Pub Date : 2024-10-25DOI: 10.1016/j.brachy.2024.08.057
Alexander Lukez MD , Brian Egleston MPP, PhD , Jeremy Price MD, PhD
<div><h3>Purpose</h3><div>We sought to utilize the National Cancer Database (NCDB) to evaluate trends in radiation therapy (RT) boost modality and to assess outcomes between varying radiation modalities among medically inoperable endometrial cancer patients with locoregionally confined disease.</div></div><div><h3>Materials and Methods</h3><div>Patients with inoperable International Federation of Gynecology and Obstetrics (FIGO) stage I - IIIC2 endometrial cancer treated with radiation ± chemotherapy were analyzed. Practice patterns compared external beam radiation therapy (EBRT) versus high dose-rate (HDR) brachytherapy (BT) boost over time [2004 - 2019]. Kaplan-Meier method evaluated overall survival (OS) and Cox proportional hazard modeling assessed variables associated with OS.</div></div><div><h3>Results</h3><div>NCDB included 1,209 cases (EBRT: 780, BT: 429). EBRT boost patients were more often older (median age [y] EBRT: 70, BT: 68; p = 0.002), treated at a community or comprehensive community cancer program (p = 0.034), insured by the government (p = 0.018), and clinically node positive (p = 0.034). Phase I RT dose did not differ (median [cGy] EBRT: 4,500, BT: 4,500; p = 0.273), although phase II RT dose was lower among EBRT patients (median [cGy] EBRT: 1,440, BT: 2,080; p < 0.001). From 2004 to 2019, EBRT and BT boost rates differed (p = 0.001) with increasing rates of BT consolidation over time (cases in 2014 EBRT: 64 [76%], BT: 20 [24%]; cases in 2019 EBRT: 44 [46%], BT: 51 [54%]). Receipt of chemotherapy (odds ratio [OR] 1.64, 95% confidence interval [CI] 1.05 - 2.56; p = 0.028) was predictive of greater BT utilization while urban or metropolitan areas (rural vs urban OR 0.26, CI 0.092 - 0.74; p = 0.012; rural vs metropolitan OR 0.35, CI 0.14 - 0.92; p = 0.034) and nodal involvement (N0 vs N1 OR 0.47, CI 0.23 - 0.96; p = 0.039; N0 vs N2 OR 0.17, CI 0.035 - 0.84; p = 0.030) were associated with lower utilization of BT. Multivariable analysis (MVA) found BT was associated with lower mortality compared to EBRT (hazard ratio [HR] 0.80, CI 0.68 - 0.95; p = 0.011). MVA found these factors associated with inferior survival: increasing age (HR 1.03, CI 1.02 - 1.04; p < 0.001), greater T stage (T1 vs T2 HR 1.94, CI 1.13 - 3.33; p = 0.016; T1 vs T3 HR 1.66, CI 1.02 - 2.70; p = 0.040), greater N stage (N0 vs N1 HR 1.73, CI 1.20 - 2.49; p = 0.004), and moderately, poorly, or un-differentiated tumor grade (well differentiated [WD] vs moderately differentiated HR 1.28, CI 1.02 - 1.61; p = 0.034; WD vs poorly differentiated HR 1.75, CI 1.37 - 2.25; p < 0.001; WD vs undifferentiated HR 2.17, CI 1.32 - 3.57; p = 0.002).</div></div><div><h3>Conclusions</h3><div>The utilization of a brachytherapy boost for medically inoperable endometrial cancer has increased over time. Brachytherapy consolidation remains an effective RT modality for medically inoperable endometrial cancer, associated with lower mortality compared to EBRT consolidation.</div></
目的我们试图利用美国国家癌症数据库（NCDB）来评估放射治疗（RT）增强模式的趋势，并评估不同放射模式对局部区域局限的无法手术的子宫内膜癌患者的治疗效果。比较了2004-2019年间外照射放疗（EBRT）与高剂量率近距离放射治疗（BT）的实践模式。Kaplan-Meier法评估了总生存期（OS），Cox比例危险模型评估了与OS相关的变量。EBRT增效患者通常年龄较大（中位年龄[y] EBRT：70，BT：68；p = 0.002），在社区或综合性社区癌症项目接受治疗（p = 0.034），由政府投保（p = 0.018），临床结节阳性（p = 0.034）。第一阶段的 RT 剂量没有差异（中位数 [cGy] EBRT：4,500，BT：4,500；p = 0.273），但第二阶段的 RT 剂量在 EBRT 患者中较低（中位数 [cGy] EBRT：1,440，BT：2,080；p <0.001）。从2004年到2019年，EBRT和BT增强率存在差异（p = 0.001），随着时间的推移，BT巩固率越来越高（2014年EBRT病例：64 [76%]，BT：20 [24%]；2019年EBRT病例：44 [46%]，BT：51 [54%]）。接受化疗（几率比 [OR] 1.64，95% 置信区间 [CI] 1.05 - 2.56；P = 0.028）可预测更多的 BT 使用，而城市或大都市地区（农村 vs 城市 OR 0.26，CI 0.092 - 0.74；P = 0.012; rural vs metropolitan OR 0.35, CI 0.14 - 0.92; p = 0.034）和结节受累（N0 vs N1 OR 0.47, CI 0.23 - 0.96; p = 0.039; N0 vs N2 OR 0.17, CI 0.035 - 0.84; p = 0.030）与较低的 BT 使用率相关。多变量分析 (MVA) 发现，与 EBRT 相比，BT 与较低的死亡率相关（危险比 [HR] 0.80，CI 0.68 - 0.95；P = 0.011）。MVA 发现这些因素与较差的生存率相关：年龄增加（HR 1.03，CI 1.02 - 1.04；p < 0.001）、T 期增加（T1 vs T2 HR 1.94，CI 1.13 - 3.33；p = 0.016；T1 vs T3 HR 1.66，CI 1.02 - 2.70；p = 0.040）、N 期增加（N0 vs N1 HR 1.73，CI 1.20 - 2.49；p = 0.004），以及中度、低度或未分化肿瘤分级（分化良好 [WD] vs 中度分化 HR 1.28，CI 1.02 - 1.61；P = 0.034；WD vs 差分化 HR 1.75，CI 1.37 - 2.25; p < 0.001; WD vs 未分化 HR 2.17, CI 1.32 - 3.57; p = 0.002）。结论随着时间的推移，对医学上无法手术的子宫内膜癌使用近距离放射治疗的情况越来越多。近距离放疗巩固治疗仍然是治疗无法手术的子宫内膜癌的有效 RT 方式，与 EBRT 巩固治疗相比，其死亡率更低。
{"title":"GSOR11 Presentation Time: 5:50 PM","authors":"Alexander Lukez MD , Brian Egleston MPP, PhD , Jeremy Price MD, PhD","doi":"10.1016/j.brachy.2024.08.057","DOIUrl":"10.1016/j.brachy.2024.08.057","url":null,"abstract":"<div><h3>Purpose</h3><div>We sought to utilize the National Cancer Database (NCDB) to evaluate trends in radiation therapy (RT) boost modality and to assess outcomes between varying radiation modalities among medically inoperable endometrial cancer patients with locoregionally confined disease.</div></div><div><h3>Materials and Methods</h3><div>Patients with inoperable International Federation of Gynecology and Obstetrics (FIGO) stage I - IIIC2 endometrial cancer treated with radiation ± chemotherapy were analyzed. Practice patterns compared external beam radiation therapy (EBRT) versus high dose-rate (HDR) brachytherapy (BT) boost over time [2004 - 2019]. Kaplan-Meier method evaluated overall survival (OS) and Cox proportional hazard modeling assessed variables associated with OS.</div></div><div><h3>Results</h3><div>NCDB included 1,209 cases (EBRT: 780, BT: 429). EBRT boost patients were more often older (median age [y] EBRT: 70, BT: 68; p = 0.002), treated at a community or comprehensive community cancer program (p = 0.034), insured by the government (p = 0.018), and clinically node positive (p = 0.034). Phase I RT dose did not differ (median [cGy] EBRT: 4,500, BT: 4,500; p = 0.273), although phase II RT dose was lower among EBRT patients (median [cGy] EBRT: 1,440, BT: 2,080; p < 0.001). From 2004 to 2019, EBRT and BT boost rates differed (p = 0.001) with increasing rates of BT consolidation over time (cases in 2014 EBRT: 64 [76%], BT: 20 [24%]; cases in 2019 EBRT: 44 [46%], BT: 51 [54%]). Receipt of chemotherapy (odds ratio [OR] 1.64, 95% confidence interval [CI] 1.05 - 2.56; p = 0.028) was predictive of greater BT utilization while urban or metropolitan areas (rural vs urban OR 0.26, CI 0.092 - 0.74; p = 0.012; rural vs metropolitan OR 0.35, CI 0.14 - 0.92; p = 0.034) and nodal involvement (N0 vs N1 OR 0.47, CI 0.23 - 0.96; p = 0.039; N0 vs N2 OR 0.17, CI 0.035 - 0.84; p = 0.030) were associated with lower utilization of BT. Multivariable analysis (MVA) found BT was associated with lower mortality compared to EBRT (hazard ratio [HR] 0.80, CI 0.68 - 0.95; p = 0.011). MVA found these factors associated with inferior survival: increasing age (HR 1.03, CI 1.02 - 1.04; p < 0.001), greater T stage (T1 vs T2 HR 1.94, CI 1.13 - 3.33; p = 0.016; T1 vs T3 HR 1.66, CI 1.02 - 2.70; p = 0.040), greater N stage (N0 vs N1 HR 1.73, CI 1.20 - 2.49; p = 0.004), and moderately, poorly, or un-differentiated tumor grade (well differentiated [WD] vs moderately differentiated HR 1.28, CI 1.02 - 1.61; p = 0.034; WD vs poorly differentiated HR 1.75, CI 1.37 - 2.25; p < 0.001; WD vs undifferentiated HR 2.17, CI 1.32 - 3.57; p = 0.002).