首页 > 最新文献

Advances in Radiation Oncology最新文献

英文 中文
Radiation-Induced Lymphopenia is a Causal Mediator of Survival After Chemoradiation Therapy for Esophagus Cancer 放射诱导的淋巴细胞减少症是食道癌化放疗后生存率的一个因果中介因素
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-26 DOI: 10.1016/j.adro.2024.101579
Yiqing Chen MSc , Yan Chu PhD , Peter S.N. van Rossum MD, PhD , Clemens Grassberger PhD , Steven H. Lin MD, PhD , Radhe Mohan PhD , Brian P. Hobbs PhD

Purpose

Radiation-induced lymphopenia (RIL) is common during chemoradiation therapy. Severe lymphopenia is associated with reduced survival. Proton beam therapy (PBT), with its substantially more compact dose distributions, spares circulating lymphocytes and immune organs at risk to a greater extent than photon therapy. Recent studies comparing PBT to photon radiation therapy, specifically intensity-modulated radiation therapy (IMRT) for esophageal cancer (EC), showed that the incidence of grade 4 RIL (G4RIL) is significantly reduced among patients receiving PBT for EC. However, whether the extent of this reduction has a direct causative link with improved survival is unknown. This study applies causal mediation analysis to answer this question.

Methods and Materials

We retrospectively assessed 734 patients treated with concurrent chemoradiation therapy for biopsy-proven EC from 2004 to 2017. To address the potential for bias in the choice of radiation modality, propensity score analysis was used to evaluate and reduce imbalances between the PBT and IMRT cohorts. Causal mediation analysis was applied to decompose the total effect of radiation modality on overall survival (OS) into indirect (mediated through G4RIL) and direct effects.

Results

We found that PBT was associated with a significantly lower incidence of G4RIL and prolonged OS compared with IMRT (odds ratio, 0.41; 95% CI, 0.28-0.60; P < .001). In the propensity-matched cohort of 506 patients (253 PBT, 253 IMRT), G4RIL risk reduction with PBT versus IMRT translated into a 5% reduction in the relative rate of death (P = .032). Mediation of G4RIL explained ∼14.5% of the difference in OS.

Conclusions

G4RIL was found to mediate survival; however, a statistically significant direct effect of PBT on survival was not observed. In other words, the statistical significance of survival benefit from protons over photons in this EC cohort was lost in the absence of G4RIL risk reduction.

目的放疗诱导的淋巴细胞减少症(RIL)在化疗期间很常见。严重的淋巴细胞减少与生存率降低有关。质子束疗法(PBT)的剂量分布更为紧凑,与光子疗法相比,它能在更大程度上避免循环淋巴细胞和免疫器官遭受风险。最近的研究比较了质子束疗法和光子放射疗法,特别是针对食管癌(EC)的调强放射疗法(IMRT),结果表明,接受质子束疗法治疗食管癌的患者中,4级RIL(G4RIL)的发生率明显降低。然而,这种降低的程度是否与生存率的提高有直接的因果关系尚不清楚。本研究采用因果中介分析法来回答这一问题。方法和材料我们回顾性评估了2004年至2017年接受同期化放疗治疗的734例活检证实EC患者。为了解决放射模式选择中可能存在的偏倚,我们使用倾向评分分析来评估和减少PBT和IMRT队列之间的不平衡。结果我们发现,与 IMRT 相比,PBT 与 G4RIL 发生率显著降低和 OS 延长相关(几率比 0.41;95% CI,0.28-0.60;P < .001)。在 506 例患者(253 例 PBT,253 例 IMRT)的倾向匹配队列中,PBT 与 IMRT 相比,G4RIL 风险降低了 5%,相对死亡率降低了 5%(P = .032)。结论发现 G4RIL 对生存有中介作用;但是,没有观察到 PBT 对生存有统计学意义的直接影响。换句话说,在这个欧共体队列中,质子比光子对生存的益处在统计学上的意义因 G4RIL 风险降低而丧失。
{"title":"Radiation-Induced Lymphopenia is a Causal Mediator of Survival After Chemoradiation Therapy for Esophagus Cancer","authors":"Yiqing Chen MSc ,&nbsp;Yan Chu PhD ,&nbsp;Peter S.N. van Rossum MD, PhD ,&nbsp;Clemens Grassberger PhD ,&nbsp;Steven H. Lin MD, PhD ,&nbsp;Radhe Mohan PhD ,&nbsp;Brian P. Hobbs PhD","doi":"10.1016/j.adro.2024.101579","DOIUrl":"10.1016/j.adro.2024.101579","url":null,"abstract":"<div><h3>Purpose</h3><p>Radiation-induced lymphopenia (RIL) is common during chemoradiation therapy. Severe lymphopenia is associated with reduced survival. Proton beam therapy (PBT), with its substantially more compact dose distributions, spares circulating lymphocytes and immune organs at risk to a greater extent than photon therapy. Recent studies comparing PBT to photon radiation therapy, specifically intensity-modulated radiation therapy (IMRT) for esophageal cancer (EC), showed that the incidence of grade 4 RIL (G4RIL) is significantly reduced among patients receiving PBT for EC. However, whether the extent of this reduction has a direct causative link with improved survival is unknown. This study applies causal mediation analysis to answer this question.</p></div><div><h3>Methods and Materials</h3><p>We retrospectively assessed 734 patients treated with concurrent chemoradiation therapy for biopsy-proven EC from 2004 to 2017. To address the potential for bias in the choice of radiation modality, propensity score analysis was used to evaluate and reduce imbalances between the PBT and IMRT cohorts. Causal mediation analysis was applied to decompose the total effect of radiation modality on overall survival (OS) into indirect (mediated through G4RIL) and direct effects.</p></div><div><h3>Results</h3><p>We found that PBT was associated with a significantly lower incidence of G4RIL and prolonged OS compared with IMRT (odds ratio, 0.41; 95% CI, 0.28-0.60; <em>P</em> &lt; .001). In the propensity-matched cohort of 506 patients (253 PBT, 253 IMRT), G4RIL risk reduction with PBT versus IMRT translated into a 5% reduction in the relative rate of death (<em>P</em> = .032). Mediation of G4RIL explained ∼14.5% of the difference in OS.</p></div><div><h3>Conclusions</h3><p>G4RIL was found to mediate survival; however, a statistically significant direct effect of PBT on survival was not observed. In other words, the statistical significance of survival benefit from protons over photons in this EC cohort was lost in the absence of G4RIL risk reduction.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 10","pages":"Article 101579"},"PeriodicalIF":2.2,"publicationDate":"2024-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001428/pdfft?md5=8700e3d1bb3a630172295360a8a952bf&pid=1-s2.0-S2452109424001428-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141843498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Echocardiographic Functional Outcomes Following Regional Nodal Irradiation for Breast Cancer Using Volumetric Modulated Arc Therapy 使用容积调制弧线疗法进行乳腺癌区域结节照射后的超声心动图功能结果
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-25 DOI: 10.1016/j.adro.2024.101581
Anthony F. Yu MD, MS , Charlie White PhD , Zhigang Zhang PhD , Jennifer E. Liu MD , Erin F. Gillespie MD , Beryl McCormick MD , Atif J. Khan MD , Richard M. Steingart MD , Simon N. Powell MD, PhD , Oren Cahlon MD , Lior Z. Braunstein MD

Purpose

Regional nodal irradiation (RNI) for breast cancer yields improvements in disease outcomes, yet comprehensive target coverage often increases cardiac radiation therapy (RT) dose. Volumetric modulated arc therapy (VMAT) may mitigate high-dose cardiac exposure, although it often increases the volume of low-dose exposure. The cardiac implications of this dosimetric configuration (in contrast to historic 3D conformal techniques) remain uncertain.

Methods and Materials

Eligible patients receiving adjuvant RNI using VMAT for locoregional breast cancer were prospectively enrolled in an IRB-approved study. Echocardiograms were performed prior to RT, at the conclusion of RT, and 6 months following RT. Echocardiographic parameters were measured by a single reader and measures were compared pre- and post-RT via the signed-rank test. Changes in echocardiographic parameters over time were compared to mean and max heart doses via the Spearman correlation test.

Results

Among 19 evaluable patients (median age 38 years), 89% (n = 17) received doxorubicin and 37% (n = 7) received trastuzumab/pertuzumab combination therapy. All patients received VMAT-based whole-breast/chest wall and RNI. The average mean heart dose was 456 cGy (range, 187-697 cGy) and the average max heart dose was 3001 cGy (1560-4793 cGy). Among salient echocardiographic parameters, no significant decrement in cardiac function was observed when comparing pre-RT to 6 months post-RT: mean left ventricular ejection fraction (LVEF) was 61.8% (SD 4.4%) pre-RT and 62.7% (SD 3.8%) 6 months post-RT (P = .493); mean global longitudinal strain (GLS) was –19.3% (SD 2.2%) pre-RT and –19.6% (SD 1.8%) 6 months post-RT (P = .627). No individual patient exhibited reduced LVEF or sustained decrement in GLS. No correlations were observed for changes in LVEF or GLS when compared to mean or maximum heart doses (P > .1 for all).

