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Interim Analysis of 354 Breast Cancer Patients Randomly Treated With Hyperfractionated or Conventional Fractionated Radiation Therapy After Breast-Conserving Surgery
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International Journal of Radiation Oncology Biology Physics
irradiation according to protocol guidelines. Planning information including dose prescription, treatment technique, and beam information was requested in questionnaire. DICOM files of structure set and radiation dose and capture images of all beams’ eye view were also required to submit. The DICOM files of each institution were registered to MIM software. We assessed the inter-institutional variations in IMN delineation. In addition, we evaluated the dose-volume histogram of IMN and organ at risks including lung and heart, which were delineated by a physician as reference structure set. Results: All participating hospitals performed CT-based 3D treatment planning for breast cancer. Considerable inter-institutional variation was indicated in IMN delineation (median 6.7 cc [range 2.0 - 24.4] for BCS, median 4.2 cc [range 1.4 - 25.5] for MRM). Mean dose covered IMN (% of prescription dose) in Arm 1 and Arm 2 was 94.6 7.2% and 59.4 14.5% for BCS case (p < 0.001) and 96.9 6.8% and 58.6 23.2% for MRM case (p < 0.001), respectively. Dose variations in IMN were much greater in Arm 2 than Arm 1, even though several different treatment techniques were used for Arm 1. Mean dose and V20 (volume receiving greater than 20 Gy) of ipsilateral lung, mean dose, V20, and V30 of heart, and mean dose of coronary artery were statistically significantly lower in Arm 2 than in Arm 1. Conclusions: In general, participating institutions in the dummy run were able to comply with the protocol guidelines for KROG 08-06. However, considerable deviations were observed on IMN definition and dose coverage to IMN. More careful and continuous education and consensus about protocol guideline to reduce inter-institutional heterogeneities is essential for reliability of trial results. Author Disclosure: Y. Chung: None. C. Suh: None. Y. Cho: None. J. Lee: None. Y. Kim: None.
HFRT and 4.8% for CFRT group (p Z 0.73). No brachial plexus plexopathy occurred. Conclusions: Hyperfractionated radiation therapy provides similar efficacy and toxicity with conventional fractionated radiation therapy for breast cancer patients treated with breast conserving surgery. Long-term followup is warranted for. Author Disclosure: S. li: None. S. Wang: None. Y. Song: None. W. Wang: None. X. Liu: None. H. Ren: None. H. Fang: None. Y. Li: None.
2098 Interim Analysis of 354 Breast Cancer Patients Randomly Treated With Hyperfractionated or Conventional Fractionated Radiation Therapy After Breast-Conserving Surgery S. Li, S. Wang, Y. Song, W. Wang, X. Liu, H. Ren, H. Fang, and Y. Li; Department of Radiation Therapy, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China Purpose/Objective(s): To analyze the efficacy and toxicity of breast cancer patients randomly treated with hypofractionated radiation therapy (HFRT) or conventional fractionated radiation therapy (CFRT) after breast conserving surgery (BCS). Materials/Methods: 354 patients who met the following criteria were enrolled in this study: pathology confirmed invasive breast cancer, with breast conserving surgery, margin negative, without neoadjuvant systemic therapy, without supraclavicular or internal mammary nodal metastases, and without distant metastasis. 