</div></div><div><h3>Conclusions</h3><div>The utilization of a brachytherapy boost for medically inoperable endometrial cancer has increased over time. Brachytherapy consolidation remains an effective RT modality for medically inoperable endometrial cancer, associated with lower mortality compared to EBRT consolidation.</div></","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Page S47"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142527071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<div><h3>Purpose</h3><div>Bugando Medical Centre (BMC) is the only radiotherapy facility in northern Tanzania, and one of only two public facilities for radiotherapy in a country of 60 million. We aimed to characterize gynecologic brachytherapy at BMC and determine patient outcomes. This is the first clinical report from the department since it became operational in 2017.</div></div><div><h3>Materials and Methods</h3><div>This was a retrospective cohort study from 2019, including all patients treated with gynecologic brachytherapy at BMC. Treatment factors, patient characteristics, travel distance/time, and follow-up duration were the primary outcomes. Lack of survival data in available records precluded OS calculations.</div></div><div><h3>Results</h3><div>In 2019, BMC performed 662 brachytherapy procedures, including 204 new starts. HDR brachytherapy was performed with 2D techniques using one Cobalt-60 afterloader. Of the 204 new starts, 195 were evaluable. The median age was 51 years (IQR 44-61 yrs). Stage at diagnosis was 1B in 36 (19%), 2A in 46 (24%), 2B in 49 (25%), 3A in 9 (5%), and 3B in 50 (26%). Histology was squamous cell carcinoma in 139 (71%), adenocarcinoma in 12 (6%), and unknown/other in 44 (23%). HIV status was unknown in 148 (76%), and positive in 22 (11%). 67 patients (34%) were anemic with a hemoglobin of <10 at baseline. Patients came from 36 distinct districts in 11 regions. Median distance traveled was 144 kms (IQR 65-225 kms), and median travel time was 3 hours (IQR 1.8-4.3 hrs). There was no significant difference in disease stage by travel distance or time (p=0.7 & p=0.4). Most patients (86%) were uninsured, and 13% were covered by the national health insurance plan. All patients were treated with curative intent, 177 (91%) were treated with concurrent chemotherapy with EBRT prior to brachytherapy, and 181 (93%) completed planned brachytherapy. Majority of the cases were 3 fractions at 8 Gy/fx prescribed to point A (160 [82%]). Thirteen patients (7%) did not complete planned brachytherapy. Median total duration of treatment was 72 days (IQR 60-109 d). Median duration of EBRT and from EBRT to brachytherapy was 34 days (IQR 34-35 d) and 25 days (IQR 10-78 d) respectively. Median duration of brachytherapy was 14 days (IQR 14-18 d), and 13 (7%) had significant delays of over 40 days to complete brachytherapy. 24 of 167 patients (14%) with data available completed radiation treatment within 55 days. In post-treatment surveillance, 153 (78%) had survival follow up for review in the records. At a median follow up of 15.7 months (IQR 5.7-39.4 mos) for these patients, 2 death events were documented. Assuming a 2-year OS of 65% with 2D brachytherapy based on historical studies, we would have expected approximately 45 events during this timeframe.</div></div><div><h3>Conclusions</h3><div>In this initial report, we detailed the clinical and treatment characteristics of brachytherapy patients at BMC - the only facility in a c
{"title":"GSOR05 Presentation Time: 5:20 PM","authors":"Jim Leng MD , Franco Afyusisye BS , Mwitasrobert Gisiri MD , Pradumna Chaurasia MSc , Godwin Mtali BS , Nestory Masalu MD , Nelson Chao MD, MBA , Junzo Chino MD , Kristin Schroeder MD, MPH , Beda Likonda MD","doi":"10.1016/j.brachy.2024.08.051","DOIUrl":"10.1016/j.brachy.2024.08.051","url":null,"abstract":"<div><h3>Purpose</h3><div>Bugando Medical Centre (BMC) is the only radiotherapy facility in northern Tanzania, and one of only two public facilities for radiotherapy in a country of 60 million. We aimed to characterize gynecologic brachytherapy at BMC and determine patient outcomes. This is the first clinical report from the department since it became operational in 2017.</div></div><div><h3>Materials and Methods</h3><div>This was a retrospective cohort study from 2019, including all patients treated with gynecologic brachytherapy at BMC. Treatment factors, patient characteristics, travel distance/time, and follow-up duration were the primary outcomes. Lack of survival data in available records precluded OS calculations.</div></div><div><h3>Results</h3><div>In 2019, BMC performed 662 brachytherapy procedures, including 204 new starts. HDR brachytherapy was performed with 2D techniques using one Cobalt-60 afterloader. Of the 204 new starts, 195 were evaluable. The median age was 51 years (IQR 44-61 yrs). Stage at diagnosis was 1B in 36 (19%), 2A in 46 (24%), 2B in 49 (25%), 3A in 9 (5%), and 3B in 50 (26%). Histology was squamous cell carcinoma in 139 (71%), adenocarcinoma in 12 (6%), and unknown/other in 44 (23%). HIV status was unknown in 148 (76%), and positive in 22 (11%). 67 patients (34%) were anemic with a hemoglobin of <10 at baseline. Patients came from 36 distinct districts in 11 regions. Median distance traveled was 144 kms (IQR 65-225 kms), and median travel time was 3 hours (IQR 1.8-4.3 hrs). There was no significant difference in disease stage by travel distance or time (p=0.7 & p=0.4). Most patients (86%) were uninsured, and 13% were covered by the national health insurance plan. All patients were treated with curative intent, 177 (91%) were treated with concurrent chemotherapy with EBRT prior to brachytherapy, and 181 (93%) completed planned brachytherapy. Majority of the cases were 3 fractions at 8 Gy/fx prescribed to point A (160 [82%]). Thirteen patients (7%) did not complete planned brachytherapy. Median total duration of treatment was 72 days (IQR 60-109 d). Median duration of EBRT and from EBRT to brachytherapy was 34 days (IQR 34-35 d) and 25 days (IQR 10-78 d) respectively. Median duration of brachytherapy was 14 days (IQR 14-18 d), and 13 (7%) had significant delays of over 40 days to complete brachytherapy. 24 of 167 patients (14%) with data available completed radiation treatment within 55 days. In post-treatment surveillance, 153 (78%) had survival follow up for review in the records. At a median follow up of 15.7 months (IQR 5.7-39.4 mos) for these patients, 2 death events were documented. Assuming a 2-year OS of 65% with 2D brachytherapy based on historical studies, we would have expected approximately 45 events during this timeframe.</div></div><div><h3>Conclusions</h3><div>In this initial report, we detailed the clinical and treatment characteristics of brachytherapy patients at BMC - the only facility in a c","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Page S44"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142527135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-25DOI: 10.1016/j.brachy.2024.08.059
Jui Chih Cheng BSc, MD , Juanita Crook MD , Nikitha Moideen MD , Greg Arbour MSc , Felipe Castro Canovas MD , Deidre Batchelar PhD , Cynthesia Araujo PhD , Ross Halperin MD , Michelle Hilts PhD , David Kim MD , David Petrik MD , Jim Rose MD , Francois Bachand MD
Purpose
This single-center randomized trial compared health-related QOL for men with unfavorable localized prostate cancer treated with combined pelvic external beam radiation (EBRT) and prostate brachytherapy (BT), randomly selected for either High Dose Rate (HDR) or Low Dose Rate (LDR). We now report the efficacy outcomes.