Conclusions

VMAT for left-sided RNI yielded no significant early decrement in echocardiographic parameters of cardiac function, including LVEF and GLS, within this limited cohort. No patient exhibited significant LVEF changes, and none exhibited sustained decrements in GLS. VMAT may be a reasonable approach to cardiac avoidance in patients requiring RNI, including those receiving anthracyclines and HER2-directed therapy. Larger cohorts with longer follow-ups will be needed to validate these findings.

目的 乳腺癌区域结节照射(RNI)可改善疾病预后,但全面的靶区覆盖往往会增加心脏放疗(RT)剂量。容积调强弧形疗法(VMAT)可减轻高剂量心脏照射,但往往会增加低剂量照射量。这种剂量配置(与历史悠久的三维适形技术相比)对心脏的影响仍不确定。方法和材料一项经 IRB 批准的研究前瞻性地招募了使用 VMAT 辅助 RNI 治疗局部乳腺癌的合格患者。分别在 RT 术前、RT 术后和 RT 术后 6 个月进行超声心动图检查。超声心动图参数由一名读片员测量,并通过符号秩检验比较RT前后的测量结果。结果19名可评估患者(中位年龄38岁)中,89%(n=17)接受多柔比星治疗,37%(n=7)接受曲妥珠单抗/哌妥珠单抗联合治疗。所有患者都接受了基于VMAT的全胸/胸壁和RNI治疗。平均心脏剂量为456 cGy(范围为187-697 cGy),平均最大心脏剂量为3001 cGy(1560-4793 cGy)。在突出的超声心动图参数中,将射频消融术前与射频消融术后 6 个月进行比较,未观察到心脏功能的显著下降:射频消融术前平均左室射血分数(LVEF)为 61.8%(标清 4.4%),射频消融术后 6 个月为 62.7%(标清 3.8%)(P = .493);射频消融术前平均整体纵向应变(GLS)为 -19.3%(标清 2.2%),射频消融术后 6 个月为 -19.6%(标清 1.8%)(P = .627)。没有患者表现出 LVEF 降低或 GLS 持续下降。与平均或最大心脏剂量相比,未观察到 LVEF 或 GLS 的变化存在相关性(均为 P > .1)。没有患者的 LVEF 出现明显变化,也没有患者的 GLS 出现持续下降。对于需要接受 RNI 治疗的患者,包括接受蒽环类药物和 HER2 导向治疗的患者,VMAT 可能是一种合理的心脏回避方法。要验证这些研究结果,还需要更大范围、更长时间的随访。
{"title":"Echocardiographic Functional Outcomes Following Regional Nodal Irradiation for Breast Cancer Using Volumetric Modulated Arc Therapy","authors":"Anthony F. Yu MD, MS ,&nbsp;Charlie White PhD ,&nbsp;Zhigang Zhang PhD ,&nbsp;Jennifer E. Liu MD ,&nbsp;Erin F. Gillespie MD ,&nbsp;Beryl McCormick MD ,&nbsp;Atif J. Khan MD ,&nbsp;Richard M. Steingart MD ,&nbsp;Simon N. Powell MD, PhD ,&nbsp;Oren Cahlon MD ,&nbsp;Lior Z. Braunstein MD","doi":"10.1016/j.adro.2024.101581","DOIUrl":"10.1016/j.adro.2024.101581","url":null,"abstract":"<div><h3>Purpose</h3><p>Regional nodal irradiation (RNI) for breast cancer yields improvements in disease outcomes, yet comprehensive target coverage often increases cardiac radiation therapy (RT) dose. Volumetric modulated arc therapy (VMAT) may mitigate high-dose cardiac exposure, although it often increases the volume of low-dose exposure. The cardiac implications of this dosimetric configuration (in contrast to historic 3D conformal techniques) remain uncertain.</p></div><div><h3>Methods and Materials</h3><p>Eligible patients receiving adjuvant RNI using VMAT for locoregional breast cancer were prospectively enrolled in an IRB-approved study. Echocardiograms were performed prior to RT, at the conclusion of RT, and 6 months following RT. Echocardiographic parameters were measured by a single reader and measures were compared pre- and post-RT via the signed-rank test. Changes in echocardiographic parameters over time were compared to mean and max heart doses via the Spearman correlation test.</p></div><div><h3>Results</h3><p>Among 19 evaluable patients (median age 38 years), 89% (n = 17) received doxorubicin and 37% (n = 7) received trastuzumab/pertuzumab combination therapy. All patients received VMAT-based whole-breast/chest wall and RNI. The average mean heart dose was 456 cGy (range, 187-697 cGy) and the average max heart dose was 3001 cGy (1560-4793 cGy). Among salient echocardiographic parameters, no significant decrement in cardiac function was observed when comparing pre-RT to 6 months post-RT: mean left ventricular ejection fraction (LVEF) was 61.8% (SD 4.4%) pre-RT and 62.7% (SD 3.8%) 6 months post-RT (<em>P</em> = .493); mean global longitudinal strain (GLS) was –19.3% (SD 2.2%) pre-RT and –19.6% (SD 1.8%) 6 months post-RT (<em>P</em> = .627). No individual patient exhibited reduced LVEF or sustained decrement in GLS. No correlations were observed for changes in LVEF or GLS when compared to mean or maximum heart doses (<em>P</em> &gt; .1 for all).</p></div><div><h3>Conclusions</h3><p>VMAT for left-sided RNI yielded no significant early decrement in echocardiographic parameters of cardiac function, including LVEF and GLS, within this limited cohort. No patient exhibited significant LVEF changes, and none exhibited sustained decrements in GLS. VMAT may be a reasonable approach to cardiac avoidance in patients requiring RNI, including those receiving anthracyclines and HER2-directed therapy. Larger cohorts with longer follow-ups will be needed to validate these findings.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 10","pages":"Article 101581"},"PeriodicalIF":2.2,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001441/pdfft?md5=f086438632f3ea7e61ec0506485e2fd3&pid=1-s2.0-S2452109424001441-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141844368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Preoperative Ultrahypofractionated Radiation Therapy for Soft Tissue Sarcomas: Low Rate of Wound Complications 软组织肉瘤术前超高分次放射治疗:伤口并发症发生率低
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-23 DOI: 10.1016/j.adro.2024.101562
Alexander Mattmann MMed , Christoph Glanzmann MD , Bruno Fuchs MD, PhD , Beata Bode MD , Gabriela Studer MD , Swiss Sarcoma Network

Purpose

Normofractionated preoperative radiation therapy (nRT) with 50 Gy applied in 25 fractions represents the most widely used radiation therapy (RT) regimen in combined local treatment of soft tissue sarcomas (STSs). STSs are characterized by a low α/β ratio of 4 to 5 Gy, which may translate into a higher sensitivity for hypofractionation. Increasing data from cohorts and phase 2 trials on ultrahypofractionated RT (uhRT) regimens are available. We prospectively assessed our preoperative uhRT sarcoma patient cohort with a focus on short-term wound complications (WCs).

Methods and Materials

This is a prospective registry analysis of a single-center patient cohort, treated from 03.2020 to 10.2023 with uhRT (25 Gy in 5 fractions in 1 week). The same radiation oncologists (G.S./C.G.) and surgeon (B.F.) performed the treatment (61/61 and 58/60), as well as the same reference pathologist (B.B.) confirmed all histopathologic diagnoses. WC (according to CAN-NCIC-SR2 trial) and intermediate local control (LC) rates were assessed and compared with outcome data of a previously published cohort of 67 extremity/trunk sarcoma patients treated with nRT by the same authors (7% WC, 98% LC at 3 years).

Results

After a mean/median follow-up of 19/19 months (range, 0-46), LC at 1.5 years was 94%. Surgery was performed at a mean/median of 20/16 days (range, 4-60) after uhRT completion. WC were observed in 7/60 operated patients (12%), and in 5/51 (10%) extremity/trunk lesions. Early tolerance was excellent, limited to G0 to G1, even in 3 patients with prior RT to the same region. Clear resection margins were achieved in 55/60 patients (92%). Pathologic necrosis of ≥95% was reported in 5% and 75% achieved less than 50% necrosis.

Conclusions

These results show low rates of WC and high LC for uhRT and are comparable with our previously published nRT data. This study supports the routine use of preoperative uhRT for STS.

