1122P - The role of imaging during follow-up after radical surgery of stage IIb-c and III cutaneous malignant melanoma: Survival results from an interim analysis of a randomized prospective multicenter study (TRIM)

Background

In several countries, whole-body imaging has been introduced in the routine follow-up of high-risk cutaneous malignant melanoma (CMM) after surgery. However, evidence is lacking that earlier detection of recurrent disease by regular scans improves survival and recommendations vary considerably between countries. In Sweden, these patients have a physical examination every 6 to 12 months for 3 years and ultrasound of regional lymph node basins every 6^thmonths in the case of a positive sentinel node status. The main aim of the TRIM study is to investigate whether imaging in the follow-up program for high-risk CMM improves survival by earlier detection of recurrence.

Methods

TRIM is a nationwide prospective randomized Swedish phase III study. After radical surgery of stage IIB-C and III CMM patients are randomly assigned 1:1 (stratified for tumor stage) to follow-up by physical examinations for 3 years +/- whole-body imaging with CT or FDG-PET/CT and blood test (including S100B protein and LDH) at baseline, 6, 12, 24 and 36 months. The goal is to include 1300 patients. The first patient was enrolled in June 2017. Cut-off date for the interim analysis was August 2023 at 1000 included patients. Primary endpoint is overall survival (OS) at 5 years.

Results

There were no statistically significant differences in relapse free survival (RFS) (p=0.26), distant metastases free survival (DMFS) (p=0.22), or OS (p=0.83) between the groups at a median follow-up time of 31 months. Three-year rates for RFS were 68.7% (95% CI 64.2 -73.5%) and 65.5% (95% CI 60.9-70.5%), for DMFS 81.4% (95% CI 77.5-85.4%) versus 79.2% (95% CI 75.2-83.4%) and for OS 88% (95% CI 84.8-91.4%) versus 87.6% (95% CI 84.1-91.2%) in the standard and imaging groups respectively. There was an even stage-distribution and similar frequency of patients receiving adjuvant treatment in the two groups.

Conclusions

The interim analysis indicates that there is no benefit from imaging in the follow-up program for high-risk CMM patients. However, so far only a few patients have completed the follow up time of 5 years.

Clinical trial identification

NCT 03116412; 2023-05-26:.

Editorial acknowledgement

Legal entity responsible for the study

Uppsala University hospital.

Funding

This study was supported by grants to G.J. Ullenhag from The Research Foundation Stiftelsen Onkologiska Klinikens i Uppsala Forskningsfond and Uppsala University Hospital (ALF).

Disclosure

H. Helgadottir: Financial Interests, Personal, Invited Speaker: Pierre Fabre, MSD, BMS. R. Olofsson Bagge: Financial Interests, Institutional, Funding, Has received institutional research grants: Bristol Myers Squibb, Endomagnetics Ltd, SkyLineDx, NeraCare GmbH; Financial Interests, Personal, Invited Speaker, Has recieved speaker honorarium: Roche, Pfizer and Pierre Fabre; Financial Interests, Personal, Advisory Board: Amgen, BD/BARD, Bristol Myers Squibb, Cansr.com, Merck Sharp & Dohme (MSD, Novartis, Roche, Sanofi Genzyme; Financial Interests, Personal, Ownership Interest: SATMEG Ventures AB. G.J. Ullenhag: Financial Interests, Personal, Invited Speaker: Pierre Fabre, MSD, BMS, Novartis; Financial Interests, Personal, Other, Interview: Pierre Fabre; Financial Interests, Personal, Advisory Board: MSD, AstraZeneca, Novartis, SeqCure Immunology AB, AI Medical Technology, Sanofi; Financial Interests, Personal, Other, Protocol writing: Ilya, Boehringer Ingelheim-Ingelheim, SeqCure Immunology AB; Financial Interests, Personal, Stocks/Shares: Essity; Non-Financial Interests, Principal Investigator, LOKON 002 and LOKON 003: Lokon Pharma; Non-Financial Interests, Principal Investigator, Scandium 2: BMS; Non-Financial Interests, Principal Investigator, T-cell study: SeqCure Immunology AB; Non-Financial Interests, Principal Investigator, First line in malignant melanoma patients: Immunocore. All other authors have declared no conflicts of interest.