Materials and Methods
Consenting patients receiving pelvic EBRT (46Gy/23) combined with prostate BT were randomized to either LDR (110Gy) or HDR (15Gy) boost. HDRBT preceded EBRT by one week, while LDRBT followed. Androgen deprivation was used in 76%, beginning with three months neoadjuvant and continued for median 12 months. EBRT delivered 46 Gy/23 fractions using IMRT or VMAT in 68% and 3DcRT in 32%. Image guidance was either daily cone beam CT or implanted fiducials. All patients were followed up at 1-, 3-, and 6-mo, every 6 mo to 3 years, then annually. PSA ≤ 0.2 at 4 years defined cure. Biochemical failure-free survival (bFFS), and overall survival (OS) were calculated by Kaplan Meier methods.
Results
From 01/2014 to 12/2019, a random number generator assigned 191 men (42% IR/ 58% HR): 108 to HDR and 87 to LDR. Median age was 71. Clinical stage was T1c in 15%, T2a/b in 48%, T2c/T3a in 35% and T3b in 2%. 43% had Gleason 8 or 9. Median PSA was 11.6 ng/ml, mean 27.0 ng/ml, max 145 ng/ml. The median follow up was 73 months (43m - 116m). The median PSA nadir was 0.07 in HDR and 0.08 in LDR (p=0.16). The median time to PSA nadir was 13.8 mo in HDR and 14.1 in LDR (p=0.87). At four years, 81% of HDR and 83% of LDR had a PSA ≤ 0.2 (p=0.91). At five years, bFFS (nadir+2) for HDR and LDR were 94% and 90% respectively, and at 8 years 86% and 85% respectively. The 8-year OS for HDR and LDR was 73% and 70%. One patient in each arm had intraprostatic local failure. All failures were identified by imaging (CT, bone scan and/or PET) ± biopsy. 12 failures were distant, 3 regional and 2 combined regional and distant.
Conclusions
Previously reported primary QOL endpoint confirmed faster symptom recovery for HDR patients. In this small, randomized comparison, efficacy analysis shows no difference between LDR and HDR boost in biochemical disease-free survival at 5 and 8 years.
{"title":"Friday, July 12, 20241:30 PM - 2:45 PM PL01 Presentation Time: 1:30 PM","authors":"Jui Chih Cheng BSc, MD , Juanita Crook MD , Nikitha Moideen MD , Greg Arbour MSc , Felipe Castro Canovas MD , Deidre Batchelar PhD , Cynthesia Araujo PhD , Ross Halperin MD , Michelle Hilts PhD , David Kim MD , David Petrik MD , Jim Rose MD , Francois Bachand MD","doi":"10.1016/j.brachy.2024.08.059","DOIUrl":"10.1016/j.brachy.2024.08.059","url":null,"abstract":"<div><h3>Purpose</h3><div>This single-center randomized trial compared health-related QOL for men with unfavorable localized prostate cancer treated with combined pelvic external beam radiation (EBRT) and prostate brachytherapy (BT), randomly selected for either High Dose Rate (HDR) or Low Dose Rate (LDR). We now report the efficacy outcomes.</div></div><div><h3>Materials and Methods</h3><div>Consenting patients receiving pelvic EBRT (46Gy/23) combined with prostate BT were randomized to either LDR (110Gy) or HDR (15Gy) boost. HDRBT preceded EBRT by one week, while LDRBT followed. Androgen deprivation was used in 76%, beginning with three months neoadjuvant and continued for median 12 months. EBRT delivered 46 Gy/23 fractions using IMRT or VMAT in 68% and 3DcRT in 32%. Image guidance was either daily cone beam CT or implanted fiducials. All patients were followed up at 1-, 3-, and 6-mo, every 6 mo to 3 years, then annually. PSA ≤ 0.2 at 4 years defined cure. Biochemical failure-free survival (bFFS), and overall survival (OS) were calculated by Kaplan Meier methods.</div></div><div><h3>Results</h3><div>From 01/2014 to 12/2019, a random number generator assigned 191 men (42% IR/ 58% HR): 108 to HDR and 87 to LDR. Median age was 71. Clinical stage was T1c in 15%, T2a/b in 48%, T2c/T3a in 35% and T3b in 2%. 43% had Gleason 8 or 9. Median PSA was 11.6 ng/ml, mean 27.0 ng/ml, max 145 ng/ml. The median follow up was 73 months (43m - 116m). The median PSA nadir was 0.07 in HDR and 0.08 in LDR (p=0.16). The median time to PSA nadir was 13.8 mo in HDR and 14.1 in LDR (p=0.87). At four years, 81% of HDR and 83% of LDR had a PSA ≤ 0.2 (p=0.91). At five years, bFFS (nadir+2) for HDR and LDR were 94% and 90% respectively, and at 8 years 86% and 85% respectively. The 8-year OS for HDR and LDR was 73% and 70%. One patient in each arm had intraprostatic local failure. All failures were identified by imaging (CT, bone scan and/or PET) ± biopsy. 12 failures were distant, 3 regional and 2 combined regional and distant.</div></div><div><h3>Conclusions</h3><div>Previously reported primary QOL endpoint confirmed faster symptom recovery for HDR patients. In this small, randomized comparison, efficacy analysis shows no difference between LDR and HDR boost in biochemical disease-free survival at 5 and 8 years.</div></div>","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Page S48"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142527073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-25DOI: 10.1016/j.brachy.2024.08.006
Lauren M. Andring MD , Ramez Kouzy MDR , Kelsey L. Corrigan MD, MPH , Neil Bailard MD , Maliah Domingo BS , Bryan Fellman BS , Jasmine Varkey AGNP , Tomar Foster-Mills AGNP , Lilie Lin MD , Anuja Jhingran MD , Lauren Colbert MD , Ann H. Klopp MD, PhD , Melissa M. Joyner MD, MBA
<div><h3>Background</h3><div>An ERP is a standardized patient-centered protocol that aims to minimize symptom burden and enhance functional recovery after surgery. ERPs are widely adopted by many surgical specialties and have demonstrated improved outcomes; however, there remains no data looking at the role of an ERP for patients undergoing brachytherapy.</div></div><div><h3>Methods</h3><div>A prospective trial of cervical cancer patients treated at a single institution with definitive chemoradiation (CRT) and brachytherapy boost, before (n=33) and after (n=33) the implementation of an ERP. The ERP included referral to nutrition and social work at initial consult, pre-operative carbohydrate loading, peri-operative prophylactic symptom management, goal-directed fluid delivery, early mobility, and referral to pelvic floor physical therapy at follow-up (FU). Patient reported outcomes (PROs) were assessed using the EORTC QLQ-C30 and EORTC QLQ-CX24 validated survey metrics and were collected before CRT, at the end of treatment (EOT), and 60-day FU. Higher scores for functional scales and global health status represent favorable outcomes, while higher scores for symptom scales are unfavorable. The difference in individual patient score from EOT to FU was calculated for each domain and the median difference for each cohort was analyzed to evaluate post-procedure functional recovery. A difference of 10 points was considered significant. Wilcoxon signed rank test was used to compare median length of hospital stay between cohorts, p<0.05 was significant.</div></div><div><h3>Results</h3><div>Thirty-three patients were enrolled on the pre-ERP arm of this study, 28 (85%) completed baseline, 22 (67%) EOT, and 21 (64%) follow-up PRO metrics. An additional 33 patients were enrolled post-ERP, 28 (85%) completed baseline, 25 (76%) EOT, and 22 (67%) follow-up questionnaires. Median health related quality of life (HRQOL) at FU was significantly higher post-ERP (41.7 vs 25, p=0.001), with a median improvement from EOT of 6.7pts compared to a median decline of -8.4pts in the pre-ERP cohort. From EOT to FU both groups had an overall decrease in symptom burden, median decrease of -15.2pts post-ERP vs. -6pts pre-ERP. The post-ERP cohort reported significant improvement in dyspnea (-33pts) and emotional function (8.3pts) at FU, compared to median change of 0 in the pre-ERP cohort <strong>(Figure 1)</strong>. From the start of radiation to 60 days FU, the total number of emergency room visits without admission was 9 in the pre-ERP cohort compared to 13 in the post-ERP cohort. However, the total number of hospital admissions was significantly higher in the pre-ERP cohort (17 vs 9) and the associated median length of hospital stay was significantly longer (3.9 vs 1.8 days, p =0.028).</div></div><div><h3>Conclusion</h3><div>A standardized ERP for cervical cancer patients undergoing definitive CRT and brachytherapy led to improved HRQOL, fewer hospital admissions, decreased
