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Is Bevacizumab a Cost-Effective Regimen for Treating Cerebral Radiation Necrosis in the United States? 在美国,贝伐单抗是否是治疗脑放射性坏死的具有成本效益的方案?放射性坏死药物的成本效益分析。
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-08-30 DOI: 10.1016/j.prro.2024.08.003
Shufei Lai, Shaohong Luo, Shen Lin, Xiaoting Huang, Xiangzhen Wang, Xiongwei Xu, Xiuhua Weng

Background: Bevacizumab has been demonstrated to have superior efficacy in the treatment of cerebral radiation necrosis (CRN), but its high cost may exacerbate the disease burden. This study aimed to assess the cost-effectiveness of bevacizumab in comparison to corticosteroids for treating CRN from the US payers' perspective.

Methods: Decision tree models were constructed to simulate the process of bevacizumab and corticosteroids in CRN short-term and long-term therapy. Critical clinical data were derived from the NCT01621880 trial. Costs and utility values were obtained from the US official websites and published literature. The main outcomes were total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses were performed to assess the robustness of the models.

Results: In the short-term and long-term models, bevacizumab added 0.11 (0.46 vs 0.35) and 0.16 (0.54 vs 0.38) QALYs compared with corticosteroids therapy, with corresponding incremental costs of $12,351 and $23,253, respectively. The resultant ICERs were $112,987/QALY and $150,245/QALY for short-term and long-term treatment, respectively. The one-way sensitivity analysis indicated that utility value of nonrecurrence status, body weight, and bevacizumab price per cycle were the most influential factors for ICER of both models. At the willingness-to-pay threshold of $150,000/QALY in the United States, the probabilities of bevacizumab being cost-effective for CRN short and long-term treatment were 63.9% and 49%, respectively.

Conclusions: Compared with corticosteroids, bevacizumab is an economical alternative for CRN short-term treatment from the US payers' perspective, whereas long-term therapy draws an opposite conclusion.

背景:贝伐单抗已被证明在治疗脑放射性坏死(CRN)方面具有卓越疗效,但其高昂的费用可能会加重疾病负担。本研究旨在从美国支付方的角度评估贝伐单抗与皮质类固醇相比治疗 CRN 的成本效益:方法:构建决策树模型,模拟贝伐单抗和皮质类固醇在 CRN 短期和长期治疗中的过程。关键临床数据来自 NCT01621880 试验。成本和效用值来自美国官方网站和已发表的文献。主要结果为总成本、质量调整生命年(QALYs)和增量成本效益比(ICER)。为评估模型的稳健性,进行了单向和概率敏感性分析:在短期和长期模型中,贝伐单抗比皮质类固醇疗法分别增加了 0.11 (0.46 vs 0.35) 和 0.16 (0.54 vs 0.38) QALYs,相应的增量成本分别为 12,351 美元和 23,253 美元。因此,短期和长期治疗的 ICER 分别为 112,987 美元/QALY 和 150,245 美元/QALY。单向敏感性分析表明,不复发状态的效用值、体重和贝伐珠单抗每个周期的价格是对两个模型的 ICER 影响最大的因素。在美国,当支付意愿阈值为 150,000 美元/QALY 时,贝伐珠单抗用于 CRN 短期和长期治疗的成本效益概率分别为 63.9% 和 49%:结论:从美国付费者的角度来看,与皮质类固醇相比,贝伐单抗是 CRN 短期治疗的经济替代方案,而长期治疗的结论则与之相反。
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引用次数: 0
Vulvar Cancer: Histopathologic Considerations and Nuances to Management: Vulvar cancer considerations and nuances. 外阴癌:外阴癌:组织病理学考虑因素和管理上的细微差别:外阴癌的注意事项和细微差别。
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-08-27 DOI: 10.1016/j.prro.2024.07.008
Lindsay Burt, Elke Jarboe, Dave Gaffney, Gita Suneja, Cristina DeCesaris, Sabrina Bedell, Jeffrey Brower

Vulvar cancer, though rare, poses significant challenges in diagnosis and treatment due to its histopathological complexities and nuances. This paper reviews key aspects of the management of vulvar cancer, focusing on histopathological diagnosis, margin status interpretation, lymph node involvement assessment, and ongoing clinical trials.