185 patients were randomized to receive HFRT (whole breast 43.5 Gy / 15 f / 3 w, followed by tumor bed boost 8.7 Gy / 3 f / 3 d) and 167 to receive CFRT (whole breast 50 Gy / 25 f / 5 w, followed by tumor bed boost 10 Gy / 5 f / 1 w), using simplified intensity modulated radiation therapy or three dimensional conformal radiation therapy techniques. Acute and late toxicities were scaled with CTC3.0 Criteria. Chi-square test was used to compare the differences. Results: The median age was 46 years (range, 21-69 years). With a median follow-up of 16 months (range, 2-44 months), 1 patient developed local recurrence, 1 axillary nodal recurrence and 1 distant metastasis, all from HFRT group. No patient died. The incidence of grade 2 and 3 acute skin toxicity was 4.5% and 2.2% for HFRT group and 10.3% and 0% for CFRT (p Z 0.10). The breast cosmetic outcome was excellent/good, fair, and poor in 89.8%, 10.2% and 0% in HFRT, and 86.5%, 13.0%, 0.5% in CFRT group (p Z 0.36). The incidence of grade 2 pneumonitis was 2.2% for HFRT and 4.2% for CFRT group (p Z 0.53), no grade 3 or more pneumonitis occurred. The incidence of upper limb edema was 8.1% for HFRT and 6.0% for CFRT group (p Z 0.69), and the incidence of shoulder dysfunction was 3.2% for
2099 EBRT Versus APBI: Patient Satisfaction L.C. Keiler,1 S.M. Bitter,2 P. Cartwright,1 C. Wennerstrom,1 W. Jared,1 and D.B. Einstein1; 1Kettering Medical Center, Kettering, OH, 2University of Cincinnati College of Medicine, Cincinnati, OH Purpose/Objective(s): To determine any differences in patient satisfaction for breast cancer patients treated with either external beam radiation therapy (EBRT) or accelerated partial breast radiation (APBI) via HDR brachytherapy utilizing brachytherapy catheters from several manufacturers. Materials/Methods: Charts from 2002 to 2013 (APBI) and 2012 to 2013 (EBRT) were retrospectively reviewed. All patients were given a survey with FACET breast quality of life (QOL) and patient rated breast cosmesis (1-10), nausea, pain, dyspnea, self-consciousness, and presence of lymphedema questions. Treatment details (catheter manufacturer, radiation dosing, chemotherapy, hormone manipulation, and stage) were also collected. Results: We identified 243 APBI patients and 38 EBRT patients. Within the EBRT cohort, 25 women met departmental criteria for APBI treatment (size < 3 cm, post-menopausal). Seventeen women (68%; mean follow-up time of 7 months) treated with EBRT and seventy-eight women (32%; mean follow-up time of 16 months) treated with APBI completed the survey. Women treated with EBRT reported more nausea (p Z 0.04) and lymphedema (p Z 0.046) than those treated with APBI. A trend towards worse pain (p Z 0.06) and more self-consciousness (p Z 0.08) was also seen with EBRT. In the APBI cohort, increased duration of follow-up was significantly positively correlated with more frequent low energy (p Z 0.03, R Z 0.2), nausea (p Z 0.003, R Z 0.3), and dyspnea (p Z 0.02, R Z 0.3). The single lumen Mammosite balloon (LSmean score Z 6/10) was found to be associated with significantly decreased cosmesis when compared to the Mammosite ML (LSmean score Z 8/10; p Z 0.002) and Contura (LSmean score Z 9/10; p Z 0.001) balloons. Furthermore, the Mammosite balloon (LSmean score Z 1.1/4) was found to be associated with significantly more dyspnea when compared to the Savi (LSmean score Z 0.1/4; p Z 0.01) and Contura (LSmean score Z 0/4; p Z 0.003) devices. In the APBI cohort, older patients reported less frequent episodes of nausea (p Z 0.04, R Z -0.2), pain (p Z 0.003, R Z -0.3), and lymphedema (p Z 0.04, R Z -0.2). In the EBRT cohort, tumor size was significantly negatively correlated with pain (p Z 0.03, R Z -0.7). Conclusions: APBI treated patients tend to have worsening quality of life indicators with longer follow-up; however, their experience remains superior compared to a similarly matched EBRT cohort, albeit with a small N. Younger APBI patients and smaller tumors treated with EBRT had worse outcomes. Multi-lumen applicators provided superior cosmetic outcomes and less reported dyspnea. Author Disclosure: L.C. Keiler: None. S.M. Bitter: None. P. Cartwright: None. C. Wennerstrom: None. W. Jared: None. D.B. Einstein: None.