{"title":"GPP04 Presentation Time: 9:27 AM","authors":"Lauren M. Andring MD , Ramez Kouzy MDR , Kelsey L. Corrigan MD, MPH , Neil Bailard MD , Maliah Domingo BS , Bryan Fellman BS , Jasmine Varkey AGNP , Tomar Foster-Mills AGNP , Lilie Lin MD , Anuja Jhingran MD , Lauren Colbert MD , Ann H. Klopp MD, PhD , Melissa M. Joyner MD, MBA","doi":"10.1016/j.brachy.2024.08.006","DOIUrl":"10.1016/j.brachy.2024.08.006","url":null,"abstract":"<div><h3>Background</h3><div>An ERP is a standardized patient-centered protocol that aims to minimize symptom burden and enhance functional recovery after surgery. ERPs are widely adopted by many surgical specialties and have demonstrated improved outcomes; however, there remains no data looking at the role of an ERP for patients undergoing brachytherapy.</div></div><div><h3>Methods</h3><div>A prospective trial of cervical cancer patients treated at a single institution with definitive chemoradiation (CRT) and brachytherapy boost, before (n=33) and after (n=33) the implementation of an ERP. The ERP included referral to nutrition and social work at initial consult, pre-operative carbohydrate loading, peri-operative prophylactic symptom management, goal-directed fluid delivery, early mobility, and referral to pelvic floor physical therapy at follow-up (FU). Patient reported outcomes (PROs) were assessed using the EORTC QLQ-C30 and EORTC QLQ-CX24 validated survey metrics and were collected before CRT, at the end of treatment (EOT), and 60-day FU. Higher scores for functional scales and global health status represent favorable outcomes, while higher scores for symptom scales are unfavorable. The difference in individual patient score from EOT to FU was calculated for each domain and the median difference for each cohort was analyzed to evaluate post-procedure functional recovery. A difference of 10 points was considered significant. Wilcoxon signed rank test was used to compare median length of hospital stay between cohorts, p<0.05 was significant.</div></div><div><h3>Results</h3><div>Thirty-three patients were enrolled on the pre-ERP arm of this study, 28 (85%) completed baseline, 22 (67%) EOT, and 21 (64%) follow-up PRO metrics. An additional 33 patients were enrolled post-ERP, 28 (85%) completed baseline, 25 (76%) EOT, and 22 (67%) follow-up questionnaires. Median health related quality of life (HRQOL) at FU was significantly higher post-ERP (41.7 vs 25, p=0.001), with a median improvement from EOT of 6.7pts compared to a median decline of -8.4pts in the pre-ERP cohort. From EOT to FU both groups had an overall decrease in symptom burden, median decrease of -15.2pts post-ERP vs. -6pts pre-ERP. The post-ERP cohort reported significant improvement in dyspnea (-33pts) and emotional function (8.3pts) at FU, compared to median change of 0 in the pre-ERP cohort <strong>(Figure 1)</strong>. From the start of radiation to 60 days FU, the total number of emergency room visits without admission was 9 in the pre-ERP cohort compared to 13 in the post-ERP cohort. However, the total number of hospital admissions was significantly higher in the pre-ERP cohort (17 vs 9) and the associated median length of hospital stay was significantly longer (3.9 vs 1.8 days, p =0.028).</div></div><div><h3>Conclusion</h3><div>A standardized ERP for cervical cancer patients undergoing definitive CRT and brachytherapy led to improved HRQOL, fewer hospital admissions, decreased","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Page S18"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142526614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<div><h3>Purpose</h3><div>This presentation shares highlights of the International Atomic Energy Agency (IAEA) Technical Report Series 492 Code of Practice on brachytherapy (BT) dosimetry.</div></div><div><h3>Methods</h3><div>This IAEA Code of Practice is addressed to both secondary standards dosimetry laboratories (SSDLs) and hospitals, not addressed to primary standards dosimetry laboratories (PSDLs), and is based on the use of well-type re-entrant ionization chambers. It applies to all BT sources with intensities measurable by such detectors. The dosimetry formalism, common procedures for reference dosimetry and for calibration, reference-class instrument assessment, and commissioning of well-type chamber system are described. This Code of Practice is aimed to enable common procedures to perform dosimetry of radioactive sources used in BT, excluding beta-emitting eye plaques/applicators as well as stranded seeds and mesh-type sources. Targeted radionuclide therapy and miniature electronic brachytherapy (eBT) devices were also excluded. It provides a description of the most accurate and sensitive calibration systems available at PSDLs and recommends suitable detectors and procedures for source strength measurements at SSDLs and hospitals.</div></div><div><h3>Results</h3><div>This Code of Practice consists of ten sections and six appendices. Following the introduction in Section 1 that frames the background and scope, Section 2 provides a description of the radioactive sources currently available for BT. The dosimetric quantities reference air kerma rate, air kerma strength and absorbed dose to water are discussed in Section 3, along with the dose-rate constant and other parameters important to dosimetrically characterize BT sources. Section 4 provides a detailed description of well-type ionization chamber instrumentation and defines the requisites for reference-class instruments. It also includes a description of HDR remote afterloaders. Section 5 contextualizes the dosimetry framework that defines dissemination of primary dosimetry standards down to the hospital level. Section 6 provides an overview of the available primary standards useful for BT calibrations. Their dissemination through the adoption of a well-type chamber dosimetry system is furthermore described. Section 7 defines the dosimetry formalism employed for the determination of the dosimetry quantities used herein. The general procedure to properly perform BT dosimetry with the well-type chamber is given in Section 8, along with a description of methods to check for short and long term stability of the measurement system. Section 9 deals with estimating uncertainties typically involved with source strength measurement of LDR and HDR sources. The way measured reference quantities are useful in the clinical practice for assessing the dose to the patient is outlined in Section 10. The main BT source categories and treatment delivery methods are briefly approached. Appendices are prov
{"title":"PP05 Presentation Time: 4:36 PM","authors":"Mark Rivard Ph.D. , Larry DeWerd Ph.D. , Mauro Carrara Ph.D. , Tomislav Bokulic Ph.D. , Malcolm McEwen Ph.D. , Thorsten Sander Ph.D. , Thorsten Schneider Ph.D. , Paula Toroi Ph.D.","doi":"10.1016/j.brachy.2024.08.024","DOIUrl":"10.1016/j.brachy.2024.08.024","url":null,"abstract":"<div><h3>Purpose</h3><div>This presentation shares highlights of the International Atomic Energy Agency (IAEA) Technical Report Series 492 Code of Practice on brachytherapy (BT) dosimetry.</div></div><div><h3>Methods</h3><div>This IAEA Code of Practice is addressed to both secondary standards dosimetry laboratories (SSDLs) and hospitals, not addressed to primary standards dosimetry laboratories (PSDLs), and is based on the use of well-type re-entrant ionization chambers. It applies to all BT sources with intensities measurable by such detectors. The dosimetry formalism, common procedures for reference dosimetry and for calibration, reference-class instrument assessment, and commissioning of well-type chamber system are described. This Code of Practice is aimed to enable common procedures to perform dosimetry of radioactive sources used in BT, excluding beta-emitting eye plaques/applicators as well as stranded seeds and mesh-type sources. Targeted radionuclide therapy and miniature electronic brachytherapy (eBT) devices were also excluded. It provides a description of the most accurate and sensitive calibration systems available at PSDLs and recommends suitable detectors and procedures for source strength measurements at SSDLs and hospitals.