外阴癌虽然罕见,但由于其组织病理学的复杂性和细微差别,给诊断和治疗带来了巨大挑战。本文回顾了外阴癌治疗的主要方面,重点是组织病理学诊断、边缘状态解读、淋巴结受累评估和正在进行的临床试验。
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引用次数: 0
Survival (Time-To-Event) Curve Names and Endpoints. 生存(事件发生时间)曲线名称和终点。
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-08-24 DOI: 10.1016/j.prro.2024.08.002
Vincent D Cassidy, Ryan J Brisson, Robert J Amdur

In oncology, "survival curves" frequently appear in journal articles and meeting presentations. The most common labels on survival curves are overall survival, relapse-free survival, progression-free survival, distant metastasis-free survival, and local and/or regional control. Unfortunately, consistency in the definition of an event differs between authors for the same prescribed survival analyses. Furthermore, the quality of survival curves can be greatly impacted by the methodology used for endpoint selection. This paper will briefly explain widely used names and event endpoints for survival analyses in a way that will help radiation oncologists consistently present and interpret experimental findings that influence clinical practice decisions.

在肿瘤学领域,"生存曲线 "经常出现在期刊论文和会议报告中。生存曲线上最常见的标签有:总生存期、无复发生存期、无进展生存期、无远处转移生存期和无转移生存期:总生存期、无复发生存期、无进展生存期、无远处转移生存期以及局部和/或区域控制。遗憾的是,对于同样的生存分析,不同作者对事件定义的一致性却不尽相同。此外,终点选择方法也会对生存曲线的质量产生很大影响。本文将简要解释生存分析中广泛使用的名称和事件终点,以帮助放射肿瘤学家一致地呈现和解释影响临床实践决策的实验结果。
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引用次数: 0
A Case of Radiotherapy During Pregnancy for Oropharyngeal Cancer: Long-Term Pediatric Outcome Evaluation and Literature Review. 一例妊娠期口咽癌放疗病例:儿科长期疗效评估和文献综述。
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-08-23 DOI: 10.1016/j.prro.2024.06.018
Chiara Lucrezia Deantoni, Claudio Fiorino, Anna Chiara, Miriam Torrisi, Laura Giannini, Alessandro Loria, Andrei Fodor, Sara Broggi, Marcella Pasetti, Nadia Di Muzio, Italo Dell'Oca

Oropharyngeal cancer (OphC) is extremely rare during pregnancy, although its incidence is expected to increase in the years to come. Any delay in treatment can heavily affect cancer control and survival. Information regarding radiation therapy during pregnancy and long-term pediatric outcomes is lacking. In this article, we discuss a case of OphC in a pregnant woman, treated with surgery and radiation therapy, offering also an updated review with respect to the limited current evidence of the feasibility and clinical results of radiation therapy during pregnancy. A 39-year-old pregnant woman (through assisted fertilization) with locally advanced OphC underwent surgery and subsequent radiation therapy. A special fetal shielding device and a modified planning optimization strategy were used to reduce the dose to the fetus as much as possible. Phantom and in vivo dosimetry were performed to estimate the dose to the fetus and the related risks, according to International Commission on Radiological Protection (ICRP) publication 90. Thanks to the actions taken, the mean dose to the fetus was estimated to be around 50 mSv. A healthy baby was born at 33 weeks of gestation + 6 days. After a 10-year follow-up, the patient is in complete remission, and her 16-year-old daughter is healthy with good school performance. Adjuvant radiation therapy in OphC during pregnancy may be optimized to reduce the dose to the fetus, and the measures taken represent a realistic option to ensure the mother and baby's health.