2100 Treatment of Ductal Carcinoma In Situ With Adjuvant Accelerated Partial Breast Irradiation: A Surveillance, Epidemiology, and End ResultseBased Patterns of Care Analysis K. Demas,1 S. Grover,1 S. Sharma,1 S. Showalter,2 and G.M. Freedman1; 1 University of Pennsylvania, Philadelphia, PA, 2University of Virginia, Charlottesville, VA
International Journal of Radiation Oncology Biology Physics
irradiation according to protocol guidelines. Planning information including dose prescription, treatment technique, and beam information was requested in questionnaire. DICOM files of structure set and radiation dose and capture images of all beams’ eye view were also required to submit. The DICOM files of each institution were registered to MIM software. We assessed the inter-institutional variations in IMN delineation. In addition, we evaluated the dose-volume histogram of IMN and organ at risks including lung and heart, which were delineated by a physician as reference structure set. Results: All participating hospitals performed CT-based 3D treatment planning for breast cancer. Considerable inter-institutional variation was indicated in IMN delineation (median 6.7 cc [range 2.0 - 24.4] for BCS, median 4.2 cc [range 1.4 - 25.5] for MRM). Mean dose covered IMN (% of prescription dose) in Arm 1 and Arm 2 was 94.6 7.2% and 59.4 14.5% for BCS case (p < 0.001) and 96.9 6.8% and 58.6 23.2% for MRM case (p < 0.001), respectively. Dose variations in IMN were much greater in Arm 2 than Arm 1, even though several different treatment techniques were used for Arm 1. Mean dose and V20 (volume receiving greater than 20 Gy) of ipsilateral lung, mean dose, V20, and V30 of heart, and mean dose of coronary artery were statistically significantly lower in Arm 2 than in Arm 1. Conclusions: In general, participating institutions in the dummy run were able to comply with the protocol guidelines for KROG 08-06. However, considerable deviations were observed on IMN definition and dose coverage to IMN. More careful and continuous education and consensus about protocol guideline to reduce inter-institutional heterogeneities is essential for reliability of trial results. Author Disclosure: Y. Chung: None. C. Suh: None. Y. Cho: None. J. Lee: None. Y. Kim: None.
HFRT and 4.8% for CFRT group (p Z 0.73). No brachial plexus plexopathy occurred. Conclusions: Hyperfractionated radiation therapy provides similar efficacy and toxicity with conventional fractionated radiation therapy for breast cancer patients treated with breast conserving surgery. Long-term followup is warranted for. Author Disclosure: S. li: None. S. Wang: None. Y. Song: None. W. Wang: None. X. Liu: None. H. Ren: None. H. Fang: None. Y. Li: None.
2098 Interim Analysis of 354 Breast Cancer Patients Randomly Treated With Hyperfractionated or Conventional Fractionated Radiation Therapy After Breast-Conserving Surgery S. Li, S. Wang, Y. Song, W. Wang, X. Liu, H. Ren, H. Fang, and Y. Li; Department of Radiation Therapy, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China Purpose/Objective(s): To analyze the efficacy and toxicity of breast cancer patients randomly treated with hypofractionated radiation therapy (HFRT) or conventional fractionated radiation therapy (CFRT) after breast conserving surgery (BCS). Materials/Methods: 354 patients who met the following criteria were enrolled in this study: pathology confirmed invasive breast cancer, with breast conserving surgery, margin negative, without neoadjuvant systemic therapy, without supraclavicular or internal mammary nodal metastases, and without distant metastasis. 