</div></div><div><h3>Results</h3><div>This Code of Practice consists of ten sections and six appendices. Following the introduction in Section 1 that frames the background and scope, Section 2 provides a description of the radioactive sources currently available for BT. The dosimetric quantities reference air kerma rate, air kerma strength and absorbed dose to water are discussed in Section 3, along with the dose-rate constant and other parameters important to dosimetrically characterize BT sources. Section 4 provides a detailed description of well-type ionization chamber instrumentation and defines the requisites for reference-class instruments. It also includes a description of HDR remote afterloaders. Section 5 contextualizes the dosimetry framework that defines dissemination of primary dosimetry standards down to the hospital level. Section 6 provides an overview of the available primary standards useful for BT calibrations. Their dissemination through the adoption of a well-type chamber dosimetry system is furthermore described. Section 7 defines the dosimetry formalism employed for the determination of the dosimetry quantities used herein. The general procedure to properly perform BT dosimetry with the well-type chamber is given in Section 8, along with a description of methods to check for short and long term stability of the measurement system. Section 9 deals with estimating uncertainties typically involved with source strength measurement of LDR and HDR sources. The way measured reference quantities are useful in the clinical practice for assessing the dose to the patient is outlined in Section 10. The main BT source categories and treatment delivery methods are briefly approached. Appendices are prov","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Page S29"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142526710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-25DOI: 10.1016/j.brachy.2024.08.032
Adam Chichel PhD, Adam Kluska PhD, Artur J. Chyrek PhD, Wojciech M. Burchardt PhD
<div><h3>Purpose</h3><div>A prospective mono-institutional non-randomized open-label study (NTC05142202) is being carried out to establish the role of adjuvant multicatheter interstitial high-dose-rate brachytherapy (HDR-BT) in doubly accelerated and radiobiologically equivalent irradiation scheme of 5 × 5,4 Gy delivered in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 × 4-4,3 Gy) in selected women with low-risk invasive breast cancer or carcinoma in-situ. It is to report an interim analysis on the first 1- and 3-month early toxicity profiles and 1- and 3-month early cosmetic outcome results of a novel fractionation scheme adjuvant to breast-conserving surgery.</div></div><div><h3>Material and Methods</h3><div>Early low-risk breast cancer patients (pT<sub>is-2</sub>N<sub>0</sub>) were recruited between October 2021 and December 2023 (recruitment closed on 12/31/2024 according to protocol). Postoperative adjuvant treatment with interstitial HDR-BT was given for three days (5 fractions of 5,4 Gy; 6 hours apart; total dose 27,0 Gy) on an outpatient basis. Follow-up (FU) is continued one-month post-treatment, then three months up to 2 years, and six months up to 5 years. Early toxicity incidence (radiodermatitis, hematoma, breast infection, intraoperative breast damage, breast pain) is being assessed according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE) up to 3 months FU. We also assess early 1- and 3-month Harvard scale-based cosmetic outcomes and record patients' feedback on a four-grade subjective breast appearance scale (excellent, good, satisfying, poor). Photographic documentation is being secured.</div></div><div><h3>Results</h3><div>One hundred forty-seven women aged 65 (51-85) were enrolled. At the time of analysis, all patients reached 1-month FU, and 132 (89,9%) reached 3-month FU. Early toxicities at one-month FU were: radiodermatitis G1 - 4 (2.7%); hematoma G1 - 21 (14.3%); breast pain G1 - 24 (16.3%), G2 - 2 (1.4%). Early toxicities at three-month FU were: radiodermatitis G1 - 2 (1.5%); hematoma G1 - 4 (3%); breast pain G1 - 18 (13.6%), G2 - 1 (0.8%). No breast infections occurred. Patients subjectively assessed their cosmetic outcome after one-month post-treatment as excellent at 57.8%, good at 36.1%, satisfying at 5.4%, and poor at 0.7%; after three months, excellent at 61.4%, good at 31.1%, satisfying at 7.1%, and poor at 0.0%. Clinicians assessed cosmesis on the Harvard scale after one month as grade I - 9.5%, II - 81.6%, III - 8.9%, IV - none; after three months as grade I - 21.2%, II - 74.2%, III - 4.6%, IV - none.</div></div><div><h3>Conclusions</h3><div>The incidence of early 1- and 3-month toxicity events is low and improves quickly. Hematomas heal quickly and spontaneously. Rare local and slight painful sensations are more persistent but do not disturb patients' daily activity. Patients assess their cosmesis much better subjectively th
{"title":"BP08 Presentation Time: 5:03 PM","authors":"Adam Chichel PhD, Adam Kluska PhD, Artur J. Chyrek PhD, Wojciech M. Burchardt PhD","doi":"10.1016/j.brachy.2024.08.032","DOIUrl":"10.1016/j.brachy.2024.08.032","url":null,"abstract":"<div><h3>Purpose</h3><div>A prospective mono-institutional non-randomized open-label study (NTC05142202) is being carried out to establish the role of adjuvant multicatheter interstitial high-dose-rate brachytherapy (HDR-BT) in doubly accelerated and radiobiologically equivalent irradiation scheme of 5 × 5,4 Gy delivered in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 × 4-4,3 Gy) in selected women with low-risk invasive breast cancer or carcinoma in-situ. It is to report an interim analysis on the first 1- and 3-month early toxicity profiles and 1- and 3-month early cosmetic outcome results of a novel fractionation scheme adjuvant to breast-conserving surgery.</div></div><div><h3>Material and Methods</h3><div>Early low-risk breast cancer patients (pT<sub>is-2</sub>N<sub>0</sub>) were recruited between October 2021 and December 2023 (recruitment closed on 12/31/2024 according to protocol). Postoperative adjuvant treatment with interstitial HDR-BT was given for three days (5 fractions of 5,4 Gy; 6 hours apart; total dose 27,0 Gy) on an outpatient basis. Follow-up (FU) is continued one-month post-treatment, then three months up to 2 years, and six months up to 5 years. Early toxicity incidence (radiodermatitis, hematoma, breast infection, intraoperative breast damage, breast pain) is being assessed according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE) up to 3 months FU. We also assess early 1- and 3-month Harvard scale-based cosmetic outcomes and record patients' feedback on a four-grade subjective breast appearance scale (excellent, good, satisfying, poor). Photographic documentation is being secured.</div></div><div><h3>Results</h3><div>One hundred forty-seven women aged 65 (51-85) were enrolled. At the time of analysis, all patients reached 1-month FU, and 132 (89,9%) reached 3-month FU. Early toxicities at one-month FU were: radiodermatitis G1 - 4 (2.7%); hematoma G1 - 21 (14.3%); breast pain G1 - 24 (16.3%), G2 - 2 (1.4%). Early toxicities at three-month FU were: radiodermatitis G1 - 2 (1.5%); hematoma G1 - 4 (3%); breast pain G1 - 18 (13.6%), G2 - 1 (0.8%). No breast infections occurred. Patients subjectively assessed their cosmetic outcome after one-month post-treatment as excellent at 57.8%, good at 36.1%, satisfying at 5.4%, and poor at 0.7%; after three months, excellent at 61.4%, good at 31.1%, satisfying at 7.1%, and poor at 0.0%. Clinicians assessed cosmesis on the Harvard scale after one month as grade I - 9.5%, II - 81.6%, III - 8.9%, IV - none; after three months as grade I - 21.2%, II - 74.2%, III - 4.6%, IV - none.</div></div><div><h3>Conclusions</h3><div>The incidence of early 1- and 3-month toxicity events is low and improves quickly. Hematomas heal quickly and spontaneously. Rare local and slight painful sensations are more persistent but do not disturb patients' daily activity. Patients assess their cosmesis much better subjectively th","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Page S33"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142527276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-25DOI: 10.1016/j.brachy.2024.08.090
Robin Straathof MSc , Sharline M. van Vliet-Pérez MSc , Linda S. Wauben PhD , Ben J. Heijmen Prof. PhD , Inger-Karine K. Kolkman-Deurloo PhD , Remi A. Nout Prof. PhD , Jenny Dankelman Prof. PhD , Nick J. van de Berg PhD
