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德国霍奇金淋巴瘤研究组(GHSG)内放射治疗质量保证计划的发展。放疗参考小组的介绍、持续工作及成果。

The development of quality assurance programs for radiotherapy within the German Hodgkin Study Group (GHSG). Introduction, continuing work, and results of the radiotherapy reference panel.

作者信息

Müller Rolf-Peter, Eich Hans Theodor

机构信息

Department of Radiation Oncology, University of Cologne, Joseph-Stelzmann-Strasse 9, 50924 Köln, Germany.

出版信息

Strahlenther Onkol. 2005 Sep;181(9):557-66. doi: 10.1007/s00066-005-1437-0.

Abstract

BACKGROUND AND PURPOSE

The German Hodgkin Study Group (GHSG), including more than 500 participating centers, established a central radiotherapy (RT) reference center to improve quality of treatment, starting with the first study generation in 1978. More than 11,000 patients with Hodgkin's lymphoma (HL) have been enrolled into these trials. Extensive continuing quality assurance programs (QAPs) during the study generations have been performed. The purpose of the present article is to summarize the experiences and results of the performed and ongoing QAPs.

MATERIAL AND METHODS

A panel of expert radiation oncologists (second study generation HD4-6, 1988-1994, and third study generation HD7-9, 1993-1998) retrospectively evaluated the adequacy of treatment fields, applied radiation doses, treatment time, and technical parameters. Furthermore, a detailed analysis of relapses in correlation with the performed RT was conducted. For the fourth study generation (HD10-12, 1998-2002), the RT reference center changed from Munich to Cologne. New RT QAPs were initiated according to the demands of the new trials and former programs were enhanced: (1) central prospective radiation oncologic review of cross-sectional imaging (HD10, HD11) to create the individual radiation treatment plan; (2) retrospective analysis of the adequacy of the performed involved-field (IF) RT (HD10, HD11); (3) the multidisciplinary HD12 panel (radiation oncologists, medical oncologists, diagnostic radiologists); (4) initiation and integration of a teleradiotherapy network into the GHSG trials.

RESULTS

A strong achievement of these activities in the era of extended-field RT was to show that major deviations of radiation treatment portals and radiation dose from prospective treatment prescriptions revealed to be unfavorable prognostic factors for patients with early-stage HL (HD4). The central prospective radiation oncological review of all diagnostic imaging (HD10, HD11) showed that corrections of disease involvement in 49% of patients (593/1,214) with early stages (HD10) and in 67% of patients (936/1,397) with intermediate stages (HD11) were necessary. These procedures had a significant impact on the correctness of stage definition, allocation to treatment groups and on the extension of the IF treatment volume. Until now, 1,080 patients in HD10 and HD11 have been evaluated retrospectively with regard to the adequacy of the performed IF-RT. Although the participating institutions got a precise RT prescription, interim results reveal deviations in a significant number of cases. In the HD12 trial (advanced stages), a multidisciplinary panel of radiation oncologists, radiologists and medical oncologists reviewed all the diagnostic imaging from diagnosis throughout the treatment in comparison to the documentation forms. For patients with poor response to chemotherapy, the panel recommended RT independent of the randomization. This procedure ensured that patients with a poor response to chemotherapy received additional RT. 1,080 of 1,594 randomized patients (68%) could be analyzed. After chemotherapy, 599 patients (56%) showed residual disease (> 1.5 cm), and in 145/1,080 patients (13.5%) the panel recommended additional RT independent of the randomization arm. The introduction of electronic image transfer optimized and simplified the workflow of the QAPs. Rapid online consultation and real-time teleconferences regarding disease involvement, patient management and communication of the RT prescription with connected hospitals proved to be extremely helpful.

