentation (43%), telangiectasia (0.8%), seroma (8%), fat necrosis (5%), and fibrosis (11%). Crude local recurrence rate was 4% (n=5). 132 patients were included in this analysis, with one patient having synchronous early stage breast cancer diagnosed in each breast. Median follow up time was 14.5 months (range, 1.1 - 33.5 months). The median age at diagnosis was 61 years (range 41-83 years old), with 80% of patients being post-menopausal. Forty-two lesions (32%) were in-situ (stage 0), 88 lesions (66%) were stage 1, and 3 (2%) lesions were stage 2, with 86% being estrogen receptor positive. Fifteen (11%) patients received adjuvant chemotherapy and 100 (76%) patients initiated adjuvant hormonal therapy. The median planning target volume was 58.2 cc (range, 24.2 - 109.9 cc). The median volume receiving 150% of the prescription or more was 26.3 cc (range, 11.5 - 47.5 cc) and the median volume receiving 200% of the prescription or more was 13.0 cc (range, 6.3 - 26.1 cc). One patient discontinued treatment after the first day of treatment (2 fractions). The pain was worst on day #2 of treatment, with an average score of 0.46 (mode =0). The fatigue was worst on day #5 of treatment, with an average score of 0.22 (mode =0). One patient developed an acute skin infection; two patients developed late skin infections possibly related to the radiation treatment, one of which was grade 3. Other late toxicities were all grade 1 or 2: hyperpigmentation (43%), telangiectasia (0.8%), seroma (8%), fat necrosis (5%), and fibrosis (11%). Crude local recurrence rate was 4% (n=5). ConclusionsSAVI is a safe and effective treatment option for patients who are candidates for APBI. It is a well-tolerated technique that is convenient for patients due to the shorter overall treatment duration. Only one grade 3 toxicity reported that may have been related to radiation therapy; the remainder of toxicities was either grade 1 or 2. Local control appears to be excellent, but longer follow-up will be needed. SAVI is a safe and effective treatment option for patients who are candidates for APBI. It is a well-tolerated technique that is convenient for patients due to the shorter overall treatment duration. Only one grade 3 toxicity reported that may have been related to radiation therapy; the remainder of toxicities was either grade 1 or 2. Local control appears to be excellent, but longer follow-up will be needed.