Rigter Lisanne S, Spaander Manon C W, Moons Leon M, Bisseling Tanya M, Aleman Berthe M P, de Boer Jan Paul, Lugtenburg Pieternella J, Janus Cecile P M, Petersen Eefke J, Roesink Judith M, Raemaekers John M M, van der Maazen Richard W M, Cats Annemieke, Bleiker Eveline M A, Snaebjornsson Petur, Carvalho Beatriz, Lansdorp-Vogelaar Iris, Jóźwiak Katarzyna, Te Riele Hein, Meijer Gerrit A, van Leeuwen Flora E, van Leerdam Monique E
Department of Gastroenterology, Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, 1066 CX, The Netherlands.
Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
BMC Cancer. 2017 Feb 7;17(1):112. doi: 10.1186/s12885-017-3089-8.
Second primary malignancies are a major cause of excess morbidity and mortality in cancer survivors. Hodgkin lymphoma survivors who were treated with infradiaphragmatic radiotherapy and/or high-dose procarbazine have an increased risk to develop colorectal cancer. Colonoscopy surveillance plays an important role in colorectal cancer prevention by removal of the precursor lesions (adenomas) and early detection of cancer, resulting in improved survival rates. Therefore, Hodgkin lymphoma survivors treated with infradiaphragmatic radiotherapy and/or high-dose procarbazine could benefit from colonoscopy, or other surveillance modalities, which are expected to reduce colorectal cancer incidence and mortality. Current knowledge on clinicopathological and molecular characteristics of therapy-related colorectal cancer is limited. The pathogenesis of such colorectal cancers might be different from the pathogenesis in the general population and therefore these patients might require a different clinical approach. We designed a study with the primary aim to assess the diagnostic yield of a first surveillance colonoscopy among Hodgkin lymphoma survivors at increased risk of colorectal cancer and to compare these results with different screening modalities in the general population. Secondary aims include assessment of the test characteristics of stool tests and evaluation of burden, acceptance and satisfaction of CRC surveillance through two questionnaires.
METHODS/DESIGN: This prospective multicenter cohort study will include Hodgkin lymphoma survivors who survived ≥8 years after treatment with infradiaphragmatic radiotherapy and/or procarbazine (planned inclusion of 259 participants). Study procedures will consist of a surveillance colonoscopy with removal of precursor lesions (adenomas) and 6-8 normal colonic tissue biopsies, a fecal immunochemical test and a stool DNA test. All neoplastic lesions encountered will be classified using relevant histomorphological, immunohistochemical and molecular analyses in order to obtain more insight into colorectal carcinogenesis in Hodgkin lymphoma survivors. The Miscan-model will be used for cost-effectiveness analyses.
Evaluation of the diagnostic performance, patient acceptance and burden of colorectal cancer surveillance is necessary for future implementation of an individualized colorectal cancer surveillance program for Hodgkin lymphoma survivors. In addition, more insight into treatment-induced colorectal carcinogenesis will provide the first step towards prevention and personalized treatment. This information may be extrapolated to other groups of cancer survivors.
Registered at the Dutch Trial Registry (NTR): NTR4961 .
第二原发性恶性肿瘤是癌症幸存者发病和死亡过多的主要原因。接受膈下放疗和/或高剂量丙卡巴肼治疗的霍奇金淋巴瘤幸存者患结直肠癌的风险增加。结肠镜监测通过切除前驱病变（腺瘤）和早期发现癌症，在预防结直肠癌方面发挥着重要作用，从而提高生存率。因此，接受膈下放疗和/或高剂量丙卡巴肼治疗的霍奇金淋巴瘤幸存者可能从结肠镜检查或其他监测方式中受益，这有望降低结直肠癌的发病率和死亡率。目前关于治疗相关结直肠癌的临床病理和分子特征的知识有限。此类结直肠癌的发病机制可能与普通人群不同，因此这些患者可能需要不同的临床治疗方法。我们设计了一项研究，主要目的是评估结直肠癌风险增加的霍奇金淋巴瘤幸存者首次监测结肠镜检查的诊断率，并将这些结果与普通人群的不同筛查方式进行比较。次要目的包括评估粪便检测的检测特征，以及通过两份问卷评估结直肠癌监测的负担、接受度和满意度。
方法/设计：这项前瞻性多中心队列研究将纳入接受膈下放疗和/或丙卡巴肼治疗后存活≥8年的霍奇金淋巴瘤幸存者（计划纳入259名参与者）。研究程序将包括一次监测结肠镜检查，切除前驱病变（腺瘤）并进行6 - 8次正常结肠组织活检、一次粪便免疫化学检测和一次粪便DNA检测。所有遇到的肿瘤性病变将使用相关的组织形态学、免疫组织化学和分子分析进行分类，以便更深入了解霍奇金淋巴瘤幸存者的结直肠癌发生过程。Miscan模型将用于成本效益分析。
评估结直肠癌监测的诊断性能、患者接受度和负担对于未来为霍奇金淋巴瘤幸存者实施个性化结直肠癌监测计划是必要的。此外，更深入了解治疗引起的结直肠癌发生过程将为预防和个性化治疗迈出第一步。这些信息可能适用于其他癌症幸存者群体。
在荷兰试验注册中心（NTR）注册：NTR4961 。