CONCLUSION

Today, radiation oncologists in the GHSG perform a continuous and efficient QAP to improve treatment quality of study patients. For early favorable and unfavorable HL a central prospective review of all diagnostic imaging is performed by expert radiation oncologists to control the disease extension and to define the IF treatment volume. Retrospective analysis of RT portals by an expert panel detects faults in the applied irradiation. Participants are trained on the definition of IF-RT by workshops on the occasion of annual GHSG meetings and on the annual meetings of the German Society of Therapeutic Radiation Oncology (DEGRO). For the advanced stages a multidisciplinary panel evaluates the treatment response to chemotherapy. Patients with a poor response receive additional RT due to the panel's recommendation. The introduction of teleradiotherapy into the GHSG trials improves the dialogue between the central RT reference center and study participants and thus contributes to high RT quality for study patients.

摘要

背景与目的

德国霍奇金淋巴瘤研究组(GHSG)包括500多个参与中心,自1978年第一代研究开始就设立了一个中央放射治疗(RT)参考中心,以提高治疗质量。超过11,000例霍奇金淋巴瘤(HL)患者已纳入这些试验。在各代研究期间都开展了广泛的持续质量保证计划(QAP)。本文的目的是总结已开展和正在进行的QAP的经验与结果。

材料与方法

一组放射肿瘤学专家(第二代研究HD4 - 6,1988 - 1994年,以及第三代研究HD7 - 9,1993 - 1998年)回顾性评估了治疗野的适当性、应用的放射剂量、治疗时间和技术参数。此外,还对与所实施的RT相关的复发情况进行了详细分析。对于第四代研究(HD10 - 12,1998 - 2002年),RT参考中心从慕尼黑迁至科隆。根据新试验的要求启动了新的RT QAP,并加强了以前的计划:(1)对横断面成像进行中央前瞻性放射肿瘤学审查(HD10、HD11)以制定个体化放射治疗计划;(2)对所实施的受累野(IF)RT的适当性进行回顾性分析(HD10、HD11);(3)多学科HD12小组(放射肿瘤学家、医学肿瘤学家、诊断放射学家);(4)启动远程放射治疗网络并将其整合到GHSG试验中。

结果

在扩大野RT时代,这些活动的一个重要成果是表明,放射治疗野和放射剂量与前瞻性治疗处方的重大偏差被证明是早期HL患者(HD4)的不良预后因素。对所有诊断成像进行的中央前瞻性放射肿瘤学审查(HD10、HD11)表明,49%的早期患者(HD10中593/1,214例)和67%的中期患者(HD11中936/1,397例)的疾病累及情况需要修正。这些程序对分期定义的正确性、分配到治疗组以及IF治疗体积的范围有重大影响。到目前为止,已对HD10和HD11中的1,080例患者所实施的IF - RT的适当性进行了回顾性评估。尽管参与机构收到了精确的RT处方,但中期结果显示在大量病例中存在偏差。在HD12试验(晚期)中,由放射肿瘤学家、放射学家和医学肿瘤学家组成的多学科小组与文件记录形式相比,审查了从诊断到整个治疗过程中的所有诊断成像。对于化疗反应不佳的患者,该小组建议进行RT,而不考虑随机分组。这一程序确保了化疗反应不佳的患者接受额外的RT。1,594例随机分组患者中的1,080例(68%)可进行分析。化疗后,599例患者(56%)显示有残留病灶(>1.5 cm),在145/1,080例患者(13.5%)中,该小组建议不考虑随机分组臂而进行额外的RT。电子图像传输的引入优化并简化了QAP的工作流程。关于疾病累及情况、患者管理以及与相关医院的RT处方沟通的快速在线咨询和实时电话会议被证明非常有帮助。

结论

如今,GHSG的放射肿瘤学家开展持续且高效的QAP以提高研究患者的治疗质量。对于早期预后良好和不良的HL,由放射肿瘤学专家对所有诊断成像进行中央前瞻性审查,以控制疾病范围并确定IF治疗体积。专家小组对RT野进行回顾性分析可检测出所应用照射中的缺陷。在GHSG年会和德国放射治疗肿瘤学会(DEGRO)年会上举办的研讨会对参与者进行IF - RT定义方面的培训。对于晚期患者,多学科小组评估化疗的治疗反应。由于该小组的建议,反应不佳的患者接受额外的RT。将远程放射治疗引入GHSG试验改善了中央RT参考中心与研究参与者之间对话,从而有助于为研究患者提供高质量的RT。

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