妊娠期口咽癌(OphC)极为罕见,但预计其发病率在未来几年还会增加。任何治疗延误都会严重影响癌症的控制和生存。目前还缺乏有关孕期放疗和儿科长期疗效的信息。在本文中,我们讨论了一例妊娠期卵巢癌患者,该患者接受了手术和放射治疗,并对目前关于妊娠期放射治疗的可行性和临床效果的有限证据进行了最新回顾。一名 39 岁的孕妇(通过辅助受孕)患有局部晚期卵巢癌,她接受了手术和随后的放射治疗。为了尽可能减少胎儿所受的剂量,研究人员使用了一种特殊的胎儿屏蔽装置和一种改进的计划优化策略。根据 ICRP90 标准,进行了模拟和体内剂量测定,以估算胎儿所受剂量和相关风险。由于采取了这些措施,估计胎儿受到的平均剂量约为 50 mSv。胎儿在妊娠 33 周+6 天时健康出生。经过十年的随访,患者病情完全缓解,16 岁的女儿身体健康,学习成绩良好。妊娠期卵巢癌的辅助放疗可以优化,以减少胎儿所受的剂量,所采取的措施是确保母婴健康的现实选择。
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引用次数: 0
Patterns of Locoregional Pancreatic Cancer Recurrence After Total Neoadjuvant Therapy and Implications on Optimal Neoadjuvant Radiation Treatment Volumes. 完全新辅助治疗后局部胰腺癌复发的模式及其对最佳新辅助放射治疗量的影响
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-08-23 DOI: 10.1016/j.prro.2024.07.001
Sara E Beltran Ponce, Christina J Small, Talha Ahmad, Kishan Patel, Susan Tsai, Mandana Kamgar, Ben George, Jordan R Kharofa, Hina Saeed, Kulwinder S Dua, Callisia Clarke, Mohammad Aldakkak, Douglas B Evans, Kathleen Christians, Eric S Paulson, Beth Erickson, William A Hall

Purpose: To generate a map of local recurrences after neoadjuvant chemotherapy and radiation (total neoadjuvant therapy or TNT) followed by surgical resection for pancreatic ductal adenocarcinoma (PDAC). Such recurrence patterns will serve to inform radiation treatment planning volumes that should be given in the neoadjuvant setting.

Methods: Locoregional recurrences following TNT followed by surgery treated between 2009-2022 were radiologically identified. Recurrences were individually segmented using MIM software and complied in a single base scan. All contour compilations were used to create a threshold contour encompassing 80% of recurrences among all patients, head only, and body/tail only. The distance between organs at risk and the threshold contour were measured to design an optimal clinical target volume (CTV) contour for patients treated with TNT. Recurrence patterns were also compared to existing adjuvant guidelines to assess coverage.

Results: A database of 484 patients managed with TNT for PDAC was queried. While locoregional recurrences were rare in this cohort, we identified eighty patients with either isolated locoregional or simultaneous local and distant recurrences. Patients with diagnostic imaging at the time of recurrence were identified. The majority of recurrences were partially in the field of published contouring guidelines or volumetric expansions off of vessels, and volumetric coverage was low for all. Common areas of recurrence include the aortico-diaphragmatic junction, retro-pancreatic duodenal nodal basin, and the region to the right of the superior mesenteric artery. A novel set of proposed neoadjuvant contours was designed to cover the central-most 80% of recurrences.

Conclusions: This is the largest collection of local/regional PDAC recurrences from a cohort of patients treated exclusively with TNT. Patterns of local/regional recurrence using TNT in PDAC vary significantly from those patients with PDAC treated with a surgery-first approach. Novel contouring guidelines presented herein can help to ensure optimal coverage of high risk regions and avoid reliance on the current adjuvant guidelines to guide treatment planning.

