In an interim analysis of a Swedish phase III study (TRIM) reported in The Lancet Oncology, Ladjevardi et al found no improvement in outcomes with the addition of whole-body imaging to physical examination in a follow-up of patients undergoing radical surgery for stage IIB-C or III cutaneous malignant melanoma.
Study Details
In the multicenter trial, 983 patients were randomly assigned between June 2017 and July 2023 to receive postsurgery follow-up with 3 years of physical examination alone (n = 498) or physical examination and whole-body imaging with CT or [¹⁸F]fluorodeoxyglucose-PET-CT at baseline and at 6, 12, 24, and 36 months (n = 485). The goal of the trial is to enroll 1,300 patients, with a primary endpoint of overall survival at 5 years. The current report provides results of interim analysis for several outcome measures.
Key Findings
Median follow-up was 33.6 months (interquartile range = 16.3–49.8 months).
Death occurred in 53 patients (11%) in the physical examination group vs 54 (11%) in the imaging group (hazard ratio [HR] = 1.04, 95% confidence interval [CI] = 0.71–1.51, P = .85). Median overall survival was not reached (95% CI = not reached to not reached) in both groups. Overall survival at 3 years was 88.2% (95% CI = 85.0%–91.6%) in the physical examination group vs 87.7% (95% CI = 84.3%–91.3%) in the imaging group.
No significant difference in distant metastasis–free survival was observed, with median values not reached in either group (HR= 1.20, 95% CI = 0.89–1.64, P = .24). At 3 years, rates were 81.6% (95% CI = 77.9%–85.6%) in the physical examination group vs 79.3% (95% CI = 75.3%–83.5%) in the imaging group.
No significant difference in relapse-free survival was observed (HR = 1.10, 95% CI = 0.86–1.39, P = .45); 3-year rates were 69.3% vs 67.1%. No significant difference in locoregional relaps–free survival was observed (HR = 0.97, 95% CI = 0.70–1.36, P = .86); 3-year rates were 84.3% vs 84.1%.
The investigators concluded: “This interim analysis indicated that there is no benefit from imaging in the follow-up program for individuals with high-risk cutaneous malignant melanoma. 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.”
Gustav Ullenhag, MD, of the Department of Oncology, Uppsala University Hospital, Uppsala, Sweden, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by Stiftelsen Onkologiska Klinikens i Uppsala Forskningsfond and Uppsala University Hospital. For full disclosures of all study authors, visit thelancet.com.