目的在软组织肉瘤(STS)的联合局部治疗中,50 Gy、25 次分割的术前正分割放射治疗(normofractionated preoperative radiation therapy,nRT)是应用最广泛的放射治疗(RT)方案。软组织肉瘤的特点是α/β比值较低,仅为4到5 Gy,这可能意味着对低分次治疗的敏感性更高。关于超低分次 RT(uhRT)方案的队列和 2 期试验数据越来越多。我们对术前超低分次RT肉瘤患者队列进行了前瞻性评估,重点关注短期伤口并发症(WCs)。方法与材料这是对2020年3月至2023年10月期间接受超低分次RT(25 Gy,1周内分5次)治疗的单中心患者队列进行的前瞻性登记分析。同一放射肿瘤专家(G.S./C.G.)和外科医生(B.F.)进行了治疗(61/61 和 58/60),同一参考病理学家(B.B.)确认了所有组织病理学诊断。对WC(根据CAN-NCIC-SR2试验)和中期局部控制(LC)率进行了评估,并将其与同一作者之前发表的67例接受nRT治疗的四肢/躯干肉瘤患者的结果数据进行了比较(3年后WC率为7%,LC率为98%)。手术时间平均/中位数为 uhRT 结束后 20/16 天(4-60 天)。在7/60例手术患者(12%)和5/51例(10%)四肢/躯干病变中观察到WC。早期耐受性极佳,仅限于 G0 至 G1,甚至有 3 名患者曾在同一区域接受过 RT 治疗。55/60例患者(92%)的切除边缘清晰。据报道,5%的患者病理坏死率≥95%,75%的患者坏死率低于50%。这项研究支持对 STS 常规使用术前 uhRT。
{"title":"Preoperative Ultrahypofractionated Radiation Therapy for Soft Tissue Sarcomas: Low Rate of Wound Complications","authors":"Alexander Mattmann MMed ,&nbsp;Christoph Glanzmann MD ,&nbsp;Bruno Fuchs MD, PhD ,&nbsp;Beata Bode MD ,&nbsp;Gabriela Studer MD ,&nbsp;Swiss Sarcoma Network","doi":"10.1016/j.adro.2024.101562","DOIUrl":"10.1016/j.adro.2024.101562","url":null,"abstract":"<div><h3>Purpose</h3><p>Normofractionated preoperative radiation therapy (nRT) with 50 Gy applied in 25 fractions represents the most widely used radiation therapy (RT) regimen in combined local treatment of soft tissue sarcomas (STSs). STSs are characterized by a low <em>α/β</em> ratio of 4 to 5 Gy, which may translate into a higher sensitivity for hypofractionation. Increasing data from cohorts and phase 2 trials on ultrahypofractionated RT (uhRT) regimens are available. We prospectively assessed our preoperative uhRT sarcoma patient cohort with a focus on short-term wound complications (WCs).</p></div><div><h3>Methods and Materials</h3><p>This is a prospective registry analysis of a single-center patient cohort, treated from 03.2020 to 10.2023 with uhRT (25 Gy in 5 fractions in 1 week). The same radiation oncologists (G.S./C.G.) and surgeon (B.F.) performed the treatment (61/61 and 58/60), as well as the same reference pathologist (B.B.) confirmed all histopathologic diagnoses. WC (according to CAN-NCIC-SR2 trial) and intermediate local control (LC) rates were assessed and compared with outcome data of a previously published cohort of 67 extremity/trunk sarcoma patients treated with nRT by the same authors (7% WC, 98% LC at 3 years).</p></div><div><h3>Results</h3><p>After a mean/median follow-up of 19/19 months (range, 0-46), LC at 1.5 years was 94%. Surgery was performed at a mean/median of 20/16 days (range, 4-60) after uhRT completion. WC were observed in 7/60 operated patients (12%), and in 5/51 (10%) extremity/trunk lesions. Early tolerance was excellent, limited to G0 to G1, even in 3 patients with prior RT to the same region. Clear resection margins were achieved in 55/60 patients (92%). Pathologic necrosis of ≥95% was reported in 5% and 75% achieved less than 50% necrosis.</p></div><div><h3>Conclusions</h3><p>These results show low rates of WC and high LC for uhRT and are comparable with our previously published nRT data. This study supports the routine use of preoperative uhRT for STS.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 10","pages":"Article 101562"},"PeriodicalIF":2.2,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001258/pdfft?md5=13ab9f5fbdaeaf3249732d9525070fdb&pid=1-s2.0-S2452109424001258-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141842726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Stereotactic Magnetic Resonance–Guided Daily Adaptive Radiation Therapy for Localized Prostate Cancer: Acute and Late Patient-Reported Toxicity Outcomes 针对局部前列腺癌的立体定向 MR 引导日适应放疗(SMART):患者报告的急性和晚期毒性结果。
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-18 DOI: 10.1016/j.adro.2024.101574
Killian Nugent FFR, RCSI , Prantik Das FRCR , Dan Ford FRCR , Ami Sabharwal FRCR , Carla Perna FRCR , Nicola Dallas FRCR , Jason Lester FRCR , Philip Camilleri FRCR

Purpose

To report acute and late bowel, urinary, and sexual dysfunction patient-reported outcome measures, among patients with localized prostate cancer who underwent stereotactic magnetic resonance–guided daily adaptive radiation therapy (SMART).

Methods and Materials

All patients who completed a baseline 12-item Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events questionnaire, before undergoing SMART with 36.25 Gy in 5 fractions, were subsequently followed up with the same graded questionnaire at set time points. Latest prostate-specific antigen levels were recorded. The percentage of patients who reported no change from their baseline adverse event (AE) or reported a new ≥ “frequent or almost constant” or “severe grade or higher” AE grade during follow-up was calculated. The maximum 12-item Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events grade for each item was recorded for each patient. The percentage of toxicity levels for each separate AE item at set time points was calculated.

Results

The total number of patients was 69 with a median follow-up of 27 months. Median age of the cohort was 73 years (range, 54-85 years). The median pretreatment prostate-specific antigen level, T stage, and Gleason score were 7.5 mmol/L (range, 4.5-32 mmol/L), T2b (range, T2-T3b), and 7 (3 + 4; range, 6-9), respectively. No patient had biochemical failure during follow-up. Regarding bowel symptoms, >80% of men reported no change from baseline toxicity during follow-up. New ≥ frequent or almost constant diarrhea was reported in 9% of patients. “Almost constant” diarrhea peaked at 1 month but was absent at >33 months. Regarding urinary symptoms, increased urinary urgency was the most common complaint (39%). Twenty percent of men reported new ≥ frequent or almost constant urinary urgency incidence peaking at 1 month but absent at >33 months. New “severe” sexual dysfunction was seen in 26% of patients and was persistent at >33 months.

Conclusions

Our study is one the largest patient-reported outcomes study after prostate SMART. It shows acceptable levels of toxicity even up to 2 years after treatment.

目的报告接受立体定向磁共振引导下每日适应性放疗(SMART)的局部前列腺癌患者的急性和晚期肠道、泌尿和性功能障碍患者报告结果。方法和材料所有患者在接受5次36.25 Gy分次放疗的SMART治疗前,都填写了基线12项不良事件通用术语标准患者报告结果版本问卷,随后在设定的时间点以相同的分级问卷进行随访。记录了最新的前列腺特异性抗原水平。在随访过程中,与基线不良事件(AE)相比无变化或出现新的≥"频繁或几乎持续 "或 "严重级或更高 "AE等级的患者比例被计算出来。记录每位患者每个项目的最高 12 项《患者报告结果版不良事件通用术语标准》分级。结果患者总数为 69 人,中位随访时间为 27 个月。中位年龄为 73 岁(54-85 岁)。治疗前前列腺特异性抗原水平、T分期和格里森评分的中位数分别为7.5 mmol/L(范围为4.5-32 mmol/L)、T2b(范围为T2-T3b)和7(3 + 4;范围为6-9)。随访期间,没有患者出现生化功能衰竭。关于肠道症状,>80%的男性患者在随访期间表示与基线毒性相比没有变化。9%的患者报告出现新的≥频繁或几乎持续的腹泻。"几乎持续 "的腹泻在 1 个月时达到高峰,但在 33 个月时已消失。关于泌尿系统症状,尿急是最常见的主诉(39%)。20%的男性报告说,新的≥频繁或几乎持续的尿急症状在 1 个月时达到高峰,但在 33 个月时消失。26%的患者出现了新的 "严重 "性功能障碍,并持续了33个月。我们的研究是前列腺 SMART 治疗后最大规模的患者报告结果研究之一。研究显示,即使在治疗后 2 年,毒性水平也是可以接受的。
{"title":"Stereotactic Magnetic Resonance–Guided Daily Adaptive Radiation Therapy for Localized Prostate Cancer: Acute and Late Patient-Reported Toxicity Outcomes","authors":"Killian Nugent FFR, RCSI ,&nbsp;Prantik Das FRCR ,&nbsp;Dan Ford FRCR ,&nbsp;Ami Sabharwal FRCR ,&nbsp;Carla Perna FRCR ,&nbsp;Nicola Dallas FRCR ,&nbsp;Jason Lester FRCR ,&nbsp;Philip Camilleri FRCR","doi":"10.1016/j.adro.2024.101574","DOIUrl":"10.1016/j.adro.2024.101574","url":null,"abstract":"<div><h3>Purpose</h3><p>To report acute and late bowel, urinary, and sexual dysfunction patient-reported outcome measures, among patients with localized prostate cancer who underwent stereotactic magnetic resonance–guided daily adaptive radiation therapy (SMART).</p></div><div><h3>Methods and Materials</h3><p>All patients who completed a baseline 12-item Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events questionnaire, before undergoing SMART with 36.25 Gy in 5 fractions, were subsequently followed up with the same graded questionnaire at set time points. Latest prostate-specific antigen levels were recorded. The percentage of patients who reported no change from their baseline adverse event (AE) or reported a new ≥ “frequent or almost constant” or “severe grade or higher” AE grade during follow-up was calculated. The maximum 12-item Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events grade for each item was recorded for each patient. The percentage of toxicity levels for each separate AE item at set time points was calculated.</p></div><div><h3>Results</h3><p>The total number of patients was 69 with a median follow-up of 27 months. Median age of the cohort was 73 years (range, 54-85 years). The median pretreatment prostate-specific antigen level, T stage, and Gleason score were 7.5 mmol/L (range, 4.5-32 mmol/L), T2b (range, T2-T3b), and 7 (3 + 4; range, 6-9), respectively. No patient had biochemical failure during follow-up. Regarding bowel symptoms, &gt;80% of men reported no change from baseline toxicity during follow-up. New ≥ frequent or almost constant diarrhea was reported in 9% of patients. “Almost constant” diarrhea peaked at 1 month but was absent at &gt;33 months. Regarding urinary symptoms, increased urinary urgency was the most common complaint (39%). Twenty percent of men reported new ≥ frequent or almost constant urinary urgency incidence peaking at 1 month but absent at &gt;33 months. New “severe” sexual dysfunction was seen in 26% of patients and was persistent at &gt;33 months.</p></div><div><h3>Conclusions</h3><p>Our study is one the largest patient-reported outcomes study after prostate SMART. It shows acceptable levels of toxicity even up to 2 years after treatment.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 9","pages":"Article 101574"},"PeriodicalIF":2.2,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001374/pdfft?md5=2f27057ef5715b14ca7d268453995e9f&pid=1-s2.0-S2452109424001374-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141850364","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Carbon Ion Beam Radiation Therapy as Part of a Trimodal Therapy for Non-small Cell Superior Sulcus Tumors: The INKA Study 作为非小细胞上沟肿瘤三联疗法一部分的碳离子束放疗:INKA-研究
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-15 DOI: 10.1016/j.adro.2024.101573
Fabian Weykamp MD , Lukas Schaub MD , Martin Eichhorn MD , Hauke Winter MD , Peter Schirmacher MD, PhD , Michael Thomas MD , Uwe Haberkorn MD , Malte Ellerbrock , Sebastian Adeberg MD , Jürgen Debus MD, PhD , Klaus Herfarth MD