185 patients were randomized to receive HFRT (whole breast 43.5 Gy / 15 f / 3 w, followed by tumor bed boost 8.7 Gy / 3 f / 3 d) and 167 to receive CFRT (whole breast 50 Gy / 25 f / 5 w, followed by tumor bed boost 10 Gy / 5 f / 1 w), using simplified intensity modulated radiation therapy or three dimensional conformal radiation therapy techniques. Acute and late toxicities were scaled with CTC3.0 Criteria. Chi-square test was used to compare the differences. Results: The median age was 46 years (range, 21-69 years). With a median follow-up of 16 months (range, 2-44 months), 1 patient developed local recurrence, 1 axillary nodal recurrence and 1 distant metastasis, all from HFRT group. No patient died. The incidence of grade 2 and 3 acute skin toxicity was 4.5% and 2.2% for HFRT group and 10.3% and 0% for CFRT (p Z 0.10). The breast cosmetic outcome was excellent/good, fair, and poor in 89.8%, 10.2% and 0% in HFRT, and 86.5%, 13.0%, 0.5% in CFRT group (p Z 0.36). The incidence of grade 2 pneumonitis was 2.2% for HFRT and 4.2% for CFRT group (p Z 0.53), no grade 3 or more pneumonitis occurred. The incidence of upper limb edema was 8.1% for HFRT and 6.0% for CFRT group (p Z 0.69), and the incidence of shoulder dysfunction was 3.2% for
2099 EBRT Versus APBI: Patient Satisfaction L.C. Keiler,1 S.M. Bitter,2 P. Cartwright,1 C. Wennerstrom,1 W. Jared,1 and D.B. Einstein1; 1Kettering Medical Center, Kettering, OH, 2University of Cincinnati College of Medicine, Cincinnati, OH Purpose/Objective(s): To determine any differences in patient satisfaction for breast cancer patients treated with either external beam radiation therapy (EBRT) or accelerated partial breast radiation (APBI) via HDR brachytherapy utilizing brachytherapy catheters from several manufacturers. Materials/Methods: Charts from 2002 to 2013 (APBI) and 2012 to 2013 (EBRT) were retrospectively reviewed. All patients were given a survey with FACET breast quality of life (QOL) and patient rated breast cosmesis (1-10), nausea, pain, dyspnea, self-consciousness, and presence of lymphedema questions. Treatment details (catheter manufacturer, radiation dosing, chemotherapy, hormone manipulation, and stage) were also collected. Results: We identified 243 APBI patients and 38 EBRT patients. Within the EBRT cohort, 25 women met departmental criteria for APBI treatment (size < 3 cm, post-menopausal). Seventeen women (68%; mean follow-up time of 7 months) treated with EBRT and seventy-eight women (32%; mean follow-up time of 16 months) treated with APBI completed the survey. Women treated with EBRT reported more nausea (p Z 0.04) and lymphedema (p Z 0.046) than those treated with APBI. A trend towards worse pain (p Z 0.06) and more self-consciousness (p Z 0.08) was also seen with EBRT. In the APBI cohort, increased duration of follow-up was significantly positively correlated with more frequent low energy (p Z 0.03, R Z 0.2), nausea (p Z 0.003, R Z 0.3), and dyspnea (p Z 0.02, R Z 0.3). The single lumen Mammosite balloon (LSmean score Z 6/10) was found to be associated with significantly decreased cosmesis when compared to the Mammosite ML (LSmean score Z 8/10; p Z 0.002) and Contura (LSmean score Z 9/10; p Z 0.001) balloons. Furthermore, the Mammosite balloon (LSmean score Z 1.1/4) was found to be associated with significantly more dyspnea when compared to the Savi (LSmean score Z 0.1/4; p Z 0.01) and Contura (LSmean score Z 0/4; p Z 0.003) devices. In the APBI cohort, older patients reported less frequent episodes of nausea (p Z 0.04, R Z -0.2), pain (p Z 0.003, R Z -0.3), and lymphedema (p Z 0.04, R Z -0.2). In the EBRT cohort, tumor size was significantly negatively correlated with pain (p Z 0.03, R Z -0.7). Conclusions: APBI treated patients tend to have worsening quality of life indicators with longer follow-up; however, their experience remains superior compared to a similarly matched EBRT cohort, albeit with a small N. Younger APBI patients and smaller tumors treated with EBRT had worse outcomes. Multi-lumen applicators provided superior cosmetic outcomes and less reported dyspnea. Author Disclosure: L.C. Keiler: None. S.M. Bitter: None. P. Cartwright: None. C. Wennerstrom: None. W. Jared: None. D.B. Einstein: None.
2100 Treatment of Ductal Carcinoma In Situ With Adjuvant Accelerated Partial Breast Irradiation: A Surveillance, Epidemiology, and End ResultseBased Patterns of Care Analysis K. Demas,1 S. Grover,1 S. Sharma,1 S. Showalter,2 and G.M. Freedman1; 1 University of Pennsylvania, Philadelphia, PA, 2University of Virginia, Charlottesville, VA