<div><h3>Purpose</h3><div>The clinical introduction of novel medical devices (MDs) requires conformity to the Medical Device Regulation (MDR) 2017/745 in Europe, or the Food and Drug Administration (FDA) in the USA. Compliance is also required for hardware or software developed or modified in-house for investigational purposes, custom treatment, or hospital-specific procedures. This entails a significant workload for hospitals. For investigational MDs this includes documentation of, among others, device description, design controls, manufacturing procedures, risk analyses, and evaluations of device safety and effectiveness. This work describes our efforts from a regulatory perspective in the context of in-house development and evaluation of a novel 3D-printed brachytherapy (BT) applicator.</div></div><div><h3>Materials and Methods</h3><div>Figure 1 shows an overview of the implemented regulatory workflow. The patient-tailored ARCHITECT applicator contains optimised needle channels and is intended for locally advanced cervical cancer (LACC) patients. To establish a programme of design requirements, a process tree was constructed (IEC 62366-1:2015), and function and risk analyses (ISO 14971:2019) were performed with stakeholders. Several design iterations were created, 3D-printed, and evaluated by users in a phantom. A manufacturer was selected based on their QMS certification (ISO 13485:2016) and experience with selective laser sintering of PA-12. For this material, a biological evaluation plan (ISO 10993-1:2020) was created to demonstrate biocompatibility. Several pre-clinical evaluations were performed: (1) dose attenuation (TG-43:2004), (2) applicator channel temperature during steam sterilisation at 134°C and 3.04 bar, (3) virtual dose planning for 22 patients previously treated with a clinically used commercial applicator, and (4) needle deflection with varying insertion angles in a phantom.</div></div><div><h3>Results</h3><div>The final concept embodiment design of the ARCHITECT applicator consists of two 3D-printed halves connecting to a commercially available tandem. Evaluations showed that: (1) PA-12 had a water-equivalent response with dose attenuation differences <1% between dose depth curves for PA-12 and water, (2) in-channel temperatures of 134°C were maintained for the required 3 minutes, (3) virtual dose planning for all patients resulted in clinically acceptable plans that had similar or improved dose conformity in comparison with the clinically used configuration, and (4) maximum deviations from straight line needle paths amounted to 0.7-4.7 mm at 40 mm depth, depending on the insertion angle.</div></div><div><h3>Conclusions</h3><div>Regulatory aspects associated with the introduction of novel brachytherapy devices to the clinic have only been scarcely documented. In this work we provide a case example for the ARCHITECT applicator. A series of pre-clinical validations were performed to demonstrate safety and performance of the
{"title":"GPP04 Presentation Time: 10:57 AM","authors":"Robin Straathof MSc , Sharline M. van Vliet-Pérez MSc , Linda S. Wauben PhD , Ben J. Heijmen Prof. PhD , Inger-Karine K. Kolkman-Deurloo PhD , Remi A. Nout Prof. PhD , Jenny Dankelman Prof. PhD , Nick J. van de Berg PhD","doi":"10.1016/j.brachy.2024.08.090","DOIUrl":"10.1016/j.brachy.2024.08.090","url":null,"abstract":"<div><h3>Purpose</h3><div>The clinical introduction of novel medical devices (MDs) requires conformity to the Medical Device Regulation (MDR) 2017/745 in Europe, or the Food and Drug Administration (FDA) in the USA. Compliance is also required for hardware or software developed or modified in-house for investigational purposes, custom treatment, or hospital-specific procedures. This entails a significant workload for hospitals. For investigational MDs this includes documentation of, among others, device description, design controls, manufacturing procedures, risk analyses, and evaluations of device safety and effectiveness. This work describes our efforts from a regulatory perspective in the context of in-house development and evaluation of a novel 3D-printed brachytherapy (BT) applicator.</div></div><div><h3>Materials and Methods</h3><div>Figure 1 shows an overview of the implemented regulatory workflow. The patient-tailored ARCHITECT applicator contains optimised needle channels and is intended for locally advanced cervical cancer (LACC) patients. To establish a programme of design requirements, a process tree was constructed (IEC 62366-1:2015), and function and risk analyses (ISO 14971:2019) were performed with stakeholders. Several design iterations were created, 3D-printed, and evaluated by users in a phantom. A manufacturer was selected based on their QMS certification (ISO 13485:2016) and experience with selective laser sintering of PA-12. For this material, a biological evaluation plan (ISO 10993-1:2020) was created to demonstrate biocompatibility. Several pre-clinical evaluations were performed: (1) dose attenuation (TG-43:2004), (2) applicator channel temperature during steam sterilisation at 134°C and 3.04 bar, (3) virtual dose planning for 22 patients previously treated with a clinically used commercial applicator, and (4) needle deflection with varying insertion angles in a phantom.</div></div><div><h3>Results</h3><div>The final concept embodiment design of the ARCHITECT applicator consists of two 3D-printed halves connecting to a commercially available tandem. Evaluations showed that: (1) PA-12 had a water-equivalent response with dose attenuation differences <1% between dose depth curves for PA-12 and water, (2) in-channel temperatures of 134°C were maintained for the required 3 minutes, (3) virtual dose planning for all patients resulted in clinically acceptable plans that had similar or improved dose conformity in comparison with the clinically used configuration, and (4) maximum deviations from straight line needle paths amounted to 0.7-4.7 mm at 40 mm depth, depending on the insertion angle.</div></div><div><h3>Conclusions</h3><div>Regulatory aspects associated with the introduction of novel brachytherapy devices to the clinic have only been scarcely documented. In this work we provide a case example for the ARCHITECT applicator. A series of pre-clinical validations were performed to demonstrate safety and performance of the","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Page S67"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142527285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-25DOI: 10.1016/j.brachy.2024.08.089
Clara Fallone PhD , Ali Golestani PhD , Deepak Bhayana MD , Daniel Cho PhD
Purpose
The gold standard Brachytherapy (BT) treatment for cervical cancer uses MRI guidance. Some employ MRI-only BT planning, eliminating registration errors between MRI and CT. Challenges in MRI-only BT include accurately reconstructing applicators and catheters due to geometric distortion. Distortions should be < 2 mm for MRI-only BT planning. The EMBRACE II protocol recommends acquiring T2-weighted sequences for contouring and T1-weighted or proton-density weighted sequences for applicator reconstruction. Various sequences have been assessed for MRI-only BT. The commercially-available General Electric (GE) PROPELLER (Periodically Rotated Overlapping ParallEL Lines with Enhanced Reconstruction) sequence has not yet been evaluated for this use. This T2-weighted sequence yields high contrast resolution and reduces motion artifact. This work evaluates the use of the PROPELLER sequence in MRI-only BT planning. The use of another commercially available sequence: 3D LAVA-FLEX (liver acceleration volume acquisition) is also assessed. Utilizing 3D LAVA FLEX enables acquiring a high resolution, high signal, T1-weighted image in a relatively short time.
Materials and Methods
A cylindrical water-equivalent gel phantom was created, incorporating a Venezia (Elekta) applicator with one straight and one oblique needle. Three plastic spheres were glued on the phantom as external coordinate markers. The phantom was scanned using the PROPELLER and 3D-LAVA Flex pulse sequences with a 1.5 Tesla GE wide-bore MRI scanner and body coil. Oblique axial slices oriented in the tandem plane were acquired. The phantom was also scanned on a Philips Big Bore RT CT scanner. The slice thickness was 4 mm for PROPELLER, 2 mm for 3D-LAVA FLEX, and 1.5 mm for CT. In-plane resolution was 1 mm for the MRI images and 0.6 mm for CT images. Images were imported into the Oncentra treatment planning system (Elekta, version 4.6.2). Library modelling was used to reconstruct the Venezia applicator; catheters were manually reconstructed. Physical dimensions measured included the distance between the tandem, needles, and external markers. Measurements acquired from the MRI images were compared to those acquired from CT; distortions were calculated as the absolute difference and a maximum was computed.