Purpose

Superior sulcus tumors are frequently treated with neoadjuvant chemoradiation therapy (nCRT) followed by surgery via a trimodal approach. The INKA study evaluated the replacement of photon irradiation by carbon ion radiation therapy (C12-RT) in this regimen.

Methods and Materials

The prospective INKA study included patients with locally advanced non-small cell superior sulcus tumors (<cN3 cM0). Patients received 2 cycles of cisplatin and vinorelbine as per local standard. During the second cycle, 39 Gy(Relative biological effectiveness (RBE)) of hypofractionated C12-RT in 13 fractions were applied. Surgery following fludeoxyglucose F18 positron emission tomography–computed tomography restaging was performed 2 weeks later. The primary endpoint was feasibility and safety measured by the incidence of Common Terminology Criteria for Adverse Events (version 4.0) grade 3/4 toxicity and/or discontinuation because of any reason. Secondary endpoints included the morphologic (Response Evaluation Criteria in Solid Tumors 1.0), metabolic (Positron Emission Tomography Response Criteria in Solid Tumors 1.0), and histopathologic response after nCRT as well as quality of life measurement (QLQ-C30/LC13).

Results

Between 2015 and 2020, 14 patients were included and received nCRT. No grade 3/4 toxicity occurred, with no discontinuation because of toxicity. Before surgery, 8 patients (57%) showed a partial response on computed tomography scan. Thirteen patients showed a metabolic response (metabolic complete remission (mCR), 1; metabolic partial remission (mPR), 12). Three patients (21%) were deemed inoperable after nCRT. In patients with resection, a pathologic Complete remission (CR) was seen in 2 patients (19%) and near-complete remission (<10% vital tumor cells) in 6 patients (55%). Pain score was more than half of that at baseline (mean, 69.2 ± 26.2 vs 30.6 ± 29.1; P = .005) after completion of nCRT and before surgery.

Conclusions

The INKA trial is the first study to evaluate nCRT with C12-RT and showed excellent response, low toxicity, and rapid pain relief.

目的上腔静脉肿瘤通常采用新辅助化放疗(nCRT)治疗,然后通过三联方法进行手术。INKA研究评估了碳离子放疗(C12-RT)取代光子照射的效果。方法和材料前瞻性INKA研究纳入了局部晚期非小细胞上沟瘤(<cN3 cM0)患者。患者按照当地标准接受两个周期的顺铂和长春瑞滨治疗。在第二个周期中,患者接受了 39 Gy(相对生物效应(RBE))的低分次 C12-RT 治疗,共分 13 次进行。2 周后,在进行氟脱氧葡萄糖 F18 正电子发射断层扫描-计算机断层扫描重扫描后进行手术。主要终点是可行性和安全性,以不良事件通用术语标准(4.0版)3/4级毒性和/或因任何原因停药的发生率来衡量。次要终点包括nCRT后的形态学(实体瘤反应评价标准1.0)、代谢(正电子发射断层扫描实体瘤反应标准1.0)和组织病理学反应以及生活质量测量(QLQ-C30/LC13)。结果2015年至2020年间,14名患者被纳入并接受了nCRT。没有发生3/4级毒性,也没有因毒性而停药。手术前,8 名患者(57%)在计算机断层扫描中显示出部分反应。13名患者出现了代谢反应(代谢完全缓解(mCR),1人;代谢部分缓解(mPR),12人)。3 名患者(21%)在接受 nCRT 后被认为无法手术。在接受切除术的患者中,2 名患者(19%)获得了病理完全缓解(CR),6 名患者(55%)获得了近完全缓解(肿瘤细胞存活率为 10%)。结论INKA试验是首个评估使用C12-RT的nCRT的研究,结果显示该疗法反应良好、毒性低、疼痛缓解快。
{"title":"Carbon Ion Beam Radiation Therapy as Part of a Trimodal Therapy for Non-small Cell Superior Sulcus Tumors: The INKA Study","authors":"Fabian Weykamp MD ,&nbsp;Lukas Schaub MD ,&nbsp;Martin Eichhorn MD ,&nbsp;Hauke Winter MD ,&nbsp;Peter Schirmacher MD, PhD ,&nbsp;Michael Thomas MD ,&nbsp;Uwe Haberkorn MD ,&nbsp;Malte Ellerbrock ,&nbsp;Sebastian Adeberg MD ,&nbsp;Jürgen Debus MD, PhD ,&nbsp;Klaus Herfarth MD","doi":"10.1016/j.adro.2024.101573","DOIUrl":"10.1016/j.adro.2024.101573","url":null,"abstract":"<div><h3>Purpose</h3><p>Superior sulcus tumors are frequently treated with neoadjuvant chemoradiation therapy (nCRT) followed by surgery via a trimodal approach. The INKA study evaluated the replacement of photon irradiation by carbon ion radiation therapy (C12-RT) in this regimen.</p></div><div><h3>Methods and Materials</h3><p>The prospective INKA study included patients with locally advanced non-small cell superior sulcus tumors (&lt;cN3 cM0). Patients received 2 cycles of cisplatin and vinorelbine as per local standard. During the second cycle, 39 Gy(Relative biological effectiveness (RBE)) of hypofractionated C12-RT in 13 fractions were applied. Surgery following fludeoxyglucose F18 positron emission tomography–computed tomography restaging was performed 2 weeks later. The primary endpoint was feasibility and safety measured by the incidence of Common Terminology Criteria for Adverse Events (version 4.0) grade 3/4 toxicity and/or discontinuation because of any reason. Secondary endpoints included the morphologic (Response Evaluation Criteria in Solid Tumors 1.0), metabolic (Positron Emission Tomography Response Criteria in Solid Tumors 1.0), and histopathologic response after nCRT as well as quality of life measurement (QLQ-C30/LC13).</p></div><div><h3>Results</h3><p>Between 2015 and 2020, 14 patients were included and received nCRT. No grade 3/4 toxicity occurred, with no discontinuation because of toxicity. Before surgery, 8 patients (57%) showed a partial response on computed tomography scan. Thirteen patients showed a metabolic response (metabolic complete remission (mCR), 1; metabolic partial remission (mPR), 12). Three patients (21%) were deemed inoperable after nCRT. In patients with resection, a pathologic Complete remission (CR) was seen in 2 patients (19%) and near-complete remission (&lt;10% vital tumor cells) in 6 patients (55%). Pain score was more than half of that at baseline (mean, 69.2 ± 26.2 vs 30.6 ± 29.1; <em>P</em> = .005) after completion of nCRT and before surgery.</p></div><div><h3>Conclusions</h3><p>The INKA trial is the first study to evaluate nCRT with C12-RT and showed excellent response, low toxicity, and rapid pain relief.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 9","pages":"Article 101573"},"PeriodicalIF":2.2,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001362/pdfft?md5=7bae0f519a92a891d3aa779614bacc3b&pid=1-s2.0-S2452109424001362-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141701235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prospective Randomized Trial Comparing 2 Devices for Deep Inspiration Breath Hold Management in Breast Radiation Therapy: Results of the BRAVEHeart Trial 前瞻性随机试验:比较两种用于乳腺放疗中深吸气憋气管理的装置:BRAVEHeart 试验结果
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-15 DOI: 10.1016/j.adro.2024.101572
Hilary L. Byrne PhD , Elisabeth Steiner PhD , Jeremy Booth PhD , Gillian Lamoury BMed , Marita Morgia MBBS , Susan Carroll MBBS , Kylie Richardson , Leigh Ambrose MARTP , Kuldeep Makhija , Cameron Stanton MSc , Benjamin Zwan PhD , Michael Carr MSc , Maegan Stewart PhD , Regina Bromley MSc , John Atyeo PhD , Shona Silvester MMedSc , Natalie Plant MHSc , Paul Keall PhD

Purpose

The Breast Radiotherapy Audio Visual Enhancement for sparing the Heart (BRAVEHeart) trial prospectively randomized patients with left-sided breast cancer to 1 of 2 deep inspiration breath hold biofeedback devices: a novel chest surface tracking system and an abdominal block tracking system. The primary hypothesis was that the accuracy of chest tracking would be higher than that of abdominal tracking as the chest is a more direct surrogate of the breast target.

