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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >Up-front centralized data review and individualized treatment proposals in a multicenter pediatric Hodgkin's disease trial with 71 participating hospitals: the experience of the German-Austrian pediatric multicenter trial DAL-HD-90.
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Up-front centralized data review and individualized treatment proposals in a multicenter pediatric Hodgkin's disease trial with 71 participating hospitals: the experience of the German-Austrian pediatric multicenter trial DAL-HD-90.

机译：在多中心儿科霍奇金病试验（有71家参与医院）中进行的前期集中数据审查和个性化治疗建议：德国-奥地利儿科多中心试验DAL-HD-90的经验。

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Background and purpose: A systematic procedure for up-front centralized data review and the set-up of individualized treatment proposals was integrated prospectively into the German-Austrian multicenter trial DAL-HD-90 for pediatric Hodgkin's disease (HD) in order to introduce local radiotherapy according to the individual patient's spread of disease within a combined-modality treatment. This paper investigates the feasibility of such a procedure and its impact on the final definition of the extent and stage of disease as well as on the choice of treatment.Patients and methods: Between October 1990 and July 1995, 578 children and adolescents <18 years (259 girls, 319 boys, median age 12.9 years) with HD were enrolled into the HD-90 trial. After clinical and pathological staging (66.4/33.6%), patients were allocated to treatment groups (TG) 1 'early stage', TG2 'intermediate stage', or TG3 'advanced stage'. All groups underwent two cycles of OPPA (vincristine, prednisone, procarbazine, doxorubicin) (girls) or OEPA (E, etoposide) (boys) for induction chemotherapy. TG2 and TG3 continued on as two or four cycles, respectively, of COPP (C, cyclophosphamide). Low-dose local radiotherapy was given to the initially involved sites, with radiation doses of 25 Gy in TG1/TG2, and 20 Gy in TG3. All documentation forms, radiographs, and chest and abdominal computed tomography (CT) scans were centrally reviewed, addressing in particular the individual patient's extent and stage of disease. This review and the set-up of individualized treatment proposals were in the hands of the study coordinator, one additional pediatrician and two radiation oncologists and radiologists at the study center. During a time slot of at least 8 weeks (two cycles of standard chemotherapy in all three TGs) the individualized treatment proposals were to be sent to the participating hospital.Results: Complete sets of documentation from 564/578 patients (97.6%) were submitted sufficiently early to the study center. A total of 285 out of 574 chest radiographs, 468 out of 553 chest CT scans and 421 out of 548 abdominal CT scans were available from 71 hospitals. A total of 564 individualized treatment proposals were worked out by the review group and sent to the hospitals before radiotherapy began. Re-analysis of images and documentation forms, including laboratory and clinical data, resulted in a revision of stage in 115/571 patients (20.1%) and of TG in 76/571 patients (13.3%). A total of 67/76 patients were shifted into a higher TG, 60 patients on account of additionally detected extralymphatic involvement, five patients because of additionally detected lymph node involvement and two patients due to clinical data which had to be classified as B-symptoms. A total of 9/76 patients were shifted into a lower TG; in three patients extranodal disease and in six patents local lymph node involvement could not be confirmed.Conclusions: The up-front centralized review of patient data and consecutive set-up and delivery of individualized treatment proposals for almost every patient are feasible within a large multicenter trial. Sufficient time and manpower at the study center are needed for the review process and the set-up of individualized treatment proposals. Such a procedure has a significant impact on the homogeneity of stage definition, allocation to TG, and individualized treatment proposals.
机译：背景与目的：前瞻性地将系统化的程序进行了预先集中的数据审查，并制定了个性化的治疗方案，以期将其纳入针对儿童霍奇金病（HD）的德国奥地利多中心试验DAL-HD-90中，以引入当地联合疗法中根据个体患者的疾病传播情况进行放疗。本文研究了这种方法的可行性及其对疾病范围和阶段的最终定义以及治疗选择的影响。患者和方法：1990年10月至1995年7月，有578名18岁以下的儿童和青少年患有HD的女性（259名女孩，319个男孩，中位年龄12.9岁）被纳入了HD-90试验中。经过临床和病理分期（66.4 / 33.6％）后，将患者分为治疗组（TG）1“早期”，TG2“中级”或TG3“高级”。所有组均经历两个周期的OPPA（长春新碱，泼尼松，普卡巴嗪，阿霉素）（女孩）或OEPA（E，依托泊苷）（男孩）进行诱导化疗。 TG2和TG3分别以COPP（C，环磷酰胺）的两个或四个循环继续。对最初受累的部位进行低剂量局部放疗，TG1 / TG2的放疗剂量为25 Gy，TG3的放疗剂量为20 Gy。集中审查了所有文件形式，X光片以及胸部和腹部CT扫描，特别是针对个别患者的疾病程度和阶段。这项审查和个性化治疗方案的制定由研究协调员，研究中心的另一名儿科医生以及两名放射肿瘤学家和放射学家掌握。在至少8周的时间段内（在所有三个TG中进行两个标准化疗周期），将个性化治疗方案发送给参与医院。结果：提交了564/578例患者的完整文档（97.6％）足够早到达学习中心。共有71家医院的574例胸部X线照片中的285例，553例胸部CT扫描中的468例以及548例腹部CT扫描中的421例。回顾小组共制定了564项个性化治疗方案，并在放疗开始之前发送给医院。重新分析图像和文档形式，包括实验室和临床数据，导致115/571例患者的分期（20.1％）和TG / 76/571例患者的分期（13.3％）进行了修订。总共67/76例患者被转移到更高的TG，60例患者由于另外检测到淋巴结受累，五例患者由于另外检测到淋巴结受累，两名患者由于临床数据而不得不归类为B症状。共有9/76例患者被转移至较低的TG。在三例结外病患者和六项专利中，尚不能证实局部淋巴结受累。结论：在大型多中心医疗机构中，对每个患者的前瞻性集中检查以及连续建立和交付个性化治疗方案的建议是可行的试用。研究中心需要足够的时间和人力来进行审核过程和制定个性化的治疗方案。这样的程序对阶段定义，TG分配和个性化治疗方案的均质性有重大影响。

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