目的:绘制胰腺导管腺癌(PDAC)新辅助化疗和放疗(全新辅助治疗或 TNT)后再手术切除的局部复发图。这种复发模式将为新辅助治疗中的放射治疗计划量提供依据:方法:对2009-2022年间接受TNT治疗后进行手术治疗的局部复发病例进行放射学鉴定。使用 MIM 软件对复发灶进行单独分割,并将其合并到单个基础扫描中。所有轮廓汇编用于创建一个阈值轮廓,该阈值轮廓包括所有患者、仅头部和仅身体/尾部复发的 80%。通过测量危险器官与阈值轮廓之间的距离,为接受 TNT 治疗的患者设计出最佳临床靶体积(CTV)轮廓。复发模式也与现有的辅助治疗指南进行了比较,以评估覆盖范围:结果:查询了484名接受TNT治疗的PDAC患者的数据库。虽然局部复发在这批患者中很少见,但我们发现有80例患者出现了孤立的局部复发或同时出现局部和远处复发。我们对复发时进行了影像诊断的患者进行了鉴定。大多数复发部位部分位于已公布的轮廓指引范围内或血管外的体积扩张区,而且所有复发部位的体积覆盖率都很低。常见的复发区域包括主动脉-膈交界处、胰腺后十二指肠结节盆地以及肠系膜上动脉右侧区域。我们设计了一套新颖的新辅助治疗轮廓,以覆盖最中心的80%复发区域:结论:这是对完全接受 TNT 治疗的患者队列中局部/区域 PDAC 复发情况的最大规模收集。使用 TNT 治疗 PDAC 的局部/区域复发模式与先手术治疗的 PDAC 患者有很大不同。本文提出的新轮廓指南有助于确保高风险区域的最佳覆盖范围,避免依赖目前的辅助指南来指导治疗计划。
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引用次数: 0
Intrafraction Motion in Surface-Guided Breast Radiation Therapy and its Implications on a Single Planning Target Volume Margin Strategy. 表面引导乳腺放射治疗中的牵引运动及其对单一 PTV 边缘策略的影响。
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-08-12 DOI: 10.1016/j.prro.2024.06.017
Ciaran Malone, Samantha Ryan, Jill Nicholson, Orla McArdle, Sinead Brennan, Pat McCavana, Brendan McClean, Frances Duane

Purpose: This study quantifies intrafraction motion in surface-guided radiation therapy (SGRT) for breast cancer and considers the need for individualized intrafraction motion measures when calculating planning target volume (PTV) margins.

Methods and materials: SGRT was used to assess intrafraction motion in consecutive patients according to (1) site irradiated (whole-breast/chest wall vs whole-breast/chest wall + regional lymph nodes) and (2) the use of deep inspiration breath hold versus free breathing. Intrafraction motion variation was evaluated throughout the treatment course for all cases. Associations between intrafraction motion and patient-specific characteristics were explored. The usefulness of individualized intrafraction motion measures for PTV margin determination was considered.

Results: One hundred two patients undergoing 1360 fractions were included. On a population level, average intrafraction motion was less than 0.4 mm and 0.2 degrees for translational and rotational directions, respectively, with 95th percentiles <1.2 mm and 0.6 degrees, respectively. No clinically meaningful differences in intrafraction motion were observed according to the site irradiated or the use of deep inspiration breath hold. Consistency in intrafraction motion was noted for all patients throughout the treatment course. No clinically meaningful associations were found between intrafraction motion and patient-specific characteristics such as age, seroma volume, PTV volume, and mean body volume.

Conclusions: Intrafractional deviations with SGRT, using manufacturer-recommended regions of interest, are minimal, do not vary substantially for different treatment techniques or patient-specific characteristics, and remain constant throughout the treatment course. A universal intrafraction motion measure may be sufficient for calculating PTV margins. Further validation studies are needed to evaluate the impact of region of interest size and coverage.