Methods and Materials

Patients with left-sided breast cancer were treated in deep inspiration breath hold with intensity modulated radiation therapy delivery. Patients were randomized to either the novel chest surface system or abdominal block system for active management of breath hold with visual feedback. On both trial arms, the unallocated system was monitored passively. A total of 239,296 cine electronic portal imaging device images were analyzed retrospectively to extract the chest wall position. Treatment accuracy was quantified as the deviation of the internal chest wall during treatment relative to the planned position from the digitally reconstructed radiograph. The correlation between motion of the external surrogate and internal chest wall was calculated per-breath hold. Ease of use was assessed with questionnaires for both radiation therapists and patients and appointment length recorded.

Results

Data from 26 participants were available for analysis. No difference was found in delivered treatment accuracy between arms. Across all patients and fractions, the median correlation between internal chest wall movement and external surrogate was 0.69 for the chest surface and 0.17 for the abdominal block. Patients found it easy to follow visual feedback from both systems. No difference was found in appointment length between arms.

Conclusions

No statistical evidence was found for superior treatment accuracy, satisfaction, or appointment length for the novel chest surface tracking device compared with the abdominal block system. During deep inspiration breath hold, the median per-breath hold correlation of internal chest wall movement to the motion of the chest surface was higher than the median correlation of the abdominal block to the chest surface.

目的乳腺放疗视听增强疏通心脏(BRAVEHeart)试验对左侧乳腺癌患者进行了前瞻性随机分组,从两种深吸气屏气生物反馈装置中选择一种:新型胸部表面跟踪系统和腹部阻滞跟踪系统。主要假设是,胸部跟踪的准确性将高于腹部跟踪的准确性,因为胸部是乳腺靶点更直接的替代物。患者被随机分配到新型胸部表面系统或腹部阻滞系统,通过视觉反馈对屏气进行主动管理。在这两种试验中,未分配的系统均为被动监测。对总共 239,296 张电影电子门成像设备图像进行了回顾性分析,以提取胸壁位置。治疗的准确性被量化为治疗过程中胸壁内部相对于数字重建放射影像计划位置的偏差。外部代理和内部胸壁运动之间的相关性是按每次呼吸计算的。通过对放射治疗人员和患者进行问卷调查来评估使用的简便性,并记录预约时间。结果发现,两组放射治疗的准确性没有差异。在所有患者和分次治疗中,胸壁内部移动与外部替代物之间的中位相关性为:胸部表面 0.69,腹部阻滞 0.17。患者认为两种系统的视觉反馈都很容易理解。结论与腹部阻滞系统相比,新型胸廓表面追踪装置在治疗准确性、满意度或预约时间方面均无明显差异。在深吸气屏气期间,每次屏气时胸壁内部运动与胸腔表面运动的中位相关性高于腹部阻滞与胸腔表面的中位相关性。
{"title":"Prospective Randomized Trial Comparing 2 Devices for Deep Inspiration Breath Hold Management in Breast Radiation Therapy: Results of the BRAVEHeart Trial","authors":"Hilary L. Byrne PhD ,&nbsp;Elisabeth Steiner PhD ,&nbsp;Jeremy Booth PhD ,&nbsp;Gillian Lamoury BMed ,&nbsp;Marita Morgia MBBS ,&nbsp;Susan Carroll MBBS ,&nbsp;Kylie Richardson ,&nbsp;Leigh Ambrose MARTP ,&nbsp;Kuldeep Makhija ,&nbsp;Cameron Stanton MSc ,&nbsp;Benjamin Zwan PhD ,&nbsp;Michael Carr MSc ,&nbsp;Maegan Stewart PhD ,&nbsp;Regina Bromley MSc ,&nbsp;John Atyeo PhD ,&nbsp;Shona Silvester MMedSc ,&nbsp;Natalie Plant MHSc ,&nbsp;Paul Keall PhD","doi":"10.1016/j.adro.2024.101572","DOIUrl":"10.1016/j.adro.2024.101572","url":null,"abstract":"<div><h3>Purpose</h3><p>The Breast Radiotherapy Audio Visual Enhancement for sparing the Heart (BRAVEHeart) trial prospectively randomized patients with left-sided breast cancer to 1 of 2 deep inspiration breath hold biofeedback devices: a novel chest surface tracking system and an abdominal block tracking system. The primary hypothesis was that the accuracy of chest tracking would be higher than that of abdominal tracking as the chest is a more direct surrogate of the breast target.</p></div><div><h3>Methods and Materials</h3><p>Patients with left-sided breast cancer were treated in deep inspiration breath hold with intensity modulated radiation therapy delivery. Patients were randomized to either the novel chest surface system or abdominal block system for active management of breath hold with visual feedback. On both trial arms, the unallocated system was monitored passively. A total of 239,296 cine electronic portal imaging device images were analyzed retrospectively to extract the chest wall position. Treatment accuracy was quantified as the deviation of the internal chest wall during treatment relative to the planned position from the digitally reconstructed radiograph. The correlation between motion of the external surrogate and internal chest wall was calculated per-breath hold. Ease of use was assessed with questionnaires for both radiation therapists and patients and appointment length recorded.</p></div><div><h3>Results</h3><p>Data from 26 participants were available for analysis. No difference was found in delivered treatment accuracy between arms. Across all patients and fractions, the median correlation between internal chest wall movement and external surrogate was 0.69 for the chest surface and 0.17 for the abdominal block. Patients found it easy to follow visual feedback from both systems. No difference was found in appointment length between arms.</p></div><div><h3>Conclusions</h3><p>No statistical evidence was found for superior treatment accuracy, satisfaction, or appointment length for the novel chest surface tracking device compared with the abdominal block system. During deep inspiration breath hold, the median per-breath hold correlation of internal chest wall movement to the motion of the chest surface was higher than the median correlation of the abdominal block to the chest surface.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 9","pages":"Article 101572"},"PeriodicalIF":2.2,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001350/pdfft?md5=19ca82eaa5d654d9d1e8467002b6d58d&pid=1-s2.0-S2452109424001350-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141697156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Expenditures and Use of Hypofractionated Radiation Therapy Treating Breast Cancer Among Medicare Advantage Enrollees, 2009 to 2017 2009-2017 年医疗保险优势计划参保者治疗乳腺癌的超分割放疗支出和使用情况
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-15 DOI: 10.1016/j.adro.2024.101568
Loren Saulsberry PhD, Chuanhong Liao MS, Dezheng Huo MD, PhD

Purpose

Technology advances in cancer care have paralleled rapidly increasing expenditures in radiation therapy. The use and costs of shorter cancer radiation therapy offer potential utility in clinical practice. We evaluate use and expenditures of Medicare Advantage (MA) beneficiaries receiving hypofractionated whole breast irradiation (HF-WBI) compared with conventionally fractionated whole breast irradiation (CF-WBI) in the United States and examine the relationship of patient characteristics with HF-WBI use.

Methods and Materials

We performed a retrospective analysis of radiation therapy in MA beneficiaries using private employer-sponsored insurance claims for a pooled cross-sectional evaluation from 2009 to 2017. The study population included female MA beneficiaries with early-stage breast cancer treated with lumpectomy and whole breast irradiation.

Results

A total of 9957 women received HF-WBI, and 18,920 received CF-WBI. Older age, greater distance from home to treatment facility, and a higher proportion of college graduates in the community of residence were associated with increased HF-WBI use. Mean insurer-paid radiation therapy expenditures were significantly lower for HF-WBI versus CF-WBI (adjusted difference, $4113; 95% CI, $4030-$4,197). Mean patient out-of-pocket expenditure for HF-WBI was $426 less than that of CF-WBI. Across US states, geographic variation existed in the ratio of costs for HF-WBI relative to CF-WBI (range, 0.41-0.87).

