Department of Immunology, Genetics and Pathology, Uppsala University, Rudbeck laboratory, 75185, Uppsala, Sweden.
Department of Oncology, Uppsala University Hospital, entrance 101, 1tr, 75185, Uppsala, Sweden.
BMC Cancer. 2020 Dec 7;20(1):1197. doi: 10.1186/s12885-020-07632-4.
The incidence of cutaneous malignant melanoma (CMM) is increasing worldwide. In Sweden, over 4600 cases were diagnosed in 2018. The prognosis after radical surgery varies considerably with tumor stage. In recent years, new treatment options have become available for metastatic CMM. Early onset of treatment seems to improve outcome, which suggests that early detection of recurrent disease should be beneficial. Consequently, in several countries imaging is a part of the routine follow-up program after surgery of high risk CMM. However, imaging has drawbacks, including resources required (costs, personnel, equipment) and the radiation exposure. Furthermore, many patients experience anxiety in waiting for the imaging results and investigations of irrelevant findings is another factor that also could cause worry and lead to decreased quality of life. Hence, the impact of imaging in this setting is important to address and no randomized study has previously been conducted. The Swedish national guidelines stipulate follow-up for 3 years by clinical examinations only.
The TRIM study is a prospective randomized multicenter trial evaluating the potential benefit of imaging and blood tests during follow-up after radical surgery for high-risk CMM, compared to clinical examinations only. Primary endpoint is overall survival (OS) at 5 years. Secondary endpoints are survival from diagnosis of relapse and health-related quality of life (HRQoL). Eligible for inclusion are patients radically operated for CMM stage IIB-C or III with sufficient renal function for iv contrast-enhanced CT and who are expected to be fit for treatment in case of recurrence. The planned number of patients is > 1300. Patients are randomized to clinical examinations for 3 years +/- whole-body imaging with CT or FDG-PET/CT and laboratory tests including S100B protein and LDH. This academic study is supported by the Swedish Melanoma Study Group.
This is the first randomized prospective trial on the potential benefit of imaging as a part of the follow-up scheme after radical surgery for high-risk CMM.
The first patient was recruited in June 2017 and as of April 2020, almost 500 patients had been included at 19 centers in Sweden.
ClinicalTrials.gov , NCT03116412 . Registered 17 April 2017, https://clinicaltrials.gov/ct2/show/study/NCT03116412.
皮肤恶性黑色素瘤（CMM）的发病率在全球范围内呈上升趋势。在瑞典，2018 年诊断出超过 4600 例病例。根治性手术后的预后因肿瘤分期而异。近年来，转移性 CMM 有了新的治疗选择。早期开始治疗似乎可以改善预后，这表明复发疾病的早期发现应该是有益的。因此，在一些国家，成像已成为高风险 CMM 手术后常规随访计划的一部分。然而，成像存在一些缺点，包括所需的资源（成本、人员、设备）和辐射暴露。此外，许多患者在等待成像结果时感到焦虑，对无关发现的检查也是另一个可能导致担忧和降低生活质量的因素。因此，有必要探讨成像在这种情况下的影响，而且以前没有进行过随机研究。瑞典国家指南规定，高危 CMM 根治术后 3 年仅通过临床检查进行随访。
TRIM 研究是一项前瞻性随机多中心试验，评估了根治性手术后高风险 CMM 随访期间进行成像和血液检查的潜在益处，与仅进行临床检查相比。主要终点是 5 年总生存率（OS）。次要终点是从复发诊断开始的生存和健康相关生活质量（HRQoL）。符合纳入标准的是接受 IIB-C 期或 III 期 CMM 根治性手术且肾功能足以进行静脉内对比增强 CT 检查的患者，并且预计在复发时能够接受治疗。计划纳入的患者数> 1300 例。患者随机分为 3 年的临床检查组 +/-全身 CT 或 FDG-PET/CT 成像和实验室检查，包括 S100B 蛋白和 LDH。该学术研究得到了瑞典黑色素瘤研究小组的支持。
这是第一项关于成像作为高危 CMM 根治术后随访方案一部分的潜在益处的前瞻性随机试验。
首例患者于 2017 年 6 月入组，截至 2020 年 4 月，瑞典 19 个中心已入组近 500 例患者。
ClinicalTrials.gov，NCT03116412。于 2017 年 4 月 17 日注册，https://clinicaltrials.gov/ct2/show/study/NCT03116412。