背景和目的:本研究量化了乳腺癌体表引导放射治疗(SGRT)中的分射内运动,并考虑了在计算规划靶区(PTV)边缘时对个体化分射内运动测量的需求:方法:使用 SGRT 评估连续患者的分量内运动,根据(1)照射部位(全乳(WB)/胸壁(CW)与 WB/CW + 区域淋巴结)和(2)使用深吸气屏气(DIBH)与自由呼吸(FB)。在整个治疗过程中,对所有病例的牵引运动变化进行了评估。研究还探讨了牵引内运动与患者具体特征之间的关联。研究还考虑了用于确定PTV边缘的个体化牵引内运动测量的实用性:结果:共纳入了102名接受了1360次分割的患者。在总体水平上,平移和旋转方向的平均分段内运动分别小于0.4毫米和0.2度,第95百分位数小于1.2毫米和0.6度。根据照射部位或使用DIBH的不同,没有观察到有临床意义的分段内运动差异。在整个治疗过程中,所有患者的分段内运动均保持一致。分段内运动与患者的具体特征(如年龄、血清肿体积、PTV体积和平均体量)之间没有发现有临床意义的关联:结论:使用制造商推荐的 ROI 进行 SGRT 治疗时,点内偏差极小,不会因不同的治疗技术或患者的具体特征而发生重大变化,并且在整个治疗过程中保持不变。通用的点内运动测量方法可能足以计算 PTV 边界。还需要进一步的验证研究来评估 ROI 大小和覆盖范围的影响。
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引用次数: 0
Management of Continuous Glucose Monitors in Radiation Oncology Patients. 放射肿瘤患者连续血糖监测仪的管理。
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-08-12 DOI: 10.1016/j.prro.2024.06.016
Johnathan Zeng, Tara Kosak, Samir Malkani, Julie C Hudson, Neil E Martin, Roy B Tishler, Itai M Pashtan

Continuous glucose monitors (CGMs) are an increasingly prevalent electronic medical device used by patients with diabetes, offering several advantages over "finger sticks." There is a resulting rise in patients with CGMs seen in radiation oncology clinics. Manufacturers specify that CGMs should not be exposed to radiation (both diagnostic and therapeutic) due to the risk of device damage, creating challenges for patients and providers. We present a workflow for the management of CGMs in radiation oncology patients, beginning with systematic screening by providers and staff. We propose options for CGM management together with the device prescriber, including removal of the CGM or keeping it in place with periodic finger sticks to confirm the accuracy and offer guidance to radiation oncology providers and staff.

连续血糖监测仪(CGM)是糖尿病患者越来越普遍使用的一种电子医疗设备,与 "指血棒 "相比具有多种优势。因此,肿瘤放射科门诊中使用 CGM 的患者越来越多。制造商规定,由于设备损坏的风险,CGM 不应暴露于辐射(包括诊断性和治疗性辐射),这给患者和医疗服务提供者带来了挑战。我们介绍了放射肿瘤患者 CGM 管理的工作流程,首先由医疗服务提供者和工作人员进行系统筛查。我们提出了与设备处方者共同管理 CGM 的方案,包括移除 CGM 或将其保留在原处并定期进行指检以确认其准确性,并为放射肿瘤科医疗服务提供者和工作人员提供指导。
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引用次数: 0
Hope in a Physician-Patient With Pancreatic Cancer. 胰腺癌医患之间的希望。
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-08-10 DOI: 10.1016/j.prro.2024.06.010
Ira R Sharp
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引用次数: 0
Displacement of the Tongue Base and Soft Palate Because of Breathing Patterns During Radiation Therapy for Head and Neck Cancer. 头颈部癌症放射治疗期间因呼吸模式导致的舌根和软腭移位。
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-08-08 DOI: 10.1016/j.prro.2024.07.005
Hiroaki Ikawa, Masashi Koto
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引用次数: 0
Hypofractionated Partial Breast Reirradiation in the Conservative Retreatment of Breast Cancer Local Recurrence. 乳腺癌局部复发保守再治疗中的低分次部分乳房再照射。
IF 3.4 3区 医学 Q2 ONCOLOGY Pub Date : 2024-07-26 DOI: 10.1016/j.prro.2024.07.003
Maria Cristina Leonardi, Simona Arculeo, Samuele Frassoni, Maria Alessia Zerella, Marianna Alessandra Gerardi, Cristiana Fodor, Paolo Veronesi, Viviana Enrica Galimberti, Francesca Magnoni, Ekaterina Milovanova, Damaris Patricia Rojas, Samantha Dicuonzo, Anna Morra, Mattia Zaffaroni, Maria Giulia Vincini, Federica Cattani, Vincenzo Bagnardi, Roberto Orecchia, Barbara Alicja Jereczek-Fossa