Conclusions

HF-WBI use among MA beneficiaries with breast cancer has dramatically increased over time, surpassing CF-HBI as the dominant form of radiation therapy. HF-WBI clinical adoption has outpaced any continual cost decrease, despite wide variation across US states for this shorter radiation therapy treatment. As MA enrollment continues to expand, identifying the drivers of HF-WBI use and the sources of variation in costs of HF-WBI will help direct the quality of cancer care delivered to Medicare beneficiaries.

目的随着癌症治疗技术的进步,放射治疗的支出也在迅速增加。短程癌症放射治疗的使用和成本为临床实践提供了潜在的实用性。我们评估了在美国接受低分次全乳腺照射(HF-WBI)与常规分次全乳腺照射(CF-WBI)的医疗保险优势(MA)受益人的使用情况和支出情况,并研究了患者特征与HF-WBI使用情况的关系。研究对象包括接受肿块切除术和全乳腺照射治疗的早期乳腺癌女性医疗保险受益人。结果共有9957名女性接受了高频-全乳腺照射,18920名女性接受了低频-全乳腺照射。年龄越大、从家到治疗机构的距离越远、居住社区的大学毕业生比例越高,都与使用高频放射治疗相关。HF-WBI与CF-WBI相比,保险人支付的平均放射治疗费用明显较低(调整后差异为4113美元;95% CI为4030-4197美元)。HF-WBI患者的平均自付费用比CF-WBI低426美元。在美国各州,HF-WBI 与 CF-WBI 的费用比率存在地域差异(范围为 0.41-0.87)。结论随着时间的推移,乳腺癌医保受益人中使用 HF-WBI 的人数急剧增加,已超过 CF-HBI 成为放疗的主要形式。尽管美国各州对这种较短的放射治疗方法的采用存在很大差异,但高频-WBI 的临床采用率超过了成本的持续下降。随着医疗保险参保人数的不断扩大,确定高频-腹腔穿刺使用的驱动因素和高频-腹腔穿刺成本差异的来源将有助于指导向医疗保险受益人提供癌症护理的质量。
{"title":"Expenditures and Use of Hypofractionated Radiation Therapy Treating Breast Cancer Among Medicare Advantage Enrollees, 2009 to 2017","authors":"Loren Saulsberry PhD,&nbsp;Chuanhong Liao MS,&nbsp;Dezheng Huo MD, PhD","doi":"10.1016/j.adro.2024.101568","DOIUrl":"10.1016/j.adro.2024.101568","url":null,"abstract":"<div><h3>Purpose</h3><p>Technology advances in cancer care have paralleled rapidly increasing expenditures in radiation therapy. The use and costs of shorter cancer radiation therapy offer potential utility in clinical practice. We evaluate use and expenditures of Medicare Advantage (MA) beneficiaries receiving hypofractionated whole breast irradiation (HF-WBI) compared with conventionally fractionated whole breast irradiation (CF-WBI) in the United States and examine the relationship of patient characteristics with HF-WBI use.</p></div><div><h3>Methods and Materials</h3><p>We performed a retrospective analysis of radiation therapy in MA beneficiaries using private employer-sponsored insurance claims for a pooled cross-sectional evaluation from 2009 to 2017. The study population included female MA beneficiaries with early-stage breast cancer treated with lumpectomy and whole breast irradiation.</p></div><div><h3>Results</h3><p>A total of 9957 women received HF-WBI, and 18,920 received CF-WBI. Older age, greater distance from home to treatment facility, and a higher proportion of college graduates in the community of residence were associated with increased HF-WBI use. Mean insurer-paid radiation therapy expenditures were significantly lower for HF-WBI versus CF-WBI (adjusted difference, $4113; 95% CI, $4030-$4,197). Mean patient out-of-pocket expenditure for HF-WBI was $426 less than that of CF-WBI. Across US states, geographic variation existed in the ratio of costs for HF-WBI relative to CF-WBI (range, 0.41-0.87).</p></div><div><h3>Conclusions</h3><p>HF-WBI use among MA beneficiaries with breast cancer has dramatically increased over time, surpassing CF-HBI as the dominant form of radiation therapy. HF-WBI clinical adoption has outpaced any continual cost decrease, despite wide variation across US states for this shorter radiation therapy treatment. As MA enrollment continues to expand, identifying the drivers of HF-WBI use and the sources of variation in costs of HF-WBI will help direct the quality of cancer care delivered to Medicare beneficiaries.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 9","pages":"Article 101568"},"PeriodicalIF":2.2,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001313/pdfft?md5=a6284526993467d7929d523cbef50b0b&pid=1-s2.0-S2452109424001313-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141704013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Underuse of Postoperative Radiation After Nipple-Sparing Mastectomy for Standard Radiation Indications 乳头保留乳房切除术后标准放射适应症的术后放射利用率不足
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-14 DOI: 10.1016/j.adro.2024.101569
Wesley J. Talcott MD, MBA , Gustavo N. Marta MD, PhD , Meena S. Moran MD

Purpose

Nipple areola complex-sparing surgeries, such as nipple-sparing mastectomy (NSM), are increasingly used for women with early-stage breast cancer. In the postoperative setting, 2 major indications for postoperative radiation (PORT) with/without regional nodal irradiation (RNI) are: positive margins (margin+) and pathologically involved lymph nodes (pN+). The frequency of these adverse pathologic features and the rate of PORT utilization following NSM for these 2 indications are unknown. We determined the frequency of margin+ and pN+ following NSM compared with nipple-sparing lumpectomy/breast-conserving surgery [BCS] and identified trends in appropriate PORT administration for these standard indications in the NSM setting.

Methods and Materials

Using the National Cancer Database (NCDB), women diagnosed with cT1 to cT3,N0M0 invasive carcinoma between 2004 and 2017 who underwent NSM were compared with those who underwent BCS (with nipple preservation). The frequencies of margin+ and pN+ by surgical subtype and use of PORT with/without RNI were assessed by cohort to determine if the type of surgery was associated with radiation delivery. Overall survival between the 2 cohorts was also compared. We performed univariable/multivariable logistic and Cox regression with ORs to control for confounders.

Results

Of 624,075 women included, 611,907 underwent BCS, and 12,168 underwent NSM. The surgical margin+ rate was significantly higher for NSM at 4.5% (n = 544) than for BCS at 3.7% (n = 22,449) (P < .001) and remained significant on multivariable analysis (MVA; OR, 1.13; CI, 1.03-1.25; P = .012). Use of PORT for margins+ was significantly lower by MVA after NSM (OR, 0.07; CI, 0.06-0.09; P < .001). Similarly, pN+ rate was significantly higher for NSM at 22.5% (n = 2740) versus BCS at 13.5% (n = 82,288) (P < .001), retaining significance on MVA (OR, 1.12; CI, 1.06-1.19; P < .001). For pN+ undergoing NSM, PORT with RNI was delivered significantly less often on MVA (OR, 0.73; CI, 0.67-0.81; P < .001). Neither high-risk subgroup had differences in overall survival on MVA.

Conclusions

NSM is associated with a higher rate of margin+ and pN+ compared with BCS. Radiation is underused after NSM for these standard indications. Our results highlight the need to further refine patient selection for NSM and the importance of communicating the higher potential for adverse pathologic features (and thus, the potential need for radiation) to patients undergoing NSM.