Results
Maximum distortions of five total geometric measurements in phantom were 1.3 mm for PROPELLER and 0.7 mm for 3D LAVA-FLEX. Figure 1 reveals axial and reconstructed sagittal images using the investigated sequences and CT for the phantom.
Conclusion
Given that distortions are within 2 mm and image quality and contrast is suitable for reconstruction and contouring, PROPELLER and 3D LAVA-FLEX are appropriate pulse sequences for MR-only BT planning, and their corresponding advantages can thus be exploited.
{"title":"GPP03 Presentation Time: 10:48 AM","authors":"Clara Fallone PhD , Ali Golestani PhD , Deepak Bhayana MD , Daniel Cho PhD","doi":"10.1016/j.brachy.2024.08.089","DOIUrl":"10.1016/j.brachy.2024.08.089","url":null,"abstract":"<div><h3>Purpose</h3><div>The gold standard Brachytherapy (BT) treatment for cervical cancer uses MRI guidance. Some employ MRI-only BT planning, eliminating registration errors between MRI and CT. Challenges in MRI-only BT include accurately reconstructing applicators and catheters due to geometric distortion. Distortions should be < 2 mm for MRI-only BT planning. The EMBRACE II protocol recommends acquiring T2-weighted sequences for contouring and T1-weighted or proton-density weighted sequences for applicator reconstruction. Various sequences have been assessed for MRI-only BT. The commercially-available General Electric (GE) PROPELLER (Periodically Rotated Overlapping ParallEL Lines with Enhanced Reconstruction) sequence has not yet been evaluated for this use. This T2-weighted sequence yields high contrast resolution and reduces motion artifact. This work evaluates the use of the PROPELLER sequence in MRI-only BT planning. The use of another commercially available sequence: 3D LAVA-FLEX (liver acceleration volume acquisition) is also assessed. Utilizing 3D LAVA FLEX enables acquiring a high resolution, high signal, T1-weighted image in a relatively short time.</div></div><div><h3>Materials and Methods</h3><div>A cylindrical water-equivalent gel phantom was created, incorporating a Venezia (Elekta) applicator with one straight and one oblique needle. Three plastic spheres were glued on the phantom as external coordinate markers. The phantom was scanned using the PROPELLER and 3D-LAVA Flex pulse sequences with a 1.5 Tesla GE wide-bore MRI scanner and body coil. Oblique axial slices oriented in the tandem plane were acquired. The phantom was also scanned on a Philips Big Bore RT CT scanner. The slice thickness was 4 mm for PROPELLER, 2 mm for 3D-LAVA FLEX, and 1.5 mm for CT. In-plane resolution was 1 mm for the MRI images and 0.6 mm for CT images. Images were imported into the Oncentra treatment planning system (Elekta, version 4.6.2). Library modelling was used to reconstruct the Venezia applicator; catheters were manually reconstructed. Physical dimensions measured included the distance between the tandem, needles, and external markers. Measurements acquired from the MRI images were compared to those acquired from CT; distortions were calculated as the absolute difference and a maximum was computed.</div></div><div><h3>Results</h3><div>Maximum distortions of five total geometric measurements in phantom were 1.3 mm for PROPELLER and 0.7 mm for 3D LAVA-FLEX. Figure 1 reveals axial and reconstructed sagittal images using the investigated sequences and CT for the phantom.</div></div><div><h3>Conclusion</h3><div>Given that distortions are within 2 mm and image quality and contrast is suitable for reconstruction and contouring, PROPELLER and 3D LAVA-FLEX are appropriate pulse sequences for MR-only BT planning, and their corresponding advantages can thus be exploited.</div></div>","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Pages S66-S67"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142527286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-25DOI: 10.1016/j.brachy.2024.08.088
Linda Rossi PhD, Rik Bijman PhD, Henrike Westerveld MD, PhD, Miranda Christianen MD, Lorne Luthart RTT, Michele Huge RTT, Inger-Karine Kolkman-Deurloo PhD, Jan-Willem Mens MD, Huda Abusaris MD, Raymond de Boer MD, Sebastiaan Breedveld PhD, Ben Heijmen (Prof), Remi Nout MD (Prof)
<div><h3>Purpose</h3><div>Fully automated adaptive treatment planning for image-guided cervical cancer brachytherapy following EMBRACE II planning aims, using ‘BiCycle’, was recently been developed. Favorable results were achieved in retrospective research studies [Oud et al., Radiother Oncol 148:143, 2020; Bijman et al., Radiother Oncol 170(S390), 2022; Rossi et al. Radiother Oncol 182(S92), 2023]. In this study, BiCycle was implemented parallel to the clinical routine to prospectively evaluate its impact on plan quality and workload. Dosimetrical parameters and planning times were prospectively collected as well as subjective plan scoring by five of the six clinicians performing cervical cancer brachytherapy.</div></div><div><h3>Materials and Methods</h3><div>Between June 2022 and January 2023, max. 2 patients per week were included, if compatible with clinical workload. Each patient was treated with an intracavitary applicator with interstitial needles, using a manually generated plan, without modifying clinical practice. Manual plan generation was performed by an RTT in Oncentra-Brachy (OCB) (Elekta) followed by a manual plan adjustment togehter with the treating physician (if desired), leading to a Man_Adj plan used for delivery. After treatment, an automated plan was generated using BiCycle aiming at the same CTVHR D90% as in the Man_Adj plan (Auto plan generation). The plan was then imported into OCB and evaluated, and optionally adjusted without access to the Man_Adj plan by the same treating physician who also evaluated and adjusted the manual plan, resulting in an Auto_Adj plan. Next, the treating physician compared Auto_Adj and Man_Adj plans using Visual Analogue Scales (VAS) for i) overall plan quality, ii) target structures doses only, iii) OARs doses only and iv) loading pattern only. For each VAS, the clinician first selected the favorable plan and then expressed the importance of superiority using a 0-100 scale. Both for manual planning and autoplanning, times needed to generate and adjust the plan were recorded.</div></div><div><h3>Results</h3><div>Data of 41 fraction plans were included, resulting in 37 evaluable plans due to 3 not evaluated in time, and 1 missing informed consent. Auto_Adj plans resulted in superior plan quality compared to Man_Adj in almost all aspects. While CTVHR D90% and GTVRES D98% improved by 0.3 and 1.7 Gy, respectively, CTVIR D98% decreased by 1.3 Gy, while always remaining within constraints (results expressed in total EBRT+BT EQD2Gy doses). Auto_Adj reduced bladder, rectum, sigmoid and bowel D2cc by on average by 3.7, 3.0, 1.0, 1.4 Gy, respectively. Treating physicians expressed an overall preference for Auto_Adj, which was preferred in 28, 17, 30 and 7 plans out of 37 for VAS overall, CTV, OARs and loading pattern respectively, while Man_Adj was preferred in 2, 1, 2 and 9 plans respectively. Planning+adjustment times significantly reduced with automated planning for all fractions (Figure 1), with a r
{"title":"GPP02 Presentation Time: 10:39 AM","authors":"Linda Rossi PhD, Rik Bijman PhD, Henrike Westerveld MD, PhD, Miranda Christianen MD, Lorne Luthart RTT, Michele Huge RTT, Inger-Karine Kolkman-Deurloo PhD, Jan-Willem Mens MD, Huda Abusaris MD, Raymond de Boer MD, Sebastiaan Breedveld PhD, Ben Heijmen (Prof), Remi Nout MD (Prof)","doi":"10.1016/j.brachy.2024.08.088","DOIUrl":"10.1016/j.brachy.2024.08.088","url":null,"abstract":"<div><h3>Purpose</h3><div>Fully automated adaptive treatment planning for image-guided cervical cancer brachytherapy following EMBRACE II planning aims, using ‘BiCycle’, was recently been developed. Favorable results were achieved in retrospective research studies [Oud et al., Radiother Oncol 148:143, 2020; Bijman et al., Radiother Oncol 170(S390), 2022; Rossi et al. Radiother Oncol 182(S92), 2023]. In this study, BiCycle was implemented parallel to the clinical routine to prospectively evaluate its impact on plan quality and workload. Dosimetrical parameters and planning times were prospectively collected as well as subjective plan scoring by five of the six clinicians performing cervical cancer brachytherapy.