Purpose: To evaluate the outcome of partial breast reirradiation (re-PBI) with intensity modulated radiation therapy using a hypofractionated scheme for breast cancer (BC) local relapse (LR) operated on with repeat breast-conservative surgery.

Methods and materials: Intensity modulated radiation therapy-based re-PBI was performed using either helical or step-and-shoot modality to deliver 37.05 Gy in 13 fractions in 2.5 weeks. Cumulative incidence of second LR, toxicity, disease-free survival (DFS), BC-specific survival, and overall survival were evaluated.

Results: Between May 2012 and May 2021, 70 patients had re-PBI. The median follow-up (FU) was 6.3 years (quartiles 1-3, 4.0-8.1.). The median age at first LR was 62 years. The median primary BC first LR interval was 12.4 years (range, 1.6-26.7 years). Luminal A-like first LR accounted for 41% of the cases, and the median size was 0.8 cm. During FU, 18 (26%) patients showed a subsequent event: 3 second LRs (corresponding to an 8-year cumulative rate of 4%), 3 regional nodal recurrences, 7 distant metastases, and 5 other primary tumors. At 8 years, DFS, BC-specific survival, and overall survival were 76%, 90%, and 90%, respectively. At multivariate analysis, grade 3 and extensive intraductal components were independent predictors for DFS. For 51 and 46 patients, chronic toxicity and cosmesis were evaluated, respectively: 4% had grade 3 fibrosis, and cosmesis was deemed good/excellent in just >60% of the cases.

Conclusions: Re-PBI after repeat breast-conservative surgery represents a feasible alternative to mastectomy with regard to local control, showing an acceptable toxicity profile. A long-term FU is crucial to better understand the pattern of relapse and consolidate the position of re-PBI in clinical practice.

目的:评估使用强度调制RT(IMRT)进行乳腺部分再照射(re-PBI)的疗效,采用低分量方案治疗乳腺癌(BC)局部复发(LR)和重复保乳手术(re-BCS):方法:基于IMRT的再保乳手术采用螺旋或阶梯射频模式,在2.5周内分13次照射37.05 Gy。结果:在2012年5月至2021年5月期间,患者共接受了4次IMRT治疗,其中2次为第2次LR的累积发生率(CumI)、毒性、无病生存率(DFS)、BC特异性生存率(BCSS)和总生存率(OS):结果:2012年5月至2021年5月,70名患者接受了再PBI治疗。中位随访时间(FU)为 6.3 年(Q1-Q3,4.0-8.1 年)。第一次LR的中位年龄为62岁。原发性 BC-1 1stLR 的中位间隔为 12.4 年(范围:1.6-26.7)。腔隙 A 型第 1LR 占 41%,中位大小为 0.8 厘米。在治疗期间,18 例(26%)患者出现了后续事件:3 例 2snLR(8 年累计率为 4%)、3 例区域结节复发、7 例远处转移和 5 例其他原发肿瘤。8年后,DFS、BCSS和OS分别为76%、90%和90%。在多变量分析中,3级和广泛导管内成分是预测DFS的独立因素。分别对 51 名和 46 名患者的慢性毒性和外观进行了评估:4%的患者出现了3级纤维化,超过60%的病例被认为外观良好/极佳:结论:就局部控制而言,再行前列腺切除术后再行盆腔转移术是乳房切除术的一种可行替代方案,其毒性也可接受。为了更好地了解复发模式并巩固再行乳房指压术在临床实践中的地位,长期的FU至关重要。
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引用次数: 0
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Practical Radiation Oncology
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