目的乳头乳晕复合体保留手术,如乳头乳晕保留乳房切除术(NSM),越来越多地用于早期乳腺癌女性患者。在术后环境中,术后放射(PORT)与/或区域结节照射(RNI)的两个主要适应症是:边缘阳性(边缘+)和病理受累淋巴结(pN+)。这些不良病理特征的发生频率以及 NSM 后针对这两种适应症使用 PORT 的比例尚不清楚。我们确定了与保留乳头的肿块切除术/保乳手术[BCS]相比,NSM术后出现margin+和pN+的频率,并确定了在NSM术中针对这些标准适应症适当使用PORT的趋势。方法和材料利用国家癌症数据库(NCDB),将2004年至2017年间诊断为cT1至cT3、N0M0浸润性癌并接受NSM术的女性与接受BCS术(保留乳头)的女性进行了比较。按手术亚型和有/无RNI的PORT使用情况评估了边缘+和pN+的频率,以确定手术类型是否与放射剂量有关。我们还比较了两个队列的总生存率。结果 在纳入的 624,075 名女性中,611,907 人接受了 BCS,12,168 人接受了 NSM。NSM的手术切缘+率为4.5%(n = 544),明显高于BCS的3.7%(n = 22,449)(P < .001),并且在多变量分析(MVA;OR,1.13;CI,1.03-1.25;P = .012)中仍然显著。在 NSM 之后的 MVA 中,PORT 对 margins+ 的使用率明显降低(OR,0.07;CI,0.06-0.09;P <;.001)。同样,NSM 的 pN+ 率为 22.5%(n = 2740),明显高于 BCS 的 13.5%(n = 82288)(P <.001),而 MVA 的 pN+ 率仍然显著(OR, 1.12; CI, 1.06-1.19; P <.001)。对于接受 NSM 的 pN+ 患者,在 MVA 中使用 RNI 的 PORT 频率显著降低(OR,0.73;CI,0.67-0.81;P < .001)。结论与 BCS 相比,NSM 的边缘+和 pN+ 率更高。对于这些标准适应症,NSM术后未充分利用放射治疗。我们的研究结果凸显了进一步完善 NSM 患者选择的必要性,以及向接受 NSM 的患者告知不良病理特征的可能性较高(因此可能需要放疗)的重要性。
{"title":"Underuse of Postoperative Radiation After Nipple-Sparing Mastectomy for Standard Radiation Indications","authors":"Wesley J. Talcott MD, MBA ,&nbsp;Gustavo N. Marta MD, PhD ,&nbsp;Meena S. Moran MD","doi":"10.1016/j.adro.2024.101569","DOIUrl":"10.1016/j.adro.2024.101569","url":null,"abstract":"<div><h3>Purpose</h3><p>Nipple areola complex-sparing surgeries, such as nipple-sparing mastectomy (NSM), are increasingly used for women with early-stage breast cancer. In the postoperative setting, 2 major indications for postoperative radiation (PORT) with/without regional nodal irradiation (RNI) are: positive margins (margin+) and pathologically involved lymph nodes (pN+). The frequency of these adverse pathologic features and the rate of PORT utilization following NSM for these 2 indications are unknown. We determined the frequency of margin+ and pN+ following NSM compared with nipple-sparing lumpectomy/breast-conserving surgery [BCS] and identified trends in appropriate PORT administration for these standard indications in the NSM setting.</p></div><div><h3>Methods and Materials</h3><p>Using the National Cancer Database (NCDB), women diagnosed with cT1 to cT3,N0M0 invasive carcinoma between 2004 and 2017 who underwent NSM were compared with those who underwent BCS (with nipple preservation). The frequencies of margin+ and pN+ by surgical subtype and use of PORT with/without RNI were assessed by cohort to determine if the type of surgery was associated with radiation delivery. Overall survival between the 2 cohorts was also compared. We performed univariable/multivariable logistic and Cox regression with ORs to control for confounders.</p></div><div><h3>Results</h3><p>Of 624,075 women included, 611,907 underwent BCS, and 12,168 underwent NSM. The surgical margin+ rate was significantly higher for NSM at 4.5% (n = 544) than for BCS at 3.7% (n = 22,449) (<em>P</em> &lt; .001) and remained significant on multivariable analysis (MVA; OR, 1.13; CI, 1.03-1.25; <em>P</em> = .012). Use of PORT for margins+ was significantly lower by MVA after NSM (OR, 0.07; CI, 0.06-0.09; <em>P</em> &lt; .001). Similarly, pN+ rate was significantly higher for NSM at 22.5% (n = 2740) versus BCS at 13.5% (n = 82,288) (<em>P</em> &lt; .001), retaining significance on MVA (OR, 1.12; CI, 1.06-1.19; <em>P</em> &lt; .001). For pN+ undergoing NSM, PORT with RNI was delivered significantly less often on MVA (OR, 0.73; CI, 0.67-0.81; <em>P</em> &lt; .001). Neither high-risk subgroup had differences in overall survival on MVA.</p></div><div><h3>Conclusions</h3><p>NSM is associated with a higher rate of margin+ and pN+ compared with BCS. Radiation is underused after NSM for these standard indications. Our results highlight the need to further refine patient selection for NSM and the importance of communicating the higher potential for adverse pathologic features (and thus, the potential need for radiation) to patients undergoing NSM.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 9","pages":"Article 101569"},"PeriodicalIF":2.2,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001325/pdfft?md5=01c5de86b1891fdf19575a41b5e164c5&pid=1-s2.0-S2452109424001325-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141692887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quantification of Dosimetry Improvement With or Without Patient Surface Guidance 采用或不采用患者体表引导,量化剂量测定的改进情况
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-14 DOI: 10.1016/j.adro.2024.101570
Ke Sheng PhD, FAAPM, DABR , Minsong Cao PhD , Andrew Godley PhD , Mu-Han Lin PhD , Lukas Henze MEng , Laura Hammond MSc , Laurence Delombaerde PhD , Kirsten Hierholz Dipl -Ing , Jana Kouptsidis MSc

Purpose

Noncoplanar beams and arcs are routinely used to improve dosimetry for intracranial cases, but their application for extracranial cases has been hampered by the risk of collision. This has led to conservative beam selection whose impact on plan dosimetry has not been previously studied.

Methods and Materials

A full-body 3-dimensional patient surface was acquired using optical cameras for a single lung patient at the time of computed tomography simulation. Eight stereotactic body radiation therapy (SBRT) plans were created for the patient, with varying degrees of noncoplanarity and deliverability. The plans included volumetric modulated arc therapy and intensity modulated radiation therapy (IMRT) plans ranging from simple, coplanar arcs to multiple noncoplanar arcs and IMRT beams. A total of 70 fields were created across the 8 plans, of which 21 fields were undeliverable with a 5-cm buffer. Organs-at-risk (OARs) metrics including R50, Dmax 2 cm from the PTV, lung V20, and chest wall V30 were evaluated. Five expert SBRT dosimetrists from 5 institutions evaluated field deliverability, with or without the guidance of the clearance map.

Results

In the dosimetry evaluation, a clear trend in increasing dosimetric compactness and OAR sparing is observed with increasing plan noncoplanarity. R50, Dmax 2 cm, lung V20, and chest wall V30 decreased 41%, 39%, 43%, and 57%, respectively, from plan 1 (2 coplanar partial arcs) to plan 8 (19 noncoplanar IMRT beams). In the observer tests, the expert dosimetrists’ ability to accurately discern beam deliverability because of collision significantly increases with the clearance map. The errors in predicting colliding fields were eliminated using the whole-body surface and clearance map, and the user was able to select fields based on plan quality and patient comfort instead of being overly conservative.

Conclusion

The study shows that incorporating a personalized, whole-body clearance map in the treatment planning workflow can facilitate the adoption of noncoplanar beams or arcs that benefit the SBRT plan dosimetry.

目的非共面光束和弧线通常用于改善颅内病例的剂量测定,但在颅外病例中的应用却受到碰撞风险的阻碍。方法和材料在进行计算机断层扫描模拟时,使用光学相机获取了单肺部患者的全身三维表面。为患者创建了八种立体定向体放射治疗(SBRT)计划,这些计划具有不同程度的非平面性和可投射性。这些计划包括容积调制弧形疗法和强度调制放射治疗(IMRT)计划,范围从简单的共面弧形到多个非共面弧形和 IMRT 射束。8 个计划共创建了 70 个场,其中 21 个场在 5 厘米缓冲区内无法传送。对风险器官(OARs)指标进行了评估,包括R50、距PTV 2厘米的Dmax、肺V20和胸壁V30。来自 5 家机构的 5 位 SBRT 剂量测定专家在清除图的指导下或不在清除图的指导下对野外投射能力进行了评估。从计划 1(2 个共面部分弧线)到计划 8(19 个非共面 IMRT 光束),R50、Dmax 2 cm、肺 V20 和胸壁 V30 分别下降了 41%、39%、43% 和 57%。在观察者测试中,随着间隙图的增加,剂量测定专家准确辨别因碰撞导致的射束可输送性的能力也显著提高。使用全身表面和间隙图消除了预测碰撞场的误差,用户能够根据计划质量和患者舒适度选择场,而不是过于保守。
{"title":"Quantification of Dosimetry Improvement With or Without Patient Surface Guidance","authors":"Ke Sheng PhD, FAAPM, DABR ,&nbsp;Minsong Cao PhD ,&nbsp;Andrew Godley PhD ,&nbsp;Mu-Han Lin PhD ,&nbsp;Lukas Henze MEng ,&nbsp;Laura Hammond MSc ,&nbsp;Laurence Delombaerde PhD ,&nbsp;Kirsten Hierholz Dipl -Ing ,&nbsp;Jana Kouptsidis MSc","doi":"10.1016/j.adro.2024.101570","DOIUrl":"10.1016/j.adro.2024.101570","url":null,"abstract":"<div><h3>Purpose</h3><p>Noncoplanar beams and arcs are routinely used to improve dosimetry for intracranial cases, but their application for extracranial cases has been hampered by the risk of collision. This has led to conservative beam selection whose impact on plan dosimetry has not been previously studied.</p></div><div><h3>Methods and Materials</h3><p>A full-body 3-dimensional patient surface was acquired using optical cameras for a single lung patient at the time of computed tomography simulation. Eight stereotactic body radiation therapy (SBRT) plans were created for the patient, with varying degrees of noncoplanarity and deliverability. The plans included volumetric modulated arc therapy and intensity modulated radiation therapy (IMRT) plans ranging from simple, coplanar arcs to multiple noncoplanar arcs and IMRT beams. A total of 70 fields were created across the 8 plans, of which 21 fields were undeliverable with a 5-cm buffer. Organs-at-risk (OARs) metrics including R50, Dmax 2 cm from the PTV, lung V20, and chest wall V30 were evaluated. Five expert SBRT dosimetrists from 5 institutions evaluated field deliverability, with or without the guidance of the clearance map.</p></div><div><h3>Results</h3><p>In the dosimetry evaluation, a clear trend in increasing dosimetric compactness and OAR sparing is observed with increasing plan noncoplanarity. R50, Dmax 2 cm, lung V20, and chest wall V30 decreased 41%, 39%, 43%, and 57%, respectively, from plan 1 (2 coplanar partial arcs) to plan 8 (19 noncoplanar IMRT beams). In the observer tests, the expert dosimetrists’ ability to accurately discern beam deliverability because of collision significantly increases with the clearance map. The errors in predicting colliding fields were eliminated using the whole-body surface and clearance map, and the user was able to select fields based on plan quality and patient comfort instead of being overly conservative.</p></div><div><h3>Conclusion</h3><p>The study shows that incorporating a personalized, whole-body clearance map in the treatment planning workflow can facilitate the adoption of noncoplanar beams or arcs that benefit the SBRT plan dosimetry.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 9","pages":"Article 101570"},"PeriodicalIF":2.2,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001337/pdfft?md5=72abedba7c03476b91252b0d8940b6fe&pid=1-s2.0-S2452109424001337-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141695523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
18F-Flotufolastat Positron Emission Tomography in African American Patients With Suspected Prostate Cancer Recurrence: Findings From the Phase 3 SPOTLIGHT Study 18F-Flotufolastat 正电子发射断层扫描在疑似前列腺癌复发的非裔美国患者中的应用:SPOTLIGHT 3 期研究结果
IF 2.2 Q3 ONCOLOGY Pub Date : 2024-07-14 DOI: 10.1016/j.adro.2024.101571
Soroush Rais-Bahrami MD , Mark Fleming MD , Benjamin Gartrell MD , William C. Lavely MD , Albert Chau MSc , Phillip Davis MD , David M. Schuster MD

