Physical examinations and whole-body imaging versus physical examinations alone during follow-up after radical surgery of stage IIB-C and III cutaneous malignant melanoma (TRIM): an interim analysis of a multicentre, randomised, phase 3 trial in Sweden.

However, there is scarce evidence that earlier detection of recurrent disease by regular scanning improves survival. In this interim analysis, we investigated whether imaging in the follow-up programme for high-risk cutaneous malignant melanoma improves survival and assessed whether the study should continue to include participants.

然而，目前缺乏证据表明通过定期扫描更早地检测到复发性疾病能够改善生存率。在这项中期分析中，我们研究了在高风险皮肤恶性黑色素瘤随访计划中使用成像是否能改善生存，并评估了研究是否应继续招募参与者。

Methods

TRIM is a multicentre, randomised, phase 3 trial in Sweden.

TRIM 是在瑞典进行的一项多中心、随机、III期试验。

Eligible participants are aged 18 years and older with sufficient renal function for intravenously contrast-enhanced CT and are expected to be fit for treatment in case of recurrence.

符合条件的参与者年龄在18岁或以上，具有足够的肾功能以进行静脉内对比增强CT，并且预计在复发时适合治疗。

After radical surgery of stage IIB-C and III cutaneous malignant melanoma, participants were randomly assigned (1:1, stratified by tumour stage and method of radiological assessment) to 3 years of follow-up by physical examinations alone (standard group) or to physical examinations plus whole-body imaging with CT or [18F]fluorodeoxyglucose-PET-CT at baseline, 6, 12, 24, and 36 months (experimental group).

在对IIB-C期和III期皮肤恶性黑色素瘤进行根治性手术后，参与者被随机分配（1:1，按肿瘤分期和放射学评估方法分层）接受仅通过体格检查进行3年的随访（标准组）或在基线、6个月、12个月、24个月和36个月时接受体格检查加全身CT或[18F]氟脱氧葡萄糖-PET-CT成像（实验组）。

The goal is to include 1300 participants.

目标是纳入1300名参与者。

The primary endpoint is overall survivalat 5 years and will be reported in the final analysis when data are mature.

主要终点是5年总生存，在数据成熟时将在最终分析中报告。

In this interim report, no endpoints were predefined; we present overall survival, relapse-free survival, locoregional relapse-free survival, and distant metastasis-free survival, analysed by intention to intervene.

在这份中期报告中，没有预定义的终点；我们呈现了总生存、无复发生存、局部区域无复发生存和无远处转移生存，按干预意向分析。

This study is registered with ClinicalTrials.gov, NCT03116412, and recruitment is ongoing.

该研究已在ClinicalTrials.gov注册，注册号为NCT03116412，目前仍在招募中。

Results

Between June 8, 2017, and July 28, 2023, 983 participants were randomly allocated to the standard (n=498; 296 [59%] male, 202 [41%] female) or experimental (n=485; 309 [64%] male, 176 [36%] female) group.

在2017年6月8日至2023年7月28日期间，共有983名参与者被随机分配到标准治疗组（n=498；男性296人[59%]，女性202人[41%]）或实验治疗组（n=485；男性309人[64%]，女性176人[36%]）。

There were no statistically significant differences in overall survival(not reached [NR; 95% CI NR-NR] vs NR [NR-NR]; hazard ratio[HR] 1·04 [95% CI 0·71-1·51], p=0·85) or distant metastasis-free survival (NR [NR-NR] vs NR [NR-NR]; HR 1·20 [0·89-1·64], p=0·24) between the groups at a median follow-up time of 33·6 months (IQR 16·3-49·8). 3-year overall survivalrates were 88·2% (95% CI 85·0-91·6) in the standard group versus 87·7% (84·3-91·3) in the experimental group and distant metastasis-free survival was 81·6% (77·9-85·6) in the standard group versus 79·3% (75·3-83·5) in the control group.

在中位随访时间为33.6个月（四分位数间距16.3-49.8）时，两组在总生存（未达到[NR; 95%置信区间NR-NR] vs NR [NR-NR]；风险比[HR] 1.04 [95%置信区间0.71-1.51]，p=0.85）或远处转移无病生存（NR [NR-NR] vs NR [NR-NR]；HR 1.20 [0.89-1.64]，p=0.24）方面没有统计学上的显著差异。3年总生存率在标准组为88.2%（95%置信区间85.0-91.6），而在实验组为87.7%（84.3-91.3）；远处转移无病生存率在标准组为81.6%（77.9-85.6），而在对照组为79.3%（75.3-83.5）。

interpretation

This interim analysis indicated that there is no benefit from imaging in the follow-up programme for individuals with high-risk cutaneous malignant melanoma.

这项中期分析表明，对于高风险皮肤恶性黑色素瘤患者，在随访计划中使用影像学检查并没有益处。

However, only a few participants have completed the follow-up time of 5 years, and the numerical difference between the study groups in distant metastasis-free survival motivates us to continue the study according to protocol.

然而，只有少数参与者完成了5年的随访时间，研究组之间在无远处转移生存方面的数值差异激励我们按照协议继续研究。

funding

Stiftelsen Onkologiska Klinikens i Uppsala Forskningsfond and Uppsala University Hospital.

乌普萨拉大学医院肿瘤科研究基金会。