</div></div><div><h3>Materials and Methods</h3><div>Between June 2022 and January 2023, max. 2 patients per week were included, if compatible with clinical workload. Each patient was treated with an intracavitary applicator with interstitial needles, using a manually generated plan, without modifying clinical practice. Manual plan generation was performed by an RTT in Oncentra-Brachy (OCB) (Elekta) followed by a manual plan adjustment togehter with the treating physician (if desired), leading to a Man_Adj plan used for delivery. After treatment, an automated plan was generated using BiCycle aiming at the same CTVHR D90% as in the Man_Adj plan (Auto plan generation). The plan was then imported into OCB and evaluated, and optionally adjusted without access to the Man_Adj plan by the same treating physician who also evaluated and adjusted the manual plan, resulting in an Auto_Adj plan. Next, the treating physician compared Auto_Adj and Man_Adj plans using Visual Analogue Scales (VAS) for i) overall plan quality, ii) target structures doses only, iii) OARs doses only and iv) loading pattern only. For each VAS, the clinician first selected the favorable plan and then expressed the importance of superiority using a 0-100 scale. Both for manual planning and autoplanning, times needed to generate and adjust the plan were recorded.</div></div><div><h3>Results</h3><div>Data of 41 fraction plans were included, resulting in 37 evaluable plans due to 3 not evaluated in time, and 1 missing informed consent. Auto_Adj plans resulted in superior plan quality compared to Man_Adj in almost all aspects. While CTVHR D90% and GTVRES D98% improved by 0.3 and 1.7 Gy, respectively, CTVIR D98% decreased by 1.3 Gy, while always remaining within constraints (results expressed in total EBRT+BT EQD2Gy doses). Auto_Adj reduced bladder, rectum, sigmoid and bowel D2cc by on average by 3.7, 3.0, 1.0, 1.4 Gy, respectively. Treating physicians expressed an overall preference for Auto_Adj, which was preferred in 28, 17, 30 and 7 plans out of 37 for VAS overall, CTV, OARs and loading pattern respectively, while Man_Adj was preferred in 2, 1, 2 and 9 plans respectively. Planning+adjustment times significantly reduced with automated planning for all fractions (Figure 1), with a r","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Pages S65-S66"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142527287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-25DOI: 10.1016/j.brachy.2024.08.084
Åsa Carlsson Tedgren (Professor) , Linda Persson PhD , Ilias Billas PhD , Graham Bass PhD , Thorsten Sander PhD , Simon Dahlander MSc
<div><h3>Purpose/Objective</h3><div>In radiotherapy, independent verification of the treatment fields is standard practice. However, for <sup>106</sup>Ru eye plaque brachytherapy there is no such method available. This has led to many hospitals performing treatments without verification of plaque absorbed dose rate to water [1], as also addressed by the AAPM TG No 221 [2]. To enhance the safety of brachytherapy treatments for intraocular tumors, we devised an independent measurement protocol to determine depth-dose curves from <sup>106</sup>Ru eye-plaques using a new high precision setup equipment and diode detector.</div></div><div><h3>Material/Methods</h3><div>The absorbed dose rate to water was measured from five plaques (Bebig Eckert and Ziegler), four CCB types and one CCA type, using three PTW microSilicon detectors with a prototype, dedicated setup equipment from the plaque vendor named BetaCheck-106. The diodes were calibrated in <sup>60</sup>Co at the Swedish secondary standards metrology laboratory. Beam quality correction factors along the lines of the TRS-398 protocol [3] were calculated with the PENELOPE Monte Carlo code and detector blueprints. Absorbed dose rate measurements were performed in the water-filled PMMA phantom. Furthermore, the depth-dose curves were validated against vendor data and data from alanine detectors measurements with the latter performed at the primary standard laboratory of the National Physical Laboratory, UK and traceable to a <sup>60</sup>Co primary standard of absorbed dose to water.</div></div><div><h3>Result</h3><div>The absorbed dose rates to water measured with the diodes and alanine detectors fell within the vendor's expanded measurement uncertainty, 11% (<em>k</em>=2), but were lower than the vendor's values. For the CCB applicators at the 2 mm distance reference point, the absorbed dose rates measured with the diode detectors were on average 9% lower, while the absorbed dose rates measured with alanine detectors were 7.4% lower. For the CCA applicator, the absorbed dose rate was 7% and 4.6% lower for diode- and alanine detectors, respectively. Preliminary results are shown in Figure 1.</div></div><div><h3>Conclusion</h3><div>Our study shows an efficient measurement protocol for verifying <sup>106</sup>Ru eye-plaque absorbed dose-rates. The dose rates measured by diode and alanine detectors both show lower dose rates compared to vendor certificates, but are still within the vendor's expanded measurement uncertainty. The discrepancy will be further investigated. The dedicated setup equipment provided high repeatability, which is crucial for reliably measuring the steep dose gradients from <sup>106</sup>Ru. Diode detectors calibrated in <sup>60</sup>Co with Monte Carlo calculated detector correction factors provide vendor independent traceability. The methodology offers hospitals a feasible way to verify absorbed dose-rate to water depth dose curves and so increase safety of patient treatments and f
{"title":"PHSOR10 Presentation Time: 9:45 AM","authors":"Åsa Carlsson Tedgren (Professor) , Linda Persson PhD , Ilias Billas PhD , Graham Bass PhD , Thorsten Sander PhD , Simon Dahlander MSc","doi":"10.1016/j.brachy.2024.08.084","DOIUrl":"10.1016/j.brachy.2024.08.084","url":null,"abstract":"<div><h3>Purpose/Objective</h3><div>In radiotherapy, independent verification of the treatment fields is standard practice. However, for <sup>106</sup>Ru eye plaque brachytherapy there is no such method available. This has led to many hospitals performing treatments without verification of plaque absorbed dose rate to water [1], as also addressed by the AAPM TG No 221 [2]. To enhance the safety of brachytherapy treatments for intraocular tumors, we devised an independent measurement protocol to determine depth-dose curves from <sup>106</sup>Ru eye-plaques using a new high precision setup equipment and diode detector.</div></div><div><h3>Material/Methods</h3><div>The absorbed dose rate to water was measured from five plaques (Bebig Eckert and Ziegler), four CCB types and one CCA type, using three PTW microSilicon detectors with a prototype, dedicated setup equipment from the plaque vendor named BetaCheck-106. The diodes were calibrated in <sup>60</sup>Co at the Swedish secondary standards metrology laboratory. Beam quality correction factors along the lines of the TRS-398 protocol [3] were calculated with the PENELOPE Monte Carlo code and detector blueprints. Absorbed dose rate measurements were performed in the water-filled PMMA phantom. Furthermore, the depth-dose curves were validated against vendor data and data from alanine detectors measurements with the latter performed at the primary standard laboratory of the National Physical Laboratory, UK and traceable to a <sup>60</sup>Co primary standard of absorbed dose to water.</div></div><div><h3>Result</h3><div>The absorbed dose rates to water measured with the diodes and alanine detectors fell within the vendor's expanded measurement uncertainty, 11% (<em>k</em>=2), but were lower than the vendor's values. For the CCB applicators at the 2 mm distance reference point, the absorbed dose rates measured with the diode detectors were on average 9% lower, while the absorbed dose rates measured with alanine detectors were 7.4% lower. For the CCA applicator, the absorbed dose rate was 7% and 4.6% lower for diode- and alanine detectors, respectively. Preliminary results are shown in Figure 1.</div></div><div><h3>Conclusion</h3><div>Our study shows an efficient measurement protocol for verifying <sup>106</sup>Ru eye-plaque absorbed dose-rates. The dose rates measured by diode and alanine detectors both show lower dose rates compared to vendor certificates, but are still within the vendor's expanded measurement uncertainty. The discrepancy will be further investigated. The dedicated setup equipment provided high repeatability, which is crucial for reliably measuring the steep dose gradients from <sup>106</sup>Ru. Diode detectors calibrated in <sup>60</sup>Co with Monte Carlo calculated detector correction factors provide vendor independent traceability. The methodology offers hospitals a feasible way to verify absorbed dose-rate to water depth dose curves and so increase safety of patient treatments and f","PeriodicalId":55334,"journal":{"name":"Brachytherapy","volume":"23 6","pages":"Page S63"},"PeriodicalIF":1.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142527201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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