Purpose

Although African American (AA) patients are disproportionately affected by prostate cancer, they are often underrepresented in oncology clinical trials. The SPOTLIGHT study (NCT04186845) assessed the novel diagnostic positron emission tomography radiopharmaceutical, 18F-flotufolastat (18F-rhPSMA-7.3), in patients with recurrent prostate cancer. The proportion of AA patients enrolled in SPOTLIGHT (17%) was greater than typically enrolled in oncology trials (8.5%) and was representative of the US population (14%). This post hoc analysis of SPOTLIGHT evaluates the diagnostic performance of 18F-flotufolastat in AA patients.

Methods and Materials

Patients underwent positron emission tomography/computed tomography 50 to 70 minutes after intravenous administration of 296 MBq 18F-flotufolastat. Three blinded readers evaluated all images, with the majority read (agreement of ≥2 readers) result reported here. Standard of truth (SoT) was established with histopathology or correlative imaging. Data from AA patients were evaluated to determine the 18F-flotufolastat overall detection rate (DR), positive predictive value (PPV), and verified DR (VDR). VDR (SoT-verified) is equivalent to DR × PPV.

Results

In total, 61 of 366 (17%) patients were AAs. Although baseline characteristics were broadly similar, fewer AA patients (56%) had undergone prostatectomy than non-AA patients (82%). The patient-level DR was 93% (57/61) in AA patients, increasing from 67% at prostate-specific antigen <0.5 ng/mL to 100% at prostate-specific antigen ≥10 ng/mL. Patient-level DR was marginally lower in all other patients (87%, 264/305). However, when stratifying by prior treatment, DRs were similar across ethnic groups in postprostatectomy patients, but in patients with intact prostates, AA patients had higher prostate DR than non-AA patients. SoT-verification (predominantly with conventional imaging [79%]) gave a VDR of 64% and PPV of 68% in AA patients, versus 55% and 64%, respectively, in all other patients.

Conclusions

18F-Flotufolastat DRs were marginally higher in AA patients than in all other patients enrolled in SPOTLIGHT. High VDR and PPV were also achieved in AA patients from across all participating centers, indicating the broad applicability of newly US Food and Drug Administration–approved 18F-flotufolastat to the US population as a whole.

目的虽然非裔美国人(AA)患者罹患前列腺癌的比例很高,但他们在肿瘤临床试验中的代表性往往不足。SPOTLIGHT研究(NCT04186845)在复发性前列腺癌患者中评估了新型诊断性正电子发射断层扫描放射性药物18F-氟夫司他(18F-rhPSMA-7.3)。参加 SPOTLIGHT 的 AA 患者比例(17%)高于一般肿瘤试验的比例(8.5%),在美国人口中也具有代表性(14%)。本研究对 SPOTLIGHT 进行了事后分析,评估了 18F 氟氟司特对 AA 患者的诊断效果。方法与材料患者在静脉注射 296 MBq 18F 氟氟司特后 50 至 70 分钟接受正电子发射断层扫描/计算机断层扫描。三位盲读者对所有图像进行了评估,并在此报告了多数读数(≥2 位读者一致)的结果。真实标准(SoT)由组织病理学或相关成像确定。对AA患者的数据进行评估,以确定18F-氟唑司特的总检出率(DR)、阳性预测值(PPV)和验证DR(VDR)。VDR(SoT-验证)相当于DR×PPV。结果在366名患者中,共有61名(17%)为AA患者。虽然基线特征大致相似,但接受过前列腺切除术的 AA 患者(56%)少于非 AA 患者(82%)。AA患者的患者水平DR为93%(57/61),从前列腺特异性抗原为0.5纳克/毫升时的67%增加到前列腺特异性抗原≥10纳克/毫升时的100%。所有其他患者的患者水平 DR 略低(87%,264/305)。不过,如果按先前的治疗进行分层,不同种族群体的前列腺切除术后患者的前列腺特异性抗原含量相似,但在前列腺完整的患者中,AA 患者的前列腺特异性抗原含量高于非 AA 患者。SoT验证(主要采用常规成像[79%])显示,AA患者的VDR为64%,PPV为68%,而所有其他患者的VDR和PPV分别为55%和64%。所有参与中心的 AA 患者都获得了较高的 VDR 和 PPV,这表明美国食品药品管理局新近批准的 18F 氟氟司特可广泛适用于整个美国人群。
{"title":"18F-Flotufolastat Positron Emission Tomography in African American Patients With Suspected Prostate Cancer Recurrence: Findings From the Phase 3 SPOTLIGHT Study","authors":"Soroush Rais-Bahrami MD ,&nbsp;Mark Fleming MD ,&nbsp;Benjamin Gartrell MD ,&nbsp;William C. Lavely MD ,&nbsp;Albert Chau MSc ,&nbsp;Phillip Davis MD ,&nbsp;David M. Schuster MD","doi":"10.1016/j.adro.2024.101571","DOIUrl":"10.1016/j.adro.2024.101571","url":null,"abstract":"<div><h3>Purpose</h3><p>Although African American (AA) patients are disproportionately affected by prostate cancer, they are often underrepresented in oncology clinical trials. The SPOTLIGHT study (NCT04186845) assessed the novel diagnostic positron emission tomography radiopharmaceutical, <sup>18</sup>F-flotufolastat (<sup>18</sup>F-rhPSMA-7.3), in patients with recurrent prostate cancer. The proportion of AA patients enrolled in SPOTLIGHT (17%) was greater than typically enrolled in oncology trials (8.5%) and was representative of the US population (14%). This post hoc analysis of SPOTLIGHT evaluates the diagnostic performance of <sup>18</sup>F-flotufolastat in AA patients.</p></div><div><h3>Methods and Materials</h3><p>Patients underwent positron emission tomography/computed tomography 50 to 70 minutes after intravenous administration of 296 MBq <sup>18</sup>F-flotufolastat. Three blinded readers evaluated all images, with the majority read (agreement of ≥2 readers) result reported here. Standard of truth (SoT) was established with histopathology or correlative imaging. Data from AA patients were evaluated to determine the <sup>18</sup>F-flotufolastat overall detection rate (DR), positive predictive value (PPV), and verified DR (VDR). VDR (SoT-verified) is equivalent to DR × PPV.</p></div><div><h3>Results</h3><p>In total, 61 of 366 (17%) patients were AAs. Although baseline characteristics were broadly similar, fewer AA patients (56%) had undergone prostatectomy than non-AA patients (82%). The patient-level DR was 93% (57/61) in AA patients, increasing from 67% at prostate-specific antigen &lt;0.5 ng/mL to 100% at prostate-specific antigen ≥10 ng/mL. Patient-level DR was marginally lower in all other patients (87%, 264/305). However, when stratifying by prior treatment, DRs were similar across ethnic groups in postprostatectomy patients, but in patients with intact prostates, AA patients had higher prostate DR than non-AA patients. SoT-verification (predominantly with conventional imaging [79%]) gave a VDR of 64% and PPV of 68% in AA patients, versus 55% and 64%, respectively, in all other patients.</p></div><div><h3>Conclusions</h3><p><sup>18</sup>F-Flotufolastat DRs were marginally higher in AA patients than in all other patients enrolled in SPOTLIGHT. High VDR and PPV were also achieved in AA patients from across all participating centers, indicating the broad applicability of newly US Food and Drug Administration–approved <sup>18</sup>F-flotufolastat to the US population as a whole.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 9","pages":"Article 101571"},"PeriodicalIF":2.2,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001349/pdfft?md5=6326106769069cc5cc663bad23d491c8&pid=1-s2.0-S2452109424001349-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141716344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Advances in